Page Range | 11633-11843 | |
FR Document |
Page and Subject | |
---|---|
83 FR 11793 - Sunshine Act Meetings | |
83 FR 11783 - Exxon Valdez Oil Spill Public Advisory Committee | |
83 FR 11809 - Determination and Certification Under Section 490(b)(1)(A) of the Foreign Assistance Act Relating to the Largest Exporting and Importing Countries of Certain Precursor Chemicals | |
83 FR 11789 - Government in the Sunshine Act Meeting Notice | |
83 FR 11791 - Government in the Sunshine Act Meeting Notice | |
83 FR 11669 - Catalog of Federal Domestic Assistance (CFDA) No.: 10.443-Outreach and Assistance for Socially Disadvantaged Farmers and Ranchers and Veteran Farmers and Ranchers Program | |
83 FR 11815 - 2018 Report on the Effectiveness of the Terrorism Risk Insurance Program | |
83 FR 11735 - Consumer Advisory Board and Councils Solicitation of Applications for Membership | |
83 FR 11770 - Changes in Flood Hazard Determinations | |
83 FR 11772 - National Flood Insurance Program (NFIP); Assistance to Private Sector Property Insurers, Notice of FY 2019 Arrangement | |
83 FR 11766 - Changes in Flood Hazard Determinations | |
83 FR 11768 - Proposed Flood Hazard Determinations | |
83 FR 11650 - Special Regulations, Areas of the National Park System, Pea Ridge National Military Park; Bicycles | |
83 FR 11755 - Pediatric Advisory Committee and the Endocrinologic and Metabolic Drugs Advisory Committee; Amendment of Notice | |
83 FR 11646 - Fisheries of the Exclusive Economic Zone Off Alaska; Pacific Cod by Catcher Vessels Greater Than or Equal to 50 Feet Length Overall Using Hook-and-Line Gear in the Central Regulatory Area of the Gulf of Alaska | |
83 FR 11778 - Proposed Flood Hazard Determinations | |
83 FR 11788 - Notice of Availability of the Final Archeological Resources Management Plan/Environmental Impact Statement, Knife River Indian Villages National Historic Site, North Dakota | |
83 FR 11787 - Notice of Availability of the Final Environmental Impact Statement To Address the Presence of Wolves at Isle Royale National Park, Michigan | |
83 FR 11750 - Anaconda Copper Mine, Yerington, NV: Proposed Settlement Agreement and Order on Consent | |
83 FR 11751 - Adequacy Determination for the Denver-North Front Range 2008 Ozone Attainment Plan's Motor Vehicle Emissions Budgets for Transportation Conformity Purposes; State of Colorado | |
83 FR 11747 - Agency Information Collection Activities: Proposed Collection; Comment Request; Application for Reimbursement to Local Governments for Emergency Response to Hazardous Substance Releases Under CERCLA Section 123, EPA ICR Number 1425.06, OMB Control Number 2050-0077 | |
83 FR 11780 - Privacy Act of 1974; System of Records | |
83 FR 11748 - Draft Guidance on Expanded Access to TSCA Confidential Business Information; Notice of Availability and Comment Request | |
83 FR 11667 - Large Aircraft Security Program, Other Aircraft Operator Security Program, and Airport Operator Security Program; Withdrawal | |
83 FR 11752 - Agency Information Collection Activities: Proposed Collection; Comment Request | |
83 FR 11727 - New England Fishery Management Council; Public Meeting | |
83 FR 11732 - North Pacific Fishery Management Council; Public Meeting | |
83 FR 11753 - Submission for OMB Review; Comment Request | |
83 FR 11746 - Environmental Impact Statements; Notice of Availability | |
83 FR 11745 - American LNG Marketing, LLC | |
83 FR 11633 - Catastrophic Risk Protection Endorsement; Area Risk Protection Insurance Regulations; and the Common Crop Insurance Regulations, Basic Provisions | |
83 FR 11646 - Safety Zone, Brandon Road Lock and Dam to Lake Michigan Including Des Plaines River, Chicago Sanitary and Ship Canal, Chicago River, and Calumet-Saganashkee Channel, Chicago, IL | |
83 FR 11761 - Pathways to Global Unity; Public Workshop | |
83 FR 11753 - Agency Information Collection Activities: Submission for OMB Review; Comment Request | |
83 FR 11793 - Notice of Lodging of Proposed Consent Decree Under the Clean Air Act | |
83 FR 11759 - Arthritis Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments | |
83 FR 11644 - Safety Zone; Ohio River, Letart, WV | |
83 FR 11763 - Proposed Collection; 60-Day Comment Request; Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health Service (PHS) Funding Is Sought and Responsible Prospective Contractors, Office of Policy for Extramural Research Administration (OPERA), Office of Extramural Research (OER), Office of the Director, (OD) | |
83 FR 11786 - Notice of Proposed Reinstatement of Terminated Oil and Gas Lease WYW184371, Wyoming | |
83 FR 11787 - Notice of Closure, Kasha-Katuwe Tent Rocks National Monument | |
83 FR 11784 - Notice of Temporary Closure of Public Land in Lander County, Nevada | |
83 FR 11696 - Takes of Marine Mammals Incidental to Specified Activities; Taking Marine Mammals Incidental to Rocky Intertidal Monitoring Surveys Along the Oregon and California Coasts | |
83 FR 11734 - Procurement List; Additions | |
83 FR 11734 - Procurement List; Proposed Addition and Deletions | |
83 FR 11694 - Countervailing Duty Order on Certain Passenger Vehicle and Light Truck Tires From the People's Republic of China: Final Results of Countervailing Duty Administrative Review; 2014-2015 | |
83 FR 11690 - Certain Passenger Vehicle and Light Truck Tires From the People's Republic of China: Final Results of Antidumping Duty Administrative Review and Final Determination of No Shipments; 2015-2016 | |
83 FR 11679 - Large Power Transformers From the Republic of Korea: Final Results of Antidumping Duty Administrative Review; 2015-2016 | |
83 FR 11682 - Certain New Pneumatic Off-the-Road Tires From the People's Republic of China: Notice of Partial Rescission of the Antidumping Duty Administrative Review; 2016-2017 | |
83 FR 11678 - Polyester Staple Fiber From the Republic of Korea and Taiwan: Initiation of Changed Circumstances Reviews, and Consideration of Revocation of the Antidumping Duty Orders in Part | |
83 FR 11685 - Initiation of Antidumping and Countervailing Duty Administrative Reviews | |
83 FR 11681 - Fine Denier Polyester Staple Fiber From the People's Republic of China and India: Amended Final Affirmative Countervailing Duty Determination for the People's Republic of China and Countervailing Duty Orders for the People's Republic of China and India | |
83 FR 11683 - Certain Steel Nails From the People's Republic of China: Final Results of Antidumping Duty Administrative Review and Final Determination of No Shipments; 2015-2016 | |
83 FR 11677 - Approval of Subzone Expansion; Lam Research Corporation; Fremont, Livermore and Tracy, California | |
83 FR 11761 - Advisory Council on Alzheimer's Research, Care, and Services; Meeting | |
83 FR 11790 - Certain Multi-Domain Test and Measurement Instruments; Institution of Investigation | |
83 FR 11743 - Notice of Decision and Order Granting a Waiver to New Shunxiang Electrical Appliance Co., Ltd., From the Department of Energy Refrigerator, Refrigerator-Freezer, Freezer Test Procedure | |
83 FR 11740 - Notice of Decision and Order Granting a Waiver to Acuity Brands Lighting, Inc. From the Department of Energy Illuminated Exit Signs Test Procedure | |
83 FR 11738 - Notice of Decision and Order Granting Individual Waivers to Apple Inc., Microsoft Corporation, Poin2 Lab and Hefei Bitland Information Technology Co., From the Department of Energy External Power Supplies Test Procedure | |
83 FR 11809 - Notice of Determinations; Culturally Significant Objects Imported for Exhibition Determinations: “Otobong Nkanga: To Dig a Hole that Collapses Again” Exhibition | |
83 FR 11809 - Notice of Determinations; Culturally Significant Object Imported for Exhibition Determinations: Exhibition of “Snow-Covered Field With a Harrow (after Millet)” Painting | |
83 FR 11737 - International Energy Agency Meetings | |
83 FR 11703 - Meeting of the Advisory Committee on Commercial Remote Sensing | |
83 FR 11813 - Agency Information Collection Activities: Request for Comments for a New Information Collection | |
83 FR 11808 - 30-Day Notice of Proposed Information Collection: Foreign Diplomatic Services Applications (FDSA) | |
83 FR 11675 - Submission for OMB Review; Comment Request | |
83 FR 11812 - Notice of Intent To Prepare Environmental Impact Statement, I-495 & I-270 Managed Lanes Study, Montgomery and Prince George's Counties, Maryland and Fairfax County, Virginia | |
83 FR 11733 - Marine Mammals; File No. 21348 | |
83 FR 11736 - Board of Advisors to the Presidents of the Naval Postgraduate School and the Naval War College; Notice of Federal Advisory Committee Meeting | |
83 FR 11643 - Drawbridge Operation Regulation; Trent River, New Bern, NC | |
83 FR 11703 - Fish and Fish Product Import Provisions of the Marine Mammal Protection Act List of Foreign Fisheries | |
83 FR 11639 - Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses”; Partial Delay of Effective Date | |
83 FR 11754 - Draft Concept Paper: Illicit Trade in Tobacco Products After Implementation of a Food and Drug Administration Product Standard; Availability; Request for Comments | |
83 FR 11818 - Tobacco Product Standard for Nicotine Level of Combusted Cigarettes | |
83 FR 11811 - Thirty Ninth RTCA SC-216 Aeronautical Systems Security Plenary | |
83 FR 11810 - Twenty Seventh RTCA SC-214 Standards for Air Traffic Data Communications Services Plenary | |
83 FR 11649 - Regulated Navigation Areas; Harbor Entrances Along the Coast of Northern California | |
83 FR 11642 - Drawbridge Operation Regulation; St. Johns River, Jacksonville, FL | |
83 FR 11792 - Notice of Lodging of Proposed Consent Decree and Environmental Settlement Agreement Under The Clean Air Act | |
83 FR 11756 - Agency Information Collection Activities; Proposed Collection; Comment Request; MedWatch: The Food and Drug Administration Medical Products Reporting Program | |
83 FR 11791 - Certain Digital Video Receivers and Related Hardware and Software Components; Institution of Investigation | |
83 FR 11729 - Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Exempted Fishing Permits | |
83 FR 11728 - Magnuson-Stevens Act Provisions; General Provisions for Domestic Fisheries; Application for Exempted Fishing Permit | |
83 FR 11800 - Self-Regulatory Organizations; NYSE American LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Expand the Short Term Options Series Program | |
83 FR 11797 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Expand the Short Term Options Series Program | |
83 FR 11807 - Self-Regulatory Organizations; The Options Clearing Corporation; Order Approving Proposed Rule Change Related to The Options Clearing Corporation's Fee Policy | |
83 FR 11794 - Self-Regulatory Organizations; Cboe Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend the Fees Schedule | |
83 FR 11803 - Self-Regulatory Organizations; Cboe Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Establish Fees for Options That Overlie the S&P Select Sector Index Options | |
83 FR 11783 - Foreign Endangered Species; Marine Mammal Issuance of Permits | |
83 FR 11789 - Certain Light Engines and Components Thereof; Institution of Investigation | |
83 FR 11790 - Certain Load Supporting Systems, Including Composite Mat Systems, and Components Thereof; Commission Determination Not To Review an Initial Determination Granting an Unopposed Motion To Amend the Complaint and Notice of Investigation | |
83 FR 11810 - Office of Commercial Space Transportation: Notice of Availability and Request for Comment on the Spaceport Camden Draft Environmental Impact Statement (EIS), Camden County, GA | |
83 FR 11634 - Special Conditions: Honda Aircraft Company, Inc., HA-420 Airplane; Single-Place Side-Facing Lavatory Seat Dynamic Test | |
83 FR 11677 - Helena-Lewis and Clark National Forest; Montana; Stonewall Vegetation Project | |
83 FR 11633 - Guaranteed Loanmaking and Servicing Regulations; Corrections | |
83 FR 11652 - Approval and Promulgation of State Plans for Designated Facilities and Pollutants; New Hampshire; Delegation of Authority | |
83 FR 11633 - Fees for Official Inspection and Official Weighing Services Under the United States Grain Standards Act (USGSA); Correction | |
83 FR 11676 - Solicitation of Nominations for Members of the USDA Grain Inspection Advisory Committee | |
83 FR 11648 - Christmas Tree Promotion Research, and Information Order; Referendum | |
83 FR 11765 - Prospective Grant of Exclusive Patent License: Magnetic Resonance Imaging System and Method for the Measurement of Geometric Features of Axons (Including Without Limitation Diameter, Radius, Perimeter, Volume, Surface and Angle) for the Characterization and Diagnosis of Central Nervous System Diseases and Disorders | |
83 FR 11762 - Prospective Grant of an Exclusive Patent License: Anti-Marinobufagenin Antibodies and Methods for Diagnosis and Treatment of Cardiovascular Disease and Fibrotic Disease | |
83 FR 11814 - Petition for Waiver of Compliance | |
83 FR 11763 - Center for Scientific Review; Notice of Closed Meetings | |
83 FR 11765 - Center for Scientific Review; Notice of Closed Meetings | |
83 FR 11731 - Initiation of 5-Year Review for the Endangered New York Bight, Chesapeake Bay, Carolina and South Atlantic Distinct Population Segments of Atlantic Sturgeon and the Threatened Gulf of Maine Distinct Population Segment of Atlantic Sturgeon | |
83 FR 11794 - New Postal Products | |
83 FR 11654 - Increasing Recycling: Adding Aerosol Cans to the Universal Waste Regulations | |
83 FR 11785 - Notice of Availability of the Draft Supplemental Environmental Impact Statement for the West Mojave Route Network Project and Draft Land Use Plan Amendment to the California Desert Conservation Area Plan in the West Mojave Planning Area, Inyo, Kern, Los Angeles, Riverside, and San Bernardino Counties, CA | |
83 FR 11637 - Adoption of Updated EDGAR Filer Manual | |
83 FR 11649 - Representation-Case Procedures |
Agricultural Marketing Service
Federal Crop Insurance Corporation
Forest Service
Office of Advocacy and Outreach
Rural Business-Cooperative Service
Rural Utilities Service
Foreign-Trade Zones Board
International Trade Administration
National Oceanic and Atmospheric Administration
Navy Department
Centers for Medicare & Medicaid Services
Children and Families Administration
Food and Drug Administration
National Institutes of Health
Coast Guard
Federal Emergency Management Agency
Transportation Security Administration
Fish and Wildlife Service
Land Management Bureau
National Park Service
Federal Aviation Administration
Federal Highway Administration
Federal Railroad Administration
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.
Federal Crop Insurance Corporation, USDA.
Correcting amendment.
This document contains necessary amendments to address corrections in the final rule with request for comments for the Catastrophic Risk Protection Endorsement, the Area Risk Protection Insurance Basic Provisions, and the Common Crop Insurance Policy Basic Provisions which published in the
Francie Tolle, Director, Product Management, Product Administration and Standards Division, Risk Management Agency, United States Department of Agriculture, Beacon Facility, Stop 0812, Room 421, P.O. Box 419205, Kansas City, MO 64141-6205, telephone (816) 926-7730.
This correction is being published to correct section 18(f)(2)(iv) of the Common Crop Insurance Policy Basic Provisions, published November 24, 2017 (82 FR 55723-55734). The term “and” at the end of the paragraph following the semicolon was inadvertently omitted and is being added in this correction.
Administrative practice and procedure, Crop insurance, Reporting and recordkeeping requirements.
Accordingly, 7 CFR part 457 is corrected by making the following amendments:
7 U.S.C. 1506(l) and 1506(o).
Agricultural Marketing Service, USDA.
Final rule; correcting amendment.
This document corrects an error introduced into our regulations by a final rule that was published in the February 14, 2018,
Denise Ruggles, FGIS Executive Program Analyst, USDA AMS; Telephone: (816) 659-8406; Email:
In FR Doc. 2018-02884 appearing in the
Administrative practice and procedure, Exports, Grains, Reporting and recordkeeping requirements.
Accordingly, 7 CFR part 800 is corrected by making the following correcting amendments:
7 U.S.C. 71-87k.
Rural Business-Cooperative Service and Rural Utilities Service; USDA.
Final rule; technical correction.
On June 3, 2016, the Rural Business-Cooperative Service promulgated changes to its Guaranteed Loanmaking and Servicing Regulations. Following final implementation of this final rule, RBS found two technical corrections that are necessary.
Effective March 16, 2018.
Kelley Oehler, Rural Development, Business Programs, U.S. Department of Agriculture, 1400 Independence Ave. SW, Stop 3224, Washington, DC 20250-3224; email:
The Agency published a final rule on June 3, 2016 (81 FR 35984-36027) for the purpose of improving program delivery, clarifying the regulations to make them easier to understand, and reducing delinquencies.
This document makes technical corrections to the Business and Industry (B&I) Guaranteed Loan regulations in two areas: Full faith and credit and leasehold improvements.
Loan programs—business and industry, Reporting and recordkeeping requirements, Rural areas.
Accordingly, 7 CFR chapter XLII is amended by making the following correcting amendments:
5 U.S.C. 301; and 7 U.S.C. 1989.
(a) * * * The guarantee will be unenforceable by the lender to the extent that any loss is occasioned by a provision for interest on interest or default or penalty interest. * * * Any losses occasioned will be unenforceable by the lender to the extent that loan funds were used for purposes other than those specifically approved by the Agency in its Conditional Commitment or amendment thereof in accordance with § 4279.173(b). * * *
The addition and revisions read as follows:
(b) * * *
(3) * * * For purposes of determining compliance with this requirement, leasehold improvements are considered tangible assets and can serve as primary collateral.
(d) * * *
(2) Tangible balance sheet equity will be determined based upon financial statements prepared in accordance with GAAP except that, for the purposes of this subpart, leasehold improvements are to be considered tangible assets when making the tangible balance sheet equity calculation. * * * Tangible equity cannot include appraisal surplus, bargain purchase gains, or intangible assets (except for leasehold improvements). * * *
Federal Aviation Administration (FAA), DOT.
Final special conditions; request for comments.
These special conditions are issued for the Honda Aircraft Company, Inc., HA-420 airplane. This airplane will have a novel or unusual design feature associated with a single-place side-facing seat in the lavatory that can be used as a passenger seat during taxi, takeoff, and landing. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.
The special conditions are effective March 16, 2018, and are applicable March 7, 2018.
We must receive your comments by April 16, 2018.
Send comments identified by docket number FAA-2018-0200 using any of the following methods:
•
•
•
•
Bob Stegeman, Federal Aviation Administration, AIR-691, Policy & Innovation Division, Small Airplane Standards Branch, Aircraft Certification Service, 901 Locust, Kansas City, Missouri 64106; telephone (816) 329-4140; facsimile (816) 329-4090.
The FAA has determined that notice and opportunity for prior public comment are impracticable because these procedures would significantly delay issuance of the approval design and thus delivery of the affected airplanes.
We invite interested people to take part in this rulemaking by sending written comments, data, or views. The most helpful comments reference a specific portion of the special conditions, explain the reason for any recommended change, and include supporting data. We ask that you send us two copies of written comments.
We will consider all comments we receive on or before the closing date for comments. We will consider comments filed late if it is possible to do so without incurring expense or delay. We may change these special conditions based on the comments we receive.
On January 6, 2017, Honda Aircraft Company, Inc. applied for a change to Type Certificate (TC) No. A00018AT for the installation of a single-place side-facing belted lavatory seat in the HA-420 airplane. The HA-420, currently approved under TC No. A00018AT, is a 7-seat, lightweight business jet with a 43,000-foot service ceiling and a maximum takeoff weight of 9,963 pounds. The airplane is powered by two GE-Honda Aero Engines (GHAE) HF-120 turbofan engines.
The airplane will be equipped with a “belted” lavatory seat cover that a passenger can be seated in during taxi, takeoff, and landing. Therefore, compliance with the provisions of 14 CFR 23.562 and 23.785—in addition to the certification basis as established in TC No. A00018AT—and any additional requirements the FAA determines, are applicable. In this case, the approval of a side-facing seat to these provisions is considered novel or unusual; therefore, special conditions are required.
14 CFR part 23, amendment 23-36,
Under the provisions of 14 CFR 21.101, Honda Aircraft Company, Inc., must show that the HA-420, as changed, continues to meet the applicable provisions of the regulations incorporated by reference in TC No. A00018AT or the applicable regulations in effect on the date of application for the type certificate. The regulations incorporated by reference in the type certificate are commonly referred to as the “original type certification basis.” The regulations incorporated by reference in TC No. A00018AT are as follows:
14 CFR part 23, Airworthiness Standards: Normal, Utility, Acrobatic, and Commuter Airplanes, effective February 1, 1965, as amended by amendments 23-1, July 29, 1965, through amendment 23-62, dated December 2, 2011.
14 CFR part 34, Fuel Venting and Exhaust Emission Requirements for Turbine-Engine-Powered Airplanes, effective September 10, 1990, as amended by amendments 34-1, dated July 31, 1995 through amendment 34-5, dated December 31, 2012.
14 CFR part 36, Noise Standards: Aircraft Type Certification and Airworthiness Certification, effective March 11, 1994, as amended by amendments 36-1, dated December 1, 1965, through amendment 36-29, dated March 11, 2013.
Exemption 11123, dated December 16, 2014, § 23.181(b), Dynamic Stability Compliance with § 23.181(b) during takeoff and landing.
ELOS ACE-15-08, dated June 5, 2015: Use of 1-g Stall Speeds in lieu of Minimum Speed in the Stall as a Basis for Determining.
ELOS ACE-15-09, dated March 26, 2015: Electronic Display of Engine Instruments N1, N2, ITT, Oil Pressure, Oil Temperature, Fuel Flow, and Fuel Quantity on a Garmin G3000 Integrated Flight Deck.
ELOS ACE-15-10, dated March 25, 2015: Storage Battery Design and Installation Compliance.
ELOS ACE-15-11, dated September 14, 2015: Airspeed Indicator (ASI) Flap Markings.
ELOS ACE-15-15, dated September 1, 2015: Amendment 23-62 Corrections.
Special Condition No. 23-263-SC, dated March 25, 2015, Dynamic Test Requirements for Single-Place Side-Facing Seats.
Special Condition No. 23-264-SC, dated March 25, 2015, Electronic Engine Control System.
Special Condition 23-265-SC, dated June 9, 2015, Fire Extinguishing. Note: This special condition supersedes the ELOS finding of ELOS Memo ACE-15-15.
Special Condition No. 23-269-SC, dated Sept 14, 2015, Lithium-Ion Battery Installation.
Special Condition No. 23-270-SC, dated August 3, 2015: High Altitude Operations.
Special Condition Notice No. 23-271-SC, dated October 26, 2015, Cruise Speed Control.
If the Administrator finds the applicable airworthiness regulations (
The FAA issues special conditions, as defined in 14 CFR 11.19, under § 11.38,
Special conditions are initially applicable to the model for which they are issued. Should the type certificate for that model be amended later to include any other model that incorporates the same novel or unusual design feature, or should any other model already included on the same type certificate be modified to incorporate the same novel or unusual design feature, the FAA would apply these special conditions to the other model.
The HA-420 will incorporate the following novel or unusual design feature:
A single-place side-facing lavatory seat intended for taxi, takeoff, and landing.
The seat is to incorporate design features that reduce the potential for injury in the event of an accident. The seat is essentially a padded toilet cover. In a severe impact, the occupant will be restrained by a 2-point seatbelt attached to the sidewall and, in an accident, bear on an adjacent wall/bulkhead forward of the occupant. This wall/bulkhead may or may not be padded, depending upon test results. Due primarily to its close proximity to the occupant, the wall provides the same function of the upper torso restraint for forward facing occupants.
The testing should represent features in the cabin that may influence dynamic test results. Notable details include a representative bulkhead forward lavatory wall and any objects that may influence its ability to attenuate load or otherwise affect its stiffness. This could include cabin furniture or seats forward of the bulkhead.
Dynamic seat testing also requires seat attachment points be deflected in pitch and roll in order to demonstrate the seat will remain attached as the airplane deforms in an accident. In this installation, pitch and roll are not practicable and not required because the seat is primarily attached to the sidewall and the seatbelt and bulkhead primarily restrain the occupant.
In addition to the design features intended to minimize occupant injury during an accident sequence, the installation will also require operational procedures that will facilitate egress in the event of an accident, including leaving the lavatory door locked open during taxi, takeoff, and landing. The adjacent forward wall/bulkhead interior structure may have padding that will provide some protection to the head of the occupant if head injury criteria (HIC) values require it.
As discussed above, these special conditions are applicable to the HA-420. Should Honda Aircraft Company, Inc. apply at a later date for a change to the type certificate to include another model incorporating the same novel or unusual design feature, the FAA would apply these special conditions to that model as well.
This action affects only certain novel or unusual design features on one model of airplane. It is not a rule of general applicability and affects only the applicant who applied to the FAA for approval of these features on the airplane.
The FAA has determined that notice and opportunity for prior public comment are impracticable because these procedures would significantly delay issuance of the approval design and thus delivery of the affected airplanes. The FAA is requesting comments to allow interested persons to submit views that may not have been submitted in response to the prior opportunities for comment described above.
Aircraft, Aviation safety, Signs and symbols.
The authority citation for these special conditions is as follows:
49 U.S.C. 106(f), 106(g), 40113, 44701-44702; 44704, Pub. L. 113-53, 127 Stat 584 (49 U.S.C. 44704) note, 14 CFR 21.16 and 21.101(d).
Accordingly, pursuant to the authority delegated to me by the Administrator, the following special conditions are issued as part of the type certification basis for Honda Aircraft Company, Inc., HA-420 airplanes.
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(h)
(i)
(j) The following are the agreed upon methods of compliance and test requirements:
(i) One longitudinal test with the SID ATD or its equivalent, un-deformed floor, no yaw, and with all lateral structural supports (armrests/walls) will be accomplished.
(ii) One longitudinal test with the Hybrid II ATD, deformed floor, with 10 degrees yaw, and with all lateral structural supports (armrests/walls) will be accomplished.
(iii) Vertical (15 g's) test is to be conducted with modified Hybrid II ATDs with existing pass/fail criteria.
(iv) The ATD can be tethered for the floor deformation test.
(v) The seatbelt is not required to have a TSO Authorization but will need to comply with the TSO-C22g Minimum Performance Standards (MPS).
(i) The ATD head and torso must remain supported by the forward divider (wall) during the event. The ATD is not permitted to move inboard of the divider.
(ii) Honda Aircraft Company, Inc. must determine whether the last cabin seat will become a partition panel or bulkhead restraint that can increase ATD inertial loading or otherwise affect the test whether the last cabin seat is occupied or unoccupied.
(iii) The ATD should be fitted in a manner reflecting the worst occupant seating. Belts, buckles, and other clothing must remain restrained for the event duration and not become loose items of mass.
Securities and Exchange Commission.
Final rule.
The Securities and Exchange Commission (the “Commission”) is adopting revisions to the Electronic Data Gathering, Analysis, and Retrieval System (“EDGAR”) Filer Manual and related rules. The EDGAR system is scheduled to be upgraded on March 12, 2018.
Effective March 16, 2018. The incorporation by reference of the EDGAR Filer Manual is approved by the Director of the Federal Register as of March 16, 2018.
In the Division of Investment Management, for questions concerning Form N-PORT and Form N-CEN, contact Heather Fernandez at (202) 551-6708 and for questions concerning submission form type 486BXT, contact Shawn Davis at (202) 551-6413. In the Division of Trading and Markets, for questions concerning Form 13H, contact Richard Holley at (202) 551-5614. In the Division of Economic and Risk Analysis, for questions concerning the updated XBRL taxonomies, contact Brian Hankin at (202) 551-8497. In the Office of Strategic Initiatives, for questions concerning Form ID, contact Christian Windsor at (202) 551-3419 or Mellissa Duru at (202) 551-3757. In the Division of Corporation Finance, for questions concerning the draft registration statements on form type DRS and DRS/A, the draft offering statements on form type DOS and DOS/A, and submission form type SF-1MEF, contact Heather Mackintosh at (202) 551-8111. In the Office of Municipal Securities, for questions concerning Form MA-I and Form MA-I/A, contact Ahmed Abonamah at (202) 551-3887.
We are adopting an updated EDGAR Filer Manual, Volume I and Volume II, and making corresponding rule and form amendments. The Filer Manual describes the technical formatting requirements for the preparation and submission of electronic filings through the EDGAR system.
The revisions to the Filer Manual reflect changes within Volume I, entitled EDGAR Filer Manual, Volume I: “General Information,” (Version 30) (March 2018), and Volume II, entitled EDGAR Filer Manual, Volume II: “EDGAR Filing,” Version 45 (March 2018). The updated manual will be incorporated by reference into the Code of Federal Regulations.
The Filer Manual contains all the technical specifications for filers to submit filings using the EDGAR system. Filers must comply with the applicable provisions of the Filer Manual in order to assure the timely acceptance and processing of filings made in electronic format.
The EDGAR System and Filer Manual will be updated in Release 18.1 and will reflect the following changes.
The Form ID entry screen will be revised to allow filers that are applying for access codes to indicate whether they intend to submit a draft registration statement or draft offering statement. Clarifying instructions will be added to Chapter 3 (Becoming an EDGAR Filer) of the EDGAR Filer Manual, Volume I and a technical conforming amendment will be made to Form ID.
EDGAR will be revised to add the submission form type SF-1MEF, which will allow registrants to register additional securities pursuant to Rule 462(b) of the Securities Act of 1933 (the “Securities Act”) to a prior related effective registration statement filed on Form SF-1. Corresponding changes have been made to Chapter 3 (Index to Forms), Chapter 4 (Filing Fee Information) and Appendix C (EDGAR Submission Types) of the EDGAR Filer Manual, Volume II.
EDGAR will also be revised to add submission form type 486BXT for post-effective amendments to Form N-2 filed pursuant to Securities Act Rule 486(b)(1)(iii) to designate a new effective date for a post-effective amendment previously filed pursuant to Securities Act Rule 486(a). Corresponding changes have been made to Chapter 3 (Index to Forms) and Appendices A (Messages Reported by EDGAR) and C (EDGAR Submission Types) of the EDGAR Filer Manual, Volume II.
EDGAR will be updated to allow multiple accession numbers and series IDs in the header of NPORT-EX and NPORT-EX/A submissions. This will allow the filer to make a single submission for multiple series. Clarifying changes have been made to Appendix A, (Messages Reported by EDGAR) and Chapter 7 (Preparing and Transmitting EDGARLink Online Submissions) of the EDGAR Filer Manual, Volume II.
In Release No. 33-10332 (March 31, 2017) [82 FR 17545] the Commission adopted revisions to certain Commission forms to add checkboxes to the cover pages to the forms to enable registrants to indicate their status as an Emerging Growth Company, as defined in Section 6(e) of the Securities Act, and to indicate whether they were opting out of the extended transition period for complying with any new or revised financial accounting standards. Updates are being made in EDGAR Release 18.1 to allow filers submitting draft registration statements on submission form type DRS and DRS/A to provide similar indications when submitting those submission form types. Corresponding changes will be made to Chapter 7 (Preparing and Transmitting EDGARLink Online Submissions) of the EDGAR Filer Manual, Volume II.
EDGAR Release 18.1 will revise EDGAR to allow investment company filers to skip Part C of submission Forms N-CEN and N-CEN/A if all of their series are terminated. Clarifying changes have been made to Chapter 8 (Preparing and Transmitting Online Submissions) of the EDGAR Filer Manual, Volume II.
EDGAR Release 18.1 will revise EDGAR to allow filers to sort the dates provided in Items 3 and 4 of submission form types MA-I and MA-I/A in reverse chronological order. Clarifying changes have been made to Chapter 8 (Preparing and Transmitting Online Submissions) of the EDGAR Filer Manual, Volume II.
Instructions in the EDGAR Filer Manual will be revised to clarify that filers of Form 13H who are natural persons and who do not have a Tax Identification Number or TIN, should enter “00-0000000” in lieu of the TIN. Natural person filers should immediately discontinue the practice of providing their Social Security number in that field. Corresponding changes will be made to Chapter 8 (Preparing and Transmitting Online Submissions) of the EDGAR Filer Manual, Volume II.
In EDGAR Release 18.1, the EDGAR system will be upgraded to support the 2018 XBRL Taxonomies and updated SEC taxonomies COUNTRY, CURRENCY, EXCH and NAICS. Please see
EDGAR Release 18.1 will revise the EDGAR system to suspend ABS-EE and ABS-EE/A submissions (along with Combined 10-D/ABS-EE submissions and their amendments) if the Reporting Period Begin Date is after the Reporting Period End Date. Clarifying changes have been added to Appendix A (Messages Reported By EDGAR) of the EDGAR Filer Manual, Volume II.
Along with the adoption of the Filer Manual, we are amending Rule 301 of Regulation S-T to provide for the incorporation by reference into the Code of Federal Regulations of today's revisions. This incorporation by reference was approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51.
The updated EDGAR Filer Manual will be available for website viewing and printing; the address for the Filer Manual is
Since the Filer Manual and the corresponding rule and form amendments relate solely to agency procedures or practice, publication for notice and comment is not required under the Administrative Procedure Act (“APA”).
The effective date for the updated Filer Manual and the related rule and form amendments is March 16, 2018. In accordance with the APA,
We are adopting the amendments to Regulation S-T under the authority in Sections 6, 7, 8, 10, and 19(a) of the Securities Act of 1933,
We are adopting the technical conforming amendment to Form ID under the authority in Section 19(a) of the Securities Act,
Incorporation by reference, Reporting and recordkeeping requirements, Securities.
Investment companies, 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. 77c, 77f, 77g, 77h, 77j, 77s(a), 77z-3, 77sss(a), 78c(b), 78
Filers must prepare electronic filings in the manner prescribed by the EDGAR Filer Manual, promulgated by the Commission, which sets forth the technical formatting requirements for electronic submissions. The requirements for becoming an EDGAR Filer and updating company data are set forth in the updated EDGAR Filer Manual, Volume I: “General Information,” Version 30 (March 2018). The requirements for filing on EDGAR are set forth in the updated EDGAR Filer Manual, Volume II: “EDGAR Filing,” Version 45 (March 2018). Additional provisions applicable to Form N-SAR filers are set forth in the EDGAR Filer Manual, Volume III: “N-SAR Supplement,” Version 6 (January 2017). All of these provisions have been incorporated by reference into the Code
15 U.S.C. 77f, 77g, 77h, 77j, 77s, 78c(b), 78
The text of Form ID does not, and the amendment will not, appear in the Code of Federal Regulations.
By the Commission.
Food and Drug Administration, HHS.
Final rule; partial delay of effective date.
The Food and Drug Administration (FDA, the Agency, or we) is issuing this final rule to delay the effective date of amendments to the existing medical product “intended use” regulations, contained in the final rule published January 9, 2017, until further notice. This final rule delays the effective date of the amendments to allow further consideration of the substantive issues raised in the comments received regarding the amendments. This action does not delay the effective date of the portions of the January 9, 2017, final rule that describe the circumstances in which a product made or derived from tobacco that is intended for human consumption will be subject to regulation as a drug, device, or a combination product under the Federal Food, Drug, and Cosmetic Act (FD&C Act), which remains March 19, 2018.
Effective March 16, 2018, the amendments made to §§ 201.128 and 801.4, revised at 82 FR 2193 (January 9, 2017), delayed at 82 FR 9501 (February 7, 2017) until March 21, 2017, and further delayed at 82 FR 14319 (March 20, 2017) until March 19, 2018, are delayed indefinitely. Section 1100.5, added at 82 FR 2193 (January 9, 2017), delayed at 82 FR 9501 (February 7, 2017) until March 21, 2017, and further delayed at 82 FR 14319 (March 20, 2017) until March 19, 2018, is effective March 19, 2018.
For access to the docket to read background documents or comments received, go to
Kelley Nduom, Center for Drug Evaluation and Research, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6221, Silver Spring, MD 20993, 301-796-8597,
In the
In the
On February 8, 2017, various industry organizations filed a petition raising concerns with the January 2017 final rule, requesting reconsideration and a stay pursuant to 21 CFR 10.33(b) and 10.35(b) (see FDA-2015-N-2002-1977). The petition requests that FDA reconsider the amendments to the “intended use” regulations and issue a new final rule that, with respect to the intended use regulations at §§ 201.128 and 801.4, reverts to the language of the September 25, 2015, proposed rule. The petition also requests that FDA indefinitely stay the rule because petitioners argue that (1) the final rule was issued in violation of the fair notice requirement under the Administrative Procedure Act (APA) (petition at pp. 10-13) and (2) the “totality of the evidence” language in the final rule is
In the
To allow for further consideration of the substantive issues raised in these comments, in the
We received 19 comments on the proposed delay from drug and device industries, various associations and organizations, academia, and individual submitters, including a health professional and consumers. We describe and respond to the comments in sections II.B through II.D of this document. We have numbered each comment to help distinguish between different comments. We have grouped similar comments together under the same number and, in some cases, we have separated different issues discussed in the same comment and designated them as distinct comments for purposes of our responses. The number assigned to each comment or comment topic is purely for organizational purposes and does not signify the comment's value or importance or the order in which comments were received.
The majority of comments supported the proposed delay and included specific proposals and recommendations for how FDA should address issues related to intended use, and amendments to §§ 201.128 and 801.4, going forward. In the following paragraphs, we discuss and respond to such comments.
(Comment 1) Many of the comments expressed support for the delay based on legal concerns with the January 2017 final rule. Among these legal concerns were arguments that the final rule: (1) Violates the First Amendment by regulating truthful speech regarding lawful activity; (2) violates the due process clause of the Fifth Amendment to the extent that the types of evidence to be considered are not clearly defined; (3) unlawfully interferes with the practice of medicine; (4) departs from relevant statutory text, legislative history, case law, and FDA past practices, and/or (5) was issued in violation of the notice requirement under the APA based on the inclusion of the “totality of the evidence” language in that final rule. Many of these arguments were based, at least in part, on what commenters described as a broadening from the September 25, 2015, proposed rule (see 80 FR 57756 at 57764 to 57765) of the types of evidence that could be considered in determining intended use, and specifically raised concerns with the “totality of the evidence” language included in the January 2017 final rule.
(Response) We agree that it is appropriate to delay the effective date of the final rule and we will consider the legal concerns raised regarding the January 2017 final rule as we continue to work diligently on the issues relating to intended use raised in the underlying rulemaking.
(Comment 2) Several of the comments supporting the delay also included specific proposals and recommendations for how FDA should address issues related to intended use, and specifically amendments to §§ 201.128 and 801.4, going forward. For example, these comments stated that FDA should:
a. Adopt the approach set forth in the September 2015 proposed rule preamble and codified—including deletion of the “knowledge” sentences in §§ 201.128 and 801.4—and ensure that all guidance and policy documents are aligned with that approach;
b. Withdraw the January 2017 final rule and the “totality of the circumstances” test included in that rule;
c. Revise §§ 201.128 and 801.4 to make them “more consistent with applicable law”; and/or
d. Clarify that certain types of evidence, such as the following, do
(Response) The wide-ranging proposals and recommendations for how FDA should address issues related to intended use and §§ 201.128 and 801.4 in these and other comments underscore the complexities of the issues involved. We believe these comments provide additional support for the delay of the effective date of amendments to the existing medical product “intended use” regulations. The Agency needs more time to consider the feedback we received, make sure that our approach is guided by our public health mandate, and ensure the clarity of our rules on the subject. We will consider these proposals and recommendations as we continue to work diligently on the issues relating to intended use raised in the underlying rulemaking.
(Comment 3) One comment stated that the proposed rule should be delayed due to several Federal lawsuits involving FDA and vaping firms. That comment further asserted that FDA acted deceptively and violated the Constitution, that FDA should provide clear rulemaking procedures, that the
(Response) To the extent the comment intended to support the delay of the effective date of the medical product portions of the January 2017 final rule, we agree. However, to the extent the comment intended to assert that the effective date of new § 1100.5 should likewise be delayed, the comment is outside the scope of this rulemaking. In any event, we disagree that there is any reason to delay the effective date of § 1100.5. As noted in the January 2018 proposed rule, when FDA reopened the docket for the January 2017 final rule, the Agency did not receive any comments requesting that we further delay the effective date of § 1100.5 or that we make any changes to that regulation. This comment likewise did not suggest any changes to the substance of that regulation. To the extent the comment can be understood to relate to the substance of the amendments to the intended use regulations, we will consider them as we continue to work diligently on the issues relating to intended use raised in the underlying rulemaking.
(Comment 4) One comment opposed the proposed delay and asked that FDA not further delay implementation of the January 2017 final rule. The comment expressed support for the January 2017 final rule, stating that (1) the “totality of evidence” language does not lower the relevant evidentiary standard and (2) there has been adequate notice and opportunity to be heard regarding the final rule. The comment recommended that FDA build on the approach it has adopted in the past several years to address intended use issues and argued against the removal of the “knowledge” sentences in §§ 201.128 and 801.4.
(Response) With respect to the request not to delay implementation of the January 2017 final rule, under FDA regulations, the Commissioner of Food and Drugs (Commissioner) is authorized to stay, including for an indefinite time period, the effective date of any action if the stay is in the public interest and the interest of justice (see § 10.35(a) to (b), (e) to (f) (21 CFR 10.35(a) to (b), (e) to (f))). We believe that the delay is reasonable and appropriate in light of the complex issues under consideration and the wide range of concerns, proposals, and recommendations we have received in comments from stakeholders on these issues. In addition to these comments, the Agency received a petition specifically requesting that the Commissioner “indefinitely stay the Final Rule” (petition at p. 1). The petition raised a number of concerns with the January 2017 final rule, including constitutional concerns and public health concerns related to what the petition stated could be a chilling of valuable scientific speech. While the Agency remains committed to providing clarity on issues relating to intended use, we have determined that it best serves the public health for the Agency to take additional time to carefully consider all of these concerns and delay the effective date of the January 2017 final rule. The petitioners raised significant concerns with the text of the “intended use” amendments, which were echoed by several additional commenters. The Agency does not believe that indefinitely delaying the effective date of the January 2017 final rule to consider these issues will create a public health risk. To the contrary, the potential for confusion and uncertainty regarding the text of the January 2017 final rule might affect FDA's medical product jurisdiction in ways that FDA did not intend when it set out to clarify the “intended use” regulations.
Accordingly, the Commissioner has concluded that the delay is warranted because it is in the public interest and the interest of justice (see § 10.35(e)). As noted above, we will consider the concerns, recommendations, and proposals set forth in these comments as we continue to work diligently on the issues relating to intended use raised in the underlying rulemaking.
(Comment 5) Several comments supported FDA suspending rulemaking and closing the docket to address issues related to a specific drug product.
(Response) These comments appear to concern product-specific issues that are outside the scope of this rulemaking.
This rule is effective March 16, 2018. As provided at 82 FR 14319, March 20, 2017, the amendments to FDA's existing regulations describing the types of evidence that may be considered in determining a medical product's intended uses (§§ 201.128 (drugs) and 801.4 (devices)) will take effect on March 19, 2018. In order to delay that effective date, this final rule needs to be effective on or before March 19, 2018, and therefore it is not possible for this rule delaying that effective date to take effect 30 days from publication in the
We have examined the impacts of the final rule under Executive Order 12866, Executive Order 13563, Executive Order 13771, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct us to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). Executive Order 13771 requires that the costs associated with significant new regulations “shall, to the extent permitted by law, be offset by the elimination of existing costs associated with at least two prior regulations.” We believe that this final rule is not a significant regulatory action as defined by Executive Order 12866. The final rule is not a regulatory or deregulatory action for the purposes of Executive Order 13771.
The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because this final rule will impose negligible costs, if any, we certify that the final rule will not have a significant economic impact on a substantial number of small entities.
The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to prepare a written statement, which includes an assessment of anticipated costs and benefits, before issuing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $148 million, using the most current (2016) Implicit Price Deflator for the Gross Domestic Product. This final rule would not result in an expenditure in any year that meets or exceeds this amount.
We received no comments on the proposed rule that specifically addressed our preliminary regulatory impact analysis. Therefore, we retain our preliminary estimate that the final rule will maintain the status quo for the medical product industries and impose no additional burden on affected entities. In table 1, we provide the costs
We have determined under 21 CFR 25.20(h) 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 rule contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.
We have analyzed this final rule in accordance with the principles set forth in Executive Order 13132. We have determined that the rule does not contain policies that have substantial direct effects 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. Accordingly, we conclude that the rule does not contain policies that have federalism implications as defined in the Executive Order and, consequently, a federalism summary impact statement is not required.
We have analyzed this rule in accordance with the principles set forth in Executive Order 13175. We have determined that the rule does not contain policies that would 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. Accordingly, we conclude that the rule does not contain policies that have tribal implications as defined in the Executive Order and, consequently, a tribal summary impact statement is not required.
Coast Guard, DHS.
Notice of deviation from drawbridge regulation.
The Coast Guard has issued a temporary deviation from the operating schedule that governs the Florida East Coast (FEC) Railroad Bridge across the St. Johns River, mile 24.9, at Jacksonville, FL. The deviation is necessary to accommodate maintenance and repairs on the bridge. This deviation allows the bridge to remain closed to navigation with partial openings at pre-determined times during the maintenance period.
This deviation is effective without actual notice March 16, 2018 through 11:59 p.m. on March 23, 2018. For the purposes of enforcement, actual notice will be used from 1 p.m. on March 10, 2018 through March 16, 2018.
The docket for this deviation, USCG-2018-0070 is available at
If you have questions on this temporary deviation, call or email LT Allan Storm, U.S. Coast Guard Sector Jacksonville, Waterways Management Division; telephone 904-714-7616, email
The owner of the bridge, Florida East Coast Railway, requested a temporary deviation. The existing operating racks were found damaged during maintenance. The Florida East Coast (FEC) Railroad Bridge across the St. Johns River, mile 24.9, at Jacksonville, Florida is a single-leaf bascule bridge with at vertical clearance of 5 feet at mean high water in the closed position. The existing bridge operating regulation is published in 33 CFR 117.325(b).
This temporary deviation allows the bridge to remain closed to navigation from 1 p.m. on March 10, 2018 through 7:59 a.m. on March 18, 2018. The bridge will be allowed to remain in the closed to navigation positon with partial openings from 8 a.m. to 9:30 a.m. on March 18, 2018; from 8:45 a.m. to 10:15 a.m. on March 19, 2018; from 9:45 a.m. to 11:15 a.m. on March 20, 2018; from 10:30 a.m. to 12 p.m. and 4:15 p.m. to 5:45 p.m. on March 21, 2018; from 11:30 a.m. to 1 p.m. and 5 p.m. to 6:30 p.m. on March 22, 2018; and from 12:15 p.m. to 1:45 p.m. and 6 p.m. to 7:30 p.m. on March 23, 2018. During these designated time periods, the bridge will provide a partial opening with a vertical clearance of 75 feet at mean high water at the center of the channel. This temporary deviation has been coordinated with 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 anytime. The bridge will not be able to open for emergencies and there is no immediate alternate route for vessels to pass. The Coast Guard will also inform the users of the waterways 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.
The Coast Guard has issued a temporary deviation from the operating schedule that governs the U.S. 70/Alfred C. Cunningham Bridge which carries U.S. 70 and East Front Street across the Trent River, mile 0.0, at New Bern, NC. The deviation is necessary to facilitate the 2018 Neuse River Bridge Run. This deviation allows the bridge to remain in the closed-to-navigation position.
The deviation is effective from 6:45 a.m. through 10 a.m. on Saturday, March 24, 2018.
The docket for this deviation, [USCG-2018-0144] is available at
If you have questions on this temporary deviation, call or email Mr. Michael Thorogood, Bridge Administration Branch Fifth District, Coast Guard, telephone 757-398-6557, email
The North Carolina Department of Transportation, owner and operator of the U.S. 70/Alfred C. Cunningham Bridge that carries U.S. 70 and East Front Street over the Trent River, mile 0.0, at New Bern, NJ, has requested a temporary deviation from the current operating regulations to ensure the safety of the participants and spectators associated with the 2018 Neuse River Bridge Run on Saturday, March 24, 2018. This bridge is a double bascule drawbridge, with a vertical clearance of 14 feet above mean high water in the closed position and unlimited vertical clearance in the open position.
The current operating regulation is set out in 33 CFR 117.843(a). Under this temporary deviation, the bridge will be maintained in the closed-to-navigation position from 6:45 a.m. through 10 a.m. on Saturday, March 24, 2018.
The Trent River is used by a variety of vessels including small commercial vessels and recreational vessels. The Coast Guard has carefully coordinated the restrictions with waterway users in publishing this temporary 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 for emergencies, if 5 minutes prior notification is given, and there is no immediate alternative route for vessels unable to pass through the bridge in the closed position. 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.
Temporary final rule.
The Coast Guard is establishing a temporary safety zone for all navigable waters of the Ohio River from mile marker (MM) 236 to MM 239. The safety zone is needed to provide for the safety of life and property due to severe out draft from high water that have rendered the Ohio River conditions to be hazardous to navigation. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port Sector Ohio Valley (COTP) or designated representative.
This rule is effective without actual notice from March 16, 2018 until March 30, 2018. For the purposes of enforcement, actual notice will be used from February 23, 2018 until March 16, 2018.
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 Petty Officer Caitlin Furman, Marine Safety Unit Huntington, U.S. Coast Guard; telephone 304-733-0198, 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 it is impracticable. On February 22, 2018, the United States Coast Guard was informed that the severe out draft on the Ohio River by Racine Lock and Dam is expected to rise significantly over the next couple of days and will continue to result in hazardous river conditions near the Letart, WV area. This severe out draft has resulted in commercial mariners not being able to maintain safe control of their tow as they begin their northbound or southbound approach into the Letart, WV area between mile marker (MM) 236 and MM 239 on the Ohio River. We must establish this safety zone by February 23, 2018 and lack sufficient time to provide a reasonable comment period and then consider those comments before issuing this rule.
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 Sector Ohio Valley (COTP) has determined that potential hazards associated with the current river conditions starting immediately 24 hours daily from February 23, 2018 through March 30, 2018, there will be a safety concern for anyone within mile marker (MM) 236 to MM 239 on the Ohio River, near Letart, West Virginia. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone while the power line crossing is being conducted.
This rule establishes a safety zone for 24 hours daily on February 23, 2018 through March 30, 2018. The safety zone will cover all navigable waters of the Ohio River from mile marker (MM) 236 to MM 239. The duration of the zone is intended to protect personnel, vessels, and the marine environment in these navigable waters while the power line crossing is being conducted. No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative. A designated representative means 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 Captain of the Port Sector Ohio Valley(COTP) in the enforcement of the safety zone.
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. Vessel traffic will not be able to safely transit around this safety zone which will impact a small designated area of the Ohio River from mile marker (MM) 236 to MM 239 for twenty-four hours daily for 36 days a time of year when vessel traffic is normally low. Moreover, the Coast Guard will issue Broadcast Notice to Mariners via VHF-FM marine channel 16 about the zone and the rule allows 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
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 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, which guides 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 lasting only nine and a half hours that will prohibit entry within mile marker (MM) 236 to MM 239 on the Ohio River. It is 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 (REC) will be made 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) To seek permission to enter, contact the COTP or designated representative via radio on channel 16.
(3) All persons and vessels shall comply with the instruction of the COTP and designated on-scene personnel.
(e)
Coast Guard, DHS.
Notice of enforcement of regulation.
The Coast Guard will enforce a segment of the Safety Zone: Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago Sanitary and Ship Canal, Chicago River, Calumet-Saganashkee Channel on all waters of the Main Branch of the Chicago River between Columbus Drive Bridge, mile marker 326.5, and Dearborn Street Bridge, mile marker 326.1. This action is necessary to prevent collisions between mariners and to facilitate safety during the dying of the Chicago River.
The regulations in 33 Code of Federal Regulations (CFR) 165.930 will be enforced from 7:30 a.m. to 9:30 a.m. on March 17, 2018.
If you have questions about this notice of enforcement, call or email LT John Ramos, Waterways Management Division, Marine Safety Unit Chicago, at 630-986-2155, email address
The Coast Guard will enforce a segment of the Safety Zone: Brandon Road Lock and Dam to Lake Michigan including Des Plaines River, Chicago Sanitary and Ship Canal, Chicago River, Calumet-Saganashkee Channel, Chicago, IL, listed in 33 CFR 165.930. Specifically, the Coast Guard will enforce this safety zone on all waters of the Main Branch of the Chicago River between Columbus Drive Bridge, mile marker 326.5, and Dearborn Street Bridge, mile marker 326.1. Enforcement will occur from 7:30 a.m. to 9:30 a.m. on March 17, 2018. During the enforcement period, no vessel may transit this regulated area without approval from the Captain of the Port Lake Michigan or a designated representative. Vessels and persons granted permission to enter the safety zone shall obey all lawful orders or directions of the Captain of the Port Lake Michigan, or his or her on-scene representative.
This notice of enforcement is issued under the authority of 33 CFR 165.930 and 5 U.S.C. 552(a). In addition to this publication in the
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; closure.
NMFS is prohibiting directed fishing for Pacific cod by catcher vessels greater than or equal to 50 feet length overall (LOA) using hook-and-line gear in the Central Regulatory Area of the Gulf of Alaska (GOA). This action is necessary to prevent exceeding the A season allowance of the 2018 Pacific cod total allowable catch apportioned to catcher vessels greater than or equal to 50 feet LOA using hook-and-line gear in the Central Regulatory Area of the GOA.
Effective 1200 hours, Alaska local time (A.l.t.), March 14, 2018, through 1200 hours, A.l.t., June 10, 2018.
Josh Keaton, 907-586-7228.
NMFS manages the groundfish fishery in the GOA exclusive economic zone according to the Fishery Management Plan for Groundfish of the Gulf of Alaska (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679. Regulations governing sideboard protections for GOA groundfish fisheries appear at subpart B of 50 CFR part 680.
The A season allowance of the 2018 Pacific cod total allowable catch (TAC) apportioned to catcher vessels greater than or equal to 50 feet LOA using hook-and-line gear in the Central Regulatory Area of the GOA is 338 metric tons (mt), as established by the final 2018 and 2019 harvest specifications for groundfish of the GOA (83 FR 8768, March 1, 2018).
In accordance with § 679.20(d)(1)(i), the Administrator, Alaska Region, NMFS (Regional Administrator) has determined that the A season allowance of the 2018 Pacific cod TAC apportioned to catcher vessels greater than or equal to 50 feet LOA using hook-and-line gear in the Central Regulatory Area of the GOA will soon be reached. Therefore, the Regional Administrator is establishing a directed fishing allowance of 278 mt and is setting aside the remaining 60 mt as bycatch to support other anticipated groundfish fisheries. In accordance with § 679.20(d)(1)(iii), the Regional Administrator finds that this directed fishing allowance has been reached. Consequently, NMFS is prohibiting directed fishing for Pacific cod by catcher vessels greater than or equal to 50 feet LOA using hook-and-line gear in the Central Regulatory Area of the GOA. After the effective date of this closure the maximum retainable amounts at § 679.20(e) and (f) apply at any time during a trip.
This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and
The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.
This action is required by § 679.20 and is exempt from review under Executive Order 12866.
16 U.S.C. 1801
Agricultural Marketing Service, USDA.
Notification of referendum order.
This document directs that a referendum be conducted among eligible producers and importers of Christmas trees to determine whether they favor continuance of the Agricultural Marketing Service's (AMS) regulations regarding a national Christmas tree research and promotion program.
The referendum will be conducted by mail ballot from May 1 through May 31, 2018. The Department will provide the option for ballots to be returned electronically. Further details will be provided in the ballot instructions. Ballots must be received by the referendum agents no later than the close of business on May 31, 2018, to be counted.
Copies of the Christmas tree program may be obtained from: Referendum Agent, Promotion and Economics Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW, Room 1406-S, Stop 0244, Washington, DC 20250-0244, telephone: (202) 720-9915; facsimile: (202) 205-2800; or contact Victoria Carpenter at (202) 720-6930 or via electronic mail:
Victoria Carpenter, Marketing Specialist, Promotion and Economics Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW, Room 1406-S, Stop 0244, Washington, DC 20250-0244; telephone: (202) 720-9915, (202) 720-6930 (direct line); facsimile: (202) 205-2800; or electronic mail:
Pursuant to the Commodity Promotion, Research, and Information Act of 1996 (7 U.S.C. 7411-7425) (1996 Act), it is hereby directed that a referendum be conducted to ascertain whether continuance of the Christmas Tree Promotion, Research, and Information Order (7 CFR part 1214) is favored by eligible domestic producers and importers of Christmas trees. The program is authorized under the 1996 Act.
The representative period for establishing voter eligibility for the referendum shall be the period from September 1, 2017 through March 15, 2018. Persons who domestically produced or imported more than 500 trees during the representative period, and were subject to assessments during that period are eligible to vote. Persons who received an exemption from assessments pursuant to § 1214.53 for the entire representative period are ineligible to vote. The referendum will be conducted by mail ballot from May 1 through May 31, 2018. The Department will provide the option for ballots to be returned electronically. Further details will be provided in the ballot instructions.
Section 518 of the 1996 Act (7 U.S.C. 7417) authorizes required referenda. Under § 1214.81(a) of 7 CFR part 1214, the U.S. Department of Agriculture (USDA) must conduct a referendum not later than three years after assessments first begin under the order to determine whether persons subject to assessment favor continuance of the program. Assessment collection began for the newly established program in 2015. USDA would continue the program if continuance is favored by a majority of producers and importers of Christmas trees voting in the referendum.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35), the referendum ballot has been approved by the Office of Management and Budget (OMB) and assigned OMB No. 0581-0093. It has been estimated that approximately 1,800 entities will be eligible to vote in the referendum. It will take an average of 15 minutes for each voter to read the voting instructions and complete the referendum ballot.
Victoria Carpenter, Marketing Specialist, and Heather Pichelman, Director, Promotion and Economics Division, Specialty Crops Program, AMS, USDA, Stop 0244, Room 1406-S, 1400 Independence Avenue SW, Washington, DC 20250-0244, are designated as the referendum agents to conduct this referendum. The referendum procedures at 7 CFR 1214.100 through 1214.108, which were issued pursuant to the 1996 Act, shall be used to conduct the referendum.
The referendum agent will mail the ballots to be cast in the referendum and voting instructions to all known, eligible domestic producers and importers prior to the first day of the voting period. Persons who domestically produced or imported 500 or more Christmas trees during the representative period, and were subject to assessment during that period, are eligible to vote. Persons who received an exemption from assessments pursuant to § 1214.53 during the entire representative period are ineligible to vote. Any eligible producer or importer who does not receive a ballot should contact the referendum agent no later than one week before the end of the voting period. Ballots must be received by the referendum agent by 4:30 p.m. Eastern time, May 31, 2018, in order to be counted.
Administrative practice and procedure, Advertising, Consumer information, Christmas trees, Marketing agreements, Reporting and recordkeeping requirements.
7 U.S.C. 7411-7425; 7 U.S.C. 7401.
National Labor Relations Board.
Request for information; extension of time to submit responses.
The National Labor Relations Board (the Board) published a Request for Information in the
Responses to the request for information published in the
Electronic responses may be submitted by going to
For any assistance, please contact Gary Shinners at (202) 273-3737 or Roxanne Rothschild at (202) 273-2971.
On December 15, 2014, the Board published the Election Rule, which amended the Board's prior Election Regulations. 79 FR 74308 (2014). The Election Rule was adopted after public comment periods in which tens of thousands of public comments were received. The Rule was approved by a three-member Board majority, with two Board members expressing dissenting views. The amendments adopted by the final rule became effective on April 14, 2015, and have been applicable to all representation cases filed on or after that date.
Coast Guard, DHS.
Request for comments.
The Coast Guard is reopening the public comment period on the request for comments on the potential establishment of Regulated Navigation Areas (RNAs) at the harbor entrance bars to Crescent Harbor, Humboldt Bay, Noyo River, and Morro Bay that published on February 8, 2018. The comment period ended on March 12, 2018. The Coast Guard did not receive any comments on the original request for comments and has decided to re-open the comment period to provide additional opportunity for informed public comment.
The comment period for the request for comments published at 83 FR 5592 has been reopened. Comments and related material must reach the Coast Guard on or before March 30, 2018.
You may submit comments identified by docket number USCG-2017-0338, as published at 83 FR 5592 on February 8, 2018, using the Federal portal at
If you have questions about this notice, call or email Lieutenant Colleen Ryan, Coast Guard District Eleven, Waterways Management; telephone 510-437-5984, email
On February 8, 2018, we published a request for comments entitled, “Regulated Navigation Areas; Harbor Entrances Along the Coast of Northern California” at 83 FR 5592. The comment period ended on March 12, 2018. The Coast Guard did not receive any comments on the original request for comments and has decided to re-open the comment period to provide additional opportunity for informed public comment. The Coast Guard will consider any comments that are received by the agency after the original March 12th closing date, but before the publication of this notice reopening the comment period.
As discussed in the original published request for comment, the Coast Guard seeks comments and information for agency consideration and to inform any future establishment of RNAs that would create bar closure conditions as well as regulate vessel bar transits during hazardous bar conditions for all recreational, commercial fishing, and passenger vessels. The Coast Guard requests and encourages open discussion and candid feedback on the possibility of establishing RNAs for Crescent City, Humboldt Bay, Noyo River, and Morro Bay harbor bar entrances. The following considerations warrant special attention:
• Weather and sea conditions at the bars that the maritime community considers a risk to safe navigation for recreational vessels, passenger vessels, fishing vessels and deep draft vessel;
• The economic impact of bar closures and restrictions on the maritime community; and
• Preferred methods of notification for bar restrictions and closures.
We encourage you to submit comments through the Federal portal at
We accept anonymous comments. All comments received will be posted without change to
All public comments will be available in our online docket at
National Park Service, Interior.
Proposed rule.
The National Park Service proposes to promulgate special regulations for Pea Ridge National Military Park to allow bicycle use on two proposed multi-use trails located within the park. One trail will be approximately 0.55 miles in length and the other will be approximately 1.17 miles in length. Both trails will require trail construction activities to accommodate bicycles and are therefore considered new trails that will be opened to bicycles. National Park Service regulations require promulgation of a special regulation to designate new trails for bicycle use off park roads and outside developed areas.
Comments on the proposed rule must be received by 11:59 p.m. EST on May 15, 2018.
You may submit comments, identified by Regulation Identifier Number (RIN) 1024-AE41, by either of the following methods:
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Lee Terzis, NPS Denver Service Center Transportation Division, 1155 E Pearl St., Monticello, FL 32344. Phone (850) 997-9972. Email:
Pea Ridge National Military Park (the park), established in 1956 and opened to the public in 1963, preserves and commemorates the site of the March 1862 Civil War battle that helped Union forces maintain physical and political control of the State of Missouri. Administered by the National Park Service (NPS), the 4,300-acre battlefield is situated in the foothills of the Ozark Mountains 10 miles north of Rogers, Arkansas, just off of U.S. Highway 62. The park is divided into two sections: The main portion of the park is located north of U.S. Highway 62 and encompasses a majority of the historic battleground. The main portion consists of a dedicated series of soft surface trails for equestrians and pedestrians, as well as the tour road, which bicyclists share with vehicle users. The second, smaller portion is located to the south of U.S. Highway 62 along the bluffs of Little Sugar Creek and contains the Federal Trenches of the Union troops. This non-contiguous section is currently accessible from a small parking lot along Sugar Creek Road, which intersects with U.S. Highway 62, with a trail leading to the trenches.
The park contains a portion of the northern route of the Trail of Tears that is one of the few places the Trail of Tears passes through Arkansas. Eleven Cherokee Removal contingents used this route from 1837 to 1839. Through the park, the Trail of Tears generally followed the route of Telegraph Road, which is eligible for the National Register of Historic Places.
The park contains an existing road and trail system (including the Federal Trenches trail) that provides pedestrians, hikers, bicyclists, and equestrians with interpretive and recreational opportunities. This system consists of a total of 32 miles of trail, including 7.6 miles of asphalt trail, 13.9 miles of off-road hiking trail, and 10.8 miles of horse trail. Bicycles are allowed on roads but not on trails within the park.
The area surrounding the park—including local communities such as Pea Ridge, Garfield, Bentonville, Rogers, Springdale, and Fayetteville—has experienced dynamic population growth in recent years. Increased visitation to the park has created a need to improve the existing road and trail system to better accommodate travel through the park by various methods (
In November 2017, the NPS published the Pea Ridge National Military Park Trail Master Plan/Environmental Assessment (EA). The EA evaluates two action alternatives that are designed to improve visitor access to the park's historical and interpretive sites while avoiding or minimizing impacts to these sites by consolidating and restructuring the existing trail network. These alternatives also seek to improve multi-modal trail connections within the park while linking to a regional trail network outside of the park. Under both action alternatives, the NPS would expand and enhance opportunities for pedestrian trail interpretation, construct additional trailheads, modify trail loops for simplicity and interpretive value, construct additional ADA-accessible trails, install signage for the Trail of Tears, improve multi-use trails, and improve equestrian trails to avoid erosion-prone areas. These actions will meet the increasing recreational needs of the area while protecting the cultural and natural resources within the park.
The EA identifies one of the action alternatives as the NPS preferred alternative. This alternative would allow bicycle use on two proposed multi-use trails that would require trail construction activities. The first would be a 0.55-mile trail from U.S. Highway 62 to the visitor center. The second would be a 1.17-mile trail from Arkansas Highway 72 to the Sugar Creek Greenway on the western edge of the park. Bicycles would also be allowed on Ford Road, which is closed to motor vehicle use by the public, but open to motor vehicle use for administrative purposes. Bicycles would also be allowed on segments of the Tour Road, which is paved and open to motor vehicle use by the public.
With respect to the proposed bike trails, the EA evaluates (i) the suitability of the trails for bicycle use; and (ii) life cycle maintenance costs, safety considerations, methods to prevent or minimize user conflict, and methods to protect natural and cultural resources and mitigate impacts associated with bicycle use on the trails. The EA, which contains a full description of the purpose and need for taking action, scoping, the alternatives considered, maps, and the environmental impacts associated with the project, may be viewed on the park's planning website at
This proposed rule would implement the preferred alternative in the EA and authorize the Superintendent to designate bicycle use on the two trails described above. In order to accommodate bicycles, both trails will require construction activities that will be conducted in accordance with sustainable trail design principles and guidelines. NPS regulations at 36 CFR 4.30 require a special rule to designate these trails for bicycles use because they are located outside of developed areas. Bicycle use would not be authorized by the Superintendent until the trail construction activities are completed.
The proposed rule would add a new section 7.95 to 36 CFR part 7—Special Regulations, Areas of the National Park System for the park. The proposed rule would require the Superintendent to notify the public of trail designation for bicycle use and identify the designation on maps available in the office of the Superintendent and other places convenient to the public. The rule would also authorize the Superintendent to establish closures, conditions, or restrictions for bicycle use on designated trails in accordance with 36 CFR 4.30. After notifying the public, the Superintendent would be able to take these actions for reasons of public health and safety, natural and cultural resource protection, and other management activities and objectives.
Executive Order 12866 provides that the Office of Information and Regulatory Affairs in the Office of Management and Budget will review all significant rules. The Office of Information and Regulatory Affairs has determined that this rule is not significant.
Executive Order 13563 reaffirms the principles of Executive Order 12866 while calling for improvements in the nation's regulatory system to promote predictability, to reduce uncertainty, and to use the best, most innovative, and least burdensome tools for achieving regulatory ends. The executive order directs agencies to consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice for the public where these approaches are relevant, feasible, and consistent with regulatory objectives. Executive Order 13563 emphasizes further that regulations must be based on the best available science and that the rulemaking process must allow for public participation and an open exchange of ideas. The NPS has developed this rule in a manner consistent with these requirements.
This rule is not an E.O. 13771 regulatory action because this rule is not significant under Executive Order 12866.
This rule will not have a significant economic effect on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
This rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. This rule:
(a) Does not have an annual effect on the economy of $100 million or more.
(b) Will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions.
(c) Does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises.
This rule does not impose an unfunded mandate on State, local, or tribal governments or the private sector of more than $100 million per year. The rule does not have a significant or unique effect on State, local or tribal governments or the private sector. It addresses public use of national park lands, and imposes no requirements on other agencies or governments. A statement containing the information required by the Unfunded Mandates Reform Act (2 U.S.C. 1531
This rule does not effect a taking of private property or otherwise have takings implications under Executive Order 12630. A takings implication assessment is not required.
Under the criteria in section 1 of Executive Order 13132, the rule does not have sufficient federalism implications to warrant the preparation of a Federalism summary impact statement. This proposed rule only affects use of federally-administered lands and waters. It has no outside effects on other areas. A Federalism summary impact statement is not required.
This rule complies with the requirements of Executive Order 12988. This rule:
(a) Meets the criteria of section 3(a) requiring that all regulations be reviewed to eliminate errors and ambiguity and be written to minimize litigation; and
(b) Meets the criteria of section 3(b)(2) requiring that all regulations be written in clear language and contain clear legal standards.
The Department of the Interior strives to strengthen its government-to-government relationship with Indian Tribes through a commitment to consultation with Indian Tribes and recognition of their right to self-governance and tribal sovereignty. The NPS has evaluated this rule under the criteria in Executive Order 13175 and under the Department's tribal consultation policy and has determined that tribal consultation is not required
Nevertheless, the NPS recognizes that the park contains significant archeological sites and the Trail of Tears, which are considered very important to the following tribes: Absentee Shawnee Tribe, Cherokee Nation of Oklahoma, Jena Band of the Choctaw Indians, The Osage Nation, Shawnee Tribe of Oklahoma, Quapaw Tribe of Oklahoma, United Keetoowah Band of Cherokee Indians, The Chickasaw Nation, Caddo Nation, and the Muscogee (Creek) Nation. The park consulted with these tribes throughout the development of the EA and incorporated comments by adjusting proposed trails to mitigate or avoid impacts to these areas of interest.
This rule does not contain information collection requirements, and a submission to the Office of Management and Budget under the Paperwork Reduction Act is not required. The NPS may not conduct or sponsor and you are not required to respond to a collection of information unless it displays a currently valid OMB control number.
The NPS has prepared the EA to determine whether this rule will have a significant impact on the quality of the human environment under the National Environmental Policy Act of 1969. A copy of the EA can be found online at
This rule is not a significant energy action under the definition in Executive Order 13211. A Statement of Energy Effects in not required.
The NPS is required by Executive Orders 12866 (section 1(b)(12)) and 12988 (section 3(b)(1)(B)), and 13563 (section 1(a)), and by the Presidential Memorandum of June 1, 1998, to write all rules in plain language. This means that each rule the NPS publishes must:
(a) Be logically organized;
(b) Use the active voice to address readers directly;
(c) Use common, everyday words and clear language rather than jargon;
(d) Be divided into short sections and sentences; and
(e) Use lists and tables wherever possible.
If you feel that the NPS has not met these requirements, send the NPS comments by one of the methods listed in the
It is the policy of the Department of the Interior, whenever practicable, to afford the public an opportunity to participate in the rulemaking process. Accordingly, interested persons may submit written comments regarding this proposed rule by one of the methods listed in the
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 the NPS in your comment to withhold your personal identifying information from public review, the NPS cannot guarantee that it will be able to do so.
District of Columbia, National parks, Reporting and recordkeeping requirements.
In consideration of the foregoing, the National Park Service proposes to amend 36 CFR part 7 as set forth below:
54 U.S.C. 100101, 100751, 320102; Sec. 7.96 also issued under D.C. Code 10-137 and D.C. Code 50-2201.07.
(a)
(i) A trail from U.S. Highway 62 to the visitor center (approximately 0.55 miles).
(ii) A trail from Arkansas Highway 72 to the Sugar Creek Greenway on the western edge of the park (approximately 1.17 miles).
(2) A map showing trails open to bicycle use will be available at park visitor centers and posted on the park website. The Superintendent will provide notice of all bicycle route designations in accordance with § 1.7 of this chapter. The Superintendent may limit, restrict, or impose conditions on bicycle use, or close any trail to bicycle use, or terminate such conditions, closures, limits, or restrictions in accordance with § 4.30 of this chapter.
(b) [Reserved]
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to approve a request from the New Hampshire Department of Environmental Services (NH DES) for delegation of authority to implement and enforce the Federal Plan Requirements for Sewage Sludge Incineration Units Constructed on or before October 14, 2010 (SSI Federal Plan). under Clean Air Act (CAA).
Written comments must be received on or before April 16, 2018.
Submit your comments, identified by Docket ID No. EPA-R01-OAR-2018-0069 at
Patrick Bird, Air Permits, Toxic, & Indoor Programs Unit, U.S. Environmental Protection Agency, Region 1, 5 Post Office Square—Suite 100, Mail Code: OEP05-2, Boston, MA 02109-3912, tel. (617) 918-1287, email
Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA.
The EPA is proposing to approve the NH DES request for delegation of authority to implement and enforce the SSI Federal Plan found at 40 CFR part 62 subpart LLL and to adhere to the terms and conditions prescribed in the Memorandum of Agreement (MoA) signed by the EPA and the NH DES, as further explained further in this action. The purpose of this SSI Federal Plan delegation is to transfer primary implementation and enforcement responsibility from the EPA to the NH DES for all affected facilities within the jurisdiction of the State of New Hampshire. However, nothing in this action, nor in the MoA, shall be construed to prohibit the EPA from enforcing the SSI Federal Plan.
Sections 111(d) and 129 of the CAA require states to submit plans to control certain pollutants (designated pollutants) at existing solid waste combustor facilities (designated facilities) whenever standards of performance have been established under section 111(b) for new sources of the same type and the EPA has established emission guidelines for such existing sources. A designated pollutant is any pollutant for which no air quality criteria has been issued or which is not included on a list published under section 108(a) (national ambient air quality standards) or section 112 (hazardous air pollutants) of the CAA, but emissions of which would be subject to a standard of performance for new stationary sources under section 111(b). In addition, section 129 of the CAA also requires the EPA to promulgate emission guidelines for solid waste incineration units that emit specific air pollutants or a mixture of air pollutants. These pollutants include organics (dioxins and dibenzofurans), carbon monoxide, metals (cadmium, lead and mercury), acid gases (hydrogen chloride, sulfur dioxide and oxides of nitrogen), particulate matter and opacity (as appropriate).
On March 21, 2011 (76 FR 15372), the EPA promulgated new source performance standards and emission guidelines for sewage sludge incineration (SSI) units at 40 CFR part 60 subparts LLLL and MMMM, respectively. The designated facility to which the emission guidelines applies is existing SSI units, as stipulated in subpart MMMM, that commenced construction on or before October 14, 2010.
Pursuant to section 129 of the CAA, state plan requirements must be “at least as protective” as the emission guidelines and become federally enforceable upon approval by the EPA. The procedures for adoption and submittal of state plans are codified in 40 CFR part 60, subpart B. For states that fail to submit a plan, the EPA is required to develop and implement a Federal Plan within two years following promulgation of the emission guidelines. The EPA implementation and enforcement of the Federal Plan is viewed as an interim measure until states assume their role as the preferred implementers of the emission guidelines requirements stipulated in the Federal Plan. Accordingly, the EPA promulgated the SSI Federal Plan on April 29, 2016. In this rulemaking, the EPA strongly encouraged state and local agencies in jurisdictions that did not submit approvable State Plans to request delegation of the SSI Federal Plan so that they can have the primary responsibility for implementing and enforcing regulations affecting existing source SSI unit, consistent with the intent of section 129 of the CAA.
On November 14, 2017, the NH DES submitted to the EPA a request for delegation of authority to implement and enforce the SSI Federal Plan. The EPA evaluated the NH DES request for delegation pursuant to the provisions of the SSI Federal Plan and the EPA's Delegation Manual.
In parallel with our review of the delegation request, the EPA prepared the MoA which defines the policies, responsibilities, and procedures by which the SSI Federal Plan will be administered by both the NH DES and the EPA. The MoA is the mechanism for the transfer of responsibility from the EPA to the NH DES.
Both the EPA and the NH DES signed the MoA in which the parties agreed to the terms and conditions regarding the responsibility to implement and enforce the policies, responsibilities and procedures of the SSI Federal Plan. The MoA became effective upon signature by the EPA on December 22, 2017.
Under the EPA's Delegation Manual, item 7-139, the Regional Administrator is authorized to delegate implementation and enforcement of sections 111(d)/129 Federal Plans to state environmental agencies. The Regional Administrator may consider delegating authority to implement and enforce Federal Plans to a state provided the following conditions are met: (1) The state does not already have an EPA approved State Plan; (2) the state submits a demonstration of adequate resources and legal authority to administer and enforce the Federal Plan; and (3) the state enters into a MoA with the Regional Administrator that sets forth the terms, conditions and effective date of the delegation and that serves as the mechanism for the transfer of authority.
NH DES has met all of the EPA's delegation requirements as described above. The reader may view the NH DES letter to the EPA requesting delegation and the MoA signed by both parties at
The EPA has evaluated the NH DES submittal for consistency with the CAA, EPA regulations, and EPA policy. The NH DES has met all the requirements of the EPA's guidance for obtaining delegation of authority to implement and enforce the SSI Federal Plan. The NH DES entered into a MoA with the EPA, and it became effective on December 22, 2017. Accordingly, the EPA is proposing to approve the NH DES request dated November 14, 2017 for delegation of authority to implement and enforce the Federal Plan for existing SSI units. The EPA will continue to retain certain specific authorities reserved to the EPA in the SSI Federal Plan and as indicated in the MoA (
Under the Clean Air Act, the Administrator is required to approve a state plan submission that complies with the provisions of the CAA section 111(d) and 129(b)(2) and applicable Federal regulations. 42 U.S.C. 7411(d) and 7429(b)(2); 40 CFR 62.02(a). Thus, in reviewing state plan submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves a state delegation request as meeting Federal requirements and does not impose additional requirements beyond those already imposed by state law. For that reason, this action:
• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• 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 Clean Air Act; and
• Does not provide 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, this rulemaking does not apply on any Indian reservation land or in any other area where 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).
Environmental protection, Air pollution control, Administrative practice and procedure, Carbon monoxide, Intergovernmental relations, Lead, Nitrogen dioxide, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Waste treatment and disposal.
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA or the Agency) is proposing to add hazardous waste aerosol cans to the universal waste program under the federal Resource Conservation and Recovery Act (RCRA) regulations. This proposed change, once finalized, would benefit the wide variety of establishments generating and managing hazardous waste aerosol cans, including the retail sector, by providing a clear, protective system for managing discarded aerosol cans. The streamlined universal waste regulations are expected to ease regulatory burdens on retail stores and others that discard hazardous waste aerosol cans; promote the collection and recycling of these cans; and encourage the development of municipal and commercial programs to reduce the quantity of these wastes going to municipal solid waste landfills or combustors.
Comments must be received on or before May 15, 2018. Under the Paperwork Reduction Act (PRA), comments on the information collection provisions are best assured of consideration if the Office of Management and Budget (OMB) receives a copy of your comments on or before April 16, 2018.
Submit your comments, identified by Docket ID No. EPA-HQ-
Tracy Atagi, Office of Land and Emergency Management (5304P), Environmental Protection Agency, 1200 Pennsylvania Avenue NW, Washington, DC 20460; telephone number: 703-308-8672; email address:
This proposed rulemaking would affect persons who generate, transport, treat, recycle, or dispose of hazardous waste aerosol cans, herein referred to as aerosol cans, unless those persons are households or very small quantity generators (VSQGs). Entities potentially affected by this action include over 18,000 industrial facilities in 18 different industries (at the 2-digit North American Industry Classification System (NAICS) code level). Most of these industries have relatively few entities that are potentially affected. The two top economic sectors (at the 2-digit NAICS code level) with the largest percentage of potentially affected entities are the retail trade industry (NAICS code 44-45), representing 65% of the affected Large Quantity Generator universe, and Manufacturing (NAICS code 31-33), representing 20% of the affected Large Quantity Generator universe. Potentially affected categories and entities include, but are not necessarily limited to:
This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be regulated by this action. This table lists the types of entities that EPA is now aware could potentially be regulated by this action. Other entities not listed in the table could also be regulated. To determine whether your entity is regulated by this action, you should carefully examine the applicability criteria found in Section IV of this action. If you have questions regarding the applicability of this action to a particular entity, consult the person listed in the
The Environmental Protection Agency (EPA) is proposing to add hazardous waste aerosol cans to the list of universal wastes regulated under the Resource Conservation and Recovery Act (RCRA) regulations. This proposed change, once finalized, would benefit the wide variety of establishments generating and managing aerosol cans, including the retail sector, by providing a clear, practical system for handling discarded aerosol cans.
These regulations are proposed under the authority of sections 2002(a), 3001, 3002, 3004, and 3006 of the Solid Waste Disposal Act, as amended by the Resource Conservation and Recovery Act (RCRA), and as amended by the Hazardous and Solid Waste Amendments (HSWA), 42 U.S.C. 6921(a), 6921, 6922, 6924, and 6926.
This proposed action, if finalized as proposed, is expected to result in an annual cost savings of $3.0 million to $63.3 million. Information on the estimated future economic impacts of this action is presented in Section VII of this notice, as well as in the Regulatory Impact Analysis (RIA) available in the docket for this proposed action. Note
In addition to cost savings, EPA's analysis shows qualitative benefits to adding aerosol cans to the universal waste program, including improved implementation of and compliance with the hazardous waste program and increased recovery and recycling of aerosol cans.
Aerosol cans are widely used for dispensing a broad range of products including paints, solvents, pesticides, food and personal care products, and many others. The Consumer Specialty Products Association (CSPA) estimates that 3.82 billion aerosol cans were filled in the United States in 2015 for use by commercial and industrial facilities as well as by households.
A typical aerosol can consists of several components, including (but not limited to): (1) The can or container storing both propellant and the product; (2) an actuator or button at the top of the can that is pressed to deliver the product; (3) a valve which controls delivery or flow of the product; (4) the propellant (a compressed gas or liquefied gas), which provides the pressure in the container to expel or release the product when the actuator is pressed to open the valve; (5) the product itself; and (6) a dip tube which is connected to the valve to bring the product up through the can to be released when the actuator is pressed.
The can itself is typically a small steel or aluminum container, designed to be hand-held, which is sealed with its contents under pressure. The can's design is intended to prevent unwanted releases of the contents to the environment under normal handling and storage conditions. However, when aerosol cans are mismanaged, particularly when exposed to excessive heat, the resulting increase in internal pressure can reach a point beyond the design strength of the can, thereby causing it to burst and release its contents. At the point of bursting, the contents of the can have been heated to a temperature and pressure far above ambient environmental conditions, causing the contents to rapidly vaporize and be forcefully released. One or more of the following may occur when a can bursts as a result of over-heating: (1) If the propellant or product are ignitable, the contents of the can may readily catch fire as they are released and exposed to atmospheric oxygen, creating a rapidly burning vapor “fireball”; (2) the bottom of the can may detach as a result of a manufacturing defect or an external force, causing the upper part of the can to become a projectile; or (3) the can may fragment as it bursts, releasing metal shards.
Aerosol cans frequently contain flammable propellants such as propane or butane which can cause the aerosol can to demonstrate the hazardous characteristic for ignitability (40 CFR 261.21).
Any person who generates a solid waste, as defined in 40 CFR 261.2, must determine whether the solid waste qualifies as hazardous waste. The waste may be hazardous either because it is listed as a hazardous waste in subpart D of 40 CFR part 261 or because it exhibits one or more of the characteristics of hazardous waste, as provided in subpart C of 40 CFR part 261. As discussed above, aerosol cans are frequently hazardous due to the ignitability characteristic, and in some cases may also contain listed or exhibit other hazardous waste characteristics.
Many, but not all, generators of aerosol cans identified or listed as a hazardous waste are subject to the full RCRA subtitle C hazardous waste management requirements, including all applicable requirements of 40 CFR parts 260 through 268. Depending on their activities, some generators have only to meet the requirements of part 262, including on-site management, pre-transport, and manifesting. Under 40 CFR 262.14, very small quantity generators (VSQGs), defined as facilities that generate less than or equal to 100 kilograms of hazardous waste in a calendar month, are not subject to the RCRA subtitle C hazardous waste management standards, provided they send their waste to a municipal solid waste landfill or non-municipal nonhazardous waste facility approved by the state for the management of VSQG wastes and meet other conditions. In addition, households that generate waste aerosol cans are exempt from the federal hazardous waste management requirements under the household hazardous waste exemption in 40 CFR 261.4(b)(1).
Facilities that treat, store, and/or dispose of hazardous waste aerosol cans are subject to the requirements of 40 CFR part 264 (for permitted facilities), or the requirements of 40 CFR part 265 (for interim status facilities). However, when hazardous waste aerosol cans are recycled, the recycling process itself is not subject to regulation, except as indicated in 40 CFR 261.6(d). EPA has interpreted the current hazardous waste regulations to mean that puncturing and draining an aerosol can, if performed for the purpose of recycling (
Hazardous waste aerosol cans that contain pesticides are also subject to the requirements of Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), including compliance with the instructions on the label. In general, the statement on aerosol pesticide product FIFRA labels prohibits the puncturing of the cans. However, in April 2004, EPA
• The puncturing of the container is performed by a person who, as a general part of his or her profession, performs recycling and/or disposal activities;
• The puncturing is conducted using a device specifically designed to safely puncture aerosol cans and effectively contain the residual contents and any emissions thereof; and
• The puncturing, waste collection, and disposal, are conducted in compliance with all applicable federal, state and local waste (solid and hazardous waste) and occupational safety and health laws and regulations.
EPA anticipates that this 2004 FIFRA determination would not be affected by the proposed addition of hazardous waste aerosol cans to the universal waste rules.
The retail sector as a whole handles a very large number of diverse products, which change over time and may, in many instances, become regulated as hazardous waste under RCRA when discarded. As a result, retailers are required to make hazardous waste determinations for a variety of products being discarded at stores located across the country.
In 2014, EPA published a Notice of Data Availability (NODA) for the Retail Sector as part of the Agency's continuing efforts to better understand concerns from all stakeholders regarding RCRA's applicability to the retail sector, as well as to obtain information and feedback on issues affecting the retail sector. (79 FR 8926, February 14, 2014) In the NODA, EPA requested comment on a series of topics related to retail operations, waste management practices and management of materials that may become hazardous waste when discarded. This specifically included requests for information regarding aerosol cans (
In response to comments on the Retail Sector NODA, the Agency published the
In 1995, EPA promulgated the universal waste rule (60 FR 25492, May 11, 1995) to establish a streamlined hazardous waste management system for widely generated hazardous wastes as a way to encourage environmentally sound collection and proper management of the wastes within the system. Hazardous waste batteries, certain hazardous waste pesticides, mercury-containing equipment, and hazardous waste lamps are already included on the federal list of universal wastes. The universal waste regulations in 40 CFR part 273 are a set of alternative hazardous waste management standards that operate in lieu of regulation under 40 CFR parts 260 through 272 for specified hazardous wastes.
Handlers and transporters who generate or manage items designated as a universal waste are subject to the management standards under 40 CFR part 273, rather than the full RCRA subtitle C regulations. Handlers include both facilities that generate universal waste and facilities that receive universal waste from other universal waste handlers, accumulate the universal waste and then send the universal waste to another handler, a destination facility or a foreign destination. Handlers do not include facilities that treat, dispose of, or recycle universal waste except as provided in the universal waste regulations. The regulations distinguish between “large quantity handlers of universal waste” (those who handle more than 5,000 kilograms of total universal waste at one time) and “small quantity handlers of universal waste” (those who handle 5,000 kilograms or less of universal waste at one time). The 5,000-kilogram accumulation criterion applies to the quantity of all universal wastes accumulated. The streamlined standards include requirements for storage, labeling and marking, preparing the waste for shipment off site, employee training, response to releases, and, in the case of large quantity handlers, notification and tracking of universal waste shipments. Transporters of universal waste are also subject to less stringent requirements than the full subtitle C hazardous waste transportation regulations. The primary difference between the universal waste transporter requirements and the subtitle C transportation requirements is that no manifest is required for transport of universal waste.
Under the universal waste rule, destination facilities are those facilities that treat, store, dispose, or recycle universal wastes. Universal waste destination facilities are subject to all currently applicable requirements for hazardous waste treatment, storage, and disposal facilities (TSDFs) and must receive a RCRA permit for such activities. Destination facilities that recycle universal waste and that do not store that universal waste prior to recycling in accordance with 40 CFR 261.6(c)(2) may be exempt from permitting under the federal regulations (see 40 CFR 273.60(b)). Finally, some states are authorized to add wastes that are not federal universal wastes to their lists of universal wastes. Therefore, in some states, aerosol cans are already regulated as a universal waste.
Four states, California, Colorado, Utah and New Mexico, already have universal waste aerosol can programs in place, and two more states, Ohio and Minnesota, have proposed to add aerosol cans to their universal waste regulations.
The aerosol can universal waste programs of California, Colorado, Utah and New Mexico, as well as Ohio's proposed aerosol can universal waste program, allow for puncturing and draining of aerosol cans by universal
EPA is proposing to add aerosol cans to the universal waste rule, because the Agency believes that this waste meets the factors that describe hazardous waste that is appropriate for management under the streamlined universal waste system. Adding aerosol cans to the universal waste rule simplifies handling and disposal of the wastes for generators, while ensuring that aerosol cans are sent to the appropriate destination facilities, where they will be managed as a hazardous waste with all applicable subtitle C requirements. Management as universal waste under the proposed requirements is also expected to facilitate environmentally sound recycling of the metal used to make the cans. The universal waste regulations include eight factors to consider in evaluating whether a waste is appropriate for inclusion in the universal waste rule. These factors, codified at 40 CFR 273.81, are to be used to determine whether regulating a particular hazardous waste under the streamlined standards would improve overall management of the waste and, therefore, whether the waste is a good candidate for the universal waste rule. As the Agency noted in the preamble to the final universal waste rule (60 FR 25513), not every factor must be met for a waste to be appropriately regulated under the universal waste system. However, consideration of all the factors should result in a conclusion that regulating a particular hazardous waste under 40 CFR part 273 will improve waste management. EPA has examined information on aerosol cans, including information submitted in the public comments on the 2014 Retail NODA,
As discussed in Section III, aerosol cans frequently demonstrate the hazardous characteristic for ignitability (40 CFR 261.21) due to the nature of the propellant used. In addition, the contents (propellant or product) may also cause the can to be a hazardous waste for other reasons if discarded.
EPA has documented in the Regulatory Impact Analysis (RIA) developed for this proposal, that large and small quantity generators that manage hazardous waste aerosol cans can be found in 18 different industries (at the 2-digit North American Industry Classification System (NAICS) code level). Thus, aerosol cans are commonly generated by a wide variety of types of establishments, including households, retail and commercial businesses, office complexes, very small quantity generators, small businesses, government organizations, as well as large industrial facilities.
As documented in the RIA, more than 18,000 large and small quantity generators manage hazardous waste aerosol cans. Quantities generated vary depending on the type of generator and the situations associated with generation. For example, a retail store may determine that large quantities of aerosol cans, which can no longer be sold or donated, must be discarded as hazardous waste. On the other hand, entities that use aerosol cans in their day-to-day operations may generate small quantities of partially-used hazardous waste aerosol cans on a sporadic basis. Data from the RIA demonstrate that in 2015, large quantity generators that generated hazardous waste aerosol cans generated an average of 1.8 tons per year (approximately 4,100 cans), while small quantity generators generated an average of 0.5 tons per year (approximately 1,100 cans). The median amounts are 0.12 tons (approximately 274 cans) and 0.04 tons (approximately 85 cans) for large quantity generators and small quantity generators respectively, per year.
The baseline universal waste requirements of notification, labeling, training, response to releases found in 40 CFR part 273 subparts B and C and the proposed specific requirements for management of aerosol cans in 40 CFR 273.13 and 40 CFR 273.33 as discussed Section IV below are designed to ensure close stewardship of the hazardous waste aerosol cans.
Aerosol cans are designed to contain the products they hold during the periods of storage and transportation as they move from the manufacturer, to the retailer, and ultimately to the final customer. As long as they remain intact, therefore, EPA expects that hazardous waste aerosol cans would present a lower risk as compared to other types of hazardous waste that are not contained as-generated under normal management conditions. In addition, the ignitability risk posed during accumulation and transport is addressed by standards set by the Department of Transportation, Office of Safety and Health Administration, and local fire codes.
Finally, as discussed below, the proposed management standards for aerosol cans that are punctured and drained at the handler would address the ignitability risk, and help prevent releases, and thus EPA believes that the risks posed by the activities proposed are addressed by the universal waste designation.
Managing hazardous waste aerosol cans under the universal waste program is expected to increase the number of these items collected, and to increase the number of aerosol cans being diverted from the non-hazardous waste stream into the hazardous waste stream because it would allow generators, especially those that generate this waste sporadically, to send it to a central consolidation point. Under the universal waste rule, a handler of universal waste can send the universal waste to another handler, where it can be consolidated into a larger shipment for transport to a destination facility. Therefore, under the proposed rule it would be more economical to send hazardous waste aerosol cans to recycling for recovery of metal values. EPA thus expects such management to not only advance the RCRA goal of increased resource conservation, but also to increase proper disposal as hazardous waste, making it less likely that it will be sent for improper disposal in municipal landfills or municipal incinerators. In addition, because of the streamlined structure of the universal waste rule makes aerosol can collection programs more economical, hazardous waste aerosol cans that might otherwise be sent to a municipal landfill under a VSQG or household hazardous waste exemption, would be more easily collected and consolidated for hazardous waste disposal by those who are interested in managing it this way. This waste would be diverted from the municipal solid waste stream to universal waste management.
The structure and requirements of the universal waste rule are well suited to the circumstances of handlers of hazardous waste aerosol cans and their participation in the universal waste program will improve compliance with the hazardous waste regulations. In particular, handlers of hazardous waste aerosol cans who are infrequent generators of hazardous waste and who might otherwise be unfamiliar with the more complex subtitle C management structure, but who generate hazardous waste aerosol cans will be able to more easily send this waste for proper management. Therefore, adding aerosol cans to the universal waste rule would offer a protective hazardous waste management system that is likely to be more accessible, particularly for the retail sector, which can pose unique compliance challenges as compared to manufacturing and other “traditional” RCRA-regulated sectors.
As discussed above, the factors included in 40 CFR 273.81 are designed to determine whether regulating a particular hazardous waste under the streamlined standards of the universal waste rules would improve the overall management of the waste. Because in this case, as at least four states have added aerosol cans to their universal waste programs, those states' experiences with management of aerosol cans under their respective universal waste programs provides a useful source of information to inform EPA's judgment on whether to propose adding aerosol cans to the national universal waste program.
Information supplied to EPA from those states' officials indicates that their programs improve the implementation of the hazardous waste program. Specifically, State waste management officials have represented to EPA that these programs have been operating well and achieving their objective of facilitating safe management of hazardous waste aerosol cans.
If EPA's proposal to include aerosol cans in the list of Universal Waste is finalized as proposed, EPA expects that the number of aerosol cans that are diverted from municipal solid waste landfills and incinerators to recycling or disposal in subtitle C facilities would increase. Small and large quantity generators are already required to manage their hazardous waste aerosol cans under RCRA subtitle C. As a result of implementation of this rule in the states, some of these generators would likely begin managing their aerosol cans as a universal waste, either to save money or to improve implementation of their existing waste management program. One of the streamlined provisions of the universal waste rule allows consolidation of aerosol cans at central locations, which makes it easier for smaller users to arrange for hazardous waste recycling or disposal of these materials when they are generated. EPA intends to encourage individual households and VSQGs to participate in such programs, which would divert aerosol cans from the municipal waste stream.
In summary, EPA believes that management of hazardous waste aerosol cans can best be implemented through a universal waste approach where handlers are operating within a simple, streamlined management system with some limited oversight. The universal waste program addresses the environmental concerns surrounding the management of such wastes, while at the same time putting into place a structure that will allow for and encourage increased collection of aerosol cans for recycling.
EPA is proposing that an “aerosol can” be defined as an intact container
EPA also intends this definition to be limited to sealed containers whose intended use is to dispense a material by means of a propellant or compressed gas. Aerosol cans are designed to contain those materials until they are intended for release and to present minimal risk during normal storage and transport. Other types of containers, including compressed gas canisters and propane cylinders, present a greater risk than aerosol cans and would not be included.
Utah's definition of aerosol cans includes a size limitation of twenty-four ounces for aerosol cans that would qualify under their universal waste provisions. EPA has not, however, included a size limitation on universal waste aerosol cans in this proposal because EPA believes that aerosol cans that meet the proposed definition in general can be safely managed under the universal waste system for the reasons explained in Section III above, and has not identified reasons why size would affect the considerations described. However, EPA requests comment on whether to include a size limit of twenty-four ounces or other type of limitations on the types of aerosol cans that would be eligible for the federal universal waste rule, including any information on how such a limit would be necessary to ensure safe management of aerosol cans. EPA requests comment on the appropriate scope of the definition of “aerosol can” and the types of materials that should fall under it.
Proposed section 273.6 has specific exclusions from the coverage of the proposed rules in paragraph 273.6(b). First, the proposed rules at 273.6(b)(1) and (2) exclude from the definition of “aerosol can” those cans that are not yet a waste under 40 CFR part 261, and those cans that are not hazardous waste, respectively. An aerosol can would only be subject to the proposed rule if it is considered a hazardous waste under 40 CFR part 261, and before a material can be determined to be a hazardous waste, it first must be determined to be a solid waste. Accordingly, any aerosol can that is not yet a solid waste (for example, because it is not yet discarded) would also not be subject to this section. Consistent with prior universal waste rules, the proposed rule at 273.6(c) also explains that a used aerosol can becomes a waste on the date it is discarded, and an unused aerosol can becomes a waste on the date the handler decides to discard it.
A solid waste may be a hazardous waste either because it is listed as a hazardous waste in subpart D of 40 CFR part 261 or because it exhibits one or more of the characteristics of hazardous waste, as provided in subpart C of 40 CFR part 261. For example, as discussed in Section II above, aerosol cans are frequently hazardous due to the ignitability characteristic, and in some cases may also contain listed hazardous waste or materials exhibiting another hazardous characteristic. If a solid waste aerosol can is determined to be non-hazardous then it is also not subject to the proposed universal waste regulations.
In proposed 273.6(b)(3), EPA specifically excludes aerosol cans that have been emptied of their contents (both propellant and product). Once the contents of a universal waste aerosol can have been removed, the emptied can is considered a new point of generation and is subject to a hazardous waste determination per 40 CFR 262.11. An aerosol can that meets the definition of empty container in 40 CFR 261.7 is not subject to hazardous waste regulation, and may be recycled as scrap metal.
The proposed rules also exclude at 273.4(b)(4), aerosol cans that show evidence of leakage, spillage, or damage that could cause leakage under reasonably foreseeable conditions. Through this exclusion, EPA intends that hazardous waste aerosol cans that are not intact continue to be subject to the full hazardous waste standards. The protectiveness of the proposed management standards described below relies in part on the fact that the aerosol cans to be managed in accordance with those rules are not leaking or otherwise damaged where contents or propellants could be dispersed out of the can, because such uncontrolled release could pose risk to human health and the environment, including an increased risk of fire. A leaking or damaged hazardous waste aerosol can that presents a risk of the contents or propellants being dispersed out of the can would need to be managed as RCRA hazardous waste under 40 CFR parts 260 through 272. Therefore, this provision includes all discarded, intact, non-empty hazardous waste aerosol cans.
Under this proposed rule, the existing universal waste requirements currently applicable to small quantity handlers of universal waste (SQHUWs) and large quantity handlers of universal waste (LQHUWs) would also be applicable to handlers of discarded aerosol cans. For both SQHUWs and LQHUWs, these requirements include waste management standards, labeling and marking, accumulation time limits, employee training, response to releases, requirements related to off-site shipments, and export requirements. LQHUWs are subject to additional notification and tracking requirements. For the labeling requirement, EPA is proposing that either each aerosol can, or a container in which the aerosol cans are contained, must be labeled or marked clearly with any of the following phrases: “Universal Waste—Aerosol Can(s),” “Waste Aerosol Can(s)”, or “Used Aerosol Can(s)”.
In addition, EPA is proposing that small and large quantity universal waste handlers must follow certain specific management standards while handling their aerosol cans. Under this proposal, all handlers must manage their universal waste aerosol cans in a manner designed to prevent releases to the environment. This includes accumulating universal waste aerosol cans in containers that are structurally sound and compatible with the contents of the can, and show no evidence of leaks, spills, or damage that could cause leaks under reasonably foreseeable conditions. Handlers may sort aerosol cans by type and consolidate intact aerosol cans in larger containers, remove actuators to reduce the risk of accidental release, and under certain conditions, may puncture and drain aerosol cans that are being recycled, as described below.
As discussed in Section II above, under the current hazardous waste regulations, puncturing and draining an aerosol can, if performed as part of the recycling process (
However, EPA expects that puncturing and draining activities at universal waste handlers will be different from those currently performed by hazardous waste generators. Because handlers may receive universal waste from many other handlers, the volume of aerosol cans punctured and drained at a commercial universal waste handler is likely to be much greater than at a typical hazardous waste generator (which can only puncture and drain its own hazardous waste aerosol cans). In addition, under the universal waste regulations, handlers can store their universal waste up to a year, which could increase the number of cans punctured and drained at one time if the facility processes the cans in batches.
Because of the likely differences between recycling of aerosol cans at hazardous waste generators versus recycling of aerosol cans at universal waste handlers, EPA is proposing specific management standards for the puncturing and draining of aerosol cans at universal waste handlers, similar to the requirements currently being implemented in states that have added aerosol cans to their list of universal waste. The aerosol can universal waste programs of California, Colorado, Utah and New Mexico, as well as Ohio's proposed aerosol can universal waste program, allow for puncturing and draining of aerosol cans by universal waste handlers, as long as specific management standards and waste characterization requirements are met.
Similar to the current state requirements, EPA is proposing that puncturing and draining activities must be conducted by a commercial device specifically designed to safely puncture aerosol cans and effectively contain the residual contents and any emissions thereof. Puncturing and draining systems for aerosol cans are available from multiple commercial vendors. These devices generally consist of an enclosed puncturing device that punctures an aerosol can, allowing the contents to be drained into an attached container. In many cases, these containers are 55-gallon drums with a filter made of carbon or similar materials to capture any gases that may escape the 55-gallon drum during the puncturing and draining process.
Manufacturers of aerosol can puncturing and draining devices include instructions for their use.
However, the Agency has previously investigated the performance of at least one aerosol can puncturing and draining device through EPA's Environmental Technology Verification (ETV) program. The ETV review demonstrated one type of drum-top puncturing and draining system was effective in processing at least 187 cans before breakthrough of volatile chemicals occurred, which was significantly less than the 600-750 cans recommended by some manufacturers. The drum that contained the drained liquid from the aerosol cans was also never more than 25% full before breakthrough occurring. These findings were contrary to manufacturer recommendations of ensuring the container is not filled past 70% full in order to avoid breakthrough of volatile chemicals. In addition, the ETV program found that halogenated compounds (
The performance of aerosol can puncturing and draining devices will vary by manufacturer and it remains the responsibility of the operator to ensure that the puncturing device is properly draining the contents of the aerosol cans into the drum, that breakthrough is not occurring, and that aerosol cans incompatible with the device are not punctured. For example, information is readily available regarding potential incompatibilities for aerosol can propellants with puncturing devices containing rubber seals or gaskets.
Therefore, EPA is proposing that handlers must establish a written procedure detailing how to safely puncture and drain universal waste aerosol can (including operation and maintenance of the unit; segregation of incompatible wastes; and proper waste management practices to prevent fires or releases), and ensure employees operating the device are trained in the proper procedures. At minimum, EPA is proposing that the written procedure address the operation and maintenance of the unit including its proper assembly; segregation of incompatible wastes; and proper waste management practices, (
EPA is also proposing that the actual puncturing of the cans should be done in a manner designed to prevent fires and to prevent the release of the aerosol can contents to the environment. This includes, but is not limited to, locating the equipment on a solid, flat surface in a well-ventilated area.
In addition, EPA is proposing that the contents from the cans should be immediately transferred from the waste aerosol can, or puncturing device if applicable, to a container or tank and that the contents are subject to a hazardous waste determination under 40 CFR 262.11. The handler becomes that hazardous waste generator of the hazardous aerosol can contents and must manage those waste in accordance with applicable RCRA regulations.
The proposed rule would also require that a written procedure be in place in the event of a spill or release and a spill clean-up kit should be provided. All spills or leaks of the contents of the aerosol cans should be cleaned up promptly.
Finally, EPA notes that all puncturing, waste collection, and disposal, must be conducted in compliance with all applicable federal, state and local waste (solid and hazardous waste) and occupational safety and health laws and regulations.
In addition, EPA is requesting comment on establishing further limitations on puncturing and draining of aerosol cans, similar to limitations that have been established by state waste management programs either through regulations or guidance. Many states have issued guidelines for puncturing and draining aerosol cans under their hazardous waste program. Some state guidelines recommend against the generator puncturing and draining certain types of aerosol cans due to the possible incompatibility with the puncturing and draining equipment or the contents of other cans being drained, or due to the hazardous nature of the contents. These aerosol cans include, but are not limited to, cans containing the following contents: Ethers including ethyl ether, chlorinated compounds, pesticides, herbicides, freons, foamers, corrosive cleaners and unknowns.
In addition, EPA is requesting comment on limiting puncturing and draining practices to handlers that are not commercial processors (
This proposed rule would not change any of the existing requirements applicable to universal waste transporters. Under 40 CFR 273.9, the definition of a universal waste transporter is “a person engaged in the off-site transportation of universal waste by air, rail, highway, or water.” Persons meeting the definition of universal waste transporter include those persons who transport universal waste from one universal waste handler to another, to a processor, to a destination facility, or to a foreign destination. These persons are subject to the universal waste transporter requirements of part 273, subpart D. EPA notes that this proposed rule also would not affect the applicability of shipping requirements under the hazardous waste materials regulations of the Department of Transportation. Transporters continue to be subject to these requirements, if applicable (
This proposed rule would not change any of the existing requirements applicable to universal waste destination facilities (subpart E of part 273). Under 40 CFR 273.9, the definition of a destination facility is “a facility that treats, disposes of, or recycles a particular category of universal waste” (except certain activities specified in the regulations at § 273.13(a) and (c) and § 273.33(a) and (c)).
Adding hazardous waste aerosol cans to the federal definition of universal wastes would not impose any requirements on households and very small quantity generators for managing these cans. Household waste continues to be exempt from RCRA subtitle C regulations under 40 CFR 261.4(b)(1). However, under the universal waste rule, households and VSQGs may choose to manage their hazardous waste aerosol cans in accordance with either the VSQG regulations under 40 CFR 261.5 or as a universal waste under part 273 (40 CFR 273.8(a)(2)). It should be noted, however, that 40 CFR 273.8(b) would continue to apply. Under this provision, if household or VSQG wastes are mixed with universal waste subject to the requirements of 40 CFR part 273 (
This proposed rule would not change the applicability of land disposal restriction (LDR) requirements to universal waste. Under the existing regulations (40 CFR 268.1(f)), universal waste handlers and transporters are exempt from the land disposal restriction (LDR) requirements regarding testing, tracking, and recordkeeping in 40 CFR 268.7 and the storage prohibition in 40 CFR 268.50. EPA proposes to amend 40 CFR 268.1(f) to add aerosol can universal waste for consistency. This proposed rule would also not change the regulatory status of destination facilities; they remain subject to the full LDR requirements.
As part of this rulemaking, EPA is proposing four technical corrections to the universal waste standards for mercury-containing equipment in 40 CFR 273.13(c)(2)(iii) and (iv) and 273.33(c)(2)(iii) and (iv). Each of these paragraphs contains a reference to 40 CFR 262.34, which was removed and reserved as part of the November 28, 2016, Hazardous Waste Generator Improvements Rule (81 FR 85732). EPA neglected to update these references as part of its corresponding changes in that rule and is correcting that mistake here. In all four places, EPA is proposing that the regulation refer to 40 CFR 262.16 or 262.17, as applicable.
Under section 3006 of RCRA, EPA may authorize qualified states to administer and enforce the RCRA hazardous waste program within the state. Following authorization, EPA retains enforcement authority under sections 3008, 3013, and 7003 of RCRA, although authorized states have primary enforcement responsibility. The standards and requirements for state authorization are found at 40 CFR part 271. Prior to enactment of the Hazardous and Solid Waste Amendments of 1984 (HSWA), a State with final RCRA authorization administered its hazardous waste program entirely in lieu of EPA administering the federal program in
Authorized states are required to modify their programs only when EPA enacts federal requirements that are more stringent or broader in scope than existing federal requirements. RCRA section 3009 allows the states to impose standards more stringent than those in the federal program (see also 40 CFR 271.1). Therefore, authorized states may, but are not required to, adopt federal regulations, both HSWA and non-HSWA, that are considered less stringent than previous federal regulations.
This proposed rule would be less stringent than the current federal program. Because states are not required to adopt less stringent regulations, they would not have to adopt the universal waste regulations for aerosol cans, although EPA encourages them to do so. Some states have already added aerosol cans to the list of universal wastes in that state, and others may do so in the future. If a state's standards for aerosol cans are less stringent than those in the final rule, the state would have to amend its regulations to make them at least equivalent to the federal standards and pursue authorization.
Additional information about these statutes and Executive Orders can be found at
This action is not a significant regulatory action because it does not have a significant economic impact nor does it raise novel legal or policy issues. The Office of Management and Budget (OMB) waived review.
This action is expected to be an Executive Order 13771 deregulatory action. Details on the estimated cost savings of this proposed rule can be found in EPA's analysis of the potential costs and benefits associated with this action.
The information collection activities in this proposed rule will be submitted for approval to the Office of Management and Budget (OMB) under the PRA. The Information Collection Request (ICR) documents that the EPA prepared have been assigned EPA ICR number 1597.12 and ICR number 2513.03. You can find copies of the ICRs in the docket for this rule, and they are briefly summarized here.
Because aerosol cans managed under the proposed rule are not counted toward a facility's RCRA generator status, respondents will see a reduction in burden. This is because the aerosol cans would not be subject to recordkeeping and reporting requirements as hazardous waste, and the respondent may no longer be subject to hazardous waste generator recordkeeping and reporting requirements, depending on the quantity of non-aerosol can hazardous waste they generate. The existing universal waste requirements currently applicable to small quantity handlers of universal waste (SQHUWs) and large quantity handlers of universal waste (LQHUWs) would also be applicable to handlers of aerosol can waste. For both SQHUWs and LQHUWs, these requirements include labeling and marking, employee training, response to releases, and export requirements. LQHUWs are also subject to additional notification and tracking requirements.
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 OMB control numbers for the EPA's regulations in 40 CFR are listed in 40 CFR part 9. The OMB Control Number for this proposed rule is 2050-0145. Submit your comments on the Agency's need for this information, the accuracy of the provided burden estimates and any suggested methods for minimizing respondent burden to the EPA using the docket identified at the beginning of this rule. You may also send your ICR-related comments to OMB's Office of Information and Regulatory Affairs via email to
I certify that this proposed action will not have a significant economic impact on a substantial number of small entities under the RFA. In making this determination, the impact of concern is any significant adverse economic impact on small entities. An agency may certify that a rule will not have a significant economic impact on a substantial number of small entities if the rule relieves regulatory burden, has no net burden or otherwise has a positive economic effect on the small entities subject to the rule. As documented in the Regulatory Impact Analysis found in the docket for this
As documented in the Regulatory Impact Analysis found in the docket for this proposal, this proposed action does not contain an unfunded mandate of $100 million or more as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments.
As documented in the Regulatory Impact Analysis found in the docket for this proposal, this proposed action does not have federalism implications. It will not have substantial direct effects 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.
This proposed action does not have tribal implications as specified in Executive Order 13175. Because the proposed rule is expected to result in net cost savings, EPA does not expect that it would result in any adverse impacts on tribal entities. Thus, Executive Order 13175 does not apply to this proposed action.
This proposed action is not subject to Executive Order 13045 because it is not economically significant as defined in Executive Order 12866, and because the EPA does not believe the environmental health or safety risks addressed by this proposed action present a disproportionate risk to children. This proposed action's health and risk assessments are contained in the
This proposed action is not subject to Executive Order 13211, because it is not a significant regulatory action under Executive Order 12866.
This rulemaking does not involve technical standards.
The EPA believes that this proposed action does not have disproportionately high and adverse human health or environmental effects on minority populations, low-income populations and/or indigenous peoples, as specified in Executive Order 12898 (59 FR 7629, February 16, 1994).
The documentation for this decision is contained in
Environmental protection, Administrative practice and procedure, Hazardous waste.
Environmental protection, Hazardous waste, Recycling.
Environmental protection, Hazardous waste, Packaging and containers.
Environmental protection, Hazardous waste, Packaging and containers.
Environmental protection, Hazardous waste, Reporting and recordkeeping requirements.
Environmental protection, Hazardous materials transportation, Reporting and recordkeeping requirements.
Environmental protection, Hazardous materials transportation, Hazardous waste.
For the reasons set out in the preamble, title 40, chapter I of the Code of Federal Regulations, parts 260, 261, 264, 265, 268, 270, and 273 are proposed to be amended as follows:
42 U.S.C. 6905, 6912(a), 6921- 6927, 6930, 6934, 6935, 6937, 6938, 6939, and 6974.
The revisions and additions read as follows:
(4) Lamps as described in § 273.5 of this chapter; and
(5) Aerosol cans as described in § 273.6 of this chapter.
(2) Does not mean:
(i) A person who treats (except under the provisions of 40 CFR 273.13(a) or (c), or 40 CFR 273.33(a) or (c)), disposes of, or recycles (except under the provisions of 40 CFR 273.13(e) or 40 CFR 273.33(e)) universal waste; or
42 U.S.C. 6905, 6912(a), 6921, 6922, 6924(y), and 6938.
The revisions and additions read as follows:
(d) Lamps as described in § 273.5 of this chapter; and
(e) Aerosol cans as described in § 273.6 of this chapter.
42 U.S.C. 6905, 6912(a), 6924, and 6925.
The revision and addition read as follows:
(g) * * *
(11) * * *
(iv) Lamps as described in § 273.5 of this chapter; and
(v) Aerosol cans as described in § 273.6 of this chapter.
42 U.S.C. 6905, 6906, 6912, 6922, 6923, 6924, 6925, 6935, 6936, and 6937.
The revision and addition read as follows:
(c) * * *
(14) * * *
(iv) Lamps as described in § 273.5 of this chapter; and
(v) Aerosol cans as described in § 273.6 of this chapter.
42 U.S.C. 6905, 6912(a), 6921, and 6924.
The revision and addition read as follows:
(f) * * *
(4) Lamps as described in § 273.5 of this chapter; and
(5) Aerosol cans as described in § 273.6 of this chapter.
42 U.S.C. 6905, 6912, 6924, 6925, 6927, 6939, and 6974.
The revision and addition read as follows:
(c) * * *
(2) * * *
(viii) * * *
(D) Lamps as described in § 273.5 of this chapter; and
(E) Aerosol cans as described in § 273.6 of this chapter.
42 U.S.C. 6922, 6923, 6924, 6925, 6930, and 6937.
The revision and addition read as follows:
(a) * * *
(4) Lamps as described in § 273.5 of this chapter; and
(5) Aerosol cans as described in § 273.6 of this chapter.
(a)
(b)
(1) Aerosol cans that are not yet a waste under part 261 of this chapter. Paragraph (c) of this section describes when an aerosol cans becomes a waste;
(2) Aerosol cans that are not hazardous waste. An aerosol can is a hazardous waste if the aerosol can exhibits one or more of the characteristics identified in part 261, subpart C of this chapter or the aerosol can contains a substance that is listed in part 261, subpart D of this chapter;
(3) Aerosol cans that meet the standard for empty containers under part 261.7 of this chapter, and
(4) Aerosol cans that show evidence of leakage, spillage, or damage that could cause leakage under reasonably foreseeable conditions.
(c)
(1) A used aerosol can become a waste on the date it is discarded.
(2) An unused aerosol can become a waste on the date the handler decides to discard it.
The revision and addition read as follows to read as follows:
(4) Lamps as described in § 273.5; and
(5) Aerosol cans as described in § 273.6.
(b) Does not mean:
(1) A person who treats (except under the provisions of 40 CFR 273.13(a) or (c), or 40 CFR 273.33(a) or (c)), disposes of, or recycles (except under the provisions of 40 CFR 273.13(e) or 40 CFR 273.33(e)) universal waste; or
(c) * * *
(2) * * *
(iii) Ensures that a mercury clean-up system is readily available to immediately transfer any mercury resulting from spills or leaks from broken ampules from that containment device to a container that meets the requirements of 40 CFR 262.16 or 262.17, as applicable.
(iv) Immediately transfers any mercury resulting from spills or leaks from broken ampules from the containment device to a container that meets the requirements of 40 CFR 262.16 or 262.17, as applicable.
(e)
(1) Universal waste aerosol cans must be accumulated in a container that is structurally sound, compatible with the contents of the aerosol cans, and lacks evidence of leakage, spillage, or damage that could cause leakage under reasonably foreseeable conditions;
(2) A small quantity handler of universal waste may conduct the following activities as long as each individual aerosol can is not breached and remains intact:
(i) Sorting aerosol cans by type;
(ii) Mixing intact cans in one container; and
(iii) Removing actuators to reduce the risk of accidental release.
(3) A small quantity handler of universal waste who punctures and drains their aerosol cans must recycle the empty punctured aerosol cans and meet the following requirements while puncturing and draining hazardous waste aerosol cans:
(i) Conduct puncturing and draining activities using a device specifically designed to safely puncture aerosol cans and effectively contain the residual contents and any emissions thereof;
(ii) Establish a written procedure detailing how to safely puncture and drain universal waste aerosol can (including proper assembly, operation and maintenance of the unit; segregation of incompatible wastes; and proper waste management practices to prevent fires or releases), maintain a copy of the manufacturer's specification and instruction onsite, and ensure employees operating the device are trained in the proper procedures;
(iii) Ensure that puncturing of the can is in a manner designed to prevent fires and to prevent the release of any component of universal waste to the environment. This includes, but is not limited to, locating the equipment on a solid, flat surface in a well ventilated area;
(iv) Immediately transfer the contents from the waste aerosol can, or puncturing device if applicable, to a container or tank that meets the applicable requirements of § 262.14, 262.15, 262.16, or 262.17;
(v) Conduct a hazardous waste determination on the emptied aerosol can and its contents per 40 CFR 262.11. Any hazardous waste generated as a result of puncturing and draining the aerosol can is subject to all applicable requirements of 40 CFR parts 260 through 272. The handler is considered the generator of the hazardous waste and is subject to 40 CFR part 262;
(vi) If the contents are determined not to be hazardous, the handler may manage the waste in any way that is in compliance with applicable federal, state or local solid waste regulations; and
(vii) A written procedure must be in place in the event of a spill or release and a spill clean-up kit must be provided. All spills or leaks of the contents of the aerosol cans must be cleaned up promptly.
(f) Universal waste aerosol cans (
(b) * * *
(4) A list of all the types of universal waste managed by the handler (
* * *
(c) * * *
(2) * * *
(iii) Ensures that a mercury clean-up system is readily available to immediately transfer any mercury resulting from spills or leaks of broken ampules from that containment device to a container that meets the requirements of 40 CFR 262.16 or 262.17, as applicable.
(iv) Immediately transfers any mercury resulting from spills or leaks from broken ampules from the containment device to a container that meets the requirements of 40 CFR 262.16 or 262.17, as applicable.
(e)
(1) Universal waste aerosol cans must be accumulated in a container that is structurally sound, compatible with the contents of the aerosol cans, and lacks evidence of leakage, spillage, or damage that could cause leakage under reasonably foreseeable conditions;
(2) A large quantity handler of universal waste may conduct the following activities as long as each individual aerosol can is not breached and remains intact:
(i) Sorting aerosol cans by type; and
(ii) Mixing intact cans in one container; and (iii) Removing actuators to reduce the risk of accidental release;
(3) A large quantity handler of universal waste who punctures and drains their aerosol cans must recycle the empty punctured aerosol cans and meet the following requirements while puncturing and draining hazardous waste aerosol cans:
(i) Conduct puncturing and draining activities using a device specifically designed to safely puncture aerosol cans and effectively contain the residual contents and any emissions thereof;
(ii) Establish a written procedure detailing how to safely puncture and drain universal waste aerosol can (including proper assembly, operation and maintenance of the unit; segregation of incompatible wastes; and proper waste management practices to prevent fires or releases), maintain a copy of the manufacturer's specification and instruction onsite, and ensure employees operating the device are trained in the proper procedures;
(iii) Ensure that puncturing of the can is in a manner designed to prevent fires and to prevent the release of any component of universal waste to the environment. This includes, but is not limited to, locating the equipment on a solid, flat surface in a well ventilated area;
(iv) Immediately transfer the contents from the waste aerosol can, or puncturing device if applicable, to a container or tank that meets the applicable requirements of § 262.14, 15, 16, or 17;
(v) Conduct a hazardous waste determination on the emptied aerosol can and its contents per 40 CFR 262.11. Any hazardous waste generated as a result of puncturing and draining the aerosol can is subject to all applicable requirements of 40 CFR parts 260 through 272. The handler is considered the generator of the hazardous waste and is subject to 40 CFR part 262;
(vi) If the contents are determined not to be hazardous, the handler may manage the waste in any way that is in compliance with applicable federal, state or local solid waste regulations; and
(vii) A written procedure must be in place in the event of a spill or release and a spill clean-up kit must be provided. All spills or leaks of the contents of the aerosol cans must be cleaned up promptly.
(f) Universal waste aerosol cans (
Transportation Security Administration, DHS.
Notice of proposed rulemaking; withdrawal.
The Transportation Security Administration (TSA) is withdrawing its rulemaking concerning the proposed establishment of a large aircraft security program (LASP). TSA published a notice of proposed rulemaking (NPRM) for LASP on October 30, 2008. In the NPRM, TSA proposed that certain private and corporate aircraft operations should adopt security standards similar to those of commercial aircraft operations, including the use of security programs, crew vetting, and passenger watchlist matching. The NPRM also proposed new requirements for airports that serve the private and corporate operations. TSA held a series of public meetings and reviewed more than 7,000 public comments submitted in response to the NPRM. Based on all of the information received and a re-evaluation of the proposal in light of risk-based principles, TSA has decided not to pursue this rulemaking at this time.
TSA is withdrawing the proposed rule published in Part III of the
Alan Paterno, Office of Security Policy and Engagement, TSA-28, Transportation Security Administration, 601 South 12th Street, Arlington, VA 20598-6028; telephone (571) 227-5698; facsimile (571) 227-2928; email
TSA administers an extensive range of regulatory programs that address security for scheduled and charter commercial aviation operations.
TSA proposed to require—
• (1) Non-commercial, large aircraft operators to adopt a security program like the security programs that commercial aviation services must implement;
• (2) Large aircraft operators to contract with TSA-approved auditors to conduct audits of the operators' compliance with their security programs, and with TSA-approved watch-list service providers to verify that their passengers are not on the No Fly and/or Selectee portions of the consolidated terrorist watch-lists maintained by the Federal Government;
• (3) Security measures for large aircraft operators in all-cargo operations and for operators of passenger aircraft with a MTOW of over 45,500 kilograms (100,309.3 pounds), operated for compensation or hire; and
• (4) Certain airports that serve large aircraft to adopt new security programs.
TSA believed the proposed rule would yield benefits in the areas of transportation security and accountability. TSA included a “break-even” analysis that showed the tradeoffs between program cost and program benefits that would be required for the LASP to be a cost-beneficial undertaking. TSA estimated that under the NPRM, covered aircraft operators, airport operators, passengers, and TSA would incur approximately $1.4 billion in costs over 10 years to comply with the proposed LASP, discounted at 7 percent in 2006 dollars.
TSA received more than 7,000 comments from pilots, aircraft operators, airports, aviation workers, individuals, members of congress, aviation associations, and civic organizations. TSA also held numerous public meetings to solicit stakeholder input on the NPRM. Many supported some aspects of the LASP NPRM, but the overwhelming majority of commenters objected to it based on their views that it increased costs unnecessarily, created burdensome new processes, and would lead small airport and aircraft operators to go out of business causing widespread loss of employment. These commenters also asserted that there was no need for the LASP NPRM, as evidenced in part by the fact that there was no specific statutory mandate for it.
TSA analyzed the comments carefully and considered issuing a supplemental notice of proposed rulemaking (SNPRM) to incorporate some of the ideas from the commenters into a new proposal. As part of this evaluation, TSA considered separating out some of the requirements into stand-alone rules, because the LASP NPRM covered several different kinds of airport and aircraft operations. Also, TSA considered changing the scope of the large aircraft that would be subject to the new regulations.
Based on all of the foregoing information and consistent with risk-based principles, TSA has decided to withdraw the LASP rulemaking at this time. In reaching this decision, TSA considered the relative costs and benefits of the NPRM identified through the agency's preliminary analysis. Moreover, TSA has several regulatory initiatives underway that are required by statute and have deadlines.
As part of TSA's ongoing review of existing regulatory programs and to reduce the costs of regulations,
Office of Advocacy and Outreach (OAO), USDA.
Funding Opportunity Announcement (FOA).
This notice announces the availability of funds and solicits applications from community-based and non-profit organizations, institutions of higher education, and Tribal entities to compete for financial assistance through the Outreach and Assistance for Socially Disadvantaged Farmers and Ranchers and Veteran Farmers and Ranchers Program (hereinafter known as the “2501 Program”). Individual applicants do not meet the eligibility criteria.
Funding is being provided to eligible entities who, in partnership with the Office of Advocacy and Outreach (OAO), will conduct outreach initiatives and training to achieve the overall goal of the 2501 Program—to assist socially disadvantaged and veteran farmers and ranchers in owning and operating farms and ranches while increasing their participation in agricultural programs and services provided by the U.S. Department of Agriculture (USDA).
Only one project proposal may be submitted per eligible entity. Proposals must be submitted through
Two (2) teleconferences will be held during the open period of this announcement to answer any clarifying questions on the following dates:
To join each session, please use the following information:
To file a program discrimination complaint, you may obtain a complaint form by sending an email to
Send your completed complaint form or letter to USDA by mail, fax, or email:
U.S. Department of Agriculture, Office of Advocacy and Outreach, Attn: Kenya Nicholas, Program Director, J.L. Whitten Building, Room 520-A, 1400 Independence Avenue SW, Washington, DC 20250,
Funding will be awarded based on peer competition within the three categories described below along with the amount of anticipated funding for each category. The OAO reserves discretion to allocate funding between the three categories based upon the number and quality of applications received. Funding will be awarded based on peer competition within the three categories. There is no commitment by the OAO to fund any particular application or to select a specific number of recipients within each category.
1.
2.
3.
The OAO is committed to ensuring that socially disadvantaged and veteran farmers and ranchers are able to equitably participate in USDA programs. Differences in demographics, culture, economics, and other factors preclude a single approach to identifying solutions that can benefit our underserved farmers and ranchers. Community-based and non-profit organizations, higher education institutions, and eligible Tribal entities can play a critical role in addressing the unique difficulties they face and can help improve their ability to start and maintain successful agricultural businesses. With 2501 Program funding, organizations can extend our outreach efforts to connect with and assist socially disadvantaged and veteran farmers and ranchers and to provide them with information on available USDA resources.
1. The 2501 Program was authorized by the Food, Agriculture, Conservation, and Trade Act of 1990. The Food, Conservation, and Energy Act of 2008 expanded the authority of the Secretary of Agriculture (the Secretary) to provide awards under the program and transferred the administrative authority to the OAO. The Agricultural Act of 2014 further expanded the program to include outreach and assistance to veterans. The 2501 Program extends USDA's capacity to work with members of farming and ranching communities by funding projects that enhance the equitable participation of socially disadvantaged and veteran farmers and ranchers in USDA programs. It is the OAO's intention to build lasting relationships between USDA, the recipient's organizations, and socially disadvantaged and veteran farmers and ranchers.
2. Only one proposal will be accepted from each organization.
The 2501 Program provides funding to eligible organizations for training and technical assistance projects designed to assist socially disadvantaged and veteran farmers and ranchers in owning and operating viable agricultural enterprises. Proposals must be consistent with requirements stated in 7 U.S.C. 2279(a)(2). Under this statute, the outreach and technical assistance program funds shall be used exclusively:
1. To enhance coordination of the outreach, technical assistance, and education efforts authorized under agriculture programs;
2. To assist the Secretary of Agriculture in:
a. Reaching current and prospective socially disadvantaged farmers or ranchers and veteran farmers or ranchers in a linguistically appropriate manner; and
b. improving the participation of those farmers and ranchers in USDA programs.
Proposals from eligible entities must address two or more of the following priority areas:
1. Assist socially disadvantaged or veteran farmers and ranchers in owning and operating successful farms and ranches;
2. Improve participation among socially disadvantaged or veteran farmers and ranchers in USDA programs;
3. Build relationships between current and prospective farmers and ranchers who are socially disadvantaged or veterans and USDA's local, state, regional, and National offices;
4. Introduce agriculture-related information to socially disadvantaged or veteran farmers and ranchers through innovative training and technical assistance techniques; and
5. Introduce agricultural education targeting socially disadvantaged youth, and/or socially disadvantaged beginning farmers and ranchers, in rural and persistent poverty communities.
To encourage information sharing and to build capacity among recipients, the OAO may require Project Directors to attend an annual training conference that can be expensed with awarded grant funds not to exceed $1,000 per award for up to two authorized entity personnel. The conference will allow recipients, USDA officials, and other agriculture-related guests to share ideas and lessons learned; provide training on performance and financial reporting requirements; and provide information on USDA programs and services. In addition, Project Directors will have an opportunity to make contacts and gather information on best practices.
1. Outputs (Activities). The term “output” means an outreach, educational component, or assistance activity, task, or associated work product related to improving the ability of socially disadvantaged and veteran farmers and ranchers to own and operate farms and ranches, assistance with agriculture related activities, or guidance for participation in USDA programs. Outputs may be quantitative or qualitative but must be measurable during the period of performance.
Examples of outputs from the projects to be funded under this announcement may describe an organization's activities and their participants such as: Number of workshops or meetings held and number of participants attending; frequency of services or training delivered; and to whom and/or development of products, curriculum, or resources provided. Other examples include but are not limited to the following:
a. Number of socially disadvantaged and veteran farmers or ranchers served;
b. number of conferences or training sessions held and number of socially disadvantaged and veteran farmers and ranchers who attended;
c. type and topic of educational materials distributed at outreach events;
d. creation of a program to enhance the operational viability of socially disadvantaged and veteran farmers and ranchers;
e. number of completed applications submitted for consideration for USDA programs; or
f. activity that supports increased participation of socially disadvantaged farmers and ranchers and veteran farmers and ranchers in USDA programs.
Progress and Financial Reports will be required, as specified in Section VI, Subsection D, “Reporting Requirement.”
2. Outcomes (Results). The term “outcome” means the difference or effect that has occurred as a result from carrying out an activity, workshop, meeting, or from delivery of services related to a programmatic goal or objective. Outcomes refer to the final impact, change, or result that occurs as a direct result of the activities performed in accomplishing the objectives and goals of your project. Outcomes may refer to results that are agricultural, behavioral, social, or economic in nature. Outcomes may reflect an increase in knowledge or skills, a greater awareness of available resources or programs, or actions taken by stakeholders as a result of learning.
Project Directors will be required to document anticipated outcomes that are funded under this announcement which should include but are not limited to:
a. Increase in participation in USDA programs among socially disadvantaged and veteran farmers and ranchers;
b. increase in receptiveness of socially disadvantaged and veteran farmers and ranchers to outreach efforts through effective communication;
c. increase in economic stability of socially disadvantaged and veteran
d. increase in community marketing and sales opportunities for the products of socially disadvantaged and veteran farmers and ranchers; or
e. increased use of resource conservation and sustainability practices among socially disadvantaged and veteran farmers and ranchers.
3. Performance Measures. Performance measures are tied to the goals or objectives of each activity and ultimately the overall purpose of the project. They provide insight into the effectiveness of proposed activities by indicating areas where a project may need adjustments to ensure success. Applicants must develop performance measure expectations which will occur as a result of their proposed activities. These expectations will be used as a mechanism to track the progress and success of a project. Project performance measures should include statements such as: Whether workshops or technical assistance will meet the needs of farmers or ranchers in the service area and why; how much time will be spent in group training or individual hands-on training of farmers and ranchers in the service area; or whether activities will meet the demands of stakeholders. Project performance measures must include the assumptions used to make those estimates.
Consider the following questions when developing performance measurement statements:
• What is the measurable short-term and long-term impact the project will have on servicing or meeting the needs of stakeholders?
• How will the organization measure the effectiveness and efficiency of their proposed activities to meet their overall goals and objectives?
The statutory authority for this action is 7 U.S.C. 2279, as amended, which authorizes award funding for projects designed to provide outreach and assistance to socially disadvantaged and veteran farmers and ranchers.
The total estimated funding expected to be available for awards under this competitive opportunity is $8.4 million.
The performance period for projects selected from this solicitation will not begin prior to the effective award date. The maximum project period is one (1) year. Projects that are part of multi-year initiatives will only be funded for 1 year.
Funding for selected projects will be in the form of a grant which must be fully executed no later than September 30, 2018. The anticipated Federal involvement will be limited to the following activities:
1. Approval of recipients' final budget and statement of work accompanying the grant agreement;
2. Monitoring of recipients' performance through quarterly and final financial and performance reports; and
3. Evaluation of recipients' use of federal funds through desk audits and on-site visits.
1. Any community-based organization, network, or coalition of community-based organizations that:
• Demonstrates experience in providing agricultural education or other agricultural-related services to socially disadvantaged and veteran farmers and ranchers;
• provides documentary evidence of work with, and on behalf of, socially disadvantaged and veteran farmers and ranchers during the 3-year period preceding the submission of a proposal for assistance under this program; and
• does not or has not engaged in activities prohibited under Section 501(c)(3) of the Internal Revenue Code of 1986.
2. An 1890 or 1994 institution of higher education (as defined in 7 U.S.C. 7601).
3. An American Indian Tribal community college or an Alaska Native cooperative college.
4. A Hispanic-serving Institution of higher education (as defined in 7 U.S.C. 3103).
5. Any other institution of higher education (as defined in 20 U.S.C. 1001) that has demonstrated experience in providing agricultural education or other agricultural-related services to socially disadvantaged farmers and ranchers.
6. An Indian Tribe (as defined in 25 U.S.C. 5304) or a national tribal organization that has demonstrated experience in providing agricultural education or other agriculturally-related services to socially disadvantaged farmers and ranchers.
7. All other organizations or institutions that received funding under this program before January 1, 1996, but only with respect to projects that the Secretary considers similar to projects previously carried out by the entity under this program.
Matching is not required for this program.
Applications from eligible entities that meet all criteria will be evaluated as follows:
1. Proposals must comply with the submission instructions and requirements set forth in Section IV of this announcement. Pages in excess of the page limitation will not be considered.
2. Proposals must be received through
3. Proposals received after the submission deadline will not be considered. Please note that in order to submit proposals, organizations must create accounts in
4. Proposals must address a minimum of two or more of the priority areas that provide outreach and assistance to socially disadvantaged or veteran farmers and ranchers as stated in Section I, Subsection B, Scope of Work.
5. Incomplete or partial applications will not be eligible for consideration.
It is a requirement to register for SAM (
Per 2 CFR part 200, applicants are required to: (1) Be registered in SAM prior to submitting an application; (2) provide a valid unique entity identifier in the application; and (3) continue to maintain an active SAM registration with current information at all times during which the organization has an active Federal award or an application or plan under consideration by a Federal awarding agency. The OAO may not make a Federal award to an applicant until the applicant has complied with all applicable unique entity identifier and SAM requirements.
SAM contains the publicly available data for all active exclusion records entered by the Federal Government identifying those parties excluded from receiving Federal contracts, certain subcontracts, and certain types of Federal financial and non-financial assistance and benefits. All applicant organizations and their key personnel will be vetted through SAM.gov to ensure they are in compliance with this requirement and not on the Excluded Parties List. Organizations identified as having delinquent Federal debt may contact the Treasury Offset Program at (800) 304-3107 for instructions on resolution, but will not be awarded a 2501 Program grant prior to resolution.
Applicants may download individual grant proposal forms from
Applicants are required to submit proposals through
Federal agencies post funding opportunities on
Proposals must be submitted by May 15, 2018, via
All submissions must contain completed and electronically signed original application forms, as well as a Project Summary, Project Narrative, and a Budget Narrative as described below:
1.
Please note, additional forms will be required from organizations being awarded the 2501 Grant.
2.
Number each page of each attachment and indicate the total number of pages per attachment (
•
•
○ Discuss the merits of your proposed project. Specifically, proposals must: (1) Define and establish the existence of the needs of socially disadvantaged farmers and ranchers, veteran farmers and ranchers, or both in the defined geographic area; (2) identify the experience of the organization(s) taking part in the project; (3) identify the names of organizations that will be your partners in the project, if any; (4) identify the geographic area of service; and (5) discuss the potential impact of the project.
○ Identify the qualifications, relevant experience, education, and publications of each Project Director or collaborator. Also, specifically address the work to be completed by key personnel and the roles and responsibilities within the scope of the proposed project. This includes past completed projects and financial management experiences.
○ In an organized format, create a timeline for each task to be accomplished during the period of performance timeframe. Relate each task to one of the five priority areas in Section I, Subsection B. The timeline is part of the 15 page limit but can be as simple as a one-page description of tasks.
Organizations with previously approved indirect cost rates must submit their Negotiated Indirect Cost Rate Agreement (NICRA) with this application in Attachment 3. All submitted NICRA agreements must be CURRENT. Other funding sources may also be identified in this attachment. Each cost indicated must be reasonable, allocable, necessary, and allowable under the Federal Cost Principles (2 CFR part 200, subpart E-Cost Principles) in order to be funded. The Budget Narrative should not exceed two pages and is
•
1. SF-424, Application for Federal Assistance
Ensure this is completed with accuracy; particularly email addresses and phone numbers. The OAO may not be able to reach you if your information is incorrect.
2. Project Summary Page (no more than 250 words)
3. Project Narrative including a timeline (no more than 15 pages, 12 point font, and 1 inch margins only)
To ensure fairness and uniformity for all applicants, Project Narratives not conforming to this stipulation may not be considered.
4. SF-424A, Budget Information-Non-Construction Programs
5. SF 424B, Assurances—Non-Construction Programs
6. Budget Narrative (not to exceed 2 pages)
7. Key Contacts Form (include the Project Director/Manager and Financial Representative). Provide first, middle, and last names.
Please ensure this form is completed with accuracy. Individuals not listed on an applicants' Key Contact Form will not receive information about or access to data that concerns the applicant organization.
8. Résumés of key personnel, current Negotiated Indirect Cost Rate Agreements, Partnership Agreements, Letters of Intent, Support, or Recommendation, proof of 501(c)(3) status (if applicable), etc.
Best practice notes:
• Complete the following as soon as possible:
(1) Obtain a registered DUNs number.
(2) Register and maintain an active System for Award Management (SAMs) account.
(3) Register in
• Only submit Adobe PDF file format documents to
• Name your documents with short titles to prevent issues with uploading/downloading documents from
• Do not password protect any submitted forms or documents.
• Ensure all the information on your SF-424 Application and Key Contact forms are correct. Include first, middle, and last names on Key Contact forms.
Where to Upload Attachments on Your Application. There are three blocks on the application where you may upload attachments:
• On block 14, click on “Add Attachment” to upload your Project Summary and Project Narrative.
• In the section that reads “Budget Narrative File(s)”, type in the “Mandatory Budget Narrative Filename”. Just below the file name, click on “Add Mandatory Budget Narrative” to upload your Budget Narrative.
• After block 15, click on “Add Attachments” to add all your supporting documents (résumés, Partnership Agreements, Letters of Support, etc.).
Funding may be used to provide sub-awards, which includes using sub-awards to fund partnerships; however, the recipient must utilize at least 50 percent of the total funds awarded, and no more than three subcontracts will be permitted. All sub-awardees must comply with applicable requirements for sub-awards. Applicants must provide documentation of a competitive bidding process for services, contracts, and products, including consultant contracts, and conduct cost and price analyses to the extent required by applicable procurement regulations.
The OAO awards funds to
The closing date and time for receipt of proposal submissions is May 15, 2018, at 11:59 p.m., EST, via
In accordance with 2 CFR part 200, the names of entities submitting proposals, as well as proposal contents and evaluations, will be kept confidential to the extent permissible by law. Any information that the applicant wishes to have considered as confidential, privileged, or proprietary should be clearly marked as such in the proposal. If an applicant chooses to include confidential or proprietary information in the proposal, it will be kept confidential to the extent permitted by law.
1. The OAO may not assist individual applicants by reviewing draft proposals or providing advice on how to respond to evaluation criteria. However, the OAO will respond to questions from individual applicants regarding eligibility criteria, administrative issues related to the submission of the proposal, and requests for clarification regarding the announcement. Any questions should be submitted to
2. The OAO will post questions and answers relating to this funding opportunity during its open period on the Frequently Asked Questions (FAQs) section of our website:
3. Please visit our website at:
Only eligible entities whose proposals meet the threshold criteria in Section III of this announcement will be reviewed according to the evaluation criteria set forth below. Applicants should explicitly and fully address these criteria as part of their proposal package. Each proposal will be reviewed under the regulations established under 2 CFR part 200.
A review panel that is independent of OAO will use a point system to rate each proposal, awarding a maximum of 100 points (90 points, plus an additional 10 discretionary points for programmatic priorities). Each proposal will be reviewed by at least two members of the Independent Review Panel who will review and score all applications submitted. The Independent Review Panel will numerically score and rank each application within the three categories and funding decisions will be based on their recommendations to the designated approving official. Final funding decisions will be made by the designated approving official.
All applications will be reviewed by members of an Independent Review Panel. Panel members are selected based upon training and experience in relevant fields including outreach, technical assistance, cooperative extension services, civil rights, education, statistical, and ethnographic data collection and analysis, and agricultural programs, and are drawn from a diverse group of experts to create a balanced panel.
1. The successful applicant will be notified by the OAO via telephone, email, and/or postal mail. The notification will advise the applicant that its proposed project has been evaluated and recommended for award. The notification will be sent to the
2. The OAO will also send notification to unsuccessful applicants via email or postal mail. The notification will be sent to the
3. Within 10 days of award status notification, unsuccessful applicants may request feedback on their application. Feedback will be provided as expeditiously as possible. Feedback sessions will be scheduled contingent upon the number of requests and in accordance with 7 CFR 2500.026.
All awards resulting from this solicitation will be administered in accordance with the Office of Management and Budget (OMB) Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards codified at 2 CFR part 200, as supplemented by USDA implementing regulations at 2 CFR parts 400 and 415, and OAO Federal Financial Assistance Programs—General Award Administrative Procedures, 7 CFR part 2500.
In compliance with its obligations under Title VI of the Civil Rights Act of 1964 and Executive Order 13166, it is the policy of the OAO to provide timely and meaningful access for persons with Limited English Proficiency (LEP) to projects, programs, and activities administered by Federal grant recipients. Recipient organizations must comply with these obligations upon acceptance of grant agreements as written in OAO's Terms and Conditions. Following these guidelines is essential to the success of our mission to improve access to USDA programs for socially disadvantaged and veteran farmers and ranchers.
In accordance with the Federal Funding Accountability and Transparency Act (FFATA) and the USDA implementation, all applicants must obtain and provide an identifying number from Dun and Bradstreet's (D&B) Data Universal Numbering System (DUNS). Applicants can receive a DUNS number, at no cost, by calling the toll-free DUNS number request line at (866) 705-5711, or visiting the D&B website at
In addition, FFATA requires applicants to register with the System for Award Management (SAM).
All applicants must register for an account on
In accordance with 2 CFR part 200, the following reporting requirements will apply to awards provided under this FOA. The OAO reserves the right to revise the schedule and format of reporting requirements as necessary in the award agreement.
1. Quarterly Progress Reports and Financial Reports will be required.
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•
2. Final Progress and Financial Reports will be required upon project completion. This report should include a summary of the project or activity throughout the funding period, achievements of the project or activity, and a discussion of overall successes and issues experienced in conducting the project or project activities. The final Financial Report should consist of a complete SF-425 indicating the total costs of the project. Final Progress and Financial Reports must be submitted to the designated OAO official within 90 days after the completion of the award period as follows:
3.
The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments are requested regarding (1) whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of burden 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 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 regarding this information collection received by April 16, 2018 will be considered. Written comments should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB),
An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.
Agricultural Marketing Service, USDA.
Notice to solicit nominees.
The Department of Agriculture's (USDA) Agricultural Marketing Service (AMS) is seeking nominations for individuals to serve on the USDA Grain Inspection Advisory Committee (Advisory Committee). The Advisory Committee meets twice annually to advise AMS on the programs and services it delivers under the U.S. Grain Standards Act (USGSA). Recommendations by the Advisory Committee help AMS better meet the needs of its customers who operate in a dynamic and changing marketplace. The realignment of offices within the U.S. Department of Agriculture authorized by the Secretary's Memorandum dated November 14, 2017, eliminates the Grain Inspection, Packers and Stockyard Administration (GIPSA) as a standalone agency. The grain inspection activities formerly part of GIPSA are now organized under AMS.
AMS will consider nominations received by April 30, 2018.
Submit nominations for the Advisory Committee by completing form AD-755 and mail to:
• Kendra Kline, U.S. Department of Agriculture, 1400 Independence Ave. SW, Rm. 2043-S, Mail Stop 3614, Washington, DC 20250-3611, or
•
Form AD-755 may be obtained via USDA's website:
Kendra Kline, telephone (202) 690- 2410 or email
As required by section 21 of the USGSA (7 U.S.C. 87j), as amended, the Secretary of Agriculture (Secretary) established the Advisory Committee on September 29, 1981, to provide advice to the AMS Administrator on implementation of the USGSA. As specified in the USGSA, each member's term is 3 years and no member may serve successive terms.
The Advisory Committee consists of 15 members, appointed by the Secretary, who represent the interests of grain producers, processors, handlers, merchandisers, consumers, exporters, and scientists with expertise in research related to the policies in section 2 of the USGSA (7 U.S.C. 74). While members of the Advisory Committee serve without compensation, USDA reimburses them for travel expenses, including per diem in lieu of subsistence, for travel away from their homes or regular places of business in performance of Advisory Committee service (see 5 U.S.C. 5703).
A list of current Advisory Committee members and other relevant information are available on web at
AMS is seeking nominations for individuals to serve on the Advisory Committee. Applications submitted during the previous nomination period, December 06, 2016-January 20, 2017, will be considered unless notification is provided the individual no longer is available for consideration.
Nominations are open to all individuals without regard to race, color, religion, gender, national origin, age, mental or physical disability, marital status, or sexual orientation. To ensure that recommendations of the Advisory Committee take into account the needs of the diverse groups served by the USDA, membership shall include, to the extent practicable, individuals with demonstrated ability to represent minorities, women, and persons with disabilities.
The final selection of Advisory Committee members and alternates is made by the Secretary.
Forest Service, USDA.
Notice of intent to prepare a Supplemental Environmental Impact Statement.
The Helena-Lewis and Clark National Forest, Lincoln Ranger District, Montana, intends to prepare a Supplemental Environmental Impact Statement (SEIS) for the Stonewall Vegetation Project. The project area was impacted by wildfire in 2017 and a preliminary analysis of those effects has shown that supplemental analysis should be completed to assess the change in conditions resulting from the Park Creek Fire.
The Draft SEIS is expected May 2018, and the Final SEIS is expected August 2018.
Laura Conway, Team Leader, (406) 791-7739;
Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 between 8 a.m. and 8 p.m., Eastern Time, Monday through Friday.
The Stonewall Vegetation Project Record of Decision (ROD) was signed by Helena-Lewis and Clark Forest Supervisor William Avey on August 25, 2016 and with it, the Final Environmental Impact Statement (FEIS) was released to the public. The project was preliminarily enjoined by a court order and therefore implementation had not begun.
In July 2017, two wildfires ignited in the project area, eventually burning 18,000 acres, 13,390 of which were in the Stonewall project area. The fire burned all or portions of 16 treatment units, totaling 2,719 acres. Treatment units possessing viable harvest potential will be carried forward for analysis in this SEIS. The SEIS will supplement the Stonewall Vegetation Project FEIS by providing an updated analysis of environmental effects in light of the acres impacted by the Park Fire in July and August of 2017. Only those resources measurably affected by the changed baseline will be analyzed in the SEIS. These resources include soils, hydrology, fuels, vegetation, economics, fisheries and wildlife habitat.
Wildfire affected the project area one year after environmental analysis and before implementation. The original purpose, to improve the mix of vegetation and structure across the landscape to make it more resilient to wildfire, remains on those acres not impacted by the 2017 Park Fire. Fuel reduction treatments can influence fire behavior to enhance community protection and allow fire to function in its natural role.
The proposed action consists of approximately 1890 acres of treatments included in the selected alternative in the ROD. These treatments include 550 acres of pre-commercial thinning, 19 acres of improvement cuts, 345 acres of shelterwood cuts, 65 acres of clearcut, 25 acres of sanitation cuts, 300 acres of low intensity prescribed fire, and 555 acres of whitebark pine restoration. Less than one mile of temporary road is proposed, and this would be obliterated after implementation. Maintenance would occur on up to 31 miles of road. The proposed action includes the site-specific forest plan amendment for elk habitat as described in the 2016 ROD.
Helena-Lewis and Clark Forest Supervisor.
The decision will authorize vegetation treatments remaining under the Selected Alternative based on the updated analysis.
Preliminary issues identified include lynx habitat, elk security, hiding cover, and thermal cover.
A Notice of Intent (NOI) published on January 13, 2010 initiated the scoping process for the Stonewall Vegetation Project. The start of a 30-day scoping period began on January 16, 2010. In accordance with 40 CFR 1502.9(c)(4), no scoping will be conducted for this SEIS.
The Draft SEIS will be available for public comment as required by 40 CFR 1503.1. The Draft SEIS will be announced for public review and comment in
This NOI is being published pursuant to regulation (40 CFR 1508.22) implementing the procedural provision of the National Environmental Policy Act fof 1969, as amended (42 U.S.C. 4321
On January 3, 2018, the Executive Secretary of the Foreign-Trade Zones (FTZ) Board docketed an application submitted by the City of San Jose, grantee of FTZ 18, requesting an expansion of Subzone 18F, subject to the existing activation limit of FTZ 18, on behalf of Lam Research Corporation, in Fremont, Livermore and Tracy, California.
The application was processed in accordance with the FTZ Act and Regulations, including notice in the
Enforcement and Compliance, International Trade Administration, Department of Commerce.
Based upon a request from DAK Americas, LLC, Nan Ya Plastics Corporation, America, Auriga Polymers, and Palmetto Synthetics LLC (
Applicable March 16, 2018.
Emily Halle or Nicholas Czajkowski, AD/CVD Operations, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone (202) 482-0176 or (202) 482-1395, respectively.
On May 25, 2000, Commerce published the AD orders on PSF from Korea and Taiwan.
The product covered by the orders is certain polyester staple fiber (PSF). PSF is defined as synthetic staple fibers, not carded, combed or otherwise processed for spinning, of polyesters measuring 3.3 decitex (3 denier, inclusive) or more in diameter. This merchandise is cut to lengths varying from one inch (25 mm) to five inches (127 mm). The merchandise subject to these orders may be coated, usually with a silicon or other finish, or not coated. PSF is generally used as stuffing in sleeping bags, mattresses, ski jackets, comforters, cushions, pillows, and furniture. Merchandise of less than 3.3 decitex (less than 3 denier) currently classifiable under the Harmonized Tariff Schedule of the United States (HTSUS) at subheading 5503.20.00.25 is specifically excluded from these orders. Also specifically excluded from these orders are polyester staple fibers of 10 to 18 denier that are cut to lengths of 6 to 8 inches (fibers used in the manufacture of carpeting). In addition, low-melt PSF is excluded from these orders. Low-melt PSF is defined as a bi-component fiber with an outer sheath that melts at a significantly lower temperature than its inner core.
The merchandise subject to these orders is currently classifiable in the HTSUS at subheadings 5503.20.00.45 and 5503.20.00.65.
The domestic producers propose that the
Pursuant to section 751(b)(1) of the Act, Commerce will conduct a changed circumstances review upon receipt of a request an interested party that shows changed circumstances sufficient to warrant a review of an order.
Section 782(h)(2) of the Act and 19 CFR 351.222(g)(1)(i) provide that Commerce may revoke an order (in whole or in part) if it determines that producers accounting for substantially all of the production of the domestic like product have expressed a lack of interest in the order, in whole or in part. In addition, in the event Commerce determines that expedited action is warranted, 19 CFR 351.221(c)(3)(ii) permits Commerce to combine the notices of initiation and preliminary results. In its administrative practice, Commerce has interpreted “substantially all” to mean producers accounting for at least 85 percent of the total U.S. production of the domestic like product covered by the order.
The domestic producers did not submit any documentation supporting their claim that they account for substantially all of the domestic production of PSF. We are providing interested parties with the opportunity to address the issue of domestic industry support with respect to this requested partial revocation of the orders, as explained below. After examining comments, if any, concerning domestic industry support, Commerce will issue the preliminary results of these changed circumstances reviews.
Interested parties are invited to provide comments and/or factual information regarding these changed circumstances reviews, including comments concerning industry support. Comments and factual information may be submitted to Commerce no later than ten days after the date of publication of this notice. Rebuttal comments and rebuttal factual information may be filed with Commerce no later than seven days after the comments and/or factual information are filed.
Commerce intends to publish in the
Enforcement and Compliance, International Trade Administration, Department of Commerce.
On September 7, 2017, the Department of Commerce (Commerce) published in the
Applicable March 16, 2018.
John Drury (Hyosung) or Moses Song (Hyundai), AD/CVD Operations, Office VI, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-0195 or (202) 482-5041, respectively.
On September 7, 2017, Commerce published the
The Issues and Decision Memorandum is a public document and is on file electronically
Commerce exercised its discretion to toll all deadlines affected by the closure of the Federal Government from January 20 through 22, 2018. If the new deadline falls on a non-business day, in accordance with Commerce's practice, the deadline will become the next business day. The revised deadline for the final results of this review is now March 9, 2018.
The scope of this order covers large liquid dielectric power transformers (LPTs) having a top power handling capacity greater than or equal to 60,000 kilovolt amperes (60 megavolt amperes), whether assembled or unassembled, complete or incomplete. The merchandise subject to the order is currently classified in the Harmonized Tariff Schedule of the United States at subheadings 8504.23.0040, 8504.23.0080, and 8504.90.9540. For a complete description of the scope of the order,
All issues raised in the case and rebuttal briefs by parties to this administrative review are addressed in the Issues and Decision Memorandum. For a list of the issues raised by parties,
Commerce has made no changes to the
The final weighted-average dumping margins are as follows:
The final weighted-average dumping margins assigned to Hyosung and Hyundai for the final results in this review are based on total facts available with adverse inferences. Accordingly, no disclosure of calculations is necessary for these final results.
Pursuant to section 751(a)(2)(A) of the Act, and 19 CFR 351.212(b), Commerce has determined, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries of subject merchandise in accordance with the final results of this review. Commerce shall instruct CBP to apply an
We intend to issue assessment instructions directly to CBP 15 days after publication of the final results of this review.
The following cash deposit requirements will be effective upon publication of this notice for all shipments of subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication of these final results, as provided by section 751(a)(2) of the Act: (1) The cash deposit rate for respondents noted above will be equal to the weighted-average dumping margins established in the final results of this administrative review; (2) for merchandise exported by producers or exporters not covered in this administrative review but covered in a prior segment of the proceeding, the cash deposit rate will continue to be the company specific rate published for the most recently completed segment of this proceeding; (3) if the exporter is not a firm covered in this review, a prior review, or the original investigation, but the producer is, the cash deposit rate will be the rate established for the most recently completed segment of this proceeding for the producer of the subject merchandise; and (4) the cash deposit rate for all other producers or exporters will continue to be 22.00 percent, the all-others rate established in the less-than-fair-value investigation.
This notice also serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f) to file a certificate regarding the reimbursement of antidumping and/or countervailing duties prior to liquidation of the relevant entries during the period of review. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of antidumping and/or countervailing duties did occur and the subsequent assessment of doubled antidumping duties.
This notice also serves as a reminder to parties subject to administrative protective orders (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3), which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of the return/destruction of APO materials, or conversion to judicial protective order, is hereby requested. Failure to comply with the regulations and the terms of an APO is a sanctionable violation.
We are issuing and publishing this notice in accordance with sections 751(a)(1) and 777(i)(1) of the Act, and 19 CFR 351.213(h) and 19 CFR 351.221(b)(5).
The scope of this order covers LPTs having a top power handling capacity greater than or equal to 60,000 kilovolt amperes (60 megavolt amperes), whether assembled or unassembled, complete or incomplete.
Incomplete LPTs are subassemblies consisting of the active part and any other parts attached to, imported with or invoiced with the active parts of LPTs. The “active part” of the transformer consists of one or more of the following when attached to or otherwise assembled with one another: The steel core or shell, the windings, electrical insulation between the windings, the mechanical frame for an LPT.
The product definition encompasses all such LPTs regardless of name designation, including but not limited to step-up transformers, step-down transformers, autotransformers, interconnection transformers, voltage regulator transformers, rectifier transformers, and power rectifier transformers.
The LPTs subject to this order are currently classifiable under subheadings 8504.23.0040, 8504.23.0080 and 8504.90.9540 of the Harmonized Tariff Schedule of the United States (HTSUS). Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the scope of this order is dispositive.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
Based on affirmative final determinations by the Department of Commerce (Commerce) and the International Trade Commission (ITC), Commerce is issuing countervailing duty orders on fine denier polyester staple fiber (fine denier PSF) from the People's Republic of China (China) and India. Also, as explained in this notice, Commerce is amending its final affirmative determination with respect to China to correct the rates assigned to Jiangyin Hailun Chemical Fiber Co. Ltd. (Hailun Chemical) and All-Others.
Applicable March 16, 2018.
Yasmin Bordas at (202) 482-3813 and Davina Friedmann at (202) 482-0698 (China); Trisha Tran at (202) 482-4852 and Eli Lovely at (202) 482-1593 (India); AD/CVD Operations, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230.
In accordance with section 705(d) of the Tariff Act of 1930, as amended (the Act), and 19 CFR 351.210(c), on January 23, 2018, Commerce published its affirmative final determinations in the countervailing duty investigations of fine denier PSF from China and India.
On March 7, 2018, the ITC notified Commerce of its final affirmative determination, pursuant to section 705(d) of the Act, that an industry in the United States is materially injured within the meaning of section 705(b)(1)(A)(i) of the Act, by reason of subsidized imports of fine denier PSF from China and India.
The product covered by these orders is fine denier PSF from China and India. For a complete description of the scope of these orders,
As discussed above, after analyzing Hailun Chemical's allegation, we determined, in accordance with section 705(e) of the Act and 19 CFR 351.224(f), that ministerial errors were made in certain calculations for the
As stated above, on March 7, 2018, in accordance with section 705(d) of the Act, the ITC notified Commerce of its final determination that an industry in the United States is materially injured by reason of subsidized imports of fine denier PSF from China and India.
As a result of the ITC's final determination, in accordance with section 706(a) of the Act, Commerce will direct U.S. Customs and Border Protection (CBP) to assess, upon further instruction by Commerce, countervailing duties on unliquidated entries of fine denier PSF from China and India entered, or withdrawn from warehouse, for consumption on or after November 6, 2017, the date of publication of the
In accordance with section 706 of the Act, Commerce will instruct CBP to reinstitute liquidation on all entries of subject merchandise from China and India, applicable the date of publication of the ITC's notice of final affirmative injury determination in the
Section 703(d) of the Act states that instructions issued pursuant to an affirmative preliminary determination may not remain in effect for more than four months. In the underlying investigations, Commerce published the
Therefore, in accordance with section 703(d) of the Act and our practice, we will instruct CBP to terminate the suspension of liquidation and to liquidate, without regard to countervailing duties, unliquidated entries of fine denier PSF from China and India entered, or withdrawn from warehouse, for consumption, after March 5, 2018, the date the provisional measures expired, until and through the day preceding the date of publication of the ITC's final injury determination in the
This notice constitutes the countervailing duty orders with respect to fine denier PSF from China and India pursuant to section 706(a) of the Act. Interested parties can find a list of countervailing duty orders at
These orders are issued and published in accordance with section 706(a) of the Act and 19 CFR 351.211(b).
The merchandise covered by these orders is fine denier polyester staple fiber (fine denier PSF), not carded or combed, measuring less than 3.3 decitex (3 denier) in diameter. The scope covers all fine denier PSF, whether coated or uncoated. The following products are excluded from the scope:
(1) PSF equal to or greater than 3.3 decitex (more than 3 denier, inclusive) currently classifiable under Harmonized Tariff Schedule of the United States (HTSUS) subheadings 5503.20.0045 and 5503.20.0065.
(2) Low-melt PSF defined as a bi-component polyester fiber having a polyester fiber component that melts at a lower temperature than the other polyester fiber component, which is currently classifiable under HTSUS subheading 5503.20.0015.
Fine denier PSF is classifiable under the HTSUS subheading 5503.20.0025. Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the scope of these orders is dispositive.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
On November 13, 2017, the Department of Commerce (Commerce) initiated an administrative review of the antidumping duty order on certain new pneumatic off-the-road tires (OTR Tires) from the People's Republic of China (China) for three companies. Based on timely withdrawal of requests for review, we are now rescinding this administrative review with respect to two of these companies: Maxon Int'l Co., Limited (Maxon); and Tianjin Leviathan International Trade Co., Ltd. (Leviathan).
Applicable March 16, 2018.
Alex Rosen, 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) 482-7814.
On September 1, 2017, Commerce published a notice of opportunity to request an administrative review of the antidumping duty order on OTR Tires from China.
Pursuant to 19 CFR 351.213(d)(1), the Secretary will rescind an administrative review, in whole or in part, if a party who requested the review withdraws the request within 90 days of the date of publication of the notice of initiation of the requested review. Leviathan and Maxon timely withdrew their respective requests for an administrative review; no other party requested a review of
Commerce will instruct U.S. Customs and Border Protection (CBP) to assess antidumping duties on all appropriate entries. For Leviathan and Maxon, the companies for which this review is rescinded, antidumping duties shall be assessed at rates equal to the cash deposit of estimated antidumping duties required at the time of entry, or withdrawal from warehouse, for consumption, in accordance with 19 CFR 351.212(c)(1)(i). Commerce intends to issue appropriate assessment instructions to CBP 15 days after publication of this notice.
This notice serves as a reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping and/or countervailing duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of antidumping and/or countervailing duties occurred and the subsequent assessment of doubled antidumping duties.
This notice serves as a final reminder to parties subject to an administrative protective order (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under an APO in accordance with 19 CFR 351.305, which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of the return/destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.
This notice is issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Act, and 19 CFR 351.213(d)(4).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Commerce) determines that The Stanley Works (Langfang) Fastening Systems Co., Ltd. and Stanley Black & Decker, Inc. (collectively, Stanley), a manufacturer/exporter of certain steel nails from the People's Republic of China (China), sold subject merchandise in the United States at prices below normal value during the period of review (POR), August 1, 2015, through July 31, 2016. We are also not granting a separate rate to Tianjin Lianda Group Co., Ltd. (Tianjin Lianda).
Applicable March 16, 2018.
Matthew Renkey or Courtney Canales, AD/CVD Operations, Office V, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone (202) 482-2312 or (202) 482-4997, respectively.
Commerce published the
In accordance with 19 CFR 351.309, we invited parties to comment on our
The merchandise covered by the
We addressed all issues raised in the case and rebuttal briefs by parties to this review in the I&D Memo. Attached to this notice, as an Appendix, is a list of the issues which parties raised. The I&D Memo is a public document and is on file in the Central Records Unit (CRU), Room B8024 of the main Department of Commerce building, as well as electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at
Based on a review of the record and comments received from interested parties regarding our
In the
Commerce conducted this review in accordance with section 751(a)(1)(B) of the Act. In the
The weighted-average dumping margins for the administrative review are as follows:
Pursuant to section 751(a)(2)(A) of the Tariff Act of 1930, as amended (the Act), and 19 CFR 351.212(b), Commerce has determined, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries of subject merchandise in accordance with the final results of this review. Commerce intends to issue appropriate assessment instructions directly to CBP 15 days after publication
Where the respondent reported reliable entered values, we calculated importer- (or customer-) specific
For respondents that were not selected for individual examination in this administrative review and which qualified for a separate rate, the assessment rate is equal to the weighted-average dumping margin assigned to Stanley, 5.98 percent.
Pursuant to Commerce's assessment practice, for entries that were not reported in the U.S. sales databases submitted by companies individually examined during this review, Commerce will instruct CBP to liquidate such entries at the China-wide entity rate. Additionally, if Commerce determines that an exporter had no shipments of the subject merchandise, any suspended entries that entered under that exporter's case number (
The following cash deposit requirements will be effective upon publication of the final results of this administrative review for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date, as provided for by section 751(a)(2)(C) of the Act: (1) For the exporters listed above, the cash deposit rate will be the rate established in the final results of review (except, if the rate is zero or
We intend to disclose the calculations performed regarding these final results within five days of the date of publication of this notice to parties in this proceeding in accordance with 19 CFR 351.224(b).
This notice also serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this POR. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of doubled antidumping duties.
This notice also serves as a reminder to parties subject to administrative protective order (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3), which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of the return or destruction of APO materials, or conversion to judicial protective order, is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.
We are issuing and publishing these final results of administrative review in accordance with sections 751(a)(1) and 777(i) of the Act, and 19 CFR 351.221(b)(5).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Commerce) has received requests to conduct administrative reviews of various antidumping and countervailing duty orders and findings with January anniversary dates. In accordance with Commerce's regulations, we are initiating those administrative reviews.
Applicable March 16, 2018.
Brenda E. Brown, Office of AD/CVD Operations, Customs Liaison Unit, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230, telephone: (202) 482-4735.
Commerce has received timely requests, in accordance with 19 CFR 351.213(b), for administrative reviews of various antidumping and countervailing duty orders and findings with January anniversary dates.
All deadlines for the submission of various types of information, certifications, or comments or actions by Commerce discussed below refer to the number of calendar days from the applicable starting time.
If a producer or exporter named in this notice of initiation had no exports, sales, or entries during the period of review (POR), it must notify Commerce within 30 days of publication of this notice in the
In the event Commerce limits the number of respondents for individual examination for administrative reviews initiated pursuant to requests made for the orders identified below, except for the administrative review of the antidumping duty order on wooden bedroom furniture from the People's Republic of China (China), Commerce intends to select respondents based on U.S. Customs and Border Protection (CBP) data for U.S. imports during the period of review. We intend to place the CBP data on the record within five days of publication of the initiation notice and to make our decision regarding respondent selection within 30 days of publication of the initiation
In the event Commerce decides it is necessary to limit individual examination of respondents and conduct respondent selection under section 777A(c)(2) of the Act:
In general, Commerce has found that determinations concerning whether particular companies should be “collapsed” (
In the event that Commerce limits the number of respondents for individual examination in the antidumping duty administrative review of wooden bedroom furniture from China, for the purposes of this segment of the proceeding,
Pursuant to 19 CFR 351.213(d)(1), a party that has requested a review may withdraw that request within 90 days of the date of publication of the notice of initiation of the requested review. The regulation provides that Commerce may extend this time if it is reasonable to do so. In order to provide parties additional certainty with respect to when Commerce will exercise its discretion to extend this 90-day deadline, interested parties are advised that Commerce does not intend to extend the 90-day deadline unless the requestor demonstrates that an extraordinary circumstance has prevented it from submitting a timely withdrawal request. Determinations by Commerce to extend the 90-day deadline will be made on a case-by-case basis.
In proceedings involving non-market economy (NME) countries, Commerce begins with a rebuttable presumption that all companies within the country are subject to government control and, thus, should be assigned a single antidumping duty deposit rate. It is Commerce's policy to assign all exporters of merchandise subject to an administrative review in an NME country this single rate unless an exporter can demonstrate that it is sufficiently independent so as to be entitled to a separate rate.
To establish whether a firm is sufficiently independent from
All firms listed below that wish to qualify for separate rate status in the administrative reviews involving NME countries must complete, as appropriate, either a separate rate application or certification, as described below. In addition, all firms that wish to qualify for separate-rate status in the antidumping duty administrative review of wooden bedroom furniture from China must complete, as appropriate, either a separate-rate certification or application, as described below, and respond to the additional questions and the Q&V questionnaire on Commerce's website at
Entities that currently do not have a separate rate from a completed segment of the proceeding
For exporters and producers who submit a separate-rate status application or certification and subsequently are selected as mandatory respondents, these exporters and producers will no longer be eligible for separate rate status unless they respond to all parts of the questionnaire as mandatory respondents.
Furthermore, this notice constitutes public notification to all firms for which an antidumping duty administrative review of wooden bedroom furniture from China has been requested, and that are seeking separate rate status in the review, that they must submit a timely separate rate application or certification (as appropriate) as described above, and a timely response to the Q&V questionnaire and the additional questions in the document package on Commerce's website in order to receive consideration for separate-rate status. In other words, Commerce will not give consideration to any timely separate rate certification or application made by parties who failed to respond in a timely manner to the Q&V questionnaire and the additional questions. All information submitted by respondents in the antidumping duty administrative review of wooden bedroom furniture from China is subject to verification. As noted above, the separate rate certification, the separate rate application, the Q&V questionnaire, and the additional questions will be available on Commerce's website on the date of publication of this notice in the
In accordance with 19 CFR 351.221(c)(1)(i), we are initiating administrative reviews of the following antidumping and countervailing duty orders and findings. We intend to issue the final results of these reviews not later than January
During any
For the first administrative review of any order, there will be no assessment of antidumping or countervailing duties on entries of subject merchandise entered, or withdrawn from warehouse, for consumption during the relevant provisional-measures “gap” period, of the order, if such a gap period is applicable to the POR.
Interested parties must submit applications for disclosure under administrative protective orders in accordance with the procedures outlined in Commerce's regulations at 19 CFR 351.305. Those procedures apply to administrative reviews included in this notice of initiation. Parties wishing to participate in any of these administrative reviews should ensure that they meet the requirements of these procedures (
Commerce's regulations identify five categories of factual information in 19 CFR 351.102(b)(21), which are summarized as follows: (i) Evidence submitted in response to questionnaires; (ii) evidence submitted in support of allegations; (iii) publicly available information to value factors under 19 CFR 351.408(c) or to measure the adequacy of remuneration under 19 CFR 351.511(a)(2); (iv) evidence placed on the record by Commerce; and (v) evidence other than factual information described in (i)-(iv). These regulations require any party, when submitting factual information, to specify under which subsection of 19 CFR 351.102(b)(21) the information is being submitted and, if the information is submitted to rebut, clarify, or correct factual information already on the record, to provide an explanation identifying the information already on the record that the factual information seeks to rebut, clarify, or correct. The regulations, at 19 CFR 351.301, also provide specific time limits for such factual submissions based on the type of factual information being submitted. Please review the final rule, available at
Any party submitting factual information in an antidumping duty or countervailing duty proceeding must certify to the accuracy and completeness
Parties may request an extension of time limits before a time limit established under Part 351 expires, or as otherwise specified by the Secretary.
These initiations and this notice are in accordance with section 751(a) of the Act (19 U.S.C. 1675(a)) and 19 CFR 351.221(c)(1)(i).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Commerce) determines that Giti Tire Global Trading Pte. Ltd. (Giti) and its affiliates as well as Qingdao Sentury Tire Co., Ltd. (Sentury) and its affiliates, manufacturers/exporters of certain passenger vehicle and light truck tires (passenger tires) from the People's Republic of China (China), sold subject merchandise in the United States at prices below normal value (NV) during the period of review (POR) January 27, 2015, through July 31, 2016.
Applicable March 16, 2018.
Toni Page, Lingjun Wang, or Jun Jack Zhao, AD/CVD Operations, Office VII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-1398, (202) 482-2316, or (202) 482-1396, respectively.
Commerce published the preliminary results of this administrative review of passenger tires from China on September 7, 2017.
Commerce exercised its discretion to toll all deadlines affected by the closure of the Federal Government from January 20 through 22, 2018. If the new deadline falls on a non-business day, in accordance with Commerce's practice, the deadline will become the next business day. The revised deadline for the final results of this review is now March 9, 2018.
The scope of the order is passenger vehicle and light truck tires. Passenger vehicle and light truck tires are new pneumatic tires, of rubber, with a passenger vehicle or light truck size designation.
All issues raised in the case and rebuttal briefs are addressed in the accompanying Issues and Decision Memorandum.
In the
In the
In the
In addition, Commerce inadvertently listed Haohua Orient International Trade Ltd. and Nankang (Zhangjiagang Free Trade Zone) Rubber Industrial Co., Ltd as both qualifying for and not qualifying for separate rate status.
Further, Commerce continues to find that the remaining entities listed as not qualifying for separate rates have failed to demonstrate an absence of
Pursuant to section 772(c)(1)(C) of the Act, Commerce has granted an export subsidy adjustment to Giti and Sentury. In addition, pursuant to sections 777A(f)(1)(A)-(C) of the Act, Commerce has granted a double-remedy adjustment to Giti and Sentury for these final results. The antidumping duty rate assigned to the non-examined exporters which qualify for a separate rate reflects the export subsidy and double-remedy adjustments granted to the mandatory respondents.
Commerce finds that the following weighted-average dumping margins exist for the POR:
Pursuant to section 751(a)(2)(C) of the Act, and 19 CFR 351.212(b)(1), Commerce has determined, and CBP shall assess, antidumping duties on all appropriate entries of subject merchandise, where applicable, in accordance with the final results of this review. Commerce intends to issue assessment instructions to CBP 15 days after the date of publication of these final results of review.
Pursuant to Commerce practice, for entries that were not reported in the U.S. sales database submitted by an exporter individually examined during this review, Commerce will instruct CBP to liquidate such entries at the rate for the PRC-wide entity.
In accordance with section 751(a)(2)(C) of the Act, the final results of this review shall be the basis for the assessment of antidumping duties on POR entries, and for future deposits of estimated antidumping duties, where applicable.
Commerce will instruct CBP to require a cash deposit for antidumping duties equal to the weighted-average amount by which NV exceeds U.S. price. The following cash deposit requirements will be effective upon publication of the final results of this administrative review for shipments of the subject merchandise from China entered, or withdrawn from warehouse, for consumption on or after the publication date of this notice, as provided by section 751(a)(2)(C) of the Act: (1) For the exporters listed above, the cash deposit rate will be equal to the weighted-average dumping margin established in the final results of this review (except, if the rate is
This notice also serves as a reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties and/or countervailing duties prior to liquidation of the relevant entries during this POR. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of antidumping duties and/or countervailing duties has occurred, and the subsequent assessment of double antidumping duties and/or an increase in the amount of antidumping duties by the amount of the countervailing duties.
This notice serves as the only reminder to parties subject to administrative protective order (APO) of their responsibility concerning the disposition of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of return or destruction of APO materials, or conversion to judicial protective order, is hereby requested. Failure to comply with the regulations and the terms of an APO is a sanctionable violation.
We are issuing and publishing these results of review in accordance with sections 751(a)(1) and 777(i)(1) of the Act.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Commerce) determines that the mandatory respondents GITI Tire Global Trading Pte. Ltd./GITI Tire (USA) Ltd./GITI Radial Tire (Anhui) Company Ltd. (GITI Anhui Radial)/GITI Tire (Fujian) Company Ltd (GITI Fujian)/GITI Tire (Hualin) Company Ltd. (GITI Hualin) (collectively, GITI) and Cooper (Kunshan) Tire Co., Ltd. (Cooper), exporters of passenger vehicle and light truck tires from the People's Republic of China (China) received countervailable subsidies during the period of review (POR) December 1, 2014, through December 31, 2015. We also find that Zhongce Rubber Group Company Limited (Zhongce) received countervailable subsidies during the POR, based on adverse facts available.
Applicable March 16, 2018.
Andrew Huston, AD/CVD Operations, Office VII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone (202) 482-4261.
Commerce published the
We invited interested parties to comment on the
On December 8, 2017, in accordance with section 751(a)(3)(A) of the Act, Commerce extended the period for issuing the final results of this review by 60 days, to March 6, 2018.
The products covered by the order are certain passenger vehicle and light truck tires from China. A full description of the scope of the order is contained in the Issues and Decision Memorandum.
All issues raised in interested parties' briefs are addressed in the Issues and Decision Memorandum accompanying this notice. A list of the issues raised by interested parties and to which we responded in the Issues and Decision Memorandum is provided in Appendix I to this notice. The Issues and Decision Memorandum is a public document and is on file electronically
Based on case briefs, rebuttal briefs, and all supporting documentation, we made changes from the
Commerce conducted this review in accordance with section 751(a)(1)(A) of the Tariff Act of 1930, as amended (the Act). For each of the subsidy programs found to be countervailable, we find that there is a subsidy,
In accordance with 19 CFR 351.221(b)(5), we calculated a countervailable subsidy rate for the mandatory respondents, Cooper and GITI, and a rate based on facts available for Zhongce. For the non-selected companies subject to this review,
We will disclose to the parties in this proceeding the calculations performed for these final results within five days of the date of publication of this notice in the
Consistent with 19 CFR 351.212(b)(2), we intend to issue assessment instructions to U.S. Customs and Border Protection (CBP) 15 days after the date of publication of these final results of review, to liquidate shipments of subject merchandise entered, or withdrawn from warehouse, for consumption, on or after December 1, 2014, through December 31, 2015, at the
In accordance with section 751(a)(1) of the Act, we intend to instruct CBP to collect cash deposits of estimated countervailing duties in the amounts shown for each of the respective companies listed above. These cash deposit requirements, when imposed, shall remain in effect until further notice.
This notice also serves as a reminder to parties subject to administrative protective order (APO) of their responsibility concerning the destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of the return or destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a sanctionable violation.
We are issuing and publishing these results in accordance with sections 751(a)(1) and 777(i)(1) of the Act.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; issuance of an incidental harassment authorization.
In accordance with the regulations implementing the Marine Mammal Protection Act (MMPA) as amended, notification is hereby given that NMFS has issued an incidental harassment authorization (IHA) to the Partnership for Interdisciplinary Study of Coastal Oceans (PISCO) at the University of California Santa Cruz (UCSC) to incidentally harass, by Level B harassment only, marine mammals during rocky intertidal monitoring surveys.
This Authorization is effective from March 12, 2018, through March 11, 2019.
Rob Pauline, Office of Protected Resources, NMFS, (301) 427-8401. Electronic copies of the application and supporting documents, as well as a list of the references cited in this document, may be obtained online at:
Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361
An authorization for incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s), will not have an unmitigable adverse impact on the availability of the species or stock(s) for subsistence uses (where relevant), and if the permissible methods of taking and requirements pertaining to the mitigation, monitoring and reporting of such takings are set forth.
NMFS has defined “negligible impact” in 50 CFR 216.103 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.
The MMPA states that the term “take” means to harass, hunt, capture, kill or attempt to harass, hunt, capture, or kill any marine mammal.
Except with respect to certain activities not pertinent here, 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 patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering (Level B harassment).
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 (CE 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 determined that the issuance of the IHA qualifies to be categorically excluded from further NEPA review.
On September 26, 2017, NMFS received a request from PISCO for an IHA to take marine mammals incidental to rocky intertidal monitoring surveys along the Oregon and California coasts. PISCO's request is for take of California sea lions (
This IHA would cover one year of a larger project for which PISCO obtained prior IHAs. This multiyear annual survey involves surveying rocky intertidal zones in a number of locations in Oregon and California. NMFS has previously issued five IHAs for this ongoing survey project (77 FR 72327, December 5, 2012; 78 FR 79403, December 30, 2013; 79 FR 73048, December 9, 2014; 81 FR 7319, February 2, 2016; 82 FR 12568, March 6, 2017). PISCO complied with all the requirements (
PISCO requested an IHA to continue rocky intertidal monitoring work that has been ongoing for 20 years. PISCO focuses on understanding the nearshore ecosystems of the U.S. west coast through a number of interdisciplinary collaborations. The program integrates long-term monitoring of ecological and oceanographic processes at dozens of sites with experimental work in the lab and field. A short description of project components is found below. A detailed description of the planned intertidal monitoring project was provided in the
PISCO's research is conducted throughout the year, but will begin no sooner than March 12, 2018 and end on March 11, 2019. Most sites are sampled one to two times per year over a 1-day period (4-6 hours per site) during a negative low tide series. Due to the large number of research sites, scheduling constraints, the necessity for negative low tides and favorable weather/ocean conditions, exact survey dates are variable and difficult to predict. Some sampling may occur in all months.
Sampling sites occur along the California and Oregon coasts. Community Structure Monitoring sites range from Ecola State Park near Cannon Beach, Oregon to Government Point located northwest of Santa Barbara, California. Biodiversity Survey sites extend from Ecola State Park south to Cabrillo National Monument in San Diego County, California. Exact locations of sampling sites can be found in Tables 1 and 2 of PISCO's application.
Community Structure Monitoring involves the use of permanent photoplot quadrats, which target specific algal and invertebrate assemblages (
Biodiversity Surveys are part of a long-term monitoring project and are conducted every 3-5 years across 142 established sites. Nineteen Biodiversity Survey sites will be visited in 2018. These Biodiversity Surveys involve point contact identification along permanent transects, mobile invertebrate quadrat counts, sea star band counts, and tidal height topographic measurements. Five of the Biodiversity Survey sites are also Community Structure sites, leaving 14 sites that are only Biodiversity Survey sites. As such, a total of 62 unique sites would be visited under the IHA.
The intertidal zones where PISCO conducts intertidal monitoring are also areas where pinnipeds can be found hauled out on the shore at or adjacent to some research sites. Pinnipeds have been recorded at 17 out of the 62 survey sites. Accessing portions of the intertidal habitat at these locations may cause incidental Level B (behavioral) harassment of pinnipeds through some unavoidable approaches if pinnipeds are hauled out directly in the study plots or while biologists walk from one location to another. No motorized equipment is involved in conducting these surveys.
A notice of NMFS' proposal to issue an IHA was published in the
The option for issuing renewal IHAs has been in NMFS's incidental take regulations since 1996. Nonetheless, NMFS will provide additional information to the Commission as well as consider the best way to provide addition information to the public on the renewal process.
A detailed description of the species likely to be affected by the monitoring project, including brief introductions to the species and relevant stocks as well as available information regarding population trends and threats, and information regarding local occurrence, were provided in the
The effect of stressors associated with the specified activity (
NMFS described potential impacts to marine mammal habitat in detail in our
This section provides an estimate of the number of incidental takes authorized through this IHA, which will inform both NMFS' consideration of whether the number of takes is “small” 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 patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering (Level B harassment).
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 researchers. Based on the nature of the activity, Level A harassment is neither anticipated nor authorized.
As described previously, no mortality is anticipated or authorized for this activity. Below we describe how the take is estimated.
In this section we provide the information about the presence, density, or group dynamics of marine mammals that will inform the take calculations. Take estimates are based on historical marine mammal observations at each site from previous PISCO survey activities. Marine mammal observations are done as part of PISCO site observations, which include notes on physical and biological conditions at the site. The maximum number of marine mammals, by species, seen at any given time throughout the sampling day is recorded at the conclusion of sampling. A marine mammal is counted if it is seen on access ways to the site, at the site, or immediately up-coast or down-coast of the site. Marine mammals in the water immediately offshore are also recorded. Any other relevant information, including the location of a marine mammal relevant to the site, any unusual behavior, and the presence of pups is also noted.
The observations described above formed the basis from which researchers with extensive knowledge and experience at each site estimated the actual number of marine mammals that may be subject to take. Take estimates for each species for which take is authorized were based on the following equation:
For take estimates, PISCO looked at sites that have consistently had a marine mammal presence and used the maximum number of marine mammals previously observed at these sites that could be subject to take (
Individual species' totals for each survey site were summed to arrive at a total estimated take number. Numbers are rounded up to the nearest value of 5 (
Harbor seals are expected to occur at 15 locations with expected taken numbers ranging from 5 to 25 animals per visit (Table 2 in PISCO's application). These locations will be subject to 21 site visits under the IHA. It is anticipated that there will be 230 exposures of adult harbor seals and 25 exposures of weaned pups. Therefore, NMFS has authorized 255 harbor seal takes. This is an increase over the proposed number of 203 takes included in the notice for the proposed IHA (83 FR 3308; January 24, 2018). The increase is due to draft 2017 monitoring plan data which showed increased take of adult seals at several locations (
California sea lions are expected to be present at five sites with eight scheduled visits as shown in Table 3 in the application. Eighty-five adult and five pup exposures are expected to be taken. Therefore, NMFS has authorized 90 California sea lion takes.
Northern elephant seals are only expected to occur at one site this year, Piedras Blancs, which will experience two separate visits (See Table 4 in application). Up to 10 adult and 40 weaned pup exposures are anticipated. Therefore, NMFS has authorized 50 Northern elephant seal takes.
NMFS has authorized the take, by Level B harassment only, of 255 harbor seals, 90 California sea lions, and 50 northern elephant seals. These numbers are considered to be maximum take estimates; therefore, actual take may be less if animals decide to haul out at a different location for the day or animals are out foraging at the time of the survey activities.
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.
PISCO will implement several mitigation measures to reduce potential take by Level B (behavioral disturbance) harassment. Measures are listed below.
• Researchers will observe a site from a distance, using binoculars if necessary, to detect any marine mammals prior to approach to determine if mitigation is required
• Researchers will avoid pinnipeds along access ways to sites by locating and taking a different access way. Researchers will keep a safe distance from and not approach any marine mammal while conducting research, unless it is absolutely necessary to flush a marine mammal in order to continue conducting research (
• Researchers will avoid making loud noises (
• Researches will monitor the offshore area for predators (such as killer whales and white sharks) and avoid flushing of pinnipeds when predators are observed in nearshore waters. Note that PISCO has never observed an offshore predator while researchers were present at any of the survey sites.
• Intentional flushing will not occur if dependent pups are present to avoid mother/pup separation and trampling of pups. Staff shall reschedule work at sites where pups are present, unless other means of accomplishing the work can be done without causing disturbance to mothers and dependent pups.
• To avoid take of Steller sea lions, northern fur seals, or Guadalupe fur seals, any site where they are present will not be approached and will be sampled at a later date.
• Researchers will promptly vacate sites at the conclusion of sampling.
The primary method of mitigating the risk of disturbance to pinnipeds, which will be in use at all times, is the selection of judicious routes of approach to study sites, avoiding close contact with pinnipeds hauled out on shore, and the use of extreme caution upon approach. Each visit to a given study site will last for approximately 4-6
Based on our evaluation of the applicant's measures, NMFS has determined that the required 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 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.
PISCO will contribute to the knowledge of pinnipeds in California and Oregon by noting observations of: (1) Unusual behaviors, numbers, or distributions of pinnipeds, such that any potential follow-up research can be conducted by the appropriate personnel; (2) tag-bearing carcasses of pinnipeds, allowing transmittal of the information to appropriate agencies and personnel; and (3) rare or unusual species of marine mammals for agency follow-up.
Monitoring requirements in relation to PISCO's rocky intertidal monitoring will include observations made by the applicant. Information recorded will include species counts (with numbers of pups/juveniles when possible) of animals present before approaching, numbers of observed disturbances, and descriptions of the disturbance behaviors during the monitoring surveys, including location, date, and time of the event. For consistency, any reactions by pinnipeds to researchers will be recorded according to a three-point scale shown in Table 2. Note that only observations of disturbance Levels 2 and 3 should be recorded as takes.
In addition, observations regarding the number and species of any marine mammals observed, either in the water or hauled-out, at or adjacent to a site, are recorded as part of field observations during research activities. Information regarding physical and biological conditions pertaining to a site, as well as the date and time that research was conducted are also noted. This information will be incorporated into a monitoring report for NMFS.
If at any time the specified activity clearly causes the take of a marine mammal in a manner prohibited by this IHA, such as an injury (Level A harassment), serious injury, or mortality, PISCO shall immediately cease the specified activities and report the incident to the Office of Protected Resources, NMFS, and the West Coast Regional 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 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 shall not resume until NMFS is able to review the circumstances of the prohibited take. NMFS will work with PISCO to determine what measures are necessary to minimize the likelihood of further prohibited take and ensure MMPA compliance. PISCO may not resume the activities until notified by NMFS.
In the event that an injured or dead marine mammal is discovered and it is determined that the cause of the injury or death is unknown and the death is relatively recent (
In the event that an injured or dead marine mammal is discovered and it is determined that the injury or death is not associated with or related to the activities authorized in the IHA (
A draft final report must be submitted to NMFS Office of Protected Resources within 60 days after the conclusion of the 2018 field season or 60 days prior to the start of the next field season if a new IHA will be requested. The report will include a summary of the information gathered pursuant to the monitoring requirements set forth in the IHA. A final report must be submitted to the Director of the NMFS Office of Protected Resources and to the NMFS West Coast Regional Administrator within 30 days after receiving comments from NMFS on the draft final report. If no comments are received from NMFS, the draft final report will be considered the final report.
PISCO complied with the mitigation and monitoring that were required under the IHA issued in February 2016. In compliance with the IHA, PISCO submitted a report detailing the activities and marine mammal monitoring they conducted. The IHA required PISCO to conduct counts of pinnipeds present at study sites prior to approaching the sites and to record species counts and any observed reactions to the presence of the researchers.
From December 3, 2016, through February 2, 2017 researchers conducted rocky intertidal sampling at numerous sites in California and Oregon (see Table 12 in PISCO's 2016 monitoring report). Tables 7, 8, and 9 in PISCO's monitoring report outline marine mammal observations and reactions. During this period there were 96 takes of harbor seals, 1 take of California sea lions, and 22 takes of northern elephant seals. NMFS had authorized the take of 203 harbor seals, 720 California sea lions, and 40 Northern Elephant seals under that IHA. PISCO also submitted a preliminary monitoring report associated with the existing IHA for the period covering February 21, 2017 through November 30, 2017. PISCO recorded 63 takes of harbor seals and 3 takes of California sea lions. There were no takes of northern elephant seals. NMFS had authorized the take of 233 harbor seals, 90 California sea lions, and 60 northern elephant seals under the existing IHA.
Based on the results from the monitoring report, we conclude that these results support our original findings that the mitigation measures set forth in the 2016 and 2017 IHAs effected the least practicable impact on the species or stocks. There were no stampede events during these years and most disturbances were Level 1 and 2 from the disturbance scale meaning the animal did not fully flush but observed or moved slightly in response to researchers. Those that did fully flush to the water did so slowly. Most of these animals tended to observe researchers from the water and then re-haulout farther up-coast or down-coast of the site within approximately 30 minutes of the disturbance.
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 (
No injuries or mortalities are anticipated to occur as a result of PISCO's rocky intertidal monitoring surveys and none are authorized. The risk of marine mammal injury, serious injury, or mortality associated with rocky intertidal monitoring increases somewhat if disturbances occur during breeding season. These situations present increased potential for mothers and dependent pups to become separated and, if separated pairs do not quickly reunite, the risk of mortality to pups (
Typically, even those reactions constituting Level B harassment would result at most in temporary, short-term behavioral disturbance. In any given study season, researchers will visit select sites one to two times per year for
Of the marine mammal species anticipated to occur in the planned activity areas, none are listed under the ESA. Taking into account the planned mitigation measures, effects to marine mammals are generally expected to be restricted to short-term changes in behavior or temporary abandonment of haulout sites, pinnipeds are not expected to permanently abandon any area that is surveyed by researchers, as is evidenced by continued presence of pinnipeds at the sites during annual monitoring counts. No adverse effects to prey species are anticipated and habitat impacts are limited and highly localized, consisting of the placement of permanent bolts in the intertidal zone. Based on the analysis contained herein of the likely effects of the specified activity on marine mammals and their habitat, and taking into consideration the implementation of the requied mitigation and monitoring measures, NMFS finds that the total marine mammal take from PISCO's rocky intertidal monitoring program will not adversely affect annual rates of recruitment or survival and, therefore, will have a negligible impact on the affected species or stocks.
In summary and as described above, the following factors primarily support our determination that the impacts resulting from this activity are not expected to adversely affect the species or stock through effects on annual rates of recruitment or survival:
• No pinniped mortality is anticipated or authorized;
• Only a small number of pups are expected to be disturbed;
• Effects of the survey activities would be limited to short-term, localized behavioral changes;
• Nominal impacts to pinniped habitat; and
• Effectiveness of mitigation measures.
Based on the analysis contained herein of the likely effects of the specified activity on marine mammals and their habitat, and taking into consideration the implementation of the monitoring and mitigation measures, NMFS finds that the total marine mammal take from the planned 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 section 101(a)(5)(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.
Table 3 presents the abundance of each species or stock, the authorized take estimates, and the percentage of the affected populations or stocks that may be taken by Level B harassment. The numbers of animals authorized to be taken would be considered small relative to the relevant stocks or populations (0.82-1.03 percent for harbor seals, and <0.01 percent for California sea lions and northern elephant seals).
Based on the analysis contained herein of the planned activity (including the required mitigation and monitoring measures) and the anticipated take of marine mammals, NMFS 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.
Section 7(a)(2) of the Endangered Species Act of 1973 (ESA: 16 U.S.C. 1531
No incidental take of ESA-listed species is authorized 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 determinations, we have issued an IHA to PISCO for conducting the described activities related to rocky intertidal monitoring
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.
Notice of meeting.
The Advisory Committee on Commercial Remote Sensing (“ACCRES” or “the Committee”) will meet April 3, 2018.
The meeting is scheduled as follows: April 3, 2018, 9:00 a.m.-4:00 p.m. There will be a one hour lunch break from 12:15 p.m.-1:15 p.m.
The meeting will be held at the Silver Spring Civic Center—The Spring Room, 1 Veterans Place, Silver Spring, MD 20910.
Samira Patel, NOAA/NESDIS/CRSRA, 1335 East West Highway, G-101, Silver Spring, Maryland 20910; (301) 713-7077 or
As required by Section 10(a)(2) of the Federal Advisory Committee Act, 5 U.S.C. App. 2 (FACA) and its implementing regulations,
The meeting will be open to the public pursuant to Section 10(a)(1) of the FACA. During the meeting, the Committee will receive updates on NOAA's Commercial Remote Sensing Regulatory Affairs activities and discuss updates to the commercial remote sensing regulatory regime. The Committee will also discuss updates in the regulations and new technological activities in space. The Committee will be available to receive public comments on its activities.
The meeting is physically accessible to people with disabilities. Requests for special accommodations may be directed to Samira Patel, NOAA/NESDIS/CRSRA, 1335 East West Highway, G-101, Silver Spring, Maryland 20910; (301) 713-7077 or
Any member of the public who plans to attend the open meeting should RSVP to Samira Patel at (301) 713-7077, or
ACCRES expects that public statements presented at its meetings will not be repetitive of previously-submitted oral or written statements. In general, each individual or group making an oral presentation may be limited to a total time of five minutes. Written comments sent to NOAA/NESDIS/CRSRA on or before March 27, 2018 will be provided to Committee members in advance of the meeting. Comments received too close to the meeting date will normally be provided to Committee members at the meeting.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of availability.
NMFS is publishing its final 2017 List of Foreign Fisheries (LOFF), as required by the regulations implementing the Fish and Fish Product Import Provisions of the Marine Mammal Protection Act (MMPA). The final LOFF reflects new information received during the comment period on interactions between commercial fisheries exporting fish and fish products to the United States and marine mammals, and updates and revisions to the draft LOFF. NMFS has classified each commercial fishery on the final LOFF into one of two categories, either “export” or “exempt”, based upon frequency and likelihood of
Nina Young, NMFS F/IASI at
In August 2016, NMFS published a final rule (81 FR 54390; August 15, 2016) implementing the fish and fish product import provisions (section 101(a)(2)) of the MMPA. This rule established conditions for evaluating a harvesting nation's regulatory programs to address incidental and intentional mortality and serious injury of marine mammals in its fisheries producing fish and fish products exported to the United States.
Under this rule, fish or fish products cannot be imported into the United States from commercial fishing operations that result in the incidental mortality or serious injury of marine mammals in excess of United States standards. Fish and fish products from export and exempt fisheries identified by the Assistant Administrator for Fisheries in the LOFF can only be imported into the United States if the harvesting nation has applied for and received a comparability finding from NMFS. The rule established procedures that a harvesting nation must follow and conditions it must meet to receive a comparability finding for a fishery. The rule also established provisions for intermediary nations to ensure that such nations do not import and re-export to the United States fish or fish products that are subject to an import prohibition.
Based on information provided by nations, industry, the public, and other readily available sources, NMFS identified nations with commercial fishing operations that export fish and fish products to the United States and classified each of those fisheries based on their frequency of marine mammal interactions as either “exempt” or “export” fisheries (see definitions below). The entire list of these export and exempt fisheries, organized by nation (or economy), constitutes the LOFF.
Under the MMPA, the United States prohibits imports of commercial fish or fish products caught in commercial fishing operations resulting in the incidental killing or serious injury (bycatch) of marine mammals in excess of United States standards (16 U.S.C. 1371(a)(2)). NMFS published regulations implementing these MMPA import provisions in August 2016 (81 FR 54390; August 15, 2016). The regulations apply to any foreign nation with fisheries exporting fish and fish products to the United States, either directly or through an intermediary nation.
The LOFF is integral to the implementation of the MMPA import provisions. As described below, the LOFF lists foreign commercial fisheries that export fish and fish products to the United States and that have been classified as either “export” or “exempt” based on the frequency and likelihood of interactions or incidental mortality and serious injury of a marine mammal. A harvesting nation must apply for and receive a comparability finding for each of its export and exempt fisheries to continue to export fish and fish products from those fisheries to the United States. For all fisheries, to receive a comparability finding under this program, the harvesting nation must prohibit intentional killing of marine mammals in the course of commercial fishing operations in the fishery or demonstrate that it has procedures to reliably certify that exports of fish and fish products to the United States were not harvested in association with the intentional killing or serious injury of marine mammals.
The classifications of “exempt fishery” or “export fishery” determine the criteria that a nation's fishery must meet to receive a comparability finding for that fishery. A comparability finding is required for both exempt and export fisheries, but the criteria for exempt and export fisheries differ.
For an exempt fishery, the criteria to receive a comparability finding are limited only to conditions related to the prohibition of intentional killing or injury of marine mammals (see 50 CFR 216.24(h)(6)(iii)(A)). For an export fishery, the criteria to receive a comparability finding include the conditions related to the prohibition of intentional killing or injury of marine mammals (see 50 CFR 216.24(h)(6)(iii)(A)) and the requirement to develop and maintain regulatory programs comparable in effectiveness to the U.S. regulatory program for reducing incidental marine mammal bycatch (see 50 CFR 216.24(h)(6)). The definitions of “exempt” and “export” fishery are below.
NMFS included a five-year exemption period (which began 1 January 2017) in this process to allow foreign harvesting nations time to develop, as appropriate, regulatory programs comparable in effectiveness to U.S. programs at reducing marine mammal bycatch. During this exemption period, NMFS, based on the final LOFF, and in consultation with the Secretary of State, will consult with harvesting nations with commercial fishing operations identified as export or exempt fisheries for purposes of notifying the harvesting nation of the requirements of the MMPA. NMFS will continue to urge harvesting nations to gather information about marine mammal bycatch in their commercial fisheries to inform the next draft and final LOFF (slated for 2020). NMFS will re-evaluate foreign commercial fishing operations and publish a notice of availability of the draft for public comment, and a notice of availability of the final revised LOFF in the
Based on the information in this final LOFF, in 2019, nations must provide a progress report to NMFS on their efforts to develop monitoring and regulatory programs comparable to the U.S. regulatory program.
If, during the five-year exemption period, the United States determines that a marine mammal stock is immediately and significantly adversely affected by an export fishery, NMFS may use its emergency rulemaking authority to institute an import ban on products from that fishery.
Information on the frequency or likelihood of interactions or bycatch in most foreign fisheries was lacking or incomplete. Absent such information, NMFS used readily available
A comparability finding is a finding by NMFS that the harvesting nation for an export or exempt fishery has met the applicable conditions specified in the regulations (see 50 CFR 216.24(h)) subject to the additional considerations for comparability findings set out in the regulations. A comparability finding is required for a nation to export fish and fish products to the United States. To receive a comparability finding for an export fishery, the harvesting nation must maintain a regulatory program with respect to that fishery that is comparable in effectiveness to the U.S. regulatory program for reducing incidental marine mammal bycatch. This requirement may be met by developing, implementing and maintaining a regulatory program that includes measures that are comparable, or that effectively achieve comparable results, to the regulatory program under which the analogous U.S. fishery operates.
The definition of export fishery can be found in the implementing regulations for section 101(a)(2) of the MMPA (see 50 CFR 216.3). NMFS considers “export” fisheries to be functionally equivalent to Category I and II fisheries under the U.S. regulatory program (see definitions at 50 CFR 229.2). The definition of an export fishery is summarized below.
NMFS defines “export fishery” as a foreign commercial fishing operation determined by the Assistant Administrator to be the source of exports of commercial fish and fish products to the United States that have more than a remote likelihood of incidental mortality and serious injury of marine mammals in the course of its commercial fishing operations.
Where reliable information on the frequency of incidental mortality and serious injury of marine mammals caused by the commercial fishing operation is not provided by the harvesting nation, the Assistant Administrator may determine the likelihood of incidental mortality and serious injury as more than remote by evaluating information concerning factors such as fishing techniques, gear used, methods used to deter marine mammals, target fish species, seasons and areas fished, qualitative data from logbooks or fisher reports, stranding data, the species and distribution of marine mammals in the area, or other factors.
Commercial fishing operations not specifically identified in the current LOFF as either exempt or export fisheries are deemed to be export fisheries until a revised LOFF is posted, unless the harvesting nation provides the Assistant Administrator with information to properly classify a foreign commercial fishing operation not on the LOFF. The Assistant Administrator may also request additional information from the harvesting nation, as well as consider other relevant information about such commercial fishing operations and the frequency of incidental mortality and serious injury of marine mammals, to properly classify the foreign commercial fishing operation.
The definition of exempt fishery can be found in the implementing regulations for section 101(a)(2) of the MMPA (see 50 CFR 216.3). NMFS considers “exempt” fisheries to be functionally equivalent to Category III fisheries under the U.S. regulatory program (see definitions at 50 CFR 229.2).
NMFS defines an exempt fishery as a foreign commercial fishing operation determined by the Assistant Administrator to be the source of exports of commercial fish and fish products to the United States that have a remote likelihood of, or no known, incidental mortality and serious injury of marine mammals in the course of commercial fishing operations. A commercial fishing operation that has a remote likelihood of causing incidental mortality and serious injury of marine mammals is one that, collectively with other foreign fisheries exporting fish and fish products to the United States, causes the annual removal of:
(1) Ten percent or less of any marine mammal stock's bycatch limit, or
(2) More than ten percent of any marine mammal stock's bycatch limit, yet that fishery by itself removes one percent or less of that stock's bycatch limit annually, or
(3) Where reliable information has not been provided by the harvesting nation on the frequency of incidental mortality and serious injury of marine mammals caused by the commercial fishing operation, the Assistant Administrator may determine whether the likelihood of incidental mortality and serious injury is “remote” by evaluating information such as fishing techniques, gear used, methods to deter marine mammals, target fish species, seasons and areas fished, qualitative data from logbooks or fisher reports, stranding data, the species and distribution of marine mammals in the area, or other factors at the discretion of the Assistant Administrator.
A foreign fishery will not be classified as an exempt fishery unless the Assistant Administrator has reliable information from the harvesting nation, or other information, to support such a finding.
NMFS organized the LOFF by harvesting nation (or economy). Each harvesting nation's LOFF may include “exempt fisheries,” “export fisheries,” and “export fisheries with no information”. The fisheries listing includes defining factors including geographic location of harvest, gear-type, target species, or a combination thereof. Where known, the LOFF also includes a list of the marine mammals that interact with each commercial fishing operation, and, when available, indicates the level of incidental mortality and serious injury of marine mammals in each commercial fishing operation.
NMFS reviewed and considered documentation provided by nations; the public; and other sources of information, where available, including fishing vessel records; reports of on-board fishery observers; information from off-loading facilities, port-side government officials, enforcement entities and documents, transshipment vessel workers and fish importers; government vessel registries; regional fisheries management organization (RFMO) or intergovernmental agreement
First, NMFS identified imports of fish and fish products by nation using the U.S. foreign trade database for commercial fisheries imports found at:
For commercial fishing operations, NMFS requested information on the number of participants, number of vessels, gear type, target species, area of operation, fishing season, and any information regarding the frequency of marine mammal incidental mortality and serious injury, including programs to assess marine mammal populations or bycatch. NMFS also requested that nations submit copies of any laws, decrees, regulations, or measures to reduce incidental mortality and serious injury of marine mammals in their commercial fishing operations or prohibit the intentional killing or injury of marine mammals.
NMFS also evaluated information submitted by the nations and the public in response to the
Based on these information sources, NMFS developed and published a draft LOFF in the
The LOFF includes a list of marine mammal species and/or stocks incidentally or intentionally killed or injured in a commercial fishing operation. The list of species and/or stocks incidentally or intentionally killed or injured includes “serious” and “non-serious” documented injuries and interactions with fishing gear, including interactions such as depredation.
NMFS reviewed information submitted by nations and readily available scientific information including co-occurrence models demonstrating distributional overlap of commercial fishing operations and marine mammals to determine which species or stocks to include as incidentally or intentionally killed or injured in or interacting with a fishery. NMFS also reviewed, when available, injury determination reports, bycatch estimation reports, observer data, logbook data, disentanglement network data, fisher self-reports, and the information referenced in the definition of exempt and export fishery (see above or 50 CFR 216.3).
NMFS will re-evaluate foreign commercial fishing operations and publish in the
To change a fishery's classification, nations or other interested stakeholders must provide observer data, logbook summaries (preferably over a five-year period), or reports that specifically indicate the presence or absence of marine mammal interactions, quantify such interactions wherever possible, provide additional information on the location and operation of the fishery, details about the gear type and how it is used, maps showing the distribution of marine mammals and the operational area of the fishery; information regarding marine mammal populations and the biological impact of that fishery on those populations, and/or any other documentation that clearly demonstrates that a fishery is either an export or exempt fishery. Data from independent onboard observer programs documenting marine mammal interaction and bycatch is preferable. Such data can be summarized and averaged over at least a five-year period and include information on the observer program including the percent coverage, number of vessels and sets or hauls observed. Nations should also indicate whether bycatch estimates from observer data are observed minimum counts or extrapolated estimates for the entire fishery. Nations submitting logbook information should include details about the reporting system, including examples of forms and requirements for reporting.
Dolphin (family
Section 609 of Public Law 101-162 (“Sec. 609”) prohibits imports of certain categories of shrimp unless the President certifies to the Congress by May 1, 1991, and annually thereafter, that either: (1) The harvesting nation has adopted a program governing the incidental taking of sea turtles in its commercial shrimp fishery comparable to the program in effect in the United States and has an incidental take rate comparable to that of the United States; or (2) the particular fishing environment of the harvesting nation does not pose a threat of the incidental taking of sea turtles. On May 1, 2017, the Department of State certified that 13 shrimp-harvesting nations and 4fisheries have a regulatory program comparable to that of the United States governing the incidental taking of the relevant species of sea turtles in the course of commercial shrimp harvesting and that the particular fishing environments of 26 shrimp-harvesting nations, one economy, and three fisheries do not pose a threat of the incidental taking of covered sea turtles in the course of such harvesting (83 FR 21295 May 5, 2017). All nations exporting wild-caught shrimp and shrimp products to the United States, regardless of whether they are certified under this provision, must also comply with the MMPA import rule, be included on the LOFF, and have a comparability finding. Nations in compliance with the MMPA import rule, but not certified under Public Law 101-162, cannot export wild-caught shrimp to the United States.
If estimates of the total incidental mortality and serious injury were available and a bycatch limit calculated for a marine mammal stock, NMFS used the quantitative and tiered analysis to classify foreign commercial fishing operations as export or exempt fisheries under the category definition within 50 CFR 229.2 and the procedures used to categorize U.S. fisheries as Category I, II, or III, at
In most cases, however, NMFS either did not receive any information or found that the information provided was incomplete, lacking detail regarding marine mammal interactions, and/or lacking quantitative information on the frequency of interactions. Where nations provided estimates of bycatch or NMFS found estimates of bycatch in published literature, national reports, or through other readily available sources, NMFS classified the fishery as an export fishery if the information indicated that there was a likelihood that the mortality and serious injury was more than remote. The code or designation in the LOFF for the determination “presence of bycatch” is recorded as “
Because bycatch estimates are lacking for most fisheries, NMFS relied on three considerations to assess the likelihood of bycatch or interaction with marine mammals, including: (1) Co-occurrence, the spatial and seasonal distribution and overlap of marine mammals and fishing operations; (2) analogous gear, evaluation of records of bycatch and assessment of risk, where such information exists, in analogous U.S. and international fisheries or gear types; and (3) overarching classifications, evaluation of gears and fishing operations and their risk of marine mammal bycatch (see section below for further discussion). Published scientific literature provides numerous risk assessments of marine mammal bycatch in fisheries, routinely using these approaches to estimate marine mammal mortality rates, identify information gaps, set priorities for conservation, and transfer technology for deterring marine mammals from gear and catch. Findings from the most recent publications cited in this
The co-occurrence of marine mammal populations with a commercial fishing operation can be a measure of risk. NMFS evaluated, when available, the distribution and spatial overlap of marine mammal populations and commercial fishing operations to determine whether the probability for marine mammal interactions or bycatch in that fishery is more than remote. Resources that NMFS used to consider co-occurrence include OBIS-SEAMAP
Where a nation did not provide documentation or information was not readily available on the amount of marine mammal bycatch in a fishery or the co-occurrence, NMFS classified a fishery as exempt or export by analogy to similar U.S. or international fisheries and gear types interacting with similar marine mammal stocks. NMFS consulted the United States' domestic MMPA List of Fisheries found at:
When no analogous gear, fishery, or fishery information existed, or insufficient information was provided by the nation, and information was not readily available, NMFS classified the commercial fishing operation as an export fishery per the definition of “export fishery” at 50 CFR 216.3. These fishing operations will remain classified as export fisheries until the harvesting nation provides the reliable information necessary to classify properly the fishery or, in the course of revising the LOFF, such information becomes readily available to NMFS. The code or designation for the determination “no information” is recorded as “
In some cases, NMFS recorded multiple codes as the rationale for a fishery classification. For example, NMFS may have received insufficient information from a nation, still lacks information in some columns, yet classified the fishery by analogy. In that instance, the codes used to classify the fishery would be: “
Additional terms in the LOFF include “none provided,” “no information,” and “none documented.” “None provided” indicates the nation did not provide information and no information could be found through research and literature searches. “None documented” indicates that neither the nation nor reference material have documented interactions with marine mammals either through observers or logbooks. “No information” indicates that though the nation provided relevant information about the fishery, it did not provide specific information and documentation on the marine mammal species interactions for that fishery or estimates of marine mammal bycatch.
Due to a lack of information about marine mammal bycatch, NMFS used gear types to classify fisheries as either export or exempt. Based on this information, NMFS reclassified some fisheries in the final LOFF. The detailed rationale for these classifications by gear type were provide in the
NMFS classified as export all trap and pot fisheries because the risk of entanglement in float/buoy lines and groundlines is more than remote, especially in areas of co-occurrence with large whales. However, NMFS classified as exempt trap and pot fisheries operating in the Gulf of Mexico and Caribbean due to the low co-occurrence with large whales in this region and an analogous U.S. Category III mixed species and lobster trap/pot fishery operating in the Gulf of Mexico and Caribbean. NMFS classifies as exempt small-scale fish, crab, and lobster pot fisheries using mitigation strategies to prevent large whale entanglements, including seasonal closures during migration periods, ropeless fishing, and vertical line acoustic release technology.
NMFS has classified as export longline gear and troll line fisheries because the likelihood of marine mammal bycatch is more than remote. However, NMFS classified as exempt longline and troll fisheries with demonstrated bycatch rates that are less than remote or an analogous U.S. Category III fishery operating in the area where the fishery occurs. The entanglement rates from marine mammals depredating on longline fisheries is largely unknown. NMFS classifies as exempt snapper/grouper bottom-set longline fisheries operating in the Gulf of Mexico and the Caribbean because they are analogous to U.S. Category III bottom-set longline gear operating in these areas. NMFS also classifies as exempt longline fisheries using a cachalotera system which prevents and, in some cases, eliminates marine mammal hook depredation and entanglement.
NMFS uniformly classified as export all gillnet, driftnet, set net, and pound net fisheries because the likelihood of marine mammal bycatch in this gear type is more than remote. No nation provided evidence that the likelihood of marine mammal bycatch in a gillnet fishery was less than remote.
NMFS classified as export purse seine fisheries unless the fishery is operating under an RFMO that has implemented conservation and management measures prohibiting the intentional encirclement of marine mammals by a purse seine. In those instances, NMFS classifies the purse seine fisheries as exempt because the evidence suggests that, where purse seine vessels do not intentionally set on marine mammals, the likelihood of marine mammal bycatch is generally remote. However, if there is documentary evidence that a nation's purse seine fishery continues to incidentally kill or injure marine mammals despite such a prohibition, NMFS classified the fishery as an export fishery. Similarly, if any nation demonstrated that it had implemented a measure prohibiting the intentional encirclement of marine mammals by a purse seine vessel, that fishery would be designated as exempt, absent evidence that it continued to incidentally kill or injure marine mammals.
NMFS has classified as export all trawl fisheries, including bream trawls and otter trawls, because the marine mammal bycatch in this gear type is more than remote, and this gear type often co-occurs with marine mammal stocks. However, the krill trawl fishery operating under changes to Commission for the Conservation of Antarctic Marine Living Resources (CCAMLR) in subareas 48.1-4 of CCAMLR is classified as exempt due to the conservation and management measure requiring marine mammal excluding devices and levels of marine mammal mortalities that are less than ten percent of the bycatch limit/PBR for marine mammal stocks that interact with that fishery.
There are several gear types that NMFS classified as exempt because they are highly selective, have a remote likelihood of marine mammal bycatch, and have analogous U.S. Category III fisheries. These gear types are: Hand collection, diving, manual extraction, hand lines, hook and line, jigs, dredges, clam rakes, beach-operated hauling nets, ring nets beach seines, lift nets, cast nets, bamboo weir, and floating mats for roe collection.
NMFS classified Danish seine fisheries as exempt based on the remote likelihood of marine mammal bycatch because of a lack of documented interactions with marine mammals. The exception are Danish seine fisheries with documentary evidence of marine mammal interactions, which NMFS classified as export.
Finally, NMFS classified as exempt most forms of aquaculture, including lines and floating cages, unless documentary evidence indicates marine mammal interactions or entanglement, particularly of large whale entanglement in aquaculture seaweed or shellfish lines, or nations that permit aquaculture facilities to intentionally kill or injure marine mammals.
NMFS reviewed information from or related to more than 160 trading partners. NMFS eliminated 25 nations from the LOFF (see Table 1 in the
Gillnets represent the vast majority of the export fisheries with documented marine mammal bycatch. Mitigation measures for gillnets are few. Active sound emitters such as “pingers” are used in gillnet fisheries to reduce small cetacean bycatch. However, pingers are not effective for all small cetacean species and may be less effective in operational fisheries than research programs (Dawson
The LOFF highlighted the clear need for bycatch monitoring programs to better estimate marine mammal bycatch and to identify where mitigation efforts are most needed. For example, several nations recommended that longline and purse seine fisheries be classified as exempt fisheries because there are few interactions with marine mammals. However, the logbook and observer data NMFS received did not substantiate that the likelihood of bycatch in these fisheries is remote.
NMFS believes accurate classification of longline fisheries, especially for tuna, and purse seine fisheries for pelagic species would benefit from monitoring programs (
Table 1 contains the twenty largest exporters to the United States by volume and value, an assessment of their data quality, and their risk of marine mammal bycatch. NMFS based its assessment of data quality on the completeness and detail of the information each nation provided. The number of export and exempt fisheries is the tally in the final LOFF. The overall risk of marine mammal bycatch is based on the type of gear most prevalent in the nation's fisheries and available information on marine mammal fisheries interactions.
Chile, Peru, Argentina, and Ecuador have large numbers of small gillnet, purse seine, and trawl vessels with marine mammal bycatch. Canada's pot fisheries for lobster and snow crab have high levels of large whale bycatch. Canada also has bycatch in its gillnet fisheries and permits the intentional killing of marine mammals in aquaculture operations. Indonesia, Thailand, and Vietnam have large processing and aquaculture sectors. These nations also have gillnet fisheries; however, their fisheries are poorly monitored, making accurate bycatch estimates and the development of mitigation measures for marine mammal bycatch difficult. NMFS may be able to reclassify these fisheries as exempt in the next iteration of the LOFF if these nations estimate their marine mammal bycatch or provide detailed information about their fishery operations.
Japan's marine mammal bycatch is particularly large in its pound net fisheries, whereas the Russia's bycatch is likely in its pot and trawl fisheries. Mexico's marine mammal bycatch includes its gillnet and trawl fisheries in the Gulf of Mexico and the Gulf of California. India's fishery bycatch is predominantly in its coastal gillnet fisheries, which include thousands of vessels. Taiwan has bycatch in its longline fisheries and drift gillnet fisheries. The United Kingdom has bycatch of harbor porpoise and common dolphins in gillnet and trawl fisheries. Russia and China provided little to no information to enable a full assessment of their fisheries and level of marine mammal risk.
Nations, some not included in this table, with high levels of documented marine mammal bycatch include South Korea (pound nets and gillnets); New Zealand (all gear types, especially trawl); and Australia (trawl and longline). However, NMFS recognizes that this evaluation may be influenced by the advanced assessment capabilities of these nations. New Zealand, Norway, and South Korea may be the only nations to have currently calculated a bycatch limit. Norway's information demonstrates that bycatch in its gillnet fisheries of harbor porpoise, gray seal, and harbor seal exceed the bycatch limits calculated for these species. South Korea, also has bycatch of several species of marine mammals in gillnet fisheries that exceed the bycatch limit.
NMFS received more than 35 comment letters on the draft LOFF for 2017 (82 FR 39762; August 22, 2017). Most of the comments were submitted by nations. Several non-governmental organizations (NGO) and industry groups also submitted comments (see general comments below), all of which are summarized below.
Several comments received were not germane to the draft LOFF and are not addressed in this section. These comments include references to actions outside the scope of the statutory mandate or actions covered under other rulemakings. Comments received are available on the internet at
In the following section, NMFS summarizes and responds to the comments applicable to the LOFF. NMFS organized the summary and response to comments as follows: (1) Changes to the LOFF and observations that apply to all nations (or economies), (2) comments and changes to the LOFF by nation (or economy), (3) general comments not associated with a nation (
More than 64 nations (or economies) did not respond to the request for public comment on the draft LOFF. These nations (or economies) include: The Bahamas, Bahrain, Bangladesh, Barbados, Benin, Brazil, British Virgin Islands, Brunei, Cameroon, Cape Verde, China, Croatia, Dominican Republic, Ecuador, Egypt, El Salvador, Federated States of Micronesia, Fiji, French Polynesia, The Gambia, Ghana, Grenada, Guinea, Guyana, Haiti, Honduras, Iran, Israel, Ivory Coast, Kenya, Kiribati, Liberia, Libya, Maldives Islands, Marshall Islands, Mauritania, Mozambique, Namibia, Nicaragua, Nigeria, Palau, Papua New Guinea, Peru, Reunion, Russia, Saudi Arabia, Senegal, Sierra Leone, South Africa, Sri Lanka, Saint Kitts Nevis, Saint Lucia, Saint Pierre Miquelon, Saint Vincent Grenadine, Tanzania, Tonga, Turkey, Turks and Caicos Islands, Ukraine, United Arab Emirates, Vanuatu, Venezuela, and Western Samoa. As a result, the fishery classifications for these nations (or economies) remain unchanged. Failure of these nations (or economies) to provide information regarding fisheries for which NMFS has none may result in a relatively high percentage of export fisheries among this group. This is also the case for several other nations (or economies) that did respond to the request for comment but did not provide information on fisheries under the category “export fishery with no information.” The category “export fishery with no information” includes products exported by nations (or economies) for which NMFS has been unable to find information (
For fisheries operating in the CCAMLR Convention Area, NMFS made the following changes: Fisheries for krill in the Antarctic Peninsula region have been combined into a single fishery pursuant to CCAMLR Conservation Measure 51-01, which manages krill fisheries in Subareas 48.1-4. This consolidation applies to the following nations fishing for krill in the CCAMLR Convention Area: Chile, China, Japan, Norway, Poland, Russia, Republic of Korea, and Ukraine. NMFS changed the classification for these fisheries from export to exempt because all trawl fisheries operating in CCAMLR are required to use marine mammal excluding devices (for krill fisheries: CM 51-01, paragraph 7: “Mitigation”). Additionally, the bycatch limit for seals in this region has been calculated at 88,200 individuals (see comments from Norway below) and the estimated incidental mortality and serious injury for all krill fisheries operating in CCAMLR is less than ten percent of the bycatch limit, making these fisheries exempt.
For nations with toothfish longline fisheries operating in both Subarea 88.1 and 88.2, NMFS combined these fisheries into one fishery. Toothfish longline fisheries operating in the CCAMLR convention area are required to carry one observer appointed in accordance with the CCAMLR Scheme of International Scientific Observation and, where possible, one additional scientific observer. Based on the observer and logbook information in the working group and Secretariat reports, toothfish longline fisheries with no documented interactions in CCAMLR were classified as exempt. NMFS classified as export toothfish longline fisheries with documented interactions, including bycatch and depredation.
Icefish and toothfish trawl fisheries operating in the CCAMLR convention area are subject to the same observer requirements. Therefore, NMFS classified as exempt icefish and toothfish trawl fisheries with no document marine mammal bycatch.
Upon further review of fish and fish product imports to the United States from Antigua and Barbuda over the last 17 years, NMFS removed squid and scallops from the category “export fisheries with no information.” Each product was imported only once, squid in 2000, and scallops in 2009. Additionally, NMFS could not find recognized commercial fisheries in the available literature, management plans for these products, or any evidence this product is processed by this nation. Therefore, these products are likely re-exports and have been removed from the final LOFF.
Changes to the Argentine export fisheries based on the information Argentina provided include combining into one export fishery: Toothfish longline fisheries operating in CCAMLR subareas 88.1 and 88.2; and toothfish longline and trawl fisheries operating off the coast of Tierra del Fuego, the Isla de los Estados and off the province of Buenos Aires; and all Argentine hake bottom trawl vessels (35 coastal, 183 freezer, and 98 refrigerated high-seas vessels) operating in the provinces of Chubut, Santa Cruz, and Rio Negro.
Additionally, NMFS removed from the LOFF the following export fisheries: The Argentine hake gillnet fishery; the tadpole lingcod (Patagonian cod) bottom trawl fishery; Patagonian blenny gillnet, trammel net, and purse seine fisheries; silver warehou and Argentine goatfish trawl fisheries; and Sao Paolo squid and Penaeid shrimp trammel nets and bottom trawl and squid bottom trawl, because these fisheries are artisanal fisheries for domestic consumption.
NMFS also changed the midwater and bottom trawl fisheries and surrounding net fisheries for blue grenadier to bottom trawl fishery for Patagonia grenadier; added Atlantic bonito, Argentine short-fin squid, and silversides trawl fisheries to the demersal coastal trawl fisheries; and combined all Argentine red shrimp bottom net outrigger vessel types into one fishery. NMFS removed from the LOFF the artisanal trammel net, as the gear type is not used for this species.
Changes made to Australian fisheries include clarification of multispecies fisheries and their associated gear types and vessel numbers. NMFS changed the multispecies and garfish hauling net fishery operating in New South Wales from export to exempt because this fishery is analogous to the Category III, U.S. beach seine fishery. The gear is deployed solely from beaches limiting the probability of co-occurrence with and bycatch of marine mammals.
NMFS changed the New South Wales eastern rock lobster trap from export to exempt; this fishery uses an at-call acoustic release system (Galvanic Time Release (GTR)) that submerges the head-gear of the trap and has been effective in eliminating marine mammal entanglements. NMFS also changed the giant crab pot fishery and the rock lobster pot fishery in Southern Australia from export to exempt because these fisheries operate solely during the summer months and close during the winter months when whales migrate through the region, significantly reducing the likelihood of entanglement.
Finally, NMFS changed from export to exempt the South Australian sardine purse seine fishery. In this fishery, Australia requires, as part of the mandatory Code of Practice, the delayed setting of nets if marine mammals are present in the area, and immediate release and safe handling practices if a mammal is detected in the net. A fisheries-independent observer program monitors the effectiveness of this practice and an annual report is generated on bycatch levels for the fishery. This practice is comparable to the RFMO conservation and management measure prohibiting the intentional encirclement of marine mammals by tuna purse seine fisheries; for this reason this fishery has been changed to exempt.
Under the category “Export Fisheries with No Information” NMFS removed the fishery for grouper because further analysis of imports from Australia for the preceding 17 years indicates only 2 years of small-scale and intermittent trade of grouper with the last import being 770 kg in 2015. Likewise, lobster (Homerus spp.) was also removed as this was likely a reporting error. Live lobsters received from Australia are rock lobster and would not be North Atlantic lobster species.
Changes made to Bahamian fisheries include combining all hand collection exempt fisheries for conch, coral, and sponge into one fishery. No further changes were made.
Based on the European Union's information, three export fisheries were added: Northern prawn beam trawl, sole otter trawl, and a northern prawn otter trawl. All fisheries operate in the southern and central North Sea and interact with harbor porpoise. Thirteen fisheries are listed as export fisheries with no information.
No fishery was reclassified, and information is lacking for several fisheries including the snapper, grouper, finfish gillnet fishery; shrimp trawl fishery, tuna longline and purse seine fisheries operating under Inter-American Tropical Tunas Commission (IATTC) and International Commission for the Conservation of Atlantic Tunas (ICCAT), and the mackerel and sardine trawl fishery.
Based on analysis of Canada's information, the following fisheries were reclassified as exempt fisheries as these fisheries operate in inland waters and have no documented marine mammal interactions or co-occurrence: Eel drift gillnet fishery operating in the gulf region, shad set gillnet fisheries operating in the gulf and Maritimes region, and smelt gillnet fishery operating in the gulf region. All chinook salmon troll fisheries operating in the Pacific region were reclassified as exempt as this gear type and fishery is analogous to the Alaska, California, Oregon, and Washington salmon troll fisheries which are listed as Category III fisheries. Kelp aquaculture in New Brunswick was reclassified as exempt as there are no documented marine mammal interactions. NMFS also reclassified as exempt several beach seine, Danish seine, jig and handline fisheries because this gear type has a remote likelihood of marine mammal bycatch. However, cunner, haddock, halibut, and cod aquaculture operations in New Brunswick maintained an export classified due to pinniped interactions.
Additionally, Canada added more than 46 new export fisheries and more than 17 exempt fisheries across all species, gear types, and areas. These fisheries were not included in the original draft LOFF. No marine mammal bycatch estimates were provided for the newly added export fisheries.
Based on the information provided by Chile, where appropriate, NMFS updated the numbers of vessels participating in various fisheries, and consolidated fisheries by fishing area.
Based on the information Costa Rica provided NMFS added to the list of export fisheries a bonito gillnet fishery and a flatfish, sole gillnet and trawl fishery. NMFS also combined the operating areas of the Eastern Tropical Pacific and Tropical Atlantic into one area for the following fisheries: The dolphinfish longline fishery; the shark, swordfish longline fishery; the shrimp trawl fishery; and the shrimp gillnet fishery.
Based on the information Cyprus provided through the European Union, NMFS added an Atlantic Bluefin tuna purse seine fishery operating in the Eastern Mediterranean Sea, Levant area (FAO division 37.3.2) to the list of export fisheries for Cyprus.
Based on the information Denmark provided through the European Union, NMFS updated the numbers of vessels
In analyzing Denmark's export data, NMFS removed the rock lobster fishery from the “export fisheries with no information” category as this product was only imported once in the past 17 years, in 2015, and in very small quantities. The predominant lobster export from Denmark to the United States is Norwegian lobster. NMFS also removed the cuttlefish fishery as this product was imported only once in the past 17 years, in 2016, and in very small quantities. The cuttlefish was imported as “preserved” indicating this is likely a re-exported product.
Also under “export fisheries with no information” Denmark provided fishery information for their Marine Stewardship Council (MSC) certified fisheries but, upon further analysis, NMFS removed the following fisheries from the LOFF because Denmark does not export these products to the United States; whiting and blue whiting, cusk eel, lingcod, smelt, monkfish, skates, capelin, pollock, hake, oyster, and clams.
NMFS changed the mussel dredge fishery from “export fishery with no information” to an exempt fishery as this coastal gear type is unlikely to interact with marine mammal stocks.
Based on the information Estonia provided through the European Union, NMFS updated the numbers of vessels participating in various fisheries, and the area of operation of fishing vessels. NMFS also added an exempt fishery for cod and other species operating in the Northeast Atlantic and added two export fisheries, one for perch, herring and pike-perch, and one for herring and sprat, operating in the International Council for the Exploration of the Sea (ICES) Area IIId of the Northeast Atlantic.
Additionally, NMFS removed from the LOFF the fisheries for Greenland halibut as the United States has not imported Greenland halibut from Estonia in the past 17 years.
Based on the information France provided through the European Union, NMFS removed swordfish from the purse seine tuna fishery in Indian Ocean Tuna Commission (IOTC) convention area and added a separate swordfish longline fishery in IOTC. NMFS added as an “export fishery with no information” an Acoupa Rouge (
Although France provided fisheries information indicating marine mammal interactions as “zero interactions reported” for select fisheries, France failed to provide summaries of vessel logbooks or observer reports to substantiate this estimate. NMFS therefore did not reclassify these fisheries and recorded the information as “no information.”
Based on the information Germany provided through the European Union, NMFS combined multispecies fisheries based on gear type and area of operation. NMFS updated gear types for fisheries to correctly classify Germany's fisheries.
Based on the information Greece provided through the European Union, NMFS combined multispecies fisheries based on gear type and area of operation. Under “export fisheries with no information,” NMFS removed crab from the LOFF as this product is inconsistently exported to the United States and is likely a re-export from Greece. The mullet indicated in the U.S. trade database is exclusively roe so NMFS combined this product with caviar.
Based on Greenland's information, NMFS deleted the following export fisheries: Atlantic salmon gillnet, Atlantic salmon open boat, and redfish trawl fisheries. The operational areas for the halibut trawl, longline, and gillnet fisheries have been combined into one fishery as have the cod poundnet, longline, and gillnet fishery (see response to Greenland comment 1). The shrimp trawl fishery was reclassified from export to exempt (see response to Greenland comment 1).
Based on information provided by Iceland, NMFS reclassified as exempt: Multispecies finfish and shellfish dredge and fishing rod fisheries, and seaweed and sea cucumber fisheries based on their gear analogy to U.S. fisheries and the remote likelihood of marine mammal bycatch. Iceland provided area(s) of operation for each gear type, the list of target species landed by each gear type, and the marine mammal interactions associated with each gear type. NMFS updated the LOFF to consolidate target fisheries based on gear type and area of operation and their associated marine mammal interactions accordingly.
NMFS moved salmon and trout aquaculture from “export fisheries with no information” to “export fishery” based on Iceland's lack of a legal requirement for documenting marine mammal interactions and lack of provisions outlawing intentional mortality or injury to marine mammals that interact with aquaculture facilities. NMFS also removed from the list of export fisheries with no information, the “other gear types” fishery as Iceland accounted for additional fisheries, specifically different types of seines and specific species gillnet fisheries. NMFS moved the Arctic char aquaculture fishery to the list of fisheries to which the “rule does not apply” since this fish is solely produced by inland aquaculture farms.
Upon further analysis of U.S. trade data, NMFS removed the rock lobster fishery as this product was only exported to the United States once in the preceding seven years in low quantities and is likely a reporting error as the United States typically imports only Norwegian and Homarus spp. lobster.
Based on the information India provided, NMFS updated vessel numbers, area of operation, bycatch species and estimates. NMFS added a multi-species handline fishery to the exempt fisheries category.
Upon further analysis of U.S. trade data, NMFS combined the fisheries for hake and lobster into the multispecies gillnet fishery for pollock, lobster and hake. NMFS removed the fisheries for tuna and turbot as Ireland has not exported either of these species to the United States during the preceding seven years. Under the category of export fisheries with no information, NMFS removed rock lobster as this species is included in the export multispecies fishery for pollock, lobster, and hake. Also under this category, NMFS removed salmon as it is included in the driftnet fishery operating in Ireland's EEZ. NMFS also removed the gillnet fishery operating in the northeast Atlantic with no specified target fishery as this fishery and its associated bycatch are included in the export fisheries for crawfish and lobster.
Based on Italy's information submitted by the European Union, NMFS updated vessel numbers; changed the gear type for the anchovy, pilchard, and sardine fishery from “seine” to “purse seine”; and removed the swordfish driftnet fishery from the LOFF based on national legislation and EU regulation banning the use of largescale driftnets.
NMFS also reclassified the clam, mussel, mollusk dredge fishery from export to exempt based on analogous gear from other dredge fisheries without marine mammal bycatch and the coastal operational area of the fishery. NMFS noted in the “detailed information” that the swordfish longline fishery appears to be operating in accordance with the National Observer Program under ICCAT.
Italy noted that most of its seabream and seabass products are from aquaculture; however, Italy did not provide the area of operation for these aquaculture facilities or details on how these species are cultured. Italy previously declared a fishery for seabass and sea bream with a gear type of “small-scale fisheries.” This fishery is lacking information on the specific gear types involved in fishing these species.
Based on Japan's revised information, NMFS updated target species, gear type, vessel number, area of operation, marine mammal interactions, marine mammal bycatch estimates, and comments for all Japan's commercial fisheries. NMFS compared bycatch and interaction estimates provided by Japan with IWC reported interactions where possible to reconcile differences. As described in the
Based on Latvia's information provided by the European Union, NMFS updated: The target species in the multispecies trapnet fisheries; fishing season for all fisheries; and marine mammal presence and interactions for fisheries to indicate harbor porpoise presence but no recorded interactions.
NMFS updated fishing season for all fisheries based on Lithuania's information provided by the European Union.
Based on the information provided by Madagascar, NMFS updated the numbers of vessels participating in the export tuna and shrimp fisheries. NMFS also added company names for seaweed and shrimp aquaculture operations.
In analyzing the U.S. trade data for Madagascar, NMFS removed the fisheries for molluscs from “export fisheries with no information” as this product was imported only three times in the past 17 years, in 2001, 2002, and 2004, and in small quantities. NMFS also removed the fisheries for marine fish and grouper, as these products were imported only once in the past 17 years, in 2016, and again in small quantities.
Upon further analysis of U.S. trade data, NMFS removed the swordfish fishery as Malta has not exported this species to the United States at any point in the preceding seven years. NMFS updated fishing seasons for all fisheries.
Based on the information Mauritius provided, NMFS added a pelagic swordfish, tuna (albacore, yellowfin, bigeye, billfishes, shortfin mako shark) vertical longline fishery. NMFS removed the swordfish, tuna (albacore, yellowfin, bigeye, billfishes, shortfin mako and shark) mid-water trawl fishery because, according to Mauritius, these species are fished using surface longline and purse seines rather than trawl gear.
Based on information provided by Mexico, NMFS updated gear type, vessel numbers, areas of operation, marine mammal interactions, and comments for select fisheries. NMFS reclassified from export to exempt the red snapper and grouper longline fisheries operating in the Gulf of Mexico because they are analogous to the U.S. Category III Southeastern U.S. Atlantic, Gulf of Mexico, and Caribbean snapper-grouper and other reef fish bottom longline/hook-and-line fisheries. Similarly, NMFS reclassified, from export to exempt, the shark longline fishery operating in the Gulf of Mexico because it is analogous to the U.S. Category III Southeastern U.S. Atlantic, Gulf of Mexico shark bottom longline/hook-and-line fishery. NMFS also reclassified the lobster trap fishery operating in the Gulf of Mexico because it is analogous to the U.S. Category III Caribbean mixed species and lobster trap/pot fisheries and has no documented marine mammal interactions.
Based on Mexico's submission, NMFS added to export fisheries, the trap, longline, and gillnet fisheries for sole, white corvina, and verdillo operating on the west coast of the Baja California Peninsula. NMFS also removed the red snapper gillnet fishery as there is no authorized gillnet fishing for snapper in the Gulf of Mexico. NMFS added herring to the sardine/mackerel purse seine and gillnet fisheries operating on the west coast of the Baja California Peninsula. Finally, NMFS changed the Gulf of California lobster fishery gear type from tangle net to trap.
Based on Mexico's information, NMFS added a cobia hand line fishery and a conch diving fishery to exempt fisheries.
Based on Mexico's submission and further analysis of U.S. trade data, in the category “export fisheries with no information,” NMFS removed the fishery for lobster (Homarus spp.) as this was likely a reporting error. Lobsters received from Mexico are rock/spiny lobster and would likely not be North Atlantic lobster species. NMFS also removed the silverside (pike, blacknose, longjaw, bigmouth, shortfin) fishery since the United States has not imported products from this fishery for over seven years. NMFS removed the eel fishery because this is a freshwater species that does not occur in marine mammal habitat and has no marine mammal interactions so the MMPA import rule does not apply.
Based on Mexico's submission and NMFS's further review, NMFS removed the Gulf weakfish/corvina trawl fishery because there is no authorized trawl fishery in the Upper Gulf of California. NMFS notes, however, if Mexico develops a finfish trawl fishery in the Upper Gulf of California, Mexico must provide the information necessary to classify the fishery and, if an export fishery, apply for a comparability finding.
Based on Morocco's information, NMFS updated gear type, vessel numbers, areas of operation, and comments for select fisheries. NMFS also combined the sardine, anchovy, and mackerel fisheries based on gear type, to indicate a trawl fishery and a purse seine fishery. NMFS also separated tuna and swordfish fisheries to more accurately characterize gear type, area of operation, and vessel numbers. Whereas previously NMFS had combined tuna and swordfish into the same fishery under each gear type, Morocco provided additional detail meriting splitting into hook and line, trap, and purse seine fisheries for tuna, and hook and line and longline fisheries for swordfish. NMFS removed the octopus pot fishery because this gear type is not used to catch octopus in Morocco. Finally, NMFS added hand collection and diving seaweed fisheries to exempt fisheries.
Based on the Netherland's information submitted by the European Union, NMFS updated fisheries to indicate where there is marine mammal co-occurrence, and the fishing season for all fisheries. NMFS also removed the sinking gillnet fishery with no specific target species because this is a recreational fishery that does not export product to the United States (see
Based on the information New Zealand provided, NMFS removed the hake (hoki, ling, white warehou) bottom longline fishery from the LOFF as it does not exist; hake is taken almost entirely by trawl. NMFS also removed shark fins (all gear types) from the LOFF as fins are a product of sharks captured in the spotted dogfish (rig), mixed inshore trawl fisheries, and surface longline fisheries for tuna, not a separate target fishery.
Based on the information Norway provided, NMFS reclassified the Norwegian krill fishery as exempt.
The largest population of fur seals is on the island of South Georgia, which supports about 95 percent of all Antarctic fur seals (IUCN 2008). In 1999/2000, when the last survey occurred, the total population was estimated between 4.5 and 6.2 million seals, and is believed to have increased by 6 percent—14 percent since the 1990/1991 season (IUCN 2008). In 2004, all populations of fur seals are believed to be either increasing or stable (SCAR EGS 2004). Assessments of fur seal population size in Area 48, where the krill fishery occurs, are not currently available. Mortalities of fur seals in the krill fishery have declined over time, but were sometimes substantial before the mandatory deployment of seal exclusion devices. In 2005, CCAMLR implemented rules requiring the use of seal exclusion devices by each vessel. Between 2008 and 2014, no fur seal mortalities were reported, only two were reported in 2015. Using a minimum stock size which includes a 30 percent reduction in the overall stock size from the last available estimate, the stock is estimated at 2.94 million individuals. A recovery factor of 0.5 results in a PBR of 88,200 individuals. Based on these calculations and the bycatch mitigation requirements the krill fishery has a remote likelihood of having bycatch levels in excess of 10 percent of the PBR-level. Based on these calculations NMFS reclassified this krill fishery as an exempt fishery.
Based on information Norway submitted to ICCAT, from 2014 through 2017 there was no reported or observed bycatch of marine mammals in the tuna longline/purse seine fisheries. Therefore, NMFS reclassified the Norwegian longline and purse seine tuna fisheries as exempt.
NMFS also reclassified the demersal fish (cod, haddock, angler fish, and tuna, saithe Danish seine fishery as exempt as this gear type has a remote likelihood of marine mammal bycatch.
Oman's fisheries remain unchanged. While Oman submitted information, the submission lacked the detail necessary for NMFS to further evaluate the frequency of marine mammal bycatch or reclassify Oman's fisheries. NMFS notes that Oman prohibits the catch of whales or marine mammals and in 2014 and 2015 Oman conducted surveys to assess the status of its marine mammal stocks, the report of which will be provided to the International Whaling Commission. NMFS further notes Oman has initiated the adoption of regulations to limit the length of driftnets and purse seines to less than 1 kilometer (km) for artisanal boats and up to 2.5 km for artisanal/
Based on Pakistan's information, NMFS removed the coral, shells, and cuttlebone fishery because it no longer exists and there have not been exports of these products since 2009. Per Pakistan's recommendations, NMFS modified the number of vessels and area of operation for nearly all Pakistan's fisheries. NMFS encourages Pakistan to further develop its marine mammal bycatch monitoring program so it can provide detailed information about marine mammal bycatch in its fisheries. NMFS also urges Pakistan to diligently look for ways to mitigate marine mammal bycatch in its gillnet fisheries or consider switching to non-entangling gear given the magnitude of the bycatch and the co-occurrence of marine mammals and gillnet fisheries.
Based on Panama's information, NMFS added three export fisheries: Forage fish purse seine fishery in the Pacific Panamanian EEZ; shrimp gillnet fishery in the Pacific Panamanian EEZ; and a large pelagics surface longline fishery outside the Panamanian EEZ within the IATTC convention area (eastern central and southeast Pacific). In addition, NMFS updated target species, number of vessels, and area of operation for the vast majority of Panamanian fisheries. Panama did not provide information on the frequency of marine mammal mortality and serious injury in any of its export fisheries.
For exempt fisheries, NMFS changed the area of operation from none provided to coastal area/EEZ. For export fisheries, NMFS changed the area of operation for several export fisheries based on the Philippines' information. NMFS reclassified sardine, herring and squid bag net and scoop nets as exempt given the small size of the gear, its operation, and the determination that the likelihood of marine mammal bycatch is remote. Also, based on the Philippines' information, NMFS added a tuna longline fishery operating in the EEZ and international waters under the WCPFC, IOTC, and ICCAT.
Based on Poland's information submitted through the European Union, NMFS updated vessel number and gear type for each fishery, and marine mammal species where co-occurrence is present. NMFS split into individual target species fisheries, fisheries that NMFS had recorded as multispecies fisheries. NMFS reclassified from “export fishery with no information” to export, the Atlantic salmon trap, gillnet, and longline fisheries, and sardine pelagic trawl fisheries. Finally, upon further analysis of U.S. trade data, NMFS removed the fishery for tuna because this species has not been exported to the United States in the preceding four years and was inconsistently exported prior to 2014.
Based on Portugal's information submitted by the European Union, NMFS updated fishing seasons for all fisheries, and combined fisheries into multispecies fisheries based on gear type and area of operation.
NMFS also changed the bluefin tuna fixed weir/trap fishery from “export fishery with no information” to export fishery, because NMFS is uncertain whether dolphins could become entangled in the net that funnels tuna to the final area where they are harvested.
Additionally, NMFS reclassified eel, crab, cuttlefish, and lobster trap fisheries from “export fisheries with no information” to export.
Based on Portugal's information, NMFS reclassified from “export fisheries with no information” to exempt fisheries the mussel raft and line aquaculture fishery, the hand collection fisheries for seaweed and snails, the handline fishery for skipjack tuna, and the coastal aquaculture fishery for clams based on the highly selective nature of the gear types used to fish these products and the remote likelihood of marine mammal bycatch.
NMFS removed from the LOFF fisheries for turbot, sea bass, and sea bream and placed them on list of foreign fisheries for which the rule does not apply as these fisheries are produced by inland aquaculture. Likewise, NMFS moved salmon to the intermediary nations list as this is a re-exported, processed product.
NMFS did not reclassify any Seychelles fisheries. Based on Seychelles' information, NMFS removed the tuna and large pelagics trawl fishery from the list of export fisheries, because this fishery is no longer permitted. NMFS added a spanner crab pot fishery to the list of export fisheries because no information was provided about this fishery.
Based on Slovenia's information submitted by the European Union, NMFS removed seaweed and albacore from the LOFF fisheries and placed them on the intermediary nations list as these are re-exported, processed products.
Upon further analysis of U.S. trade data, NMFS removed mullet, sole, hake, and whiting from the LOFF fisheries as Slovenia indicated that these are domestic fisheries for domestic consumption and are not exported to the United States. Further, the United States has not imported these products in the preceding seven years. Because Slovenia did not provide information about its mackerel fishery, which is a product exported to the United States, NMFS retained this fishery as an “export fishery with no information.”
Based on the information South Korea provided, NMFS consolidated individual fishing provinces into a broader region designation; consolidated fisheries into appropriate multispecies fisheries; and consolidated the number of vessels operating in a region. NMFS also updated marine mammal bycatch estimates for the individual fisheries.
NMFS removed yellowtail, bass, octopus, and aquacultured mussel, and mullet from the category “export fisheries with no information,” as additional information provided by South Korea indicated that mullet and bass are captured in the multispecies gillnet, longline fishery, and set net fisheries, octopus are caught in pots and traps as well as in the longline fisheries, and yellowtail are caught in the multispecies gillnet, set net, stationary net and purse seine fisheries. NMFS moved aquaculture mud loach from the LOFF to the category of “Rule Does Not Apply” as this is a freshwater species.
NMFS removed gear types of “illegal catch,” “strand,” and “driftnet” from fisheries listed under the category of export fisheries with no information because South Korea clarified these as instances of marine mammal stranding events and drifting carcasses for which the cause of death could not be attributed to a specific fishery. South Korea originally listed these marine mammal interactions as “strand” and “drift,” which NMFS incorrectly interpreted to mean lines and driftnets. The marine mammal deaths attributed to illegal catch were also removed because a specific fishery could not be identified as the cause of the interaction.
Finally, South Korea provided gear information for gear types “bamboo weir,” “anchovy lift net,” and “mosquito net.” NMFS reclassified these fisheries as exempt fisheries because NMFS review of the information of these practices indicated that the likelihood of marine mammal bycatch is remote.
Upon further review of U.S. trade data encompassing the last 17 years, NMFS removed haddock and hake from the category “export fisheries with no information.” Haddock have never been imported into the United States from South Korea, and hake was received intermittently and not since 2013. Additionally, NMFS removed from this category turbot that is caught in the multispecies stow net and stationary net fisheries, cusk that is caught in the multispecies trawl fishery, sardine that is caught in the multispecies trawl and purse seine fisheries, and shad which is caught in the multispecies purse seine, set net, and gillnet fisheries. All of these fisheries were reclassified as export.
Based on the information Saint Helena provided, NMFS reclassified from an “export fishery with no information” to an exempt fishery the Tristan rock lobster trap and hoop net fishery. The basis for this reclassification is this fishery has no documented marine mammal interaction and is analogous to the Category III Caribbean mixed species and lobster trap/pot fisheries.
Based on Spain's information submitted by the European Union, NMFS updated fishing areas for species, particularly where no information had been previously provided. NMFS added longline and purse seine fisheries for tuna and swordfish in FAO Areas 21, 31, 61, and 67. Spain's purse seine fisheries for tuna in areas 61 and 67 are operating under WCPFC conservation and management measures prohibiting the intentional encirclement of cetaceans and as such have been classified as exempt. NMFS separated into two fisheries the shark and swordfish fishery. Spain conducts a directed shark fishery with longlines within the ICCAT convention area, but NMFS does not know what additional areas shark fishing may be occurring in, or how many vessels are participating in this fishery. NMFS moved the lobster trap fishery, the anchovy and sardine purse seine fishery, and the bonito troll fishery from “export fisheries with no information” to export. NMFS classified the sea cucumber trawl fishery as export.
NMFS classified as exempt the bonito handline fishery, sea cucumber hand collection/dive fishery, the sea urchin diving fishery, and the scallop, mussel, oyster coastal aquaculture fisheries, and the gilthead bream, bass, turbot, and bluefin tuna aquaculture because the likelihood of marine mammal bycatch is remote. NMFS removed caviar from the LOFF and added it to the category “rule does not apply” because the caviar is sourced from inland aquacultured sturgeon.
Finally, NMFS reclassified the dolphinfish fishery as “export fishery with no information” because Spain provided no details on this fishery or its marine mammal bycatch.
Based on information provided by Suriname, NMFS updated vessel number, area of operation, marine mammal species interactions, and comments for select fisheries. Suriname listed additional export fisheries: Seabob shrimp trawl; deep water shrimp trawl for orange and deep water rose shrimp; bottom trawl for weakfish, grunt, croaker, snapper, catfish, hairtail, Barracuda and other demersal fish; bottom trawl for weakfish, hairtail or cutlass, drum, croaker or butterfish, sea catfish and moonfish (prosecuted by five China flagged vessels); gillnet, longline, driftnet and fyke net fishery
Based on Sweden's information submitted by the European Union, NMFS updated vessel numbers and gear types. NMFS also removed salmon from the list of export fisheries with no information as it was already accounted for in the export fisheries list.
Upon further analysis of U.S. trade data, NMFS removed pollock from the LOFF as pollock has not been imported from Sweden in the preceding seven years. NMFS also removed sardine from the list of export fisheries with no information as most imports were already accounted for under the sardine and sprat fisheries. The United States imported sardines just twice in the preceding seven years, in 2014 and 2015, and in low quantities. Sardines have not been imported since 2015.
Based on Taiwan's information, NMFS modified the squid driftnet fishery to a squid dipnet fishery and reclassified that fishery as exempt, as the gear type is too small to catch marine mammals. Also, the mullet, marine fish, seabass aquaculture fishery was removed from the LOFF as it is an inland pond aquaculture fishery. NMFS updated the number of vessels and area of operation for several exempt and export fisheries.
Based on Taiwan's information, NMFS also removed from the LOFF (under “export fisheries with no information”) the fisheries listed as operating in FAO area 71 and in Indonesia because Taiwan claims these fisheries no longer operate in those areas. From this same category, NMFS added as an export fishery the cephalopod and benthic species trawl fishery.
Thailand's fisheries are permitted and managed as multi-species pelagic or demersal fisheries. Based on Thailand's information NMFS created gillnet, longline, pot, and trawl fisheries aggregating individual species into multi-species pelagic and demersal fishes. By separating these fisheries by individual species, NMFS was duplicating fisheries; therefore, aggregating these fisheries according to how Thailand manages and permits them, while significantly reducing the number of export fisheries, provides a realistic estimate of the actual number of export fisheries. NMFS added exempt fisheries including: Whitespotted conger hand collection; whitespotted conger aquaculture; cobia aquaculture, seabass aquaculture, grouper aquaculture, demersal fish handline, and pomfret lift net fishery.
Based on information provided by Trinidad & Tobago, NMFS updated target species, gear type, vessel number, area of operation, marine mammal interactions, marine mammal bycatch estimates, and comments for select fisheries. Trinidad & Tobago listed additional fisheries. Trinidad & Tobago clarified and expanded the gear types used to prosecute tuna as dive/spear, longline, gillnet, and pelagic line. Those fisheries were added by gear type to the Trinidad & Tobago export list, with the exception of the dive/spear fishery, which was added to the exempt list due to that gear type having a remote likelihood of marine mammal mortality or serious injury.
NMFS added the following export fisheries based on information submitted by Trinidad & Tobago regarding the draft LOFF a gillnet fishery and a pelagic longline fishery for tuna, bonito, flying fish, wahoo, and dolphinfish; a banking/troll/tow/other gears fishery for croaker, salmon, weakfish, snapper, groundfish, carite, kingfish, cavali and shark; an artisanal bait seine/beach seine/Italian seine fishery for carite, kingfish, cavali, snapper, herring, weakfish, and groundfish; four artisanal multi-gear fisheries—gillnet, driftline/pelagic line, beach/land seine, and demersal longline—for tuna, bonito, flying fish, wahoo, dolphinfish, snapper and grouper.
Based on information provided by Tunisia, NMFS updated gear type, vessel number, and information for select fisheries. NMFS updated information for fisheries classified as “export fisheries with no information” and moved these fisheries to export. NMFS retained all fisheries on the exempt list except for lobster caught with gillnets. This fishery was moved to the export list because gillnets are known have more than remote likelihood of marine mammal bycatch.
Tunisia provided a list of seafood products known to be exported to the United States NMFS noted that several of these products were not on the draft LOFF, so those products were added. However, Tunisia provided no additional information for those products; therefore, they were added under “export fisheries with no information.”
Based on the United Kingdom's (UK) information submitted by the European Union, NMFS updated the fishing season for each fishery. NMFS reclassified from export to exempt lift net and dredge fisheries because of their remote likelihood of marine mammal bycatch.
Upon further analysis of U.S. trade data, NMFS removed the conch fishery as the UK only exported this product to the United States once in the preceding seven years. NMFS also removed the fisheries for sprat, skate, and hake as these fisheries did not export to the United States in the preceding seven years. The UK should consider if removing these products is merited. If the UK wishes to export these products it must provide information about these fisheries and their marine mammal bycatch.
Uruguay noted that the fishery for black hake is a common name for toothfish fished in the CCAMLR Convention Area. As their toothfish longline fisheries are already noted, the fishery for black hake is redundant. As a result, NMFS has removed this fishery. Uruguay did not provide any
In response to information submitted by Vietnam, NMFS combined fisheries utilizing the same gear type targeting multiple species, including cuttlefish, grouper, mullet, snapper, demersal fisheries, and flatfish/sole. NMFS also updated vessel numbers.
NMFS reclassified to exempt the anchovy and sardine lift net fishery because it has a remote likelihood of marine mammal bycatch. NMFS moved the mud crab and shrimp aquaculture fishery from the LOFF to the “rule does not apply” list as these species are cultured at inland aquaculture facilities.
The commenter further asserted that the LOFF does not fully assess the consequences of “thousands” of bycaught marine mammals and critically-endangered harbor porpoise (which number only 500 animals) in the Eastern Baltic Sea. Bycatch “in the thousands” for other populations or species sounds dramatic, but even a seemingly very low number of annual bycatches of this population occurring in ICES 27.3 subdivisions 24, 25, 26, 27, 28-2, 29 (and possibly in 28-1, 30 and 32) could drive this population to extinction. The commenter noted that even the bycatch of one harbor porpoise annually is too much and the list should reflect this. The commenter urged NMFS to take into account bycatch information on gray seals in the Baltic sea gillnet, fyke net and trap fisheries provided by Vanhatalo
If nations fail to establish an outright prohibition of intentional killing or to reliably certify that the product is not associated with intentional killing, NMFS will impose import restrictions under the MMPA Import Rule. NMFS expects that procedures for producing a reliable certification that the product is not associated with intentional killing would include certification programs and tracking and verification schemes. For NMFS to consider that such a scheme can “reliably” certify their claims, the documentary evidence submitted by a harvesting nation must include tracking, verification, and chain of custody procedures ensuring, throughout the entire chain of custody from the farms, to the packers, to the distributers, and finally to the importer—the ability to consistently segregate fish caught without intentional mortality and serious injury of marine mammals.
In the draft LOFF
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National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of change of times of public meeting webinar.
The New England Fishery Management Council's is convening an ad-hoc sub-panel of its Scientific and Statistical Committee to peer review two reports.
This webinar will be held on Friday, March 30, 2018, at 1 p.m. and will end at 4 p.m.
Webinar registration URL information:
Thomas A. Nies, Executive Director, New England Fishery Management Council; telephone: (978) 465-0492.
The meeting was previously scheduled for 1:30 to 4 p.m. It will now begin at 1 p.m. and end at 4 p.m. The original notice published in the
This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Thomas A. Nies, Executive Director, at (978) 465-0492, at least 5 days prior to the meeting date.
16 U.S.C. 1801
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; request for comments.
The Assistant Regional Administrator for Sustainable Fisheries, Greater Atlantic Region, NMFS, has made a preliminary determination that an Exempted Fishing Permit application submitted by the Northeast Fisheries Science Center contains all of the required information and warrants further consideration. This Exempted Fishing Permit would exempt participating vessels from the following types of fishery regulations: Minimum fish size restrictions; fish possession limits; and, in limited situations for research purposes only, retaining and landing prohibited fish species. Regulations under the Magnuson-Stevens Fishery Conservation and Management Act require publication of this notice to provide interested parties the opportunity to comment on Exempted Fishing Permit applications.
Comments must be received on or before
You may submit written comments by either of the following methods:
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Spencer Talmage, Fishery Management Specialist, 978-281-9232,
The Northeast Fisheries Science Center submitted a complete application for an Exempted Fishing Permit (EFP) on February 9, 2018, for the 2018 Study Fleet Program. The EFP would exempt 31 commercial fishing vessels from the minimum size and possession limits for species of interest, as well as allow temporary retention of species that will be discarded.
The Center established the Study Fleet Program in 2002 to more fully characterize commercial fishing operations and provide sampling opportunities to augment NOAA's National Marine Fisheries Service's data collection programs. Partnership with the commercial fishing industry allows the Center to provide samples for stock assessment and fish biology research when traditional sampling sources might otherwise be unavailable. Table 1 includes all of the regulations specified at 50 CFR part 648 that participating vessels would be exempt from for at-sea sampling, or when retaining and landing fish for research purposes. The exemptions listed in Table 1 are necessary for contracted vessels to acquire the biological samples needed to meet Center research objectives.
Any fish retained under the EFP would be delivered to Center staff upon landing. Additionally, prior to landing, the Center would issue a formal Biological Sampling Request to the vessel to retain fish for the Study Fleet
All catch would be attributed to the appropriate commercial fishing quota. For a vessel fishing on a groundfish sector trip, all catch of groundfish stocks allocated to sectors would be deducted from its sector's Annual Catch Entitlement (ACE). Once the ACE for a stock has been reached in a sector, vessels would no longer be allowed to fish in that stock area unless the sector acquires additional ACE for the stock in question. For common pool vessels, all groundfish catch would be counted toward the appropriate trimester total allowable catch (TAC). Common pool vessels would be exempt from possession and trip limits, but would still be subject to trimester TAC closures.
Vessels fishing under this EFP would be required to report via their Vessel Monitoring System (VMS) or the Interactive Voice Response (IVR) system to identify trips that would be landing species below minimum size limits and/or in excess of possession limits. Vessels not landing fish for the Center but temporarily possessing fish for at-sea sampling would not be required to call into the IVR system or report via VMS.
If approved, the NEFSC may request minor modifications and extensions to the EFP throughout the year. EFP modifications and extensions may be granted without further notice if they are deemed essential to facilitate completion of the proposed research and have minimal impact that does not change the scope of the initially approved EFP request. Any fishing activity conducted outside the scope of the exempted fishing activity would be prohibited.
16 U.S.C. 1801
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of receipt of an application for exempted fishing permit; request for comments.
NMFS announces the receipt of an application for an exempted fishing permit (EFP) from Salty Bones Fisheries, Inc. If granted, the EFP would authorize the deployment of modified wood and wire spiny lobster traps and non-containment purse traps in the Federal waters of the Gulf of Mexico (Gulf) and South Atlantic. The project would seek to determine the effectiveness of these gear types, as applicable, for attracting and collecting invasive lionfish while avoiding impacts to non-target species, protected species, and habitats.
Written comments must be received on or before April 2, 2018.
You may submit comments on the application, identified by “NOAA-NMFS-2018-0013” by any of the following methods:
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Electronic copies of the applications may be obtained from the Southeast Regional Office website at
Kelli O'Donnell, 727-824-5305; email:
The EFP is requested under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (16 U.S.C 1801
Lionfish is an invasive marine species that occurs in both the Gulf and South Atlantic. The harvest of lionfish in the Federal waters of the Gulf and South Atlantic is not currently managed by NMFS. The EFP application submitted to NMFS involves the use of prohibited gear types in Federal waters. Federal regulations prohibit the use or possession of a fish trap in Federal waters in the Gulf and South Atlantic (50 CFR 622.9(c)). In Gulf Federal waters, the term “fish trap” refers to traps capable of taking finfish, except for a trap historically used in the directed fishery for crustaceans (that is, blue crab, stone crab, and spiny lobster) (50 CFR 622.2). In South Atlantic Federal waters, the term “fish trap” refers to a trap capable of taking fish, except for a seabass pot, a golden crab trap, or a crustacean trap (that is, a type of trap historically used in the directed fishery for blue crab, stone crab, red crab, jonah crab, or spiny lobster) (50 CFR 622.2). The EFP would exempt these research activities from the regulation prohibiting the use or possession of a fish trap in Federal waters of the Gulf and South Atlantic at 50 CFR 622.9(c), and would allow the applicant to use spiny lobster traps and other traps capable of taking fish to target lionfish.
The applicant seeks an EFP to test the effectiveness of different trap designs in capturing lionfish in the Gulf and South Atlantic while avoiding impacts to non-target species, protected species, and habitats. One of the goals of the project is to determine the performance of traps as part of a lionfish population control program. Information gathered by the EFP could be used to increase efforts to control the spread of the population. The applicant also intends to sell harvested lionfish in partial support of the testing and also to explore the commercial viability of utilizing traps to harvest lionfish.
NMFS is currently analyzing the effects of testing traps to target lionfish on the environment, including on Endangered Species Act (ESA)-listed species and designated critical habitat, and other non-target species and habitat, in the Gulf and South Atlantic regions through a programmatic environmental assessment (PEA). The PEA includes alternatives that incorporate the proposed effort in this submitted EFP application and others that have been submitted, and accounts for additional expected effort associated with potential future EFP requests. NMFS expects to receive additional EFP requests to test the effectiveness of traps at targeting lionfish in the future and may authorize additional trap testing. The PEA will guide NMFS in developing permit conditions to minimize impacts to the environment, including any affected fisheries and ESA-listed species and designated critical habitat. NMFS also is consulting on the effects of authorizing trap testing under EFPs on ESA-listed species and designated critical habitat in accordance with Section 7 of the ESA.
The specific EFP request noticed here is further described and summarized below.
Salty Bones Fisheries requests an EFP to deploy spiny lobster traps with a modified funnel and prototype non-containment purse traps developed by NOAA's National Ocean Service at reef sites in the Federal waters of the Gulf and South Atlantic to target lionfish. Two vessels would conduct trap testing trips in the Gulf and one vessel in the South Atlantic. Trap deployment in the Gulf would be off southwest Florida and generally between the latitudes of24° 28′ N to 25°21′ N and between longitudes 83°00′ W to 84°00′ W. In the South Atlantic, trap deployment would generally be off the Florida Keys between latitudes 24°22.7′ N to 24°24′ N and between longitudes 82°07′ W to 82°34′ W. These locations are current spiny lobster fishing grounds and are known areas of lionfish abundance to lobster trap fishers.
As described in the application, the trap designs to be tested would be a wire basket spiny lobster trap with a modified funnel, a wood and wire spiny lobster trap with a modified funnel, and an experimental fish aggregation device based, non-containment purse trap. The two modified spiny lobster trap designs would have biodegradable trap panels and modified funnels of 3 by 6 inches (8 by 15 cm) that are slightly smaller in dimension than the funnel in a regular (non-modified) lobster trap. Current project plans would deploy up to 3,000 total modified spiny lobster traps at one time on the seafloor during the 2-year period of the project. Three vessels would each deploy approximately 500 of each of the two modified spiny lobster traps (1,000 total per vessel per trip) and up to 15 purse traps per trip in the project's first year and up to 40 total per vessel per trip the project's second year. The applicant expects to take up to four trips per vessel each month from April through July, weather permitting. Traps would be deployed via a trawl system with up to 40 traps being part of each trawl. Each trawl would use one buoyed vertical line to the surface. The applicant intends to deploy the purse traps by integrating them into the spiny lobster trawls. If the purse traps are proven functional and effective in catching lionfish with
Vessels to be used in the proposed study would be three federally permitted commercial fishing vessels. Vessel crew would be responsible for collecting detailed records during the sampling trips. Data to be collected per trip would include: Gear configuration and fishing effort data (
The applicant has requested the EFP be effective for a 2-year period from the date the EFP is issued.
NMFS finds the application warrants further consideration based on a preliminary review. Possible conditions the agency may impose on the permit, if granted, include but are not limited to, a prohibition of conducting research within marine protected areas, marine sanctuaries, special management zones, or areas where they might interfere with managed fisheries without additional authorization. Additionally, NMFS may require special protections for ESA-listed species and designated critical habitat, and may require particular gear markings. A final decision on issuance of the EFP will depend on NMFS' review of public comments received on the application, consultations with the appropriate fishery management agencies of the affected states, Councils, the U.S. Coast Guard, and a determination that they are consistent with all applicable laws.
16 U.S.C 1801
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of initiation of 5-year review; request for information.
We, NMFS, announce our intent to conduct a 5-year review for the threatened Gulf of Maine distinct population segment (DPS) of Atlantic sturgeon (
To allow us adequate time to conduct this review, we must receive your information no later than May 15, 2018. While we will continue to accept new information about any listed species at any time, failure to timely submit the information in accordance with the deadline above may preclude the information from being included in this review.
Submit your comments by including NOAA-NMFS-2018-0041, by either of the following methods:
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1. Go to
2. Click the “Comment Now!” icon, complete the required fields
3. Enter or attach your comments.
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Lynn Lankshear at the above address, by phone at 978-282-8473 or
On February 6, 2012, we listed the Gulf of Maine DPS of Atlantic sturgeon as threatened and the New York Bight, Chesapeake Bay, Carolina and South Atlantic DPSs as endangered (77 FR 5880 and 77 FR 5914). Section 4(c)(2)(A) of the ESA requires that we conduct a review of listed species at least once every five years. On the basis of such reviews, under section 4(c)(2)(B), we determine whether a species should be delisted or reclassified from endangered to threatened or from threatened to endangered. Delisting a species must be supported by the best scientific and commercial data available and only considered if such data substantiate that the species is neither endangered nor threatened for one or more of the following reasons: (1) The species is considered extinct; (2) the species is
The ESA implementing regulations at 50 CFR 424.21 require that we publish a notice in the
Background information for the Gulf of Maine, New York Bight, and Chesapeake Bay DPSs of Atlantic sturgeon is available on the NMFS GARFO website:
To ensure that the 5-year review is complete and based on the best available scientific and commercial information, we are soliciting information that has become available since the 2012 listing determination from the public, concerned governmental agencies, tribes, the scientific community, industry, environmental entities, and any other interested parties concerning the status of each of the five DPSs of Atlantic sturgeon. For example, we are aware that the Atlantic States Marine Fisheries Commission has just completed an Atlantic Sturgeon Benchmark Stock Assessment. This is an example of new information we will consider during our review. Categories of requested information include: (1) Species biology including, but not limited to, population trends, distribution, abundance, demographics, and genetics; (2) habitat conditions including, but not limited to, amount, distribution, and suitability; (3) status and trends of identified limiting factors or threats; (4) conservation measures that have been implemented that benefit the species; and (5) other new information, data, or corrections including, but not limited to, taxonomic or nomenclatural changes, identification of erroneous information contained in the list of endangered and threatened species, and improved analytical methods for evaluating extinction risk.
Since there are no recovery plans for any of the DPSs, we will analyze the available information for the 5-year review relative to the ESA definitions of endangered and threatened and in the context of the five listing factors. The five factors are: (1) The present or threatened destruction, modification, or curtailment of its habitat or range; (2) overutilization for commercial, recreational, scientific, or educational purposes; (3) disease or predation; (4) the inadequacy of existing regulatory mechanisms; or, (5) other natural or manmade factors affecting its continued existence.
During the 5-year review, we are also required to consider whether the 1996 DPS policy (61 FR 4722; February 7, 1996) is appropriately applied to the species. The DPS Policy specifies that we consider the available information with respect to three elements. These elements are: (1) The discreteness of the population segment in relation to the remainder of the of the species to which it belongs; (2) the significance of the population segment to the species to which it belong; and (3) the population segment's conservation status in relation to the ESA's standards for listing (
If you wish to provide information for this 5-year review, you may submit your information and materials electronically at
16 U.S.C. 1531
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of public meetings.
The North Pacific Fishery Management Council (Council) and its advisory committees will meet April 2 through April 10, 2018, in Anchorage, AK.
The meetings will be held Monday, April 2 through Tuesday, April 10, 2018. See
The meeting will be held at the Anchorage Hilton Hotel, 500 W 3rd Ave., Anchorage, AK 99501.
Diana Evans, Council staff; telephone: (907) 271-2809.
The Council will begin its plenary session at 8 a.m. in the Aleutian Room on Wednesday, April 4, continuing through Tuesday, April 10, 2018. The Scientific and Statistical Committee (SSC) will begin at 8 a.m. in the King Salmon/Iliamna Room on Monday, April 2, and continue through Wednesday, April 4, 2018. The Council's Advisory Panel (AP) will begin at 8 a.m. in the Dillingham/Katmai Room on Tuesday, April 3 and continue through Friday April 6, 2018. The Enforcement Committee will meet on Tuesday, April 3, 2018 in the Birch/Willow Room from 1 p.m. to 4 p.m.
The Advisory Panel will address most of the same agenda issues as the Council except B reports.
The SSC agenda will include the following issues:
The Enforcement Committee agenda will include review of the Mixing of Guided and Unguided Halibut analysis.
In addition to providing ongoing scientific advice for fishery management decisions, the SSC functions as the Council's primary peer review panel for scientific information, as described by the Magnuson-Stevens Act section 302(g)(1)(e), and the National Standard 2 guidelines (78 FR 43066). The peer review process is also deemed to satisfy the requirements of the Information Quality Act, including the OMB Peer Review Bulletin guidelines.
The Agendas are subject to change, and the latest versions will be posted at
Although other non-emergency issues not on the agenda may come before these groups for discussion, those issues may not be the subject of formal action during these meetings. Actions will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under Section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the Council's intent to take final action to address the emergency.
These meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Shannon Gleason at (907) 271-2809 at least 7 working days prior to the meeting date.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; receipt of application.
Notice is hereby given that the NMFS Northwest Fisheries Science Center (NWFSC), 2725 Montlake Boulevard East, Seattle, WA 98112-2097, (Responsible Party: M. Bradley Hanson, Ph.D.) has applied in due form for a permit to conduct research on marine mammals.
Written, telefaxed, or email comments must be received on or before April 16, 2018.
The application and related documents are available for review by selecting “Records Open for Public Comment” from the “Features” box on the Applications and Permits for Protected Species (APPS) home page,
These documents are also available upon written request or by appointment in the Permits and Conservation Division, Office of Protected Resources, NMFS, 1315 East-West Highway, Room 13705, Silver Spring, MD 20910; phone (301) 427-8401; fax (301) 713-0376.
Written comments on this application should be submitted to the Chief, Permits and Conservation Division, at the address listed above. Comments may also be submitted by facsimile to (301) 713-0376, or by email to
Those individuals requesting a public hearing should submit a written request to the Chief, Permits and Conservation Division at the address listed above. The request should set forth the specific reasons why a hearing on this application would be appropriate.
Shasta McClenahan or Amy Hapeman, (301) 427-8401.
The subject permit is requested under the authority of the Marine Mammal Protection Act of 1972, as amended (MMPA; 16 U.S.C. 1361
The applicant proposes to take marine mammals in the North Pacific Ocean in the U.S. waters of Washington, Oregon, California, Alaska, and Hawaii, and international waters, to assess the biology and ecology of marine mammals in the study area, in particular endangered Southern Resident killer whales (
In compliance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321
Concurrent with the publication of this notice in the
Committee for Purchase From People Who Are Blind or Severely Disabled.
Additions to the Procurement List.
This action adds services to the Procurement List that will be provided 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.
Amy B. Jensen, Telephone: (703) 603-7740, Fax: (703) 603-0655, or email
On 2/2/2018 (83 FR 23) and 2/9/2018 (83 FR 28), the Committee for Purchase From People Who Are Blind or Severely Disabled published notices of proposed additions to the Procurement List.
After consideration of the material presented to it concerning capability of qualified nonprofit agencies to provide the services and impact of the additions on the current or most recent contractors, the Committee has determined that the services listed below are 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 any additional reporting, recordkeeping or other compliance requirements for small entities other than the small organizations that will provide the services to the Government.
2. The action will result in authorizing small entities to provide the 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 services proposed for addition to the Procurement List.
Accordingly, the following services are added to the Procurement List:
Committee for Purchase From People Who Are Blind or Severely Disabled.
Proposed Additions to and Deletions from the Procurement List.
The Committee is proposing to add products and a service to the Procurement List that will be furnished by nonprofit agencies 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: April 15, 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: Amy B. Jensen, Telephone: (703) 603-7740, 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 additions, the entities of the Federal Government identified in this notice will be required to procure the
The following products and service are proposed for addition to the Procurement List for production by the nonprofit agencies listed:
The following products are proposed for deletion from the Procurement List:
Bureau of Consumer Financial Protection.
Notice.
Pursuant to the authorities given to the Director of the Consumer Financial Protection Bureau (Bureau) under the Wall Street Reform and Consumer Protection Act (Dodd-Frank Act) Acting Director Mick Mulvaney invites the public to apply for membership for appointment to its Consumer Advisory Board (Board), Community Bank Advisory Council, and Credit Union Advisory Council (collectively, Advisory Councils). Membership of the Board and Councils includes representatives of consumers, communities, the financial services industry and academics. Appointments to the Board are typically for three years and appointments to the Councils are typically for two years. However, the Director may amend the respective Board and Council charters from time to time during the charter terms, as the Director deems necessary to accomplish the purpose of the Board and Councils. The Bureau expects to announce the selection of new members in September 2018.
The application will be available on March 19, 2018 here:
If electronic submission is not feasible, the completed application packet can be mailed to Julian Alcazar, Outreach and Engagement Specialist, Consumer Financial Protection Bureau, 1700 G Street NW, Washington, DC 20552.
All applications for membership on the Board and Councils should be sent:
•
• Julian Alcazar, Outreach and Engagement Specialist, Consumer Financial Protection Bureau, 1700 G Street NW, Washington, DC 20552. Submissions must be postmarked on or before March 1, 2017.
•
Julian Alcazar, Outreach and Engagement Specialist, Consumer Financial Protection Bureau, at (202) 435-9885. If you require this document in an alternative electronic format, please contact
The Bureau is charged with regulating “the offering and provision of consumer financial products or services under the Federal consumer financial laws,” so as to ensure that “all consumers have access to markets for consumer financial products and services and that markets for consumer financial products and services are fair, transparent, and competitive.” Pursuant to section 1021(c) of the Wall Street Reform and Consumer Protection Act, Public Law 111-203, Dodd-Frank Act, the Bureau's primary functions are:
1. Conducting financial education programs;
2. Collecting, investigating, and responding to consumer complaints;
3. Collecting, researching, monitoring, and publishing information relevant to the function of markets for consumer financial products and services to identify risks to consumers and the proper functioning of such markets;
4. Supervising persons covered under the Dodd-Frank Act for compliance with Federal consumer financial law, and taking appropriate enforcement action to address violations of Federal consumer financial law;
5. Issuing rules, orders, and guidance implementing Federal consumer financial law; and
6. Performing such support activities as may be needed or useful to facilitate the other functions of the Bureau.
As described in more detail below, section 1014 of the Dodd-Frank Act calls for the Director of the Bureau to establish a Consumer Advisory Board to advise and consult with the Bureau regarding its functions, and to provide information on emerging trends and practices in the consumer financial markets.
Pursuant to section 1014(b) of the Dodd-Frank Act, in appointing members to the Board, “the Director shall seek to assemble experts in consumer protection, financial services, community development, fair lending and civil rights, and consumer financial products or services and representatives of depository institutions that primarily serve underserved communities, and representatives of communities that have been significantly impacted by higher-priced mortgage loans, and seek representation of the interests of covered persons and consumers, without regard to party affiliation.” The determinants of “expertise” shall depend, in part, on the constituency, interests, or industry sector the nominee seeks to represent, and where appropriate, shall include significant experience as a direct service provider to consumers.
Pursuant to section 5 of the Community Bank Advisory Council Charter, in appointing members to the Council the Director shall seek to assemble experts in consumer protection, financial services, community development, fair lending and civil rights, and consumer financial products or services and representatives of community banks that primarily serve underserved communities, and representatives of communities that have been significantly impacted by higher-priced mortgage loans, and shall strive to have diversity in terms of points of view. Only current bank or thrift employees (CEOs, compliance officers, government relations officials, etc.) will be considered for membership. Membership is limited to employees of banks and thrifts with total assets of $10 billion or less that are not affiliates of depository institutions or credit unions with total assets of more than $10 billion.
Pursuant to section 12 of the Credit Union Advisory Council Charter, in appointing members to the Council the Director shall seek to assemble experts in consumer protection, financial services, community development, fair lending and civil rights, and consumer financial products or services and representatives of credit unions that primarily serve underserved communities, and representatives of communities that have been significantly impacted by higher-priced mortgage loans, and shall strive to have diversity in terms of points of view. Only current credit union employees (CEOs, compliance officers, government relations officials, etc.) will be considered for membership. Membership is limited to employees of credit unions with total assets of $10 billion or less that are not affiliates of depository institutions or credit unions with total assets of more than $10 billion.
The Bureau has a special interest in ensuring that the perspectives of women and men, all racial and ethnic groups, and individuals with disabilities are adequately represented on the Board and Councils, and therefore, encourages applications from qualified candidates from these groups. The Bureau also has a special interest in establishing a Board that is represented by a diversity of viewpoints and constituencies, and therefore encourages applications from qualified candidates who:
1. Represent the United States' geographic diversity; and
2. Represent the interests of special populations identified in the Dodd-Frank Act, including service members, older Americans, students, and traditionally underserved consumers and communities.
Any interested person may apply for membership on the Board or Council.
A complete application packet must include:
1. A recommendation letter from a third party describing the applicant's interests and qualifications to serve on the Board or Council;
2. A complete résumé or curriculum vitae for the applicant; and
3. A one-page cover letter, which summarizes the applicant's expertise and provides reason(s) why he or she would like to join the Board or Council.
4. A complete application.
To evaluate potential sources of conflicts of interest, the Bureau will ask potential candidates to provide information related to financial holdings and/or professional affiliations, and to allow the Bureau to perform a background check. The Bureau will not review applications and will not answer questions from internal or external parties regarding applications until the application period has closed.
The Bureau will not entertain applications of federally registered lobbyists for a position on the Board and Councils.
Only complete applications will be given consideration for review of membership on the Board and Councils.
Department of the Navy, Board of Advisors to the Presidents of the Naval Postgraduate School and the Naval War College, Department of Defense.
Notice of Federal Advisory Committee Meeting.
The Department of Defense (DoD) is publishing this notice to announce that the following Federal Advisory Committee meeting of the Board of Advisors to the Presidents of the Naval Postgraduate School and the Naval War College, Board of Advisors (BOA) to The President of the Naval War College (NWC) Subcommittee will take place.
Day 1—Open to the public Thursday April 5, 2018 from 8:00 a.m. to 4:00 p.m. Day 2—Open to the public Friday April 6, 2018 from 8:30 a.m. to 11:00 a.m.
The meeting will be held at the U.S. Naval War College, 686 Cushing Road, Newport, RI 02841.
Jacquelyn (Jaye) Panza, (831) 656-2514 (Voice), (831) 656-2789 (Facsimile),
This meeting is being held under the provisions of the Federal Advisory Committee Act (FACA) of 1972 (5 U.S.C., Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended), and 41 CFR 102-3.140 and 102-3.150.
Department of Energy.
Notice of meetings.
The Industry Advisory Board (IAB) to the International Energy Agency (IEA) will meet on March 20, 2018, at OECD Conference Centre, Room CC 7, 2 Rue André Pascal, 75016 Paris, France, in connection with a joint meeting of the IEA's Standing Group on Emergency Questions (SEQ) and the IEA's Standing Group on the Oil Market (SOM) on March 21, 2018, in connection with a meeting of the SEQ on that day.
March 20-21, 2018.
2 Rue André Pascal, 75016 Paris, France.
Thomas Reilly, Assistant General Counsel for International and National Security Programs, Department of Energy, 1000 Independence Avenue SW, Washington, DC 20585, 202-586-5000.
In accordance with section 252(c)(1)(A)(i) of the Energy Policy and Conservation Act (42 U.S.C. 6272(c)(1)(A)(i)) (EPCA), the following notice of meetings is provided:
A meeting of the Industry Advisory Board (IAB) to the International Energy Agency (IEA) will be held at the OECD Conference Centre, Room CC 7, 2 Rue André Pascal, 75016 Paris, France, commencing at 09:30 a.m. on March 20, 2018. The purpose of this notice is to permit attendance by representatives of U.S. company members of the IAB at a joint meeting of the IEA's Standing Group on Emergency Questions (SEQ) and the IEA's Standing Group on the Oil Market (SOM), which is scheduled to be held at the same location and time.
The IAB will also hold a preparatory meeting among company representatives at the same location at 8:30 a.m. on March 21, 2018. The agenda for this preparatory meeting is to review the agenda for the SEQ meeting.
The agenda of the meeting is under the control of the SEQ and the SOM. It is expected that the SEQ and the SOM will adopt the following agenda:
Start meeting/Introduction.
A meeting of the Industry Advisory Board (IAB) to the International Energy Agency (IEA) will be held at the OECD Conference Centre, Room CC 7, 2 Rue André Pascal, 75016 Paris, France, commencing at 9:30 a.m. on March 21, 2018. The purpose of this notice is to permit attendance by representatives of U.S. company members of the IAB at a meeting of the IEA's Standing Group on Emergency Questions (SEQ), which is scheduled to be held at the same location and time. The IAB will also hold a preparatory meeting among company representatives at the same location at 8:30 a.m. on March 21. The agenda for this preparatory meeting is to review the agenda for the SEQ meeting.
The agenda of the SEQ meeting is under the control of the SEQ. It is expected that the SEQ will adopt the following agenda:
As provided in section 252(c)(1)(A)(ii) of the Energy Policy and Conservation Act (42 U.S.C. 6272(c)(1)(A)(ii)), the meetings of the IAB are open to representatives of members of the IAB and their counsel; representatives of members of the IEA's Standing Group on Emergency Questions and the IEA's Standing Group on the Oil Markets; representatives of the Departments of Energy, Justice, and State, the Federal Trade Commission, the General Accounting Office, Committees of Congress, the IEA, and the European Commission; and invitees of the IAB, the SEQ, the SOM, or the IEA.
Office of Energy Efficiency and Renewable Energy, Department of Energy (DOE).
Notice of decision and order.
This notice announces a Decision and Order granting Apple, Inc. (“Apple”), Microsoft Corporation (“Microsoft”), Poin2 Lab (“Poin2”) and Hefei Bitland Information Technology Co. Ltd. (“Bitland”) individual waivers from specified portions of the DOE test procedure for determining the energy efficiency of external power supplies. The petitioners are required to test and rate specifically identified external power supply basic models in accordance with the alternate test procedure described in the Decision and Order.
The Decision and Order is applicable as of March 16, 2018.
Ms. Lucy deButts, U.S. Department of Energy, Office of Energy Efficiency and Renewable Energy, Building Technologies Office, EE-5B, 1000 Independence Avenue SW, Washington, DC 20585-0121. Telephone: (202) 287-1604. Email:
Mr. Michael Kido, U.S. Department of Energy, Office of the General Counsel, Mail Stop GC-33, Forrestal Building, 1000 Independence Avenue SW, Washington, DC 20585-0103. Telephone: (202) 586-8145. Email:
On June 8, 2017 and June 22, 2017, the Information Technology Industry Council (“ITI”), on behalf of four petitioners Apple, Microsoft, Poin2, and Bitland—filed individual petitions for waiver under 10 CFR 430.27 from the current DOE test procedure for EPSs for several basic models of adaptive EPSs. On July 24, 2017, DOE published a notice announcing its receipt of the petitions for waiver, which also granted the petitioners interim waivers.
In that notice, DOE also solicited comments from interested parties on all aspects of the petition and specified an alternate test procedure that must be followed for testing and certifying the specific basic models for which the petitioners requested a waiver. 82 FR 34294. On March 16, 2018, DOE publishes the notice announcing a Decision and Order granting a waiver to the petitioners.
The Energy Policy and Conservation Act of 1975, as amended (“EPCA” or “the Act”),
The Federal testing requirements consist of test procedures that manufacturers of covered products must use as the basis for: (1) certifying to DOE that their products comply with the applicable energy conservation standards adopted pursuant to EPCA (42 U.S.C. 6295(s)), and (2) making representations about the efficiency of those products (42 U.S.C. 6293(c)). Similarly, DOE must use these test procedures to determine whether a product complies with relevant standards promulgated under EPCA. (42 U.S.C. 6295(s))
Under 42 U.S.C. 6293, EPCA sets forth the criteria and procedures DOE is required to follow when prescribing or amending test procedures for covered products. EPCA requires that test procedures prescribed or amended under this section must be reasonably designed to produce test results which reflect the energy efficiency, energy use or estimated annual operating cost of covered products during a representative average use cycle or period of use and requires that test procedures not be unduly burdensome to conduct. (42 U.S.C. 6293(b)(3)) The test procedure for external power supplies is contained in the Code of Federal Regulations (“CFR”) at 10 CFR part 430, subpart B, appendix Z, “
Under 10 CFR 430.27, any interested person may submit a petition for waiver from DOE's test procedure requirements. DOE will grant a waiver from the test procedure requirements if DOE determines either that the basic model for which the waiver was requested contains a design characteristic that prevents testing of the basic model according to the prescribed test procedures, or that the prescribed test procedures evaluate the basic model in a manner so unrepresentative of its true energy or water consumption characteristics as to provide materially inaccurate comparative data. 10 CFR 430.27(f)(2). DOE may grant the waiver subject to conditions, including adherence to alternate test procedures.
On June 8, 2017 and June 22, 2017, the Information Technology Industry Council (“ITI”), on behalf of four petitioners—Apple, Microsoft, Poin2, and Bitland—filed individual petitions for waiver under 10 CFR 430.27 from the current DOE test procedure for EPSs for several basic models of adaptive EPSs.
In the view of the petitioners, applying the DOE test procedure to the adaptive EPS basic models identified in their individual petitions would yield results that would be unrepresentative of the active-mode efficiency of those products. The DOE test procedure requires that the average active-mode efficiency for adaptive EPSs
Consequently, the petitioners seek a waiver from DOE to permit them to use an alternative test procedure to measure the energy efficiency of the specified adaptive EPSs by testing these devices at the lowest voltage, 5V, at an output power of 10W instead of 15W.
Under the current test procedure, when testing an adaptive EPS at the lowest achievable output voltage, the measured average active mode efficiency is equal to the average efficiency of the EPS tested at 100%, 75%, 50%, and 25% of the nameplate output current of the EPS at that voltage. Appendix Z, sections 2.f and 4(a)(i)(E), and Table 1. Thus, for an adaptive EPS with a lowest output voltage of 5V and a nameplate output current of 3A (resulting in a 15W output at 100% of the nameplate output current), the average active mode efficiency at the lowest output voltage would be equal to the average of the efficiencies when testing at 15W, 11.25W, 7.5W, and 3.75W. The petitioners suggested that these requirements be modified for their products when calculating the average active mode efficiency—namely, by using the average of four loading conditions representing the same respective percentages of an output current of 2A. Doing so would mean that the average active mode efficiency would equal the average of the efficiencies when testing at 10W, 7.5W, 5W, and 2.5W. The petitioners suggested taking the results from this alternative approach and comparing them against the DOE efficiency requirements at 10W.
The petitioners assert that the test procedure for the lowest voltage level does not reflect actual field usage of these products. The IEC 62680-1-2:2017 specification requires USB-compliant products to support 15W at 5V but, according to the petitioners, adaptive EPSs operating at 5V do not exceed 10W for almost all usage conditions. Petitioners state that when charging a product that supports the USB power delivery requirements and is sold or intended to be used with the EPS, the IEC 62680-1-2:2017-compliant EPS charges at 5V only with a dead battery or fully charged battery (and then at 0.5A or less). At other times when more power is needed, petitioners state that the EPS will use a higher voltage rail (greater than 5V). (A “voltage rail” refers to a single voltage provided by the relevant power supply unit through a dedicated circuit/wire used for that voltage.) The petitioners also state that the same holds true for other end-use products that support the USB power delivery requirements manufactured by each of the respective manufacturers. The petitioners provided data to demonstrate that when using an adaptive EPS that supports the IEC 62680-1-2:2017 specification to charge an end-use product of a manufacturer different from the one who manufactured the EPS, it is likely that the product would charge at less than 10W at 5V, or may even be capable of exploiting the ability of an adaptive EPS to provide higher voltages for faster charging. The only occurrence where the adaptive EPS would be used at the full 15W at 5V is in the rare instance when used with an end-use product that does not support the USB power delivery requirements, but instead supports the ability to draw 3.0A at 5V. Accordingly, the petitioners assert that the current DOE test procedure, which requires that efficiency be measured above 10W at the lowest voltage condition, results in a measurement that is grossly unrepresentative of the actual energy consumption characteristics of the adaptive EPS being tested.
On July 24, 2017, DOE published a notice announcing its receipt of the petitions for waiver, which also granted the petitioners interim waivers, solicited comments from interested parties on all aspects of the petition and specified an alternate test procedure that must be followed for testing and certifying the specific basic models for which the petitioners requested a waiver. 82 FR 34294. DOE did not receive any comments on the notice of petitions for waiver.
Based on the information provided by the petitioners, DOE has determined that the current test procedure at Appendix Z would evaluate the specified adaptive EPS basic models in a manner so unrepresentative of their true energy consumption characteristics as to provide materially inaccurate comparative data. This Decision and Order specifies that each petitioner test and rate these basic models in a manner identical to that which was provided in the interim waiver.
Each petitioner sought a test procedure waiver for certain basic models. This Decision and Order applies only to the basic models listed within this document and does not extend to any other basic models.
Consistent with 10 CFR 430.27(j), not later than 60 days after March 16, 2018 any manufacturer currently distributing in commerce in the United States a product employing a technology or characteristic that results in the same need for a waiver from the applicable test procedure must submit a petition for waiver.
Manufacturers not currently distributing such a product in commerce in the United States must petition for and be granted a waiver prior to the distribution in commerce of that product in the United States.
In accordance with 10 CFR 430.27(f)(2), DOE consulted with the Federal Trade Commission (“FTC”) staff concerning the petitioners' petition for waiver. The FTC staff did not have any objections to granting waivers to petitioners.
After careful consideration of all the material that was submitted by and on behalf of Apple, Inc. (“Apple”), Microsoft Corporation (“Microsoft”), Poin2 Lab (“Poin2”), and Hefei Bitland Information Technology Co. Ltd. (“Bitland”) in this matter, DOE grants a waiver regarding the below specified basic models. Therefore, in accordance with 10 CFR 430.27, it is
(1) Apple, Microsoft, Poin2, and Bitland must test and rate the external power supply basic models listed in paragraphs (1)(A) through (1)(D) of this section in accordance with the alternate test procedure set forth in paragraph (2) of this section.
(A) Apple must test and rate the EPSs of Apple brand basic models A1718, A1719, A1540 as set forth in paragraph (2) of this section.
(B) Microsoft must test and rate the EPSs of Microsoft brand basic model AC-100 as set forth in paragraph (2) of this section.
(C) Poin2 must test and rate the EPSs of Chicony brand basic model A16-045N1A as set forth in paragraph (2) of this section.
(D) Bitland must test and rate the EPSs of Chicony brand basic model A045R053L as set forth in paragraph (2) of this section.
(2) The alternate test procedure for the basic models listed in paragraphs (1)(A) through (1)(D) of this section is the test procedure for EPSs prescribed by DOE at 10 CFR part 430, subpart B, appendix Z, except that under section 4(a)(i)(E) and Table 1 of Appendix Z, the adaptive EPSs must be tested such that when testing at the lowest achievable output voltage (i.e., 5V), the Nameplate Output Current shall be 2A (which corresponds to an output power of 10W at the 100% loading condition). The 75%, 50%, and 25% loading conditions shall be scaled accordingly and the nameplate output power of such an EPS, at the lowest output voltage, shall be equal to 10W.
(3) Representations. Apple, Microsoft, Poin2, and Bitland must make representations about the energy use of the adaptive external power supply basic models identified in paragraph (1) of this section for compliance, marketing, or other purposes only to the extent that such products have been tested in accordance with the provisions outlined above and such representations fairly disclose the results of such testing in accordance with 10 CFR part 430, subpart B, appendix Z and 10 CFR 429.37.
(4) These waivers shall remain in effect consistent with the provisions of 10 CFR 430.27.
(5) These waivers are issued on the condition that the statements, representations, and documentation provided on behalf of and by the petitioners are valid. DOE may revoke or modify these waivers at any time if it determines the factual basis underlying the petitions for waiver is incorrect, or the results from the alternate test procedure are unrepresentative of the basic models' true energy consumption characteristics. 10 CFR 430.27(k)(1). Likewise, any of the petitioners may request that DOE rescind or modify the waiver if the petitioner discovers an error in the information provided to DOE as part of its petition, determines that the waiver is no longer needed, or for other appropriate reasons. 10 CFR 430.27(k)(2)
(6) Granting of these waivers does not release Apple, Microsoft, Poin2, or Bitland from the certification requirements set forth at 10 CFR part 429.
Signed in Washington, DC, on March 9, 2018.
Office of Energy Efficiency and Renewable Energy, Department of Energy.
Notice of decision and order.
The U.S. Department of Energy (“DOE”) announces a Decision and Order granting Acuity Brands Lighting, Inc. (Acuity) a waiver from specified portions of the DOE test procedure for determining the energy consumption of specified combination illuminated exit signs basic models. Acuity is required to test and rate the specified basic models of its combination illuminated exit signs in accordance with the alternate test procedure described in the Decision and Order.
The Decision and Order is effective on March 16, 2018.
Ms. Lucy deButts, U.S. Department of Energy, Office of Energy Efficiency and Renewable Energy, Building Technologies Office, EE-5B, 1000 Independence Avenue SW, Washington, DC 20585-0121. Telephone: (202) 287-1604. Email:
Ms. Jennifer Tiedeman, U.S. Department of Energy, Office of the General Counsel, GC-33, 1000 Independence Avenue SW, Washington, DC 20585-0121. Telephone: (202) 287-6111. Email:
On April 17, 2013, Acuity filed a petition for waiver from the applicable illuminated exit sign test procedure set forth in 10 CFR 431.204. Acuity submitted an updated petition for waiver in a letter dated March 22, 2016 and further supplemented its filing in an email submitted May 1, 2017. On June 7, 2017, DOE published a notice announcing its receipt of the petition for waiver. 82 FR 26469. In that notice, DOE also solicited comments from interested parties on all aspects of the petition and specified an alternate test procedure that must be followed for testing and certifying the specific basic models for which Acuity requested a waiver.
The Energy Policy and Conservation Act of 1975 (“EPCA” or “the Act”),
The Federal testing requirements consist of test procedures that manufacturers of covered equipment must use as the basis for: (1) Certifying to DOE that their equipment complies with the applicable energy conservation standards adopted pursuant to EPCA (42 U.S.C. 6295(s)), and (2) making representations about the efficiency of that equipment (42 U.S.C. 6293(c)). Similarly, DOE must use these test procedures to determine whether the equipment complies with relevant standards promulgated under EPCA. (42 U.S.C. 6295(s))
Under 42 U.S.C. 6293, EPCA sets forth the criteria and procedures DOE is required to follow when prescribing or amending test procedures for covered product EPCA requires that any test procedures prescribed or amended under this section must be reasonably designed to produce test results which reflect energy efficiency, energy use or estimated annual operating cost of a covered product during a representative average use cycle or period of use and requires that test procedures not be unduly burdensome to conduct. (42 U.S.C. 6293(b)(3))) The test procedure for illuminated exit signs is contained in 10 CFR part 431, subpart L.
Under 10 CFR 431.401, any interested person may submit a petition for waiver from DOE's test procedure requirements. DOE will grant a waiver from the test procedure requirements if DOE determines either that the basic model for which the waiver was requested contains a design characteristic that prevents testing of the basic model according to the prescribed test procedures, or that the prescribed test procedures evaluate the basic model in a manner so unrepresentative of its true energy consumption characteristics as to provide materially inaccurate comparative data. 10 CFR 431.401(f)(2). DOE may grant the waiver subject to conditions, including adherence to alternate test procedures.
By letter dated March 22, 2016, Acuity submitted an updated petition for waiver (the initial petition was submitted on April 17, 2013) for certain basic models of illuminated exit signs that are required to be tested according to test procedures detailed in 10 CFR 431.204. Acuity supplemented its filing with an email submitted to DOE on May 1, 2017, that further clarified the specific basic models for which the waiver was being requested.
In its petition Acuity requested a waiver for basic models that provide the dual function of exit signage and lighting for emergency egress (combination illuminated exit signs), stating that the battery used in combination illuminated exit signs requires a substantially larger capacity to provide a minimum of 90 minutes of egress lighting, as required by safety codes. Acuity further stated that it is not feasible to separate the power measurement associated with the exit signage and the egress lighting because a single battery and charging circuit supplies power for both functions. As an alternative to the test procedure currently in place at 10 CFR part 431, subpart L, Acuity recommended that, for combination illuminated exit signs, the power should be determined by applying a battery proration factor to the total battery power of the combination illuminated exit sign. The battery proration factor would be a ratio of the rated wattage of the exit sign face light sources over the combined rated wattages of the egress and exit sign face light sources. The total battery power would be the measured input power minus the rated wattages of the exit sign face light sources.
On June 7, 2017, DOE published a notice announcing receipt of Acuity's petition for waiver (hereafter “notice of petition for waiver”). 82 FR 26469. In the notice of petition for waiver, DOE proposed an alternate test procedure that provides methods to test and rate the basic models at issue. 82 FR 26469, 26470. In that notice, DOE also solicited comments from interested parties on all aspects of the petition and required Acuity to follow an alternate test procedure for testing and certifying the specific basic models for which Acuity requested a waiver.
DOE received comments from Philips Lighting (Philips) in support of granting the petition for waiver submitted by Acuity. Philips also supported the alternative test method proposed by DOE to determine the energy consumption of combination illuminated exit signs. (Philips; No. 7 at p. 1)
Based on the information provided by Acuity, DOE has determined that the test procedure at 10 CFR part 431, subpart L produces results in a manner so unrepresentative of the true energy consumption as to provide materially inaccurate comparative data for the combination illuminated exit signs listed in Acuity's petition for waiver and therefore is granting a waiver for the specified basic models (see footnote).
In addition to requesting a test procedure waiver for specified basic models in its petition, Acuity also requested that any new products introduced by the company into commerce that provide the dual function of exit signage and emergency egress lighting be covered by the waiver. DOE regulations at 10 CFR 431.401(f)(2) provide that DOE may grant a waiver, including adherence to alternate test procedures, only for “the basic model(s) for which the waiver was requested.” The Decision and Order is applicable only to the basic models listed within it and does not extend to any other basic models. Acuity may request that the scope of this waiver be extended to include additional basic models that employ the same technology as those basic models listed in this waiver using the expedited process established at 10 CFR 431.401(g). Alternatively, Acuity may submit another petition for waiver from the test procedure for additional basic models. 10 CFR 431.401(a)(1).
In its petition, Acuity sought a test procedure waiver for certain basic models. The Decision and Order is applicable only to the basic models listed within it and does not extend to any other basic models.
Consistent with 10 CFR 431.401(j), not later than 60 days after March 16, 2018 any manufacturer currently distributing in commerce in the United States equipment employing a technology or characteristic that results in the same need for a waiver from the applicable test procedure must submit a petition for waiver.
Manufacturers not currently distributing such equipment in commerce in the United States must petition for and be granted a waiver prior to the distribution in commerce of that equipment in the United States. Manufacturers may also submit a request for interim waiver pursuant to the requirements of 10 CFR 431.401.
This Decision and Order will terminate in conjunction with any future updates to the test procedure for illuminated exit signs located in 10 CFR part 431, subpart L, that address the issue presented in the waiver. At such time, testing to demonstrate compliance with standards, and any other representations of energy use, will require manufacturers to use the relevant test procedure for this equipment.
In accordance with 10 CFR 430.27(f)(2), DOE consulted with the Federal Trade Commission (FTC) staff concerning the Acuity petition for waiver. The FTC staff did not have any objections to granting a waiver to Acuity.
After careful consideration of all the material that was submitted by Acuity in this matter, DOE grants a waiver regarding the basic models specified in paragraphs (2) and (3). Therefore, in accordance with 10 CFR 431.401, it is
(1) The petition for waiver submitted by Acuity (Case No. IES-001) is hereby granted as set forth in this Order.
(2) For the following basic models:
Lithonia Lighting brand basic models: ECG LED 1F, ECG LED 2F, ECR LED 1F, ECR LED 2F, LHQM LED 1F HO GREEN, LHQM LED 1F HO RED, LHQM LED 2F HO GREEN, LHQM LED 2F HO RED, LHZ618 GREEN, LHZ618 RED, LHZ636 GREEN, LHZ636 RED, LHZ672 GREEN, and LHZ672 RED.
Holophane brand basic models: QM LED 1F GREEN, QM LED 1F HO GREEN, QM LED 1F RED, QM LED 1F HO RED, QM LED 2F GREEN, QM LED 2F HO GREEN, QM LED 2F RED, and QM LED 2F HO RED.
Navilite brand basic models: NXPCL 1F and NXPCL 2F.
Acuity must:
(a) Identify a non-combination illuminated exit sign equivalent to the combination illuminated exit sign basic model under test. A unit is an equivalent non-combination substitute only if it consists entirely of components identical to all of those of the unit whose input power demand is being determined, but does not include any auxiliary features, and contains an electrically connected battery. The equivalent unit must also have the same manufacturer and number of faces as the unit whose input power demand is being determined.
(b) Assign the input power demand of the equivalent non-combination illuminated exit sign as the input power demand of the combination illuminated exit sign basic model.
(3) For the following basic models:
Lithonia Lighting brand basic models: ECG 1F, ECG 1F HO, ECG 2F, ECG 2F HO, ECR 1F, ECR 1F HO, ECR 2F, ECR 2F HO, ECG LED 1F HO, ECG LED 2F HO, ECR LED 1F HO, ECR LED 2F HO, ECBG LED 1F, ECBG LED 2F, ECBR LED 1F, ECBR LED 2F, LHQM LED 1F GREEN, LHQM LED 1F RED, LHQM LED 2F GREEN, LHQM LED 2F RED, LHXNY W 1 R, LHXC W 1 RW, and LHXC W 2 RW.
Holophane brand basic models: LHD2D18G, LHD2D18R, LHD2D36G, LHD2D36R, LHD2D72G, LHD2D72R, LHD2S18G, LHD2S18R, LHD2S36G, LHD2S36R, LHD2S72G, and LHD2S72R.
Acuity must:
(a) For a combination illuminated exit sign basic model under test that uses only LEDs to illuminate all face(s) of the unit and does not have an equivalent unit as described in (2)(a), assign an input power demand according to the following formula:
This method requires determination of the number of faces for each basic model. Face count is the number of faces (no fewer than one) with which an illuminated exit sign basic model can be configured by an end user when all electric light sources are connected and energized.
(4) Representations. Acuity may make representations about the energy use of the specified basic models of its combination illuminated exit sign for compliance, marketing, or other purposes only to the extent that such products have been tested in accordance with the provisions above and such representations fairly disclose the results of such testing.
(5) This waiver shall remain in effect consistent with the provisions of 10 CFR 431.401.
(6) This waiver is issued on the condition that the statements, representations, and documentary materials provided by the petitioner are valid. DOE may revoke or modify this waiver at any time if it determines the factual basis underlying the petition for waiver is incorrect, or the results from the alternate test procedure are unrepresentative of the basic models' true energy consumption characteristics. 10 CFR 431.401(k)(1). Likewise, Acuity may request that DOE rescind or modify the waiver if Acuity discovers an error in the information provided to DOE as part of its petition, determines that the waiver is no longer needed, or for other appropriate reasons. 10 CFR 431.401(k)(2). As set forth above, the test procedure specified in this Decision and Order is not the identical to the test procedure offered by Acuity. If Acuity believes that its preferred test method provides representative results and is less burdensome than the test method required by this Decision and Order,
(7) Granting of this waiver does not release a petitioner from the certification requirements set forth at 10 CFR part 429.
Signed in Washington, DC, on March 9, 2018.
Office of Energy Efficiency and Renewable Energy, Department of Energy.
Notice of decision and order.
This notice announces a Decision and Order granting to New Shunxiang Electrical Appliance Co., Ltd., (“New Shunxiang”) a waiver from specified portions of the DOE test procedure for determining the energy consumption of specified refrigerator and refrigerator-freezer basic models. New Shunxiang is required to test and rate the specified basic model of its combination cooler refrigeration product in accordance with the alternate test procedure described in the Decision and Order.
This Decision and Order is effective on March 16, 2018.
Ms. Lucy deButts, U.S. Department of Energy, Office of Energy Efficiency and Renewable Energy, Building Technologies Office, EE-5B, 1000 Independence Avenue SW, Washington, DC 20585-0121. Telephone: (202) 287-1604. Email:
Mr. Michael Kido, U.S. Department of Energy, Office of the General Counsel, Mail Stop GC-33, Forrestal Building, 1000 Independence Avenue SW, Washington, DC 20585-0103. Telephone: (202) 586-8145. Email:
On October 14, 2015, New Shunxiang submitted a petition for waiver from the applicable refrigerator and refrigerator-freezer test procedure set forth in 10 CFR part 430, subpart B, appendix A (“Appendix A”). On July 19, 2017, DOE published a notice announcing its receipt of the petition for waiver from New Shunxiang. 82 FR 33099. In that notice, DOE also solicited comments from interested parties on all aspects of the petition and specified an alternate test procedure that DOE was considering to require New Shunxiang to follow for testing and certifying the specific basic models for which New Shunxiang requested a waiver.
The Energy Policy and Conservation Act of 1975 (“EPCA” or “the Act”),
The Federal testing requirements consist of test procedures that manufacturers of covered products must use as the basis for: (1) Certifying to DOE that their products comply with the applicable energy conservation standards adopted pursuant to EPCA (42 U.S.C. 6295(s)), and (2) making representations about the efficiency of that product (42 U.S.C. 6293(c)). Similarly, DOE must use these test procedures to determine whether the product complies with relevant standards promulgated under EPCA. (42 U.S.C. 6295(s))
Under 42 U.S.C. 6293, EPCA sets forth the criteria and procedures DOE is required to follow when prescribing or amending test procedures for covered products. EPCA requires that test procedures prescribed or amended under this section must be reasonably designed to produce test results which reflect the energy efficiency, energy use or estimated annual operating cost of a covered product during a representative average use cycle or period of use and requires that test procedures not be unduly burdensome to conduct. (42 U.S.C. 6293(b)(3)) The test procedure for consumer refrigerators and refrigerator-freezers is contained in 10 CFR part 430, subpart B, appendix A (“Appendix A”).
Under 10 CFR 430.27, any interested person may submit a petition for waiver from DOE's test procedure requirements. DOE will grant a waiver from the test procedure requirements if DOE determines either that the basic model for which the waiver was requested contains a design characteristic that prevents testing of the basic model according to the prescribed test procedures, or that the prescribed test procedures evaluate the basic model in a manner so unrepresentative of its true energy or water consumption characteristics as to provide materially inaccurate comparative data. 10 CFR 430.27(f)(2). DOE may grant the waiver subject to conditions, including adherence to alternate test procedures.
By email with attachment sent to DOE on October 14, 2015, New Shunxiang submitted a petition for waiver for its combination cooler refrigeration product basic model JG50-2D1. In its petition, New Shunxiang stated that it was unclear to it as to how this product would be classified under DOE's regulations. As indicated in New Shunxiang's submitted data, the product includes both a cooler (which can reach temperatures down to 40.2 degrees Fahrenheit (°F)) and a refrigerator (which can reach temperatures down to 35 °F). Such a basic model is subject to the existing refrigerator energy conservation standards for the product
Subsequent to the submission of New Shunxiang's petition, DOE issued a final rule that, among other things, established test procedures for miscellaneous refrigeration products (“MREFs”), which includes coolers and combination cooler refrigeration products. 81 FR 46768 (July 18, 2016); 81 FR 49868 (July 29, 2016). The final rule also added new definitions to DOE's regulations, including for cooler-refrigerator and combination cooler refrigeration products, and amended the definition of refrigerator. 81 FR 46791-46792. Under the new and amended definitions, the basic model for which New Shunxiang seeks a waiver currently meets the definition of both combination cooler refrigeration product and refrigerator, and the basic model will continue to meet the definition of refrigerator until October 28, 2019, the compliance date of standards for MREFs, including combination cooler refrigeration products.
The amended test procedure adopted in the final rule contains provisions specific to combination cooler refrigeration products, including a standardized cooler compartment temperature of 55 °F and a correction factor of 0.55. However, a prefatory note to Appendix A states that use of these provisions for representations of energy use for combination cooler refrigeration products is not required until the compliance date of any energy conservation standards for these products, October 28, 2019. 81 FR 46795. As explained in the July 2016 final rule, prior to the compliance date of the MREF energy conservation standards, combination cooler refrigeration products, including the product identified in New Shunxiang's petition, are subject to the energy conservation standards for refrigerators based on testing according to relevant test procedure waivers. 81 FR 46771.
DOE granted a waiver for products similar to those identified in New Shunxiang's petition for wavier—products combining a high-temperature compartment (a cooler) with a refrigerator—to Panasonic Appliances Refrigeration Systems Corporation of America (“PAPRSA”) in 2012 (under PAPRSA's previous corporate name, Sanyo E&E Corporation) (Case No. RF-022, 77 FR 49443 (August 16, 2012)), in 2013 (Case No. RF-031, 78 FR 57139; September 17, 2013)), and 2014 (Case No. RF-041, 79 FR 55769; September 17, 2014)). On October 4, 2012, DOE issued a notice of correction to its Decision and Order in Case No. RF-022 by incorporating a K-factor (correction factor) value of 0.85 when calculating the energy consumption of the affected models. 77 FR 60688. On January 26, 2016, due to issues with the equations detailed in the prior waiver decisions, DOE issued a proposed modification of its prior waivers and granted PAPRSA an interim waiver (81 FR 4270) under Case No. RF-043 to correct these known issues. In May 2017, DOE issued a Decision and Order granting PAPRSA with a waiver. See 82 FR 21209 (May 5, 2017). DOE also previously granted a similar waiver to Sub-Zero Group Inc. through an interim waiver (79 FR 55772; September 17, 2014) and a subsequent Decision and Order (80 FR 7854; February 12, 2015) under Case No. RF-040. More recently, DOE granted a similar waiver to AGA Marvel through an interim waiver (81 FR 41531; June 27, 2016) and a subsequent Decision and Order (82 FR 21211; May 5, 2017) under case RF-045.
While the recent amendments to Appendix A include provisions designed to test for compliance with the combination cooler refrigeration product standards, such compliance is not yet required. The basic models for which DOE most recently granted waivers to PAPRSA and AGA Marvel are still required to comply with the energy conservation standards for refrigerators. DOE determined in previous waivers that a correction factor of 0.85 is appropriate to account for the thermal load from loading warm items and from door openings in these products when subject to the current refrigerator energy conservation standards. Thus, the PAPRSA and AGA Marvel waivers effectively required that the manufacturers test the basic models using the test procedure specified for combination cooler refrigeration products,
DOE published a notice on July 19, 2017, announcing receipt of New Shunxiang's petition for waiver (hereafter “notice of petition for waiver”). 82 FR 33099. DOE received no comments in response to the notice of petition for waiver. DOE has determined that applying the DOE test procedure to the basic model of combination cooler refrigeration product listed in New Shunxiang's petition for waiver (
In this Decision and Order, DOE is requiring that New Shunxiang test and rate the combination cooler refrigeration product for which it has requested a waiver according to the alternate test procedure specified in this Decision and Order, which is identical to that proposed in the notice of petition for waiver.
In its petition, New Shunxiang sought a test procedure waiver for a single basic model. This Decision and Order is applicable only to the basic model listed and does not extend to any other basic models.
Consistent with 10 CFR 430.27(j), not later than 60 days after March 16, 2018 any manufacturer currently distributing in commerce in the United States a product employing a technology or characteristic that results in the same need for a waiver from the applicable test procedure must submit a petition for waiver.
Manufacturers not currently distributing such a product in commerce in the United States must petition for and be granted a waiver prior to the distribution in commerce of that product in the United States. Manufacturers may also submit a request for interim waiver pursuant to the requirements of 10 CFR 430.27.
In accordance with 10 CFR 430.27(f)(2), DOE consulted with the Federal Trade Commission (“FTC”) staff concerning the New Shunxiang petition for waiver. The FTC staff did not have any objections to granting a waiver to New Shunxiang.
After careful consideration of all the material that was submitted by New Shunxiang, DOE grants a waiver regarding the basic model specified below. Therefore, in accordance with 10 CFR 430.2,
(1) New Shunxiang must test and rate the following New Shunxiang basic model as set forth in paragraph (2) of this section: JG50-2D1.
(2) The alternate test procedure for the basic model specified in paragraph (1) of this section is the test procedure for
(3) Representations. New Shunxiang must make representations about the energy use of the specified basic model identified in paragraph (1) of this section for compliance, marketing, or other purposes only to the extent that such product has been tested in accordance with the provisions outlined above and such representations fairly disclose the results of such testing in accordance with 10 CFR part 430, subpart B, appendix A and 10 CFR 429.14.
(4) This waiver shall remain in effect consistent with the provisions of 10 CFR 430.27. This Decision and Order will terminate on October 28, 2019, in conjunction with the compliance date of the recently published standards for MREFs. Testing to demonstrate compliance with those standards, and any other representations of energy use made on or after October 28, 2019, will require manufacturers to use the relevant test procedure for these products.
(5) This waiver is issued on the condition that the statements, representations, and documentary materials provided by the petitioner are valid. DOE may revoke or modify this waiver at any time if it determines the factual basis underlying the petition for waiver is incorrect, or the results from the alternate test procedure are unrepresentative of the basic model's true energy consumption characteristics. 10 CFR 430.27(k)(1). Likewise, New Shunxiang may request that DOE rescind or modify the waiver if New Shunxiang discovers an error in the information provided to DOE as part of its petition, determines that the waiver is no longer needed, or for other appropriate reasons. 10 CFR 430.27(k)(2). If New Shunxiang believes that a test method other than that specified in this Decision and Order provides representative results and is less burdensome, New Shunxiang may submit a request for modification under 10 CFR 430.27(k)(2) that explains why DOE should adopt the test procedure submitted by New Shunxiang and addresses the reasons for DOE's modifications provided in this Decision and Order.
(6) Granting of this waiver does not release New Shunxiang from the certification requirements set forth at 10 CFR part 429.
Signed in Washington, DC, on March 9, 2018.
Office of Fossil Energy, DOE.
Notice of change in control.
The Office of Fossil Energy (FE) of the Department of Energy (DOE) gives notice of receipt of a Notice of Change in Control (Notice) filed January 9, 2018, by American LNG Marketing, LLC (ALM) in the above-referenced dockets. The Notice describes a change in control of Fortress Investment Group LLC (Fortress), the ultimate parent company of ALM. The Notice was filed under section 3 of the Natural Gas Act (NGA).
Protests, motions to intervene, or notices of intervention, as applicable, and written comments are to be filed using procedures detailed in the Public Comment Procedures section no later than 4:30 p.m., Eastern time, April 2, 2018.
Larine Moore or Amy Sweeney, U.S. Department of Energy (FE-34), Office of Regulation and International Engagement, Office of Fossil Energy, Forrestal Building, Room 3E-042, 1000 Independence Avenue SW, Washington, DC 20585, (202) 586-9478; (202) 586-2627.
Cassandra Bernstein or Ronald (R.J.) Colwell, U.S. Department of Energy (GC-76), Office of the Assistant General Counsel for Electricity and Fossil Energy, Forrestal Building, 1000 Independence Avenue SW, Washington, DC 20585, (202) 586-9793; (202) 586-8499.
As noted, ALM filed a Notice of Change in Control in the above-referenced dockets.
Additional details can be found in ALM's Notice, posted on the DOE/FE website at:
DOE/FE will review ALM's Notice in accordance with its Procedures for Changes in Control Affecting Applications and Authorizations to Import or Export Natural Gas (CIC Revised Procedures).
Interested persons will be provided 15 days from the date of publication of this notice in the
Filings may be submitted using one of the following methods: (1) Preferred method: Emailing the filing to
ALM's Notice and any filed protests, motions to intervene, notices of intervention, and comments are available for inspection and copying in the Office of Regulation and International Engagement docket room, Room 3E-042, 1000 Independence Avenue SW, Washington, DC 20585. The docket room is open between the hours of 8:00 a.m. and 4:30 p.m., Monday through Friday, except Federal holidays.
The Notice and any filed protests, motions to intervene, notices of intervention, and comments will also be available electronically by going to the following DOE/FE web address:
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:
The National Indian Gaming Commission (NIGC) has adopted the Bureau of Indian Affairs' (BIA) Spokane Tribe of Indians West Plains Casino and Mixed-Use Development Project Approval of Gaming Development and Management Spokane County WA EIS. BIA filed its Final EIS with EPA on January 25, 2013; it was published in the
Environmental Protection Agency (EPA).
Notice.
In compliance with the Paperwork Reduction Act, this document announces that EPA is planning to submit a continuing Information Collection Request (ICR) to the Office of Management and Budget (OMB). This is a request to renew an existing approved collection. This ICR is scheduled to expire on June 30, 2018. Before submitting the ICR to OMB for review and approval, EPA is soliciting comments on specific aspects of the proposed information collection as described below.
Comments must be submitted on or before May 15, 2018.
Submit your comments, identified by Docket ID No. EPA-HQ-OLEM-2018-0081 by one of the following methods:
•
•
•
•
EPA's policy is that all comments received will be included in the public docket without change and may be made available online at
Lisa Boynton, Office of Land and Emergency Management, Office of Emergency Management, (5104A) Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: 202-564-2487; fax number: 202-564-8729; email address:
EPA has established a public docket for this ICR under Docket ID No. EPA-HQ-OLEM-2018-0081 which is available for online viewing at
Use
Pursuant to section 3506(c)(2)(A) of the PRA, EPA specifically solicits comments and information to enable it to:
(i) 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;
(ii) 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;
(iii) enhance the quality, utility, and clarity of the information to be collected; and
(iv) 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,
You may find the following suggestions helpful for preparing your comments:
1. Explain your views as clearly as possible and provide specific examples.
2. Describe any assumptions that you used.
3. Provide copies of any technical information and/or data you used that support your views.
4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide.
5. Offer alternative ways to improve the collection activity.
6. Make sure to submit your comments by the deadline identified under
7. To ensure proper receipt by EPA, be sure to identify the docket ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and
Docket ID No. EPA-HQ-OLEM-2018-0081.
The ICR provides a detailed explanation of the Agency's estimate, which is only briefly summarized here:
At this time, the Agency does not anticipate any substantial changes.
EPA will consider the comments received and amend the ICR as appropriate. The final ICR package will then be submitted to OMB for review and approval pursuant to 5 CFR 1320.12. At that time, EPA will issue another
Environmental Protection Agency (EPA).
Notice.
The amendments to the Toxic Substances Control Act in June 2016 expand the categories of people to whom EPA may disclose TSCA confidential business information (CBI) by specifically authorizing EPA to disclose TSCA CBI to state, tribal, and local governments; environmental, health, and medical professionals; and emergency responders, under certain conditions, including consistency with guidance that EPA is required to develop. This document announces the availability of and solicits comments on three draft guidance documents that address this requirement. These documents are available in the docket for public review and comment.
Comments must be received on or before April 16, 2018.
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2017-0652, by one of the following methods:
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•
•
Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at
As directed by TSCA, EPA has developed draft guidance for each of three new expanded TSCA CBI access provisions. The guidance documents cover the content and form of the agreements and statements of need required under each provision, and include some basic logistical information on where and how to submit requests to EPA. EPA invites comment from prospective guidance users and other stakeholders concerning these draft guidance documents.
TSCA section 14(c)(4)(B) requires that EPA develop guidance concerning the “content and form of the statements of need and agreements required” under TSCA section 14(d)(4), (5), and (6). 15 U.S.C. 2613.
You may be potentially affected by this action if you are a state, tribal, or local government, or are employed by a government (federal, state, local, or tribal) or in the private sector and your duties concern: Chemical regulation; chemical-related law enforcement; diagnosing or treating chemical exposures; and/or chemical spill, incident, accident, or emergency response, including injury to humans or the environment. You may also be affected by this action if you have or may in the future submit information to EPA that you claim qualifies as TSCA CBI.
The potential incremental economic impacts that are associated with the information collection activities contained in the guidance documents are enumerated in the Information Collection Request (ICR) entitled “Guidance on Expanded Access to TSCA Confidential Business Information” (EPA ICR No. 2570.01 and OMB Control No. 2070-(new)), which published in the
1.
2.
Enacted on June 22, 2016, the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Pub. L. 114-182), changed and expanded many parts of TSCA (15 U.S.C. 2601
• Under TSCA section 14(d)(4), 15 U.S.C. 2613(d)(4), EPA may disclose CBI to state, tribal, and local governments;
• Under TSCA section 14(d)(5), 15 U.S.C. 2613(d)(5), EPA may, in non-emergency situations, disclose CBI to a health or environmental professional employed by a Federal or state agency or tribal government, or to a treating physician or nurse; and
• Under TSCA section 14(d)(6), 15 U.S.C. 2613(d)(6), EPA may in the event of an emergency disclose CBI to a treating or responding physician, nurse, agent of a poison control center, public health or environmental official of a state, political subdivision of a state, or tribal government, or to a first responder (including any individual duly authorized by a Federal agency, state, political subdivision of a state, or tribal government who is trained in urgent medical care or other emergency procedures, including a police officer, firefighter, or emergency medical technician).
The conditions for access vary under each of the new provisions, but generally include the following;
• The requester must show that he or she has a need for the information related to their employment, professional, or legal duties;
• The recipient of TSCA CBI is prohibited from disclosing or permitting further disclosure of the information to individuals not authorized to receive it (physicians/nurses may disclose the information to their patient); and
• EPA generally must notify the entity that made the CBI claim at least 15 days prior to disclosing the CBI. There is an exception for disclosures in emergency situations, which require that EPA make the notification as soon as practicable (see TSCA section 14(g)(2)(C)(ii)).
In addition, under these new provisions, requesters are generally required to sign an agreement and may be required to submit a statement of need to EPA. Emergency requestors only need to sign an agreement and submit a statement of need if the entity who made the claim so requests, following the notification required under TSCA section 14(g)(2)(C)(ii).
The Agency developed three separate draft guidance documents corresponding to each of the new authorities in TSCA section 14(d)(4), (5), and (6). The conditions for access vary under each of the new provisions, but generally include the following: Requesters must show that they have a need for the information related to their employment, professional, or legal duties; recipients of TSCA CBI are prohibited from disclosing or permitting further disclosure of the information to individuals not authorized to receive it (physicians/nurses may disclose the information to their patient); and except in emergency situations EPA must notify the entity that made the CBI claim at least 15 days prior to disclosing the CBI. In addition, under these new provisions, requesters (except in some emergency situations) are required to sign an agreement and may be required to submit a statement of need to EPA. In accordance with the requirements of TSCA section 14(c)(4)(B), each guidance document covers the content and form of the agreements and statements required under each provision and include information on where and how to submit requests to EPA.
Additional information about these statutes and Executive Orders can be found at
OMB has determined that these draft guidance documents qualified as significant under Executive Order 12866 (58 FR 51735, October 4, 1993). As such, the draft documents were submitted to OMB for review under Executive Orders 12866 and 13563 (76 FR 3821, January 21, 2011). Any changes to the documents that were made in response to OMB recommendations have been
In the
This action is not subject to the RFA, 5 U.S.C. 601
This action does not contain an unfunded mandate of $100 million or more as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. As such, the requirements of UMRA sections 202, 203, 204, or 205, 2 U.S.C. 1531-1538, do not apply to this action.
This action does not have federalism implications. It will not have substantial direct effects 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, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999).
This action does not have tribal implications because it will not have any effect on tribal governments, on the relationship between the Federal government and the Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes, as specified in Executive Order 13175 (65 FR 67249, November 9, 2000).
EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997), as applying only to those regulatory actions that concern environmental health or safety risks that EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of Executive Order 13045. This action is not subject to Executive Order 13045 because it does not establish an environmental standard intended to mitigate environmental health risks or safety risks.
This action is not a “significant energy action” as defined in Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not likely to have a significant adverse effect on energy supply, distribution, or use. This action is proposing service fees for TSCA, which will not have a significant effect on the supply, distribution or use of energy.
Since this action does not involve any technical standards, NTTAA section 12(d) (15 U.S.C. 272 note) does not apply to this action.
EPA believes that this action does not have disproportionately high and adverse human health or environmental effects on minority populations, low-income populations and/or indigenous peoples, as specified in Executive Order 12898 (59 FR 7629, February 16, 1994). This action does not affect the level of protection provided to human health or the environment.
15 U.S.C. 2613(c).
Environmental Protection Agency (EPA).
Notice of proposed settlement; request for public comment.
This notice announces the availability for review and comment of an administrative Settlement Agreement and Order on Consent (“Settlement”) under the Comprehensive Environmental Response, Compensation, and Liability Act of 1980, as amended (“CERCLA”), between the U.S. Environmental Protection Agency (“EPA”), and Atlantic Richfield Company regarding the Anaconda Copper Mine Site (“Site”) in Yerington, Nevada. The Settlement requires Atlantic Richfield Company to reimburse EPA $3,000,000 for Past Response Costs at the Site.
Comments must be received on or before April 16, 2018.
The Settlement Agreement is available for public inspection at the United States Environmental Protection Agency, Superfund Records Center, 75 Hawthorne Street, Room 3110, San Francisco, California 94105. Telephone: 415-947-8717. A copy of the Settlement is also available at the following link:
Dustin Minor, Assistant Regional Counsel, Office of Regional Counsel (ORC-3), Environmental Protection Agency, Region 9, 75 Hawthorne Street, San Francisco, CA 94105; tel: (415) 972-3888;
EPA deferred the non-tribal portion of the Site to the Nevada Division of Environmental Protection (NDEP) on February 5, 2018. In addition to requiring Atlantic Richfield Company to reimburse EPA $3,000,000, the Settlement terminates the existing administrative orders referred to in the Settlement. EPA terminated the existing administrative orders because future
Environmental Protection Agency (EPA).
Notice of adequacy determination.
In this notice, the Environmental Protection Agency (EPA) is notifying the public that the EPA has found the Metro-Denver/North Front Range (Metro-Denver/NFR) Moderate 2008 8-hour ozone National Ambient Air Quality Standard (NAAQS) attainment plan and its motor vehicle emissions budgets (MVEBs) adequate for transportation conformity purposes. As more fully explained in the Supplementary Information section of this notice, this finding will affect future transportation conformity determinations.
This finding is effective on April 2, 2018.
Tim Russ, Air Program, U.S. Environmental Protection Agency, Region 8, Mailcode 8P-AR, 1595 Wynkoop Street, Denver, Colorado 80202-1129, (303) 312-6479, or
Transportation conformity is required by section 176(c) of the Clean Air Act to ensure that federally funded highway and transit projects are consistent with the air quality goals established by the state implementation plan (SIP). The EPA's conformity rule provisions at 40 CFR part 93, subpart A, establish the criteria and procedures for determining whether transportation plans, programs and projects conform to the SIP. Conformity to a SIP means that transportation activities will not produce new air quality violations, worsen existing violations, or delay timely attainment of the applicable NAAQS.
The criteria by which the EPA determines whether a SIP revision's MVEBs are adequate for transportation conformity purposes are outlined at 40 CFR 93.118(e)(4), and the adequacy review process is described at 40 CFR 93.118(f)(1). We applied these criteria and followed this process in making the determinations announced in this notice.
This notice is simply an announcement of findings that the EPA has already made, as described below.
The State of Colorado submitted the Metro-Denver/NFR Moderate 2008 8-hour ozone NAAQS attainment plan, and its associated MVEBs, on May 16, 2017. As part of our adequacy review, we posted the Metro-Denver/NFR Moderate 2008 8-hour ozone NAAQS attainment plan, with its identified nitrogen oxides (NO
For the Metro-Denver/NFR Moderate 2008 8-hour ozone NAAQS attainment plan, the MVEBs we found adequate were as identified and described in Chapter 11 of the ozone attainment plan. We find that the Total Nonattainment Area Budgets of 73 tons per day (tpd) of NO
In addition, and as described in Chapter 11 of the Metro-Denver/NFR Moderate 2008 8-hour NAAQS ozone attainment plan, the Denver Regional Council of Governments (DRCOG) Metropolitan Planning Organization (MPO) and the North Front Range MPO (NFRMPO) may switch from using the combined nonattainment-area-wide MVEBs to using the sub-area MVEBs for determining transportation conformity. To switch to use of the sub-area MVEBs (or to subsequently switch back to use of the combined nonattainment-area-wide MVEBs), the DRCOG and the NFRMPO must use the process described in Chapter 11 of the Metro-Denver/NFR ozone Moderate 2008 8-hour NAAQS ozone attainment plan on pages 11-5 through 11-6.
Following the effective date listed in the
Please note that our adequacy review of the MVEBs is separate from our future rulemaking action on the Metro-Denver/NFR Moderate 2008 8-hour NAAQS ozone attainment plan SIP revision and should not be used to prejudge our ultimate approval or disapproval of that SIP revision. Even if we find the Metro-Denver/NFR Moderate 2008 8-hour NAAQS ozone attainment plan and its MVEBs adequate for transportation conformity purposes now, we may later find it necessary to disapprove the SIP revision. Should this situation arise, we would revisit our adequacy finding.
42 U.S.C. 7401
Centers for Medicare & Medicaid Services, HHS.
Notice.
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the
Comments must be received by May 15, 2018.
When commenting, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in any one of the following ways:
1.
2.
To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following:
1. Access CMS' website address at
2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to
3. Call the Reports Clearance Office at (410) 786-1326.
William Parham at (410) 786-4669.
This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection's supporting statement and associated materials (see
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. The term “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
1.
The Medicare Current Beneficiary Survey (MCBS) is the most comprehensive and complete Survey available on the Medicare population and is essential in capturing data not otherwise collected through our operations. The MCBS is an in-person, nationally-representative, longitudinal survey of Medicare beneficiaries that we sponsor and is directed by the Office of Enterprise Data and Analytics (OEDA). The survey captures beneficiary information whether aged or disabled, living in the community or facility, or serviced by managed care or fee-for-service. Data produced as part of the MCBS are enhanced with our administrative data (
The MCBS continues to provide unique insight into the Medicare program and helps CMS and our external stakeholders better understand and evaluate the impact of existing programs and significant new policy initiatives. In the past, MCBS data have been used to assess potential changes to the Medicare program. For example, the MCBS was instrumental in supporting the development and implementation of the Medicare prescription drug benefit by providing a means to evaluate prescription drug costs and out-of-pocket burden for these drugs to Medicare beneficiaries. Beginning in 2019, this proposed revision to the clearance will eliminate or streamline some questionnaire sections, add a few new measures, take advantage of administrative data to reduce the number of survey questions in some long term care facilities, and discontinue the 12th interview as had previously been collected. The revisions will result in an overall reduction in respondent burden by 25%.
Centers for Medicare & Medicaid Services, HHS.
Notice.
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the
Comments on the collection(s) of information must be received by the OMB desk officer by April 16, 2018.
When commenting on the proposed information collections, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be received by the OMB desk officer via one of the following transmissions: OMB, Office of Information and Regulatory Affairs, Attention: CMS Desk Officer, Fax Number: (202) 395-5806
To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following:
1. Access CMS' website address at website address at
2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to
3. Call the Reports Clearance Office at (410) 786-1326.
William Parham at (410) 786-4669.
Under the Paperwork Reduction Act of 1995 (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. The term “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 publish a 30-day notice in the
1.
2.
This request is to revise the automated CSBG State Plan format for states and territories by revising questions for clarity and system compatibility. It is not anticipated that these revisions will cause any additional burden to states as they have been completing the automated plan for three years. It is anticipated that the burden will continue to diminish in subsequent years due to improved pre-population and automation.
In addition to the CSBG State Plan, states will be requested to complete a CSBG Eligible Entity Master List in year one, and then make updates as necessary in subsequent years. As the states have the information about their eligible entities (or sub-grantees), the burden will be minimal to the states to complete this the first year.
Lastly, the request includes a survey for the CSBG eligible entities (or sub-grantees). The survey focuses on the customer service that the eligible entities receive from the CSBG states. The survey is optional, and this will be the third time that the eligible entities that chose to submit will complete it.
Food and Drug Administration, HHS.
Notice of availability; request for comments.
The Food and Drug Administration (FDA) is announcing the availability of a draft concept paper entitled “Illicit Trade in Tobacco Products after Implementation of an FDA Product Standard.” FDA seeks public comment on the draft concept paper regarding the potential for illicit trade markets to develop in response to a tobacco product standard. This draft concept paper is offered to stimulate dialogue around the subject of possible illicit trade in connection with tobacco product standards.
Although you can comment at any time, to ensure that the Agency considers your comment on this draft concept paper, submit either electronic or written comments by June 14, 2018.
You may submit comments as follows:
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 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
Submit written requests for single copies of this draft concept paper to the Center for Tobacco Products, Food and Drug Administration, Document Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request or include a fax number to which the draft concept paper may be sent. See the
Christopher Griffiths, Center for Tobacco Products, Food and Drug Administration, Document Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 1-877-287-1373, email:
FDA is announcing the availability of a draft concept paper entitled “Illicit Trade in Tobacco Products after Implementation of an FDA Product Standard.” On June 22, 2009, the Family Smoking Prevention and Tobacco Control Act (Pub. L. 111-31) (Tobacco Control Act) was enacted. The Tobacco Control Act grants FDA authority to implement a wide variety of product standards impacting different characteristics of existing and future tobacco products. This draft concept paper describes aspects of the tobacco product market and consumer behavior that may be relevant to the development of illicit trade markets if FDA implements a tobacco product standard. FDA faces a complex task when assessing the potential for an illicit trade market to develop in response to a tobacco product standard. While it remains difficult to measure existing illicit trade markets and use existing data to reliably predict future illicit markets, it may be possible to isolate some of the key factors that may encourage or discourage illicit trade in tobacco products. This draft concept paper assists that effort by breaking down the potential mechanics of an illicit trade market into various components, and examining the factors that could support or hinder the establishment of a persistent illicit trade market in the face of an FDA tobacco product standard. This paper first discusses the legal authority and general approach to establishing tobacco product standards, and then discusses the different components of illicit trade markets, followed by relevant research in consumer behavior and potentially applicable economic research.
FDA is providing notice and an opportunity to comment on this draft concept paper. Please provide evidence or other information supporting your comments.
Persons with access to the internet may obtain an electronic version of the draft concept paper at either
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Pediatric Advisory Committee (PAC) and the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC). This meeting was announced in the
The meeting will be held on March 22, 2018, from 8 a.m. to 6 p.m.
Marieann Brill, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5154, Silver Spring, MD 20993, 240-402-3838,
In the
FDA is revising the first paragraph of the agenda for that meeting to read as follows:
On Thursday, March 22, 2018, the PAC and EMDAC will meet to discuss drug development for the treatment of children with achondroplasia (ACH). The following topics should be considered for discussion: Evidence required to establish dose-response, study design, study duration, intended population, and endpoints. In the open session, the committee does not intend to discuss any individual research programs.
FDA is also changing the meeting procedure and closed committee deliberations as follows:
This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.
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 May 15, 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 May 15, 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 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
Amber Sanford, Office of Operations, Food and Drug Administration, Three
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.
Members of the public use FDA's MedWatch system to report adverse events, product problems, errors with the use of a human medical product, or when evidence of therapeutic failure is suspected or identified in clinical use. To ensure the marketing of safe and effective products, it is critical that postmarketing adverse outcomes and product problems are reported for all FDA-regulated human healthcare products, including drugs (prescription and nonprescription), biologics, medical devices, dietary supplements, and other special nutritional products (
The Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 353b, 355, 360i, 360
Requirements regarding mandatory reporting of adverse events or product problems have been codified in parts 310, 314, 600, and 803 (21 CFR 310, 314, 600, and 803), specifically §§ 310.305, 314.80, 314.98, 600.80, 803.30, 803.50, 803.53, 803.56, and specified in sections 503B, 760, and 761 of the FD&C Act (21 U.S.C. 353b, 379aa, and 379aa-1). Mandatory reporting of adverse reactions for human cells, tissues, and cellular- and tissue-based products (HCT/Ps) has been codified in 21 CFR 1271.350.
This voluntary version of the form may be used by healthcare professionals to submit all reports not mandated by Federal law or regulation. Individual health professionals are not required by law or regulation to submit reports to the Agency or the manufacturer with the exception of Childhood Vaccine Injury Act of 1986 (42 U.S.C. 300aa-1). Reports for vaccines are not submitted via MedWatch or MedWatch forms, but are submitted to the Vaccines Adverse Event Reporting System (see
Hospitals are not required by Federal law or regulation to submit reports associated with drug products, biological products, or special nutritional products. However, hospitals and other user facilities are required by Federal law to report medical device-related deaths and serious injuries.
Under Federal law and regulation, section 761(b)(1) of the FD&C Act, a dietary supplement manufacturer, packer, or distributor whose name appears on the label of a dietary supplement marketed in the United States is required to submit to FDA any serious adverse event report it receives regarding use of the dietary supplement in the United States. However, FDA bears the burden to gather and review evidence that a dietary supplement may be adulterated under section 402 of the FD&C Act (21 U.S.C. 342) after that product is marketed. Therefore, the Agency depends on the voluntary reporting by health professionals, and especially by consumers, of suspected serious adverse events and product quality problems associated with the use of dietary supplements. All dietary supplement reports were previously received by the Agency on paper versions of Form FDA 3500 (or Form FDA 3500B) (by mail or fax). Currently, electronic reports may be sent to the Agency via an online submission route called the Safety Reporting Portal (
Form FDA 3500 may be used to report to the Agency serious adverse events, product problems, and product use errors and therapeutic failures. The form is provided in both paper and electronic formats. Reporters may mail or fax paper forms to the Agency (a fillable PDF version of the form is available at
This voluntary version of the form may be used by consumers (
FDA supports and encourages direct reporting to the Agency by consumers of suspected serious adverse outcomes and other product problems associated with human medical products, (
On March 25, 2008, section 906 of the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85) amended section 502(n) of the FD&C Act (21 U.S.C. 352) and mandated that published direct-to-consumer advertisements for prescription drugs include the following statement printed in conspicuous text (this includes vaccine products): “You are encouraged to report negative side effects of prescription drugs to the FDA. Visit
Most private vendors of consumer medication information, the drug product-specific instructions dispensed to consumers at outpatient pharmacies, remind patients to report “side effects” to FDA and provide contact information to permit reporting via the MedWatch process.
Since 2013, FDA has made available Form FDA 3500B. It was proposed during the previous authorization in 2012 and is a version of Form FDA 3500 that is tailored for consumers and written in plain language (in conformance with the Plain Writing Act of 2010 (Pub. L. 111-274),
Form FDA 3500B evolved from several iterations of draft versions, with input from human factors experts, from other regulatory agencies, and with extensive input from consumer advocacy groups and the general public. Form FDA 3500B may be used to report to the Agency adverse events, product problems, and product use errors. The form is provided in both paper and electronic formats. Reporters may mail or fax paper forms to the Agency (a fillable PDF version of the form is available at
In sections 505(b) and (j), 503B, and 704 (21 U.S.C. 355(b) and (j), 353B, and 374) of the FD&C Act, Congress has required that important safety information relating to all human drug products be made available to the FDA so that it can take appropriate action to protect the public health when necessary. Section 702 of the FD&C Act (21 U.S.C. 372) authorizes investigational powers to the FDA for enforcement of the FD&C Act. These statutory requirements regarding mandatory reporting have been codified by FDA under parts 310 and 314 (drugs) and 600 (biological products). Mandatory reporting of adverse reactions for HCT/Ps has been codified in § 1271.350.
Section 760 of the FD&C Act provides for mandatory safety reporting for non-prescription human drug products marketed without an approved application as described in the Dietary Supplement and Nonprescription Drug Consumer Protection Act (Pub. L. 109-462, December 22, 2006), which became law on December 22, 2006. The law requires manufacturers, packers, and distributors of nonprescription, over-the-counter (OTC) human drug products marketed without an approved application (OTC monograph drug products) to submit reports of adverse experiences from domestic sources. The law also requires reports of serious adverse events to be submitted to FDA by manufacturers of dietary supplements.
Section 519 of the FD&C Act (21 U.S.C. 360i) requires manufacturers and importers of devices intended for human use to establish and maintain records, make reports, and provide information, as the Secretary of Health and Human Services may, by regulation, reasonably be required to provide assurance that such devices are not adulterated or misbranded and to otherwise assure its safety and effectiveness. The Safe Medical Devices Act of 1990 (Pub. L. 101-629), signed into law on November 28, 1990, amends section 519 of the FD&C Act. The
The proposed extension to Forms FDA 3500, 3500A, and 3500B will only have changes in the form instructions to provide clarity of reporting. The proposed changes are regulatory driven, improving the Centers' work, and improving report processing. The Agency welcomes comments about translation of Form FDA 3500B (consumer) into Spanish and other languages.
Formatting modifications are being proposed to several fields to enhance the quality, utility, and clarity of the information.
FDA estimates the burden of this collection of information as follows:
The burden estimates have not changed from the current approval.
Food and Drug Administration, HHS.
Notice, establishment of a public docket; request for comments.
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Arthritis Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
The meeting will be held on April 23, 2018, from 8 a.m. to 5 p.m.
FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-0002. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at:
FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2018-N-0976. The docket will close on April 20, 2018. Submit either electronic or written comments on this public meeting by April 20, 2018. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before April 20, 2018. The
Comments received on or before April 9, 2018, will be provided to the committee. Comments received after that date will be taken into consideration by FDA.
You may submit comments as follows:
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 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.” FDA 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
Yinghua S. Wang, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, Fax: 301-847-8533, email:
FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's website after the meeting. Background material is available at
Persons attending FDA's advisory committee meetings are advised that FDA is not responsible for providing access to electrical outlets.
For press inquiries, please contact the Office of Media Affairs at
FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to
FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website at
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).
Food and Drug Administration, HHS.
Notice of public workshop.
The Food and Drug Administration (FDA), in collaboration with the Association of Food and Drug Officials (AFDO), is announcing the following public workshop entitled “Pathways to Global Unity.” This 2
The public workshop will be held on June 11-12, 2018, from 8 a.m. to 5:30 p.m., and on June 13, 2018, from 8 a.m. to 12 p.m.
The public workshop will be held at the Doubletree by Hilton Hotel Burlington Vermont, 870 Williston Rd., Burlington, VT 05403, 802-865-6626. For directions to the hotel and information on lodging, visit
Krystal Reed, Association of Food and Drug Officials, 155 West Market St., 3rd Floor, York, PA 17401, 717-757-2888, Fax: 717-650-3650, email:
FDA has made education of the drug and device manufacturing community a high priority to help ensure the quality of FDA-regulated drugs and devices. The workshop helps to achieve objectives set forth in section 406 of the Food and Drug Administration Modernization Act of 1997 (21 U.S.C. 393), which includes working closely with stakeholders and maximizing the availability and clarity of information to stakeholders and the public. The workshop also is consistent with the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), as outreach activities by government agencies to small businesses.
The public workshop helps fulfill the Department of Health and Human Services and FDA's mission to protect the public health. The workshop will provide FDA-regulated drug and device entities with information on a number of topics concerning FDA requirements related to the production and marketing of drugs and/or devices. The public workshop's agenda is available at
To register online, please visit
If you need special accommodations due to a disability, please contact Krystal Reed (see
Assistant Secretary for Planning and Evaluation, HHS.
Notice of meeting.
This notice announces the public meeting of the Advisory Council on Alzheimer's Research, Care, and Services (Advisory Council). The Advisory Council on Alzheimer's Research, Care, and Services provides advice on how to prevent or reduce the burden of Alzheimer's disease and related dementias on people with the disease and their caregivers. During the April meeting, the Clinical Care Subcommittee will be taking charge of the theme, focusing on advancing consensus on dementia care elements to
The meeting will be held on April 27, 2018 from 9:00 a.m. to 5:00 p.m. EDT.
The meeting will be held in Room 800 in the Hubert H. Humphrey Building, 200 Independence Avenue SW, Washington, DC 20201.
Rohini Khillan (202) 690-5932,
Notice of these meetings is given under the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)(1) and (a)(2)). Topics of the Meeting: During the April meeting, the Clinical Care Subcommittee will be taking charge of the theme, focusing on advancing consensus on dementia care elements to guide new outcomes measurement. The Council will hear speakers in two sessions, one focuses on developing consensus about dementia care elements, and the second on models that are informing outcomes measurement. The meeting will also include updates on work from the previous meetings, a presentation on the final report from the October 2017 Care Summit, and federal workgroup updates.
National Institutes of Health, HHS.
Notice.
The National Institute on Aging, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the U.S. and International Patents and Patent Applications listed in the
Only written comments and/or complete applications for a license which are received by the National Cancer Institute's Technology Transfer Center on or before April 2, 2018 will be considered.
Requests for copies of the patent application, inquiries, and comments relating to the contemplated an Exclusive Patent License should be directed to: Richard T. Girards, Jr., Esq., MBA, Senior Technology Transfer Manager, NCI Technology Transfer Center, 9609 Medical Center Drive, RM 1E508 MSC 9702, Bethesda, MD 20892-9702 (for business mail), Rockville, MD 20850-9702 (for overnight courier services); Telephone: (240)-276-6825; Facsimile: (240)-276-5504; Email:
United States Provisional Patent Application No. 60/694,733 [HHS Ref No. E-092-2004/0-US-01], filed on June 27, 2005 and entitled “Anti-marinobufagenin antibodies and methods for their use;” Patent Cooperation Treaty Patent Application No. PCT/US2006/024918 [HHS Ref No. E-092-2004/0-PCT-02], filed on June 26, 2006 and entitled “Anti-marinobufagenin antibodies and methods for their use;” and U.S. and foreign patents and/or patent applications claiming priority to the aforementioned applications, including but not limited to United States Patent No. 8,038,997 [HHS Ref No. E-092-2004/0-US-03] entitled “Anti-marinobufagenin antibodies and methods for their use.”
Certain rights in the patent and these applications have been assigned to the government of the United States of America.
The prospective exclusive license territory may be worldwide and the field of use may be limited to the use of the Licensed Patent Rights for the following: (1) The use of anti-marinobufagenin antibodies for one or both of (a) the treatment of fibrotic disease and (b) the treatment of cardiovascular disease, including but not limited to preeclampsia and (2) companion diagnostics associated with the aforementioned treatments.
The patents and applications potentially to be licensed disclose antibodies (mAbs) that specifically bind marinobufagenin. They also disclose use of these mAbs in the diagnosis and treatment of cardiovascular disease such as hypertension. Further, they disclose use of these mAbs in the diagnosis and treatment of fibrotic diseases. The patents and applications potentially to be licensed also disclose technologies useful with respect to companion diagnostics for both fibrotic and cardiovascular diseases. The public substantially will benefit from the clinical and commercial development of these mAbs for the treatment and of cardiovascular as well as fibrotic disorders. The public also will benefit from the clinical and commercial development of companion diagnostics relative to these conditions.
This notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404.
In response to this Notice, the public may file comments or objections. Comments and objections, other than those in the form of a completed license application, will not be treated confidentially, and may be made publicly available.
License applications submitted in response to this Notice must be complete and in acceptable form by the expiration date of this Notice to be considered for a license. License applications submitted in response to this Notice will be presumed to contain business confidential information and any release of information in these license applications will be made only as required and upon a request under the Freedom of Information Act, 5 U.S.C. 552.
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.
National Institutes of Health, HHS.
Notice.
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institutes of Health, Office of Policy and Extramural Research Administration (OPERA), Office of Extramural Research (OER), Office of the Director (OD) will publish periodic summaries of propose projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication.
To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Kathy Hancock, Asst. Grants Compliance Officer, Division of Grants Compliance and Oversight, Office of Policy for Extramural Research Administration, 6705 Rockledge Drive, Suite 350, Bethesda, Maryland 20892 or call non-toll-free number 301-435-0949 or Email your request to
Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires: Written comments and/or suggestions from the public and affected agencies are invited to address one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the
This request is for Office of Management and Budget (OMB) approval of a Reinstatement without change of a currently approved collection resulting from the development of revised regulations regarding the Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 CFR part 50, subpart F) and Responsible Prospective Contractors (45 CFR part 94). The purpose of these regulations is to promote objectivity in research by requiring institutions to establish standards to ensure that there is no reasonable expectation that the design, conduct, or reporting of PHS-funded research will be biased by any Investigator financial conflict of interest (FCOI).
OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 677,295.
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.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
National Institutes of Health, HHS.
Notice.
The
Only written comments and/or complete applications for a license which are received by the NCI Technology Transfer Center on or before April 2, 2018 will be considered.
Requests for copies of the patent applications, inquiries, and comments relating to the contemplated Exclusive Patent License should be directed to: Surekha Vathyam, Ph.D.,
The following represents the intellectual property to be licensed under the prospective agreement:
• United States Provisional Patent Application No. 60/485,658, filed July 8, 2003, titled “Diffusion Tensor and Q-Space MRI Specimen Characterization” [HHS Reference No. E-079-2003/0-US-01], status: expired;
• United States Provisional Patent Application No. 60/571,064, filed May 14, 2004, titled “Diffusion Tensor and Q-Space MRI Specimen Characterization” [HHS Reference No. E-079-2003/0-US-04], status: expired;
• United States Patent Application No. 10/888,917, filed July 8, 2004, titled “Diffusion Tensor and Q-Space MRI Specimen Characterization” [HHS Reference No. E-079-2003/0-US-02], status: issued as Patent No. 7,643,863;
• International Patent Application No. PCT/US2004/22027, July 8, 2004, titled “Diffusion Tensor and Q-Space MRI Specimen Characterization” [HHS Reference No. E-079-2003/0-PCT-03], status: expired; and
• United States Patent Application No. 12/114,713, filed May 2, 2008, titled “Non-Invasive in vivo MRI Axon Diameter Measurement Methods” [HHS Reference No. E-079-2003/1-US-01], status: issued as Patent No. 8,380,280.
With respect to persons who have an obligation to assign their right, title and interest to the Government of the United States of America, the patent rights in these inventions have been assigned to the Government of the United States of America.
The prospective Exclusive Patent License territory may be worldwide for the following field of use:
“Magnetic Resonance Imaging system and method for the measurement of geometric features of axons (including without limitation diameter, radius, perimeter, volume, surface and angle) for the characterization and diagnosis of Central Nervous System diseases and disorders.”
A non-invasive, painless means for measuring axon diameter distribution (ADD) is disclosed in the intellectual property to be licensed, which has significance for imaging of the central nervous system, and for
This notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404. The prospective Exclusive Patent License will be royalty bearing and may be granted unless within fifteen (15) days from the date of this published notice, the National Cancer Institute receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404.
In response to this Notice, the public may file comments or objections. Comments and objections, other than those in the form of a completed license application, will not be treated confidentially, and may be made publicly available.
License applications submitted in response to this Notice must be complete and in acceptable form by the expiration date of this Notice to be considered for a license. License applications submitted in response to this Notice will be presumed to contain business confidential information and any release of information in these license applications will be made only as required and upon a request under the Freedom of Information Act, 5 U.S.C. 552.
Federal Emergency Management Agency, DHS.
Notice.
This notice lists communities where the addition or modification of Base Flood Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA) boundaries or zone designations, or the regulatory floodway (hereinafter referred to as flood hazard determinations), as shown on the Flood Insurance Rate Maps (FIRMs), and where applicable, in the supporting Flood Insurance Study (FIS) reports, prepared by the Federal Emergency Management Agency (FEMA) for each community, is appropriate because of new scientific or technical data. The FIRM, and where applicable, portions of the FIS report, have been revised to reflect these flood hazard determinations through issuance of a Letter of Map Revision (LOMR). The LOMR will be used by insurance agents and others to calculate appropriate flood insurance premium rates for new buildings and the contents of those buildings. For rating purposes, the currently effective community number is shown in the table below and must be used for all new policies and renewals.
These flood hazard determinations will be finalized on the dates listed in the table below and revise the FIRM panels and FIS report in effect prior to this determination for the listed communities.
From the date of the second publication of notification of these changes in a newspaper of local circulation, any person has 90 days in which to request through the community that the Deputy Associate Administrator for Insurance and Mitigation reconsider the changes. The flood hazard determination information may be changed during the 90-day period.
The affected communities are listed in the table below. Revised flood hazard information for each community is available for inspection at both the online location and the respective community map repository address listed in the table below. Additionally, the current effective FIRM and FIS report for each community are accessible online through the FEMA Map Service Center at
Submit comments and/or appeals to the Chief Executive Officer of the community as listed in the table below.
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC 20472, (202) 646-7659, or (email)
The specific flood hazard determinations are not described for each community in this notice. However, the online location and local community map repository address where the flood hazard determination information is available for inspection is provided.
Any request for reconsideration of flood hazard determinations must be submitted to the Chief Executive Officer of the community as listed in the table below.
The modifications are made pursuant to section 201 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance with the National Flood Insurance Act of 1968, 42 U.S.C. 4001
The FIRM and FIS report are the basis of the floodplain management measures that the community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP).
These flood hazard determinations, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own or pursuant to policies established by other Federal, State, or regional entities. The flood hazard determinations are in accordance with 44 CFR 65.4.
The affected communities are listed in the following table. Flood hazard determination information for each community is available for inspection at both the online location and the respective community map repository address listed in the table below. Additionally, the current effective FIRM and FIS report for each community are accessible online through the FEMA Map Service Center at
Federal Emergency Management Agency, DHS.
Notice.
Comments are requested on proposed flood hazard determinations, which may include additions or modifications of any Base Flood Elevation (BFE), base flood depth, Special Flood Hazard Area (SFHA) boundary or zone designation, or regulatory floodway on the Flood Insurance Rate Maps (FIRMs), and where applicable, in the supporting Flood Insurance Study (FIS) reports for the communities listed in the table below. The purpose of this notice is to seek general information and comment regarding the preliminary FIRM, and where applicable, the FIS report that the Federal Emergency Management Agency (FEMA) has provided to the affected communities. The FIRM and FIS report are the basis of the floodplain management measures that the community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP). In addition, the FIRM and FIS report, once effective, will be used by insurance agents and others to calculate appropriate flood insurance premium rates for new buildings and the contents of those buildings.
Comments are to be submitted on or before June 14, 2018.
The Preliminary FIRM, and where applicable, the FIS report for each community are available for inspection at both the online location
You may submit comments, identified by Docket No. FEMA-B-1808, to Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC 20472, (202) 646-7659, or (email)
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC 20472, (202) 646-7659, or (email)
FEMA proposes to make flood hazard determinations for each community listed below, in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR 67.4(a).
These proposed flood hazard determinations, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own or pursuant to policies established by other Federal, State, or regional entities. These flood hazard determinations are used to meet the floodplain management requirements of the NFIP and also are used to calculate the appropriate flood insurance premium rates for new buildings built after the FIRM and FIS report become effective.
The communities affected by the flood hazard determinations are
Use of a Scientific Resolution Panel (SRP) is available to communities in support of the appeal resolution process. SRPs are independent panels of experts in hydrology, hydraulics, and other pertinent sciences established to review conflicting scientific and technical data and provide recommendations for resolution. Use of the SRP only may be exercised after FEMA and local communities have been engaged in a collaborative consultation process for at least 60 days without a mutually acceptable resolution of an appeal. Additional information regarding the SRP process can be found online at
The watersheds and/or communities affected are listed in the tables below. The Preliminary FIRM, and where applicable, FIS report for each community are available for inspection at both the online location
Federal Emergency Management Agency, DHS.
Notice.
New or modified Base (1-percent annual chance) Flood Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA) boundaries or zone designations, and/or regulatory floodways (hereinafter referred to as flood hazard determinations) as shown on the indicated Letter of Map Revision (LOMR) for each of the communities listed in the table below are finalized. Each LOMR revises the Flood Insurance Rate Maps (FIRMs), and in some cases the Flood Insurance Study (FIS) reports, currently in effect for the listed communities. The flood hazard determinations modified by each LOMR will be used to calculate flood insurance premium rates for new buildings and their contents.
Each LOMR was finalized as in the table below.
Each LOMR is available for inspection at both the respective Community Map Repository address listed in the table below and online through the FEMA Map Service Center at
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC 20472, (202) 646-7659, or (email)
The Federal Emergency Management Agency (FEMA) makes the final flood hazard determinations as shown in the LOMRs for each community listed in the table below. Notice of these modified flood hazard determinations has been published in newspapers of local circulation and 90 days have elapsed since that publication. The Deputy Associate Administrator for Insurance and Mitigation has resolved any appeals resulting from this notification.
The modified flood hazard determinations are made pursuant to section 206 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance with the National Flood Insurance Act of 1968, 42 U.S.C. 4001
For rating purposes, the currently effective community number is shown and must be used for all new policies and renewals.
The new or modified flood hazard information is the basis for the floodplain management measures that the community is required either to adopt or to show evidence of being already in effect in order to remain qualified for participation in the National Flood Insurance Program (NFIP).
This new or modified flood hazard information, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own or pursuant to policies established by other Federal, State, or regional entities.
This new or modified flood hazard determinations are used to meet the floodplain management requirements of the NFIP and also are used to calculate the appropriate flood insurance premium rates for new buildings, and for the contents in those buildings. The changes in flood hazard determinations are in accordance with 44 CFR 65.4.
Interested lessees and owners of real property are encouraged to review the final flood hazard information available at the address cited below for each community or online through the FEMA Map Service Center at
Federal Emergency Management Agency, DHS.
Notice.
The Federal Emergency Management Agency announces the Fiscal Year 2019 Financial Assistance/Subsidy Arrangement for private property insurers interested in participating in the National Flood Insurance Program's Write Your Own Program.
Interested insurers must submit intent to subscribe or re-subscribe to the Arrangement by June 14, 2018.
Kelly Bronowicz, Federal Insurance and Mitigation Administration, FEMA, 400 C St. SW, Washington, DC 20472; (202) 557-9488 (phone), or
The National Flood Insurance Act of 1968 (NFIA), as amended (42 U.S.C. 4001
Pursuant to this authority, FEMA enters into a standard Financial Assistance/Subsidy Arrangement (Arrangement) with private sector property insurers, also known as Write Your Own (WYO) companies, to sell NFIP flood insurance policies under their own names and adjust and pay claims arising under the Standard Flood Insurance Policy (SFIP). Each Arrangement entered into by a WYO company must be in the form and substance of the standard Arrangement, a copy of which is published in the
Insurers interested in participating in the WYO Program for Fiscal Year 2019 must contact Clark Poland at
Prior participation in the WYO Program does not guarantee that FEMA will approve continued participation. FEMA will evaluate requests to participate in light of publicly available information, industry performance data, and other criteria listed in 44 CFR 62.24 and the FY 2019 Arrangement, copied below. Private insurance companies are encouraged to supplement this information with customer satisfaction surveys, industry awards or recognition, or other objective performance data. In addition, private insurance companies should work with their vendors and subcontractors involved in servicing and delivering their insurance lines to ensure FEMA receives the information necessary to effectively evaluate the criteria set forth in its regulations.
FEMA will send a copy of the offer for the FY 2019 Arrangement, together with related materials and submission instructions, to all private insurance companies successfully evaluated by the NFIP. If FEMA, after conducting its evaluation, chooses not to renew a Company's participation, FEMA, at its option, may require the continued performance of all or selected elements of the FY 2018 Arrangement for a period required for orderly transfer or cessation of the business and settlement of accounts, not to exceed 18 months.
Any private insurance company with questions may contact FEMA at: Kelly Bronowicz, Federal Insurance and Mitigation Administration, FEMA, 400 C St. SW, Washington, DC 20472 (mail); (202) 557-9488 (phone), or
Pursuant to 44 CFR 62.23(a), FEMA must publish the Arrangement at least 6 months prior to the Arrangement becoming effective. The FY 2019 Arrangement copied below is substantially similar to the previous year's Arrangement. FEMA has made several changes designed to improve the overall clarity and readability of the document, as well as incorporate existing WYO Program policies and requirements. Noteworthy changes include:
• Establishing timeliness requirements for the claim appeals process;
• Requiring WYO companies to submit an Operations Plan to FEMA.
• Removing the provision increasing the WYO Allowance by 1 percent of written premium over the rate indicated by expense data from non-flood insurance lines.
• Removing the cap on the maximum potential growth bonus paid to an individual WYO company, while limiting the total growth bonuses paid to all WYO companies at 2 percent of aggregate written premium.
• Formalizing FEMA's process to temporarily increase the allocated loss adjustment fee schedule when necessary to ensure supply of qualified adjusters during a catastrophic flood event.
• Removing restrictions on WYO companies choosing to offer private flood insurance, while maintaining requirements that such private flood insurance lines remain entirely separate from a WYO company's NFIP insurance business.
• Several stylistic changes designed to improve overall clarity and readability in accordance with Federal Plain Language Guidelines.
The Fiscal Year 2019 Arrangement reads as follows:
Whereas, the Congress in its “Finding and Declaration of Purpose” in the National Flood Insurance Act of 1968, Public Law 90-448, Title XIII, as amended, (“the Act” or “Act”) recognized the benefit of having the National Flood Insurance Program (the “Program” or “NFIP”) “carried out to the maximum extent practicable by the private insurance industry”; and
Whereas, the Federal Emergency Management Agency (“FEMA”), which operates the Program through its Federal Insurance and Mitigation Administration (“FIMA”), recognizes this Arrangement as coming under the provisions of Sections 1340 and 1345 of the Act (42 U.S.C. 4071 and 4081, respectively); and
Whereas, the goal of FEMA is to develop a program with the insurance industry where the risk-bearing role for the industry will evolve as intended by the Congress (Section 1304 of the Act [42 U.S.C. 4011]); and
Whereas, Section 205 of the Bunning-Bereuter-Blumenauer Flood Insurance Reform Act of 2004, Public Law 108-264, as implemented by 44 CFR 62.20, permits Program policyholders to appeal the denial of a claim, in completely or in part, to FEMA; and
Whereas, the NFIP is a program administered by FEMA, all participants of this Arrangement, and other entities operating on their behalf, shall align themselves toward the common purpose of helping survivors and their communities recover from floods by effectively delivering customer-focused flood insurance products and information; and
Whereas, the insurer (hereinafter the “Company”) under this Arrangement must charge rates established by FEMA; and
Whereas, FEMA has promulgated regulations and guidance implementing the Act and the Write Your Own (WYO) Program whereby participating private insurance companies act in a fiduciary capacity utilizing Federal funds to sell and administer the Standard Flood Insurance Policies, and has extensively regulated the participating companies' activities when selling or administering the Standard Flood Insurance Policies; and
Whereas, any litigation resulting from, related to, or arising from the Company's compliance with the written standards, procedures, and guidance issued by FEMA arises under the Act or regulations, and legal issues thereunder raise a federal question; and
Whereas, through this Arrangement, the Federal Treasury will back all flood policy claim payments by the Company; and
Whereas, FEMA developed this Arrangement to enable any interested qualified insurer to write flood insurance under its own name; and
Whereas, insured survivors recover faster and more fully than uninsusred survivors, and FEMA is committed to developing a culture of preparedness and closing the insurance gap across the nation; and
Whereas, one of the primary objectives of the Program is to provide coverage to the maximum number of buildings at risk and because the insurance industry has marketing access through its existing facilities not directly available to FEMA, FEMA concludes that coverage will be extended to those who would not otherwise be insured under the Program; andWhereas, flood insurance policies issued subject to this Arrangement must be only that insurance written by the Company in its own name under prescribed policy conditions and pursuant to this Arrangement, the Act, and any guidance issued by FEMA; and
Whereas, over time, the Program is designed to increase industry participation, and, accordingly, reduce or eliminate Government as the
Whereas, the sole parties under this Arrangement are the Company and FEMA.
Now, therefore, the parties hereto mutually undertake the following:
A. Eligibility Requirements for Participation in the NFIP.
1. Policy Administration. All fund receipt, recording, control, timely deposit requirements, and disbursement in connection with all Policy Administration and any other related activities or correspondences, must meet all requirements of the Financial Control Plan and any guidance issued by FEMA. The Company shall be responsible for:
a. Compliance with the Community Eligibility/Rating Criteria.
b. Making Policyholder Eligibility Determinations.
c. Policy Issuances.
d. Policy Endorsements.
e. Policy Cancellations.
f. Policy Correspondence.
g. Payment of Agents' Commissions.
2. Claims Processing. The Company must process all claims consistent with the Standard Flood Insurance Policy, Financial Control Plan, other guidance adopted by FEMA, and as much as possible, with the Company's standard business practices for its non-NFIP policies.
3. Reports. The Company must submit monthly financial reports and statistical transaction reports in accordance with the requirements of the NFIP Transaction Record Reporting and Processing Plan for the Company and the Financial Control Plan for business written under the WYO Program, as well as with WYO Accounting Procedures. FEMA will validate, edit, and audit in detail these data and compare and balance the results against Company reports.
4. Operations Plan. Within ninety (90) days of the commencement of this Arrangement, the Company must submit an Operations Plan to FEMA describing its efforts to perform under this Arrangement. The plan must include the following:
a. A marketing plan describing the Company's forecasted growth, efforts to achieve that growth, and ability to comply with any marketing guidelines provided by FEMA.
b. A description of the Company's NFIP flood insurance distribution network, including anticipated numbers of agents, efforts to train those agents, and an average rate of commissions paid to producers by state.
c. A catastrophic claims handling plan describing how the Company will respond and maintain service standards in catastrophic flood events.
d. A business continuity plan identifying threats and risks facing the Company's NFIP-related operations and how the Company will maintain operations in the event of a disaster affecting its operational capabilities.
B. Time Standards. Time will be measured from the date of receipt through the date mailed out. All dates referenced are working days, not calendar days. In addition to the standards set forth below, all functions performed by the Company must be in accordance with the highest reasonably attainable quality standards generally utilized in the insurance and data processing field. Continual failure to meet these requirements may result in limitations on the company's authority to write new business or the removal of the Company from the WYO Program. Applicable time standards are:
1. Application Processing—15 days (
2. Renewal processing—7 days.
3. Endorsement processing—15 days.
4. Cancellation processing—15 days.
5. Claims Draft Processing—7 days from completion of file examination.
6. Claims Adjustment—45 days average from the receipt of Notice of Loss (or equivalent) through completion of examination.
C. Policy Issuance.
1. The flood insurance subject to this Arrangement must be only that insurance written by the Company in its own name pursuant to the Act.
2. The Company must issue policies under the regulations prescribed by the Federal Emergency Management Agency, in accordance with the Act, on a form approved by FEMA.
3. All policies must be issued in consideration of such premiums and upon such terms and conditions and in such states or areas or subdivisions thereof as may be designated by FEMA and only where the Company is licensed by State law to engage in the property insurance business.
D. FEMA may require the Company to discontinue issuing policies subject to this Arrangement immediately in the event Congressional authorization or appropriation for the NFIP is withdrawn.
E. The Company must separate federal flood insurance funds from all other Company accounts, at a bank or banks of its choosing for the collection, retention and disbursement of federal funds relating to its obligation under this Arrangement, less the Company's expenses as set forth in Article III, and the operation of the Letter of Credit established pursuant to Article IV. The Company must remit all funds not required to meet current expenditures to the United States Treasury, in accordance with the provisions of the WYO Accounting Procedures Manual.
F. The Company must investigate, adjust, settle, and defend all claims or losses arising from policies issued under this Arrangement. Payment of flood insurance claims by the Company bind FEMA, subject to appeal.
G. Compliance with Agency Standards and Guidelines.
1. The Company must comply with the Act, regulations, written standards, procedures, and guidance issued by FEMA relating to the NFIP and applicable to the Company, including, but not limited to:
a. Financial Control Plan.
b. Transaction Record Reporting and Processing (TRRP) Plan.
c. Flood Insurance Manual.
d. Adjuster Claims Manual.
e. WYO Bulletins.
2. The Company must market flood insurance policies in a manner consistent with marketing guidelines established by FEMA.
3. FEMA may require the Company to collect customer service information to monitor and improve their program delivery.
4. The Company must notify its agents of the requirement to comply with State regulations regarding flood insurance agent education, notify agents of flood insurance training opportunities, and assist FEMA in periodic assessment of agent training needs.
H. Compliance with Appeals Process.
1. FEMA will notify the Company when a policyholder files an appeal. After notification, the Company must provide FEMA the following information:
a. All records created or maintained pursuant to this Arrangement requested by FEMA; and
b. A comprehensive claim file synopsis that includes a summary of the appeal issues, the Company's position on each issue, and any additional relevant information. If, in the process of writing the synopsis, the Company determines that it can address the issue raised by the policyholder on appeal without further direction, it must notify FEMA. The Company will then work directly with the policyholder to achieve resolution and update FEMA upon completion. The Company may
2. The Company must cooperate with FEMA throughout the appeal process until final resolution. This includes adhering to any written appeals guidance issued by FEMA.
3. Resolution of Appeals. FEMA will close an appeal when:
a. FEMA upholds the denial by the Company;
b. FEMA overturns the denial by the Company and all necessary actions that follow are completed;
c. The Company independently resolves the issue raised by the policyholder without further direction;
d. The policyholder voluntarily withdraws the appeal; or
e. The policyholder files litigation.
4. Processing of Additional Payments from Appeal. The Company must follow supplemental claim procedures for appeals that result in additional payment to a policyholder.
5. Time Standards.
a. Provide FEMA with requested files pursuant to Article II.H.1.a—10 business days after request.
b. Provide FEMA with comprehensive claim file synopsis pursuant to Article II.H.1.b—10 business days after request.
c. Responding to inquiries from FEMA regarding an appeal—10 business days after inquiry.
I. Other Flood Insurance. If the Company also offers flood insurance outside of the NFIP in any geographic area in which Program authorizes the purchase of flood insurance, the Company must:
1. Ensure that all public communications (whether written, recorded, electronic, or other) regarding non-NFIP flood insurance lines would not lead a reasonable person to believe that the NFIP, FEMA, or the Federal Government in any way endorses, sponsors, oversees, regulates, or otherwise has any connection with the non-NFIP flood insurance line. The Company may assure compliance with this requirement by prominently including in such communications the following statement: “This insurance product is not affiliated with the National Flood Insurance Program.”
2. Ensure that data related to this Arrangement are not used to further or support the Company's non-NFIP flood insurance lines.
A. The Company is liable for operating, administrative and production expenses, including any State premium taxes, dividends, agents' commissions or any other expense of whatever nature incurred by the Company in the performance of its obligations under this Arrangement but excluding other taxes or fees, such as municipal or county premium taxes, surcharges on flood insurance premium, and guaranty fund assessments.
B. Payment for Selling and Servicing Policies.
1. Operating and Administrative Expenses. The Company may withhold, as operating and administrative expenses, other than agents' or brokers' commissions, an amount from the Company's written premium on the policies covered by this Arrangement in reimbursement of all of the Company's marketing, operating, and administrative expenses, except for allocated and unallocated loss adjustment expenses described in Article III.C. This amount will equal the sum of the average industry expenses ratios for “Other Acq.”, “Gen. Exp.” and “Taxes” calculated by aggregating premiums and expense amounts for each of five property coverages using direct premium and expense information to derive weighted average expense ratios. For this purpose, FEMA will use data for the property/casualty industry published, as of March 15 of the prior Arrangement year, in Part III of the Insurance Expense Exhibit in A.M. Best Company's Aggregates and Averages for the following five property coverages: Fire, Allied Lines, Farmowners Multiple Peril, Homeowners Multiple Peril, and Commercial Multiple Peril (non-liability portion).
2. Agent Compensation. The Company may retain fifteen (15) percent of the Company's written premium on the policies covered by this Arrangement as the commission allowance to meet the commissions or salaries of insurance agents, brokers, or other entities producing qualified flood insurance applications and other related expenses.
3. Growth Bonus. FEMA may increase the amount of expense allowance retained by the Company depending on the extent to which the Company meets the marketing goals for the Arrangement year contained in marketing guidelines established pursuant to Article II.G. The total growth bonuses paid to companies pursuant to this Arrangement may not exceed two (2) percent of the aggregate net written premium collected by all WYO companies. FEMA will pay the Company the amount of any increase after the end of the Arrangement year.
4. Reimbursement for Services of a National Rating Organization. The Company, with the consent of FEMA as to terms and costs, may use the services of a national rating organization, licensed under state law, to help us undertake and carry out such studies and investigations on a community or individual risk basis, and to determine equitable and accurate estimates of flood insurance risk premium rates as authorized under the Act, as amended. FEMA will reimburse the Company for the charges or fees for such services under the provisions of the WYO Accounting Procedures Manual.
C. FEMA will reimburse Loss Adjustment Expenses as follows:
1. FEMA will reimburse unallocated loss adjustment expenses to the Company pursuant to a “ULAE Schedule” coordinated with the Company and provided by FEMA.
2. FEMA will reimburse allocated loss adjustment expenses to the Company pursuant to a “Fee Schedule” coordinated with the Company and provided by FEMA. To ensure the availability of qualified insurance adjusters during catastrophic flood events, FEMA may, in its sole discretion, temporarily authorize the use of an alternative Fee Schedule with increased amounts during the term of this Arrangement for losses incurred during a time frame and geographic area established by FEMA.
3. FEMA will reimburse special allocated loss expenses to the Company in accordance with guidelines issued by FEMA.
D. Loss Payments.
1. The Company must make loss payments for flood insurance policies from federal funds retained in the bank account(s) established under Article II.E and, if such funds are depleted, from federal funds derived by drawing against the Letter of Credit established pursuant to Article IV.
2. Loss payments include payments because of litigation that arises under the scope of this Arrangement, and the Authorities set forth herein. All such loss payments and related expenses must meet the documentation requirements of the Financial Control Plan and of this Arrangement, and the Company must comply with the litigation documentation and notification requirements established by FEMA. Failure to meet these requirements may result in FEMA's decision not to provide reimbursement.
3. Limitation on Litigation Costs.
a. Following receipt of notice of such litigation, the FEMA Office of Chief Counsel (“OCC”) will review the information submitted. If OCC finds that
b. In the event the FEMA determines that the litigation is grounded in actions by the Company that are significantly outside the scope of this Arrangement, and/or involves issues of agent negligence, then FEMA will notify the Company in writing within thirty (30) days that any award or judgment for damages and any costs to defend such litigation will not be recognized under Article III as a reimbursable loss cost, expense, or expense reimbursement.
c. In the event a question arises whether only part of the costs of a litigation is reimbursable, OCC may make a recommendation about the appropriate division of responsibility, if possible.
d. In the event that the Company wishes to petition for reconsideration of the determination that it will not be reimbursed for any part of the award or judgment or any part of the costs expended to defend such litigation made under Article III.D.3.a-c, it may do so by mailing, within thirty (30) days of the notice that reimbursement will not be made, a written petition to FEMA, who may request advice on other than legal matters of the WYO Standards Committee established under the WYO Financial Control Plan. The WYO Standards Committee will consider the request at its next regularly scheduled meeting or at a special meeting called for that purpose by the Chairman and issue a written recommendation to the Administrator. FEMA's final determination will be made in writing within a reasonable time to the Company.
E. The Company must make premium refunds required by FEMA to applicants and policyholders from federal flood insurance funds referred to in Article II.E, and, if such funds are depleted, from funds derived by drawing against the Letter of Credit established pursuant to Article IV. The Company may not refund any premium to applicants or policyholders in any manner other than as specified by FEMA since flood insurance premiums are funds of the Federal Government.
A. FEMA must establish Letter(s) of Credit against which the Company may withdraw funds daily, if needed, pursuant to prescribed procedures implemented by FEMA. The amounts of the authorizations will be increased as necessary to meet the obligations of the Company under Article III.C-E. The Company may only request funds when net premium income has been depleted. The timing and amount of cash advances must be as close as is administratively feasible to the actual disbursements by the recipient organization for allowable Letter of Credit expenses. Request for payment on Letters of Credit may not ordinarily be drawn more frequently than daily. This Letter of Credit may be drawn by the Company for any of the following reasons:
1. Payment of claims, as described in Article III.D;
2. Refunds to applicants and policyholders for insurance premium overpayment, or if the application for insurance is rejected or when cancellation or endorsement of a policy results in a premium refund, as described in Article III.E; and
3. Allocated and unallocated loss adjustment expenses, as described in Article III.C.
B. FEMA must provide technical assistance to the Company as follows:
1. FEMA's policy, history concerning underwriting, and claims handling.
2. A mechanism to assist in clarification of coverage and claims questions.
3. Other assistance as needed.
C. FEMA must provide the Company with a copy of all formal written appeal decisions conducted in accordance with Section 205 of the Bunning-Bereuter-Blumenauer Flood Insurance Reform Act of 2004, Public Law 108-264 and 44 CFR 62.20.
D. Prior to the end of the Arrangement period, FEMA may provide the Company a statistical summary of their performance during the signed Arrangement period. This summary will detail the Company's performance individually, as well as compare the Company's performance to the aggregate performance of all WYO companies and the NFIP Direct Servicing Agent.
A. The effective period of this Arrangement begins on October 1, 2018 and terminates no earlier than September 30, 2019, subject to extension pursuant to Article V.C. FEMA may provide financial assistance only for policy applications and endorsements accepted by the Company during this period pursuant to the Program's effective date, underwriting, and eligibility rules.
B. Pursuant to 44 CFR 62.23(a), FEMA will publish the Arrangement and the terms for subscription or re-subscription for Fiscal Year 2020 in the
C. In addition to the requirements of Article V.B, in order to assure uninterrupted service to policyholders, the Company must promptly notify FEMA in the event the Company elects not to re-subscribe to the WYO Program during the term of this Arrangement. If so notified, or if FEMA chooses not to renew the Company's participation, FEMA, at its option, may require the continued performance of all or selected elements of this Arrangement for the period required for orderly transfer or cessation of business and settlement of accounts, not to exceed eighteen (18) months after the end of this Arrangement (September 30, 2019), and may either require transfer of activities to FEMA under Article V.C.1 or allow transfer of activities to another WYO company under Article V.C.2:
1. FEMA may require the Company to transfer all activities under this Arrangement to FEMA. Within 30 calendar days of FEMA's election of this option, the Company must deliver to FEMA the following:
a. A plan for the orderly transfer to FEMA of any continuing responsibilities in administering the policies issued by the Company under the Program including provisions for coordination assistance.
b. All data received, produced, and maintained through the life of the Company's participation in the Program, including certain data, as determined by FEMA, in a standard format and medium.
c. All claims and policy files, including those pertaining to receipts and disbursements that have occurred during the life of each policy. In the event of a transfer of the services provided, the Company must provide FEMA with a report showing, on a policy basis, any amounts due from or payable to insureds, agents, brokers, and others as of the transition date.
d. All funds in its possession with respect to any policies transferred to FEMA for administration and the unearned expenses retained by the Company.
e. A point of contact within the Company responsible for addressing issues that may arise from the Company's previous participation under the WYO Program.
2. FEMA may allow the Company to transfer all activities under this Arrangement to one or more other WYO companies. Prior to commencing such transfer, the Company must submit and FEMA must approve a formal request. Such request must include the following:
a. An assurance of uninterrupted service to policyholders.
b. A detailed transfer plan providing for either: (1) The renewal of the Company's NFIP policies by one or more other WYO companies or (2) the transfer of the Company's NFIP policies to one or more other WYO companies.
c. A description who the responsible party will be for liabilities relating to losses incurred by the Company in this or preceding Arrangement years.
d. A point of contact within the Company responsible for addressing issues that may arise from the Company's previous participation under the WYO Program.
D. Cancellation by FEMA.
1. FEMA may cancel financial assistance under this Arrangement in its entirety upon thirty (30) days written notice to the Company by certified mail stating one or more of the following reasons for such cancellation:
a. Fraud or misrepresentation by the Company subsequent to the inception of the Arrangement; or
b. Nonpayment to FEMA of any amount due; or
c. Material failure to comply with the requirements of this Arrangement or with the written standards, procedures, or guidance issued by FEMA relating to the NFIP and applicable to the Company.
2. If FEMA cancels this Arrangement pursuant to Article V.D.1, FEMA may require the transfer of administrative responsibilities and the transfer of data and records as provided in Article V.C.1.a-d. If transfer is required, the Company must remit to FEMA the unearned expenses retained by the Company. In such event, FEMA will assume all obligations and liabilities owed to policyholders under such policies, arising before and after the date of transfer.
3. As an alternative to the transfer of the policies to FEMA pursuant to Article V.D.2, FEMA will consider a proposal, if it is made by the Company, for the assumption of responsibilities by another WYO company as provided in Article V.C.2.
E. In the event that the Company is unable or otherwise fails to carry out its obligations under this Arrangement by reason of any order or directive duly issued by the Department of Insurance of any jurisdiction to which the Company is subject, the Company agrees to transfer, and FEMA will accept, any and all WYO policies issued by the Company and in force as of the date of such inability or failure to perform. In such event FEMA will assume all obligations and liabilities within the scope of the Arrangement owed to policyholders arising before and after the date of transfer, and the Company will immediately transfer to FEMA all needed records and data and all funds in its possession with respect to all such policies transferred and the unearned expenses retained by the Company. As an alternative to the transfer of the policies to FEMA, FEMA will consider a proposal, if it is made by the Company, for the assumption of responsibilities by another WYO company as provided by Article V.C.2.
F. In the event the Act is amended, repealed, expires, or if FEMA is otherwise without authority to continue the Program, FEMA may cancel financial assistance under this Arrangement for any new or renewal business, but the Arrangement will continue for policies in force that shall be allowed to run their term under the Arrangement.
A. The Company must furnish to FEMA such summaries and analysis of information including claim file information, and property address, location, and/or site information in its records as may be necessary to carry out the purposes of the Act, in such form as FEMA, in cooperation with the Company, will prescribe.
B. Upon FEMA's request, the Company must provide FEMA with a true and correct copy of the Company's Fire and Casualty Annual Statement, and Insurance Expense Exhibit or amendments thereof as filed with the State Insurance Authority of the Company's domiciliary State.
A. FEMA must make available to the Company during the entire term of this Arrangement, and any continuation period required by FEMA pursuant to Article V.C, the Letter of Credit provided for in Article IV drawn on a repository bank within the Federal Reserve System. This Letter of Credit may be drawn by the Company for reimbursement of its expenses as set forth in Article IV that exceed net written premiums collected by the Company from the effective date of this Arrangement or continuation period to the date of the draw. In the event that adequate Letter of Credit funding is not available to meet current Company obligations for flood policy claim payments issued, FEMA must direct the Company to immediately suspend the issuance of loss payments until such time as adequate funds are available. The Company is not required to pay claims from their own funds in the event of such suspension.
B. The Company must remit all funds, including interest, not required to meet current expenditures to the United States Treasury, in accordance with the provisions of the WYO Accounting Procedures Manual or procedures approved in writing by FEMA.
C. In the event the Company elects not to participate in the Program in this or any subsequent fiscal year, or is otherwise unable or not permitted to participate, the Company and FEMA must make a provisional settlement of all amounts due or owing within three (3) months of the expiration or termination of this Arrangement. This settlement must include net premiums collected, funds drawn on the Letter of Credit, and reserves for outstanding claims. The Company and FEMA agree to make a final settlement, subject to audit, of accounts for all obligations arising from this Arrangement within eighteen (18) months of its expiration or termination, except for contingent liabilities that must be listed by the Company. At the time of final settlement, the balance, if any, due FEMA or the Company must be remitted by the other immediately and the operating year under this Arrangement must be closed.
If any misunderstanding or dispute arises between the Company and FEMA with reference to any factual issue under any provisions of this Arrangement or with respect to FEMA's nonrenewal of the Company's participation, other than as to legal liability under or interpretation of the Standard Flood Insurance Policy, such misunderstanding or dispute may be submitted to arbitration for a determination that will be binding upon approval by FEMA. The Company and FEMA may agree on and appoint an arbitrator who will investigate the subject of the misunderstanding or dispute and make a determination. If the Company and FEMA cannot agree on the appointment of an arbitrator, then two arbitrators will be appointed, one to be chosen by the Company and one by FEMA.
The two arbitrators so chosen, if they are unable to reach an agreement, must select a third arbitrator who must act as
This Article shall indefinitely succeed the term of this Arrangement.
In the event of negligence by the Company that has not resulted in litigation but has resulted in a claim against the Company, FEMA will not consider reimbursement of the Company for costs incurred due to that negligence unless the Company takes all reasonable actions to rectify the negligence and to mitigate any such costs as soon as possible after discovery of the negligence. The Company may choose not to seek reimbursement from FEMA.
Further, if the claim against the Company is grounded in actions significantly outside the scope of this Arrangement or if there is negligence by the agent, FEMA will not reimburse any costs incurred due to that negligence. The Company will be notified in writing within thirty (30) days of a decision not to reimburse. In the event the Company wishes to petition for reconsideration of the decision not to reimburse, the procedure in Article III.D.3.d applies.
However, in the event that the Company has made a claim payment to an insured without including a mortgagee (or trustee) of which the Company had actual notice prior to making payment, and subsequently determines that the mortgagee (or trustee) is also entitled to any part of said claim payment, any additional payment may not be paid by the Company from any portion of the premium and any funds derived from any federal letter of credit deposited in the bank account described in Article II.E. In addition, the Company agrees to hold the Federal Government harmless against any claim asserted against the Federal Government by any such mortgagee (or trustee), as described in the preceding sentence, by reason of any claim payment made to any insured under the circumstances described above.
No Member or Delegate to Congress, or Resident Commissioner, may be admitted to any share or part of this Arrangement, or to any benefit that may arise therefrom; but this provision may not be construed to extend to this Arrangement if made with a corporation for its general benefit.
At the settlement of accounts, the Company and FEMA has, and may exercise, the right to offset any balance or balances, whether on account of premiums, commissions, losses, loss adjustment expenses, salvage, or otherwise due one party to the other, its successors or assigns, hereunder or under any other Arrangements heretofore or hereafter entered into between the Company and FEMA. This right of offset shall not be affected or diminished because of insolvency of the Company.
All debts or credits of the same class, whether liquidated or unliquidated, in favor of or against either party to this Arrangement on the date of entry, or any order of conservation, receivership, or liquidation, shall be deemed to be mutual debts and credits and shall be offset with the balance only to be allowed or paid. No offset shall be allowed where a conservator, receiver, or liquidator has been appointed and where an obligation was purchased by or transferred to a party hereunder to be used as an offset.
Although a claim on the part of either party against the other may be unliquidated or undetermined in amount on the date of the entry of the order, such claim will be regarded as being in existence as of the date of such order and any credits or claims of the same class then in existence and held by the other party may be offset against it.
The Company shall not discriminate against any applicant for insurance because of race, color, religion, sex, age, handicap, marital status, or national origin.
FEMA, the Department of Homeland Security, and the Comptroller General of the United States, or their duly authorized representatives, for the purpose of investigation, audit, and examination shall have access to any books, documents, papers and records of the Company that are pertinent to this Arrangement. The Company shall keep records that fully disclose all matters pertinent to this Arrangement, including premiums and claims paid or payable under policies issued pursuant to this Arrangement. Records of accounts and records relating to financial assistance shall be retained and available for three (3) years after final settlement of accounts, and to financial assistance, three (3) years after final adjustment of such claims. FEMA shall have access to policyholder and claim records at all times for purposes of the review, defense, examination, adjustment, or investigation of any claim under a flood insurance policy subject to this Arrangement.
This Arrangement and all policies of insurance issued pursuant thereto are subject to federal law and regulations.
Inasmuch as the Federal Government is a guarantor hereunder, the primary relationship between the Company and the Federal Government is one of a fiduciary nature, that is, to assure that any taxpayer funds are accounted for and appropriately expended. The Company is a fiscal agent of the Federal Government, but is not a general agent of the Federal Government. The Company is solely responsible for its obligations to its insured under any policy issued pursuant hereto, such that the Federal Government is not a proper party to any lawsuit arising out of such policies.
42 U.S.C. 4071, 4081; 44 CFR 62.23.
Federal Emergency Management Agency, DHS.
Notice.
Comments are requested on proposed flood hazard determinations, which may include additions or modifications of any Base Flood
Comments are to be submitted on or before June 14, 2018.
The Preliminary FIRM, and where applicable, the FIS report for each community are available for inspection at both the online location
You may submit comments, identified by Docket No. FEMA-B-1815, to Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC 20472, (202) 646-7659, or (email)
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC 20472, (202) 646-7659, or (email)
FEMA proposes to make flood hazard determinations for each community listed below, in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR 67.4(a).
These proposed flood hazard determinations, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own or pursuant to policies established by other Federal, State, or regional entities. These flood hazard determinations are used to meet the floodplain management requirements of the NFIP and also are used to calculate the appropriate flood insurance premium rates for new buildings built after the FIRM and FIS report become effective.
The communities affected by the flood hazard determinations are provided in the tables below. Any request for reconsideration of the revised flood hazard information shown on the Preliminary FIRM and FIS report that satisfies the data requirements outlined in 44 CFR 67.6(b) is considered an appeal. Comments unrelated to the flood hazard determinations also will be considered before the FIRM and FIS report become effective.
Use of a Scientific Resolution Panel (SRP) is available to communities in support of the appeal resolution process. SRPs are independent panels of experts in hydrology, hydraulics, and other pertinent sciences established to review conflicting scientific and technical data and provide recommendations for resolution. Use of the SRP only may be exercised after FEMA and local communities have been engaged in a collaborative consultation process for at least 60 days without a mutually acceptable resolution of an appeal. Additional information regarding the SRP process can be found online at
The watersheds and/or communities affected are listed in the tables below. The Preliminary FIRM, and where applicable, FIS report for each community are available for inspection at both the online location
Privacy Office, Department of Homeland Security.
Notice of modified Privacy Act system of records.
In accordance with the Privacy Act of 1974, the Department of Homeland Security (DHS) proposes to modify and reissue a current DHS system of records titled, “DHS/ALL-014 Department of Homeland Security Personnel Contact Information.” This system of records covers DHS's collection and maintenance of records concerning DHS personnel (including Federal employees and contractors) for workforce accountability; DHS and non-DHS Federal employees, contractors, or other individuals who participate in or respond to all-hazard emergencies, including technical, manmade, or natural disasters, or who participate in emergency response training exercises; and individuals identified as emergency points of contact. Categories of individuals, categories of records, and retention schedules for this system of records have been modified and expanded to better reflect the Department's emergency personnel location record systems. Additionally, this notice includes non-substantive changes to simplify the formatting and text of the previously published notice. This modified system will be included in the DHS inventory of record systems.
Submit comments on or before April 16, 2018. This modified system will be effective upon publication. New or modified routine uses will be effective April 16, 2018.
You may submit comments, identified by docket number DHS-2017-0074 by one of the following methods:
•
•
•
For general and privacy questions, please contact Philip S. Kaplan,
In accordance with the Privacy Act of 1974, 5 U.S.C. 552a, DHS proposes to modify a current DHS system of records titled, “DHS/ALL-014 Personnel Emergency Contact Information.”
This system of records covers DHS's collection and maintenance of records concerning current and former DHS personnel (including Federal employees and contractors) for workforce accountability (
Categories of individuals, categories of records, and retention schedules for this system of records have been modified and expanded to better reflect the Department's emergency personnel location record systems.
Categories of individuals have been expanded to include former DHS personnel; current and former Federal employees, contractors, or other individuals (
DHS is updating the category of records to include geospatial location information. DHS may collect this information from DHS personnel, including Federal employees and contractors; current and former Federal employees, contractors, or other individuals who participate in or conduct emergency response training exercises; current and former Federal employees, contractors, or other individuals who respond to all-hazards emergencies including technical, manmade, or natural disasters. DHS collects this information in order to facilitate the response efforts of deployed DHS and non-DHS personnel to all-hazards emergencies and provide a clear operational picture of the location of emergency personnel. This enables DHS or the emergency managers to better direct emergency personnel and the overall response effort.
In the course of responding to, or planning for, all-hazards emergencies, DHS may contact, locate, and deploy DHS personnel; implement the Continuity of Operations (COOP) Plan; and participate in emergency response training exercises. DHS may also utilize Federal Government employees from other Federal agencies who are deployed as a part of a mission assignment (pursuant to 42 U.S.C. 5197(c)) and non-Federal Government employees, such as other SLTT personnel. This system of records encompasses the collection, storage, and use of information associated with such activities and for all individuals that participate in those activities. Additionally, for emergency notification purposes, DHS may contact the identified emergency contacts or next of kin of the individual.
DHS is updating the record retention schedule to reflect the new and revised General Records Schedules under the Office of Management and Budget (OMB) and the National Archives and Records Administration (NARA) M-12-18, Managing Government Records Directive (Aug. 24, 2012). The previous General Records Schedules have been superseded.
Consistent with DHS's information sharing mission, information stored in the DHS/ALL-014 Personnel Emergency Contact Information system of records notice (SORN) may be shared with other DHS Components that have a need to know the information to carry out their national security, law enforcement, immigration, intelligence, or other homeland security functions. In addition, information may be shared with appropriate Federal, state, local, tribal, territorial, foreign, or international government agencies consistent with the routine uses set forth in this SORN. This updated system will be included in the Department's inventory of record systems.
The Privacy Act embodies fair information practice principles in a statutory framework governing the means by which Federal Government agencies collect, maintain, use, and disseminate individuals' records. The Privacy Act applies to information that is maintained in a “system of records.” A “system of records” is a group of any records under the control of an agency from which information is retrieved by the name of an individual or by some identifying number, symbol, or other identifying particular assigned to the
Below is the description of the DHS/ALL-014 Personnel Emergency Contact Information System of Records. In accordance with 5 U.S.C. 552a(r), DHS has provided a report of this system of records to the Office of Management and Budget and to Congress.
Department of Homeland Security (DHS)/ALL-014 Personnel Emergency Contact Information.
Unclassified.
Records are maintained at DHS and Federal Emergency Management Agency (FEMA) Headquarters in Washington, DC and field offices. Personnel emergency contact information is typically maintained locally by individual DHS offices.
The System Manager is the Director, Office of Operations Coordination (OPS), Department of Homeland Security, Washington, DC 20528.
The Homeland Security Act of 2002, 6 U.S.C. 313, 314, 317, 320, 321a, and 711; Robert T. Stafford Disaster Relief and Emergency Assistance Act,
The purpose of this system is for DHS workforce accountability, to support DHS all-hazards emergency response deployments and exercises, and to contact designated persons in the event of an emergency.
Categories of individuals in this system include:
• Current and former DHS personnel, including Federal employees and contractors;
• Current and former Federal employees, contractors, or other individuals (
• Current and former Federal employees, contractors, or other individuals (
• Individuals identified by current or former DHS personnel as emergency points of contact, including family members and next of kin.
Categories of records related to current and former DHS personnel, including Federal employees and contractors, include:
• Name;
• Work contact information (address, email address, phone, fax);
• Personal contact information (address, email address, phone numbers, pager number, and personal identification number [PIN]);
• Company/organization name;
• Supervisor name and contact information.
Categories of records related to DHS and non-DHS individuals identified as emergency points of contact may include:
• Name;
• Work contact information (address, email address, phone, fax);
• Personal contact information (address, email address, phone numbers, pager number, and pin number); and
• Relationship to current or former DHS personnel.
Categories of records related to DHS and non-DHS Federal employees, contractors or other individuals who participate in or who respond to all-hazards emergencies including technical, manmade or natural disasters, or who participate in emergency response training exercises may include:
• Name;
• Social Security number;
• Date of birth;
• Identifiers related to deployment;
• Height, weight, and other personal characteristics, if applicable;
• Work contact information (address, email address, phone, fax);
• Personal contact information (address, email address, phone numbers, pager number, and pin number);
• Deployment contact information (lodging address and phone number) while deployed;
• Company/organization name and organization code;
• Job information (position title, start date, duty status, pay status, and employment type);
• Supervisor name and contact information;
• Deployment point of contact name and contact information;
• Approvals, authorizations, certifications, and proficiency levels for training and deployment;
• Information on deployment position (program area, position type);
• Geospatial location information;
• Status of credentials for access to regulated facilities;
• Status of Government credit card (yes or no);
• Clearance and access level;
• Deployment information (duty station, dates, and lodging);
• Skills inventory, qualifications, specialties, and proficiency levels;
• Volunteered medical information;
• Emergency response group/non-emergency response group status; and
• Emergency recall rosters.
Records are obtained from DHS personnel (including Federal employees and contractors); individuals who participate in or conduct exercises or who respond to all-hazards emergencies including technical, manmade, or natural disasters; and other government agencies.
In addition to those disclosures generally permitted under 5 U.S.C. 552a(b) of the Privacy Act, all or a portion of the records or information contained in this system may be disclosed outside DHS as a routine use pursuant to 5 U.S.C. 552a(b)(3) as follows:
A. To the Department of Justice (DOJ), including the U.S. Attorneys Offices, or other Federal agency conducting litigation or proceedings before any court, adjudicative, or administrative body, when it is relevant or necessary to the litigation and one of the following is a party to the litigation or has an interest in such litigation:
1. DHS or any component thereof;
2. Any employee or former employee of DHS in his/her official capacity;
3. Any employee or former employee of DHS in his/her individual capacity, only when DOJ or DHS has agreed to represent the employee; or
4. The United States or any agency thereof.
B. To a congressional office from the record of an individual in response to an inquiry from that congressional office made at the request of the individual to whom the record pertains.
C. To the National Archives and Records Administration (NARA) or
D. To an agency or organization for the purpose of performing audit or oversight operations as authorized by law, but only such information as is necessary and relevant to such audit or oversight function.
E. To appropriate agencies, entities, and persons when:
1. DHS determines that information from this system of records is reasonably necessary and otherwise compatible with the purpose of collection to assist another Federal recipient agency or entity in (1) responding to a suspected or confirmed breach or (2) preventing, minimizing, or remedying the risk of harm to individuals, the recipient agency or entity (including its information systems, programs, and operations), the Federal Government, or national security, resulting from a suspected or confirmed breach; or
2. DHS suspects or has confirmed that there has been a breach of this system of records; and (a) DHS has determined that as a result of the suspected or confirmed breach, there is a risk of harm to individuals, DHS (including its information systems, programs, and operations), the Federal Government, or national security; and (b) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with DHS's efforts to respond to the suspected or confirmed breach or to prevent, minimize, or remedy such harm.
F. To contractors and their agents, grantees, experts, consultants, and others performing or working on a contract, service, grant, cooperative agreement, or other assignment for DHS, when necessary to accomplish an agency function related to this system of records. Individuals provided information under this routine use are subject to the same Privacy Act requirements and limitations on disclosure as are applicable to DHS officers and employees.
G. To an appropriate Federal, state, tribal, local, international, or foreign law enforcement agency or other appropriate authority charged with investigating or prosecuting a violation or enforcing or implementing a law, rule, regulation, or order, when a record, either on its face or in conjunction with other information, indicates a violation or potential violation of law, which includes criminal, civil, or regulatory violations and such disclosure is proper and consistent with the official duties of the person making the disclosure.
H. To a Federal, state, tribal, or local agency, if the information is relevant and necessary, for the requesting agency's approval on the issuance of a security clearance or for the purpose of providing support in an all-hazards emergencies including technical, manmade, or natural disasters.
I. To Federal, state, tribal, local, international, or foreign governmental agencies or executive offices, relief agencies, and non-governmental organizations, when disclosure is appropriate for performance of the official duties required in response to all-hazards including technical, manmade, or natural disasters.
J. To identified emergency contacts of:
1. Current and former DHS personnel, including Federal employees and contractors;
2. Current and former Federal employees, contractors, or other individuals who participate in or conduct exercises; or
3. Current and former Federal employees, contractors, or other individuals who respond to all-hazards emergencies including technical, manmade, or natural disasters.
K. To the news media and the public, with the approval of the Chief Privacy Officer in consultation with counsel, when there exists a legitimate public interest in the disclosure of the information or when disclosure is necessary to preserve confidence in the integrity of DHS, or when disclosure is necessary to demonstrate the accountability of DHS's officers, employees, or individuals covered by the system, except to the extent the Chief Privacy Officer determines that release of the specific information in the context of a particular case would constitute an unwarranted invasion of personal privacy.
DHS stores records in this system electronically or on paper in secure facilities in a locked drawer behind a locked door. The records may be stored on magnetic disc, tape, and digital media.
DHS retrieves records by an individual's name, location, or other personal identifier.
Records relating to current and former DHS employees, and individuals designated as emergency points of contact, will be reviewed annually and will be updated as necessary, and will be destroyed when obsolete, or upon separation or transfer of the employee, in accordance with National Archives and Records Administration (NARA) General Records Schedule (GRS) GRS 5.3, Item No. 020 (DAA-GRS-2016-0004-0002). Records on non-DHS individuals will be deleted when obsolete and of no longer use to the Department. The Department also intends to rely on GRS 2.7, Employee Health and Safety, which is currently pending with NARA. Federal Emergency Management Agency Records Schedule EOM-16, which will cover records related to deployment activities, will be submitted by FEMA to NARA for review and approval. FEMA proposes that records related to deployment activities be considered temporary records with a cutoff at the end of each calendar year and are destroyed 50 years after the cutoff date.
DHS safeguards records in this system according to applicable rules and policies, including all applicable DHS automated systems security and access policies. DHS has imposed strict controls to minimize the risk of compromising the information that is being stored. Access to the computer system containing the records in this system is limited to those individuals who have a need to know the information for the performance of their official duties and who have appropriate clearances or permissions.
Individuals seeking access to and notification of any record contained in this system of records, or seeking to contest its content, may submit a request in writing to the Chief Privacy Officer and Headquarters or component's FOIA Officer, whose contact information can be found at
When an individual is seeking records about himself or herself from this system of records or any other Departmental system of records, the individual's request must conform to
• Explain why the individual believes the Department would have information on him/her;
• Identify which component(s) of the Department the individual believes may have the information about him or her;
• Specify when the individual believes the records would have been created; and
• Provide any other information that will help the FOIA staff determine which DHS component agency may have responsive records;
If an individual's request is seeking records pertaining to another living individual, the first individual must include a statement from the second individual certifying his/her agreement for the first individual to access his or her records.
Without the above information, the component(s) may not be able to conduct an effective search, and the individual's request may be denied due to lack of specificity or lack of compliance with applicable regulations.
For records covered by the Privacy Act or covered JRA records, see “Record Access Procedures” above.
See “Record Access procedure.”
None.
81 FR 48832 (July 26, 2016); 73 FR 61888 (October 17, 2008).
Fish and Wildlife Service, Interior.
Notice of issuance of permits.
We, the U.S. Fish and Wildlife Service, have issued permits to conduct activities with foreign endangered and/or threatened species, marine mammals, or both, under the authority of the Endangered Species Act, as amended (ESA). With some exceptions, the ESA prohibits activities involving listed species unless a Federal permit is issued that allows such activity.
Information about the applications for the permits listed in this notice is available online at
Joyce Russell, 703-358-2023.
We, the U.S. Fish and Wildlife Service, have issued permits to conduct certain activities with endangered and threatened species in response to permit applications that we received under the authority of section 10(a)(1)(A) of the Endangered Species Act of 1973 (16 U.S.C. 1531
After considering the information submitted with each permit application and the public comments received, we issued the requested permits subject to certain conditions set forth in each permit. For each application for an endangered species, we found that (1) the application was filed in good faith, (2) the granted permit would not operate to the disadvantage of the endangered species, and (3) the granted permit would be consistent with the purposes and policy set forth in section 2 of the ESA.
The permittees' original permit application materials, along with public comments we received during public comment periods for the applications, are available for review. To locate the application materials and received comments, go to
We issue this notice under the authority of the ESA, as amended (16 U.S.C. 1531
Office of the Secretary, Interior.
Meeting notice.
The Department of the Interior, Office of the Secretary is announcing a public teleconference meeting of the
April 2, 2018, at 1:30 p.m. AKST.
Grace Hall Conference Room, Suite 220, 4230 University Drive, Anchorage, Alaska; (800) 315-6338, code 72241.
Dr. Philip Johnson, Department of the Interior, Office of Environmental Policy and Compliance, 1689 “C” Street, Suite 119, Anchorage, Alaska, (907) 271-5011.
The EVOS Public Advisory Committee was created
The EVOS Public Advisory Committee meeting agenda will include discussion of outreach proposals and habitat parcels. An opportunity for public comments will be provided. The final agenda and materials for the meeting will be posted on the EVOS Trustee Council website at
Interested members of the public may submit relevant information or questions for the Committee to consider during the public meeting. Written statements must be received by March 26, 2018, so that the information may be made available to the Committee for their consideration prior to this meeting. Written statements must be supplied to Dr. Philip Johnson (see
Before including your address, phone number, email address, or other personal identifying information in your comments, please 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.
Summary minutes of the conference will be maintained by the Council Designated Federal Officer (see
Bureau of Land Management, Interior.
Notice of temporary closure.
As authorized under the provisions of the Federal Land Policy and Management Act of 1976, as amended (FLPMA), the Bureau of Land Management (BLM) Battle Mountain District Office will temporarily close and restrict uses of certain public land surrounding and including the Mill Creek Recreational Campground (Campground) in Lander County, Nevada, to all public use to provide for public safety during restoration and rehabilitation activities occurring at the site.
The temporary closure will go into effect April 16, 2018 and will remain in effect until June 14, 2018. BLM will post notice that the Campground is closed upon publication of the closure notice in the
The temporary closure order, communications plan and map of the closure area will be posted at the BLM Battle Mountain District Office, 50 Bastian Road, Battle Mountain, Nevada 89820, and on the BLM website at
Kyle Hendrix, 775-635-4000.
The Mill Fire started on Wednesday June 28, 2017, and was contained on July 1, 2017. It burned 479 acres: 249 acres on private land and the rest on BLM land within the Battle Mountain District. The fire started in the Mill Creek Campground. Before the fire was contained, the entire campground was engulfed, resulting in extensive damage to structures and recreation areas at the site. In the Campground, a toilet, two footbridges, and a kiosk/interpretive sign burned down. All 16 campsites lost their wooden barricades and one lost a picnic table. A fence that restricted cattle from access to the Campground lost most of its wooden posts and braces. This temporary closure provides for public safety while the BLM Battle Mountain District restores and rehabilitates the Campground. The public lands affected by this closure are described as follows:
The area described contains 230 acres, more or less, in Lander County, Nevada.
The temporary closure order, communications plan and map of the closure area will be posted at the BLM Battle Mountain District Office, 50 Bastian Road, Battle Mountain, Nevada 89820, and on the BLM website at
Roads leading into the public lands under the temporary closure will be posted to notify the public of the temporary closure. Under the authority of Section 303(a) of the FLPMA (43 U.S.C. 733(a)), 43 CFR 8360.0-7 and 43 CFR 8364.1, the BLM will enforce the following rules in the area described above: All public use, whether motorized, on foot, or otherwise, is prohibited.
43 CFR 8360.0-7 and 8364.1.
Bureau of Land Management, Interior.
Notice of availability.
In accordance with the National Environmental Policy Act of 1969, as amended (NEPA), and the Federal Land Policy and Management Act of 1976, as amended, the Bureau of Land Management (BLM) has prepared a Draft Land Use Plan Amendment (LUPA) and Draft Supplemental Environmental Impact Statement (DSEIS) for the West Mojave Route Network Project (WMRNP) within the West Mojave (WEMO) Planning Area of the California Desert Conservation Area (CDCA) and by this Notice is announcing the opening of the 90-day public comment period.
To ensure public comments will be considered, the BLM must receive written comments on the DSEIS/LUPA within 90 days following the date the Environmental Protection Agency publishes its Notice of Availability in the
You may submit comments related to the WMRNP by any of the following methods:
•
•
•
Copies of the WMRNP Draft LUPA and DS EIS are available in the California Desert District Office at the above address; the Ridgecrest Field Office, 300 S. Richmond Rd., Ridgecrest, CA 93555; and the Barstow Field Office, 2601 Barstow Road, Barstow CA 92311. Copies are also available online at
Matt Toedtli, Planning and Environmental Coordinator, 2601 Barstow Road, Barstow, CA 92311; telephone 760-252-6026; email
The WMRNP will delineate travel management areas, adopt transportation and travel management strategies, and designate routes on public lands in the WEMO Planning Area. The WEMO Planning Area covers 9.4-million acres of the CDCA in the western portion of the Mojave Desert in southern California, including parts of San Bernardino, Los Angeles, Riverside, Kern, and Inyo counties. The WMRNP applies to the 3.1-million acres of public lands within the WEMO Planning Area. In March 2006, the BLM signed the Record of Decision (ROD) for the WEMO Plan and Amendment to the CDCA Plan. In January 2011, the U.S. District Court for the Northern District of California partially remanded the 2006 WEMO Plan Amendment ROD back to the BLM and directed the BLM to amend the CDCA Plan and reconsider route designation throughout the WEMO Planning Area, as well as other specified issues in the 2006 WEMO Plan (Center for Biological Diversity v. U.S. Bureau of Land Management Order Re: Remedy (N.D. Cal. Jan 28, 2011)). The court's order: (1) Invalidated the “decision tree” instrument used to evaluate and designate routes; (2) found that the authorization of off-highway vehicles (OHV) routes that were not in existence in 1980 were inconsistent with the governing land use plan; (3) found that there was not a reasonable range of alternatives to the proposed action, including an inadequate discussion of the No Action alternative; and (4) found that BLM had done an inadequate analysis of impacts from the route network and the grazing program to specific resource values, including soils, cultural resources, certain biological resources, and air quality.
On September 13, 2011, the BLM issued a Notice of Intent (amended May 2, 2013, 78 FR 25758), inviting comments on the proposed scope and content of the WMRNP. The WMRNP includes a LUPA to the CDCA Plan for livestock grazing, recreation, and motor vehicle access elements for the WEMO Planning Area; an associated travel management framework; and activity-plan level route designations and implementation strategies. The lands covered in the WMRNP are those that are within livestock grazing allotments or designated as “Limited” to designated routes for motorized access. Areas “Closed” to motorized access are not proposed for change in this plan amendment and are not within the scope of the planning effort.
The 9.4-million acres WEMO Planning Area includes several large Department of Defense facilities, covering almost 3 million acres; a portion of one national park; 3 million acres of private lands; and approximately 100,000 acres of State lands, including Red Rock Canyon State Park. The planning area is also adjacent to four national parks/preserves and four national forests. Much of the planning area is managed as part of the BLM's National Landscape Conservation System, including 18 wilderness areas, three wilderness study areas, and portions of the Pacific Crest Trail and the Old Spanish National Historic Trail. The planning area also includes 60 Areas of Critical Environmental Concern, five California Desert National Conservation Lands, seven National Register Archaeological or Historic Districts, and four Critical Habitat Units for the federally listed desert tortoise.
The planning area also includes eight OHV Open Areas that provide major points of ingress to and egress from the adjacent areas “Limited” to designated routes on public land. No changes are proposed to these OHV Open Areas or their boundaries.
The BLM used a public scoping process to determine issues, impacts, and possible alternatives that could influence the scope of the environmental analysis, and to help guide the agency from planning-level decision-making to route designation in order to comply with the court order.
The BLM initially published a Notice of Availability for the DSEIS for the West Mojave Route Network Project in March 2015, which was made available for public comment. Concurrently, the BLM was considering amending the CDCA Plan through the Desert Renewable Energy Conservation Plan
During previous project scoping, the public raised the following transportation and management concerns:
• Need for a good inventory and accurate information related to the existing environment;
• Documentation and use of the regulatory criteria (43 CFR 8342.1) for route minimization;
• Mitigation for loss of access;
• Sensitive resource protection;
• Maintenance of access for various types of recreational, scientific, and other uses;
• Access to private lands;
• Trespass;
• Regional connectivity;
• Improving GIS and on-the-ground information for the public; and
• Implementation strategies such as signing, monitoring, and law enforcement.
In addition, a substantial number of comments indicated issues and needs associated with specific routes and route areas in the WEMO transportation system, and included recommendations on the designation of specific routes, including limiting use to street-legal vehicles. A few comments were also received on livestock grazing issues and the scope of the supplemental grazing program analysis.
In response to court order and on-the-ground changes since 2006, the DS EIS/LUPA, through four different alternatives, also includes consideration of the cumulative effects of the transportation system alternatives to resource values—particularly air quality, soils, cultural resources, certain biological resources, and certain sensitive species—as well as cumulative effects of livestock grazing and potential cumulative loss of recreational access opportunities. In response to public input, access considerations focused on maintaining a viable transportation network, diversifying recreational opportunities, providing access for specific users (
The draft plan amendments address specific CDCA Plan inconsistencies with regulation and policies in the WEMO Planning Area, including amending language that limits the route network to routes that existed in 1980 and travel management guidance for route designations. Changes are proposed to the land-use plan guidelines for stopping, parking, and camping adjacent to routes in Limited Access Areas within the WEMO Planning Area, and to establish a regional minimization strategy for the route network. Through Alternative 2, changes are also considered to the livestock grazing program that would reallocate forage from livestock use to wildlife use and ecosystem function in desert tortoise critical habitat for active allotments or allotments that become vacant. In addition, the Draft considers plan-level decisions modifying motorized use on four specific lakebeds, including Cuddeback Dry Lake, and competitive motorized use of routes. The Draft also considers activity-level travel management plans. Four alternatives are evaluated, including a No Action alternative.
Finally, the Draft includes activity-level specific route designation alternatives, based on the 43 CFR 8342.1 criteria and different thresholds for minimization or closure. The preferred alternative would designate a sustainable travel network and transportation system of approximately 6,300 miles from an inventory of about 16,000 miles of linear transportation features within the WEMO Planning Area, as compared to the current network of approximately 6,000 miles. The designated route network addresses the need for public, authorized, and administrative access to and across BLM-managed lands, including motorized, non-motorized, and non-mechanized modes of travel, while balancing the need to protect sensitive desert resources, and minimizing the impact to those resources.
The preferred alternative also includes network-wide minimization measures that would limit the extent of off-route stopping and parking throughout the planning area to (1) Minimize impacts to undisturbed habitat; (2) Enhance watersheds; and (3) Protect adjacent sensitive resources. Other measures are based on proximity to sensitive resources, such as riparian systems, that would enhance these resources throughout the planning area. The preferred alternative provides for designated camping and staging areas to direct intensive use to manageable locations.
Please note that public comments and information submitted, including names, street addresses, and email addresses of persons who submit comments, will be available for public review and disclosure at the above address during regular business hours (8 a.m. to 4 p.m.), Monday through Friday, except holidays.
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 to withhold your personal identifying information from public review, BLM cannot guarantee that we will be able to do so.
40 CFR 1506.6, 40 CFR 1506.10, 43 CFR 1610.2.
Bureau of Land Management, Interior.
Notice of proposed reinstatement.
As provided for under the Mineral Leasing Act of 1920, as amended, the Bureau of Land Management (BLM) received a petition from Anadarko E&P Onshore LLC for reinstatement of competitive oil and gas lease WYW184371 for land in Converse County, Wyoming. The lessee filed the petition on time, along with all rentals due since the lease terminated under the law. No leases affecting this land were issued before the petition was filed. The BLM proposes to reinstate the lease.
Chris Hite, Branch Chief for Fluid Minerals Adjudication, Bureau of Land Management, Wyoming State Office, 5353 Yellowstone Road, P.O. Box 1828, Cheyenne, Wyoming 82003; phone: 307-775-6176; email:
Persons who use a telecommunications device for the deaf may call the Federal Relay Service (FRS) at 1-800-877-8339 to contact Mr. Hite during normal business hours. The FRS
The lessee agreed to the amended lease terms for rentals and royalties at rates of $10 per acre, or fraction thereof, per year and 16
30 U.S.C. 188 and 43 CFR 3108.2-3.
Bureau of Land Management, Interior.
Notice of Temporary Closure.
Notice is hereby given that under the authority of the Federal Land Policy and Management Act of 1976, as amended (FLPMA), the Kasha-Katuwe Tent Rocks Resource Management Plan (RMP), Presidential Proclamation 7394, and other authorities, the Kasha-Katuwe Tent Rocks National Monument (Monument) will be temporarily closed to the public on twelve days each year, to allow for Pueblo de Cochiti cultural observances.
The temporary closure will be in effect beginning April 16, 2018. The closure will remain in effect for 24 months upon publication in the
Danita Burns, District Manager, Bureau of Land Management Albuquerque District Office, 100 Sun Avenue NE, Suite 330, Pan American Building, Albuquerque, New Mexico 87109; 505-761-8700.
The BLM will post temporary closure signs a week prior to a closure at the main entry to the Monument. In addition, a temporary closure notice with all applicable dates will be posted on the BLM website:
During these closure dates only BLM planning, administrative, and maintenance activities will be authorized, and no public access will be granted.
FLPMA, the Kasha-Katuwe Tent Rocks RMP, Presidential Proclamation 7394, 43 CFR 8364.1, and 43 U.S.C. 1701
National Park Service, Interior.
Notice of availability.
The National Park Service (NPS) announces the availability of the Final Environmental Impact Statement (EIS) to address the presence of wolves at Isle Royale National Park.
The NPS will execute a Record of Decision (ROD) no sooner than 30 days from the date of publication by the U.S. Environmental Protection Agency of the notice of filing of the Final EIS in the
An electronic copy of the final EIS/plan will be available for public review at
Superintendent Phyllis Green, Isle Royale National Park, ISRO Wolves, 800 East Lakeshore Drive, Houghton, Michigan 49931-1896, or by telephone at (906) 482-0984.
Pursuant to the National Environmental Policy Act, 43 U.S.C. 4321
This final EIS/plan evaluates the impacts of the no-action alternative (Alternative A) and three action alternatives (Alternatives B, C, and D). Alternative B is the preferred alternative and the environmentally preferable alternative.
Alternative A would continue existing management practices and assume no
The action alternatives include the capture and relocation of wolves from the Great Lakes Region to Isle Royale National Park. NPS would target wolves for relocation that are known to feed on moose as one of their prey sources, are in good health with no apparent injuries, and have the appropriate genetic diversity to sustain a viable population on the island. Capture and relocation efforts would take place between late fall and late winter. All of the action alternatives include monitoring which could include radio or GPS collar tracking from ground and air, scat sample collection, visual observations, and other methodology as funding is available.
Under the preferred alternative, between 20 and 30 wolves with a wide genetic diversity would be introduced to the island. Wolves may be supplemented as needed up to the third year after initial introduction. After the third year, should an unforeseen event occur that impacts the wolf population, such as a mass die-off or introduction of disease, and the goals of the alternative are not being met due to this event, wolves may be supplemented for an additional two years. No additional wolves would be brought to the island after five years from date of initial introduction.
Alternative C would involve the initial introduction of between 6 and 15 wolves. The NPS would bring wolves to the island as often as needed in order to maintain a population of wolves on the island for at least the next 20 years. Under this alternative, additional wolves may be brought based on one or more resource indicators that could include genetic health of the wolves, health of the ecosystem, and prey species population trends.
Under Alternative D, the NPS would not take immediate action and would continue current management, allowing natural processes to continue. This alternative is meant to allow the study of island ecosystem changes to continue without an apex predator and action would only be taken should the weight of evidence suggest an apex predator is necessary to ecosystem function. Resource indicators, such as population size and growth rate of moose would be used to determine if and when wolf introduction actions should be taken. If the weight of evidence indicates wolf introduction actions should be taken, NPS would follow procedures outlined within Alternative C.
The authority for publishing this notice is 40 CFR 1506.6.
National Park Service.
Notice of availability.
The National Park Service (NPS) announces the availability of the Final Archeological Resources Management Plan/Environmental Impact Statement (Final Plan/EIS), Knife River Indian Villages National Historic Site, North Dakota.
The NPS will execute a Record of Decision no sooner than 30 days from the date that the US Environmental Protection Agency publishes the Notice of Availability of the Final Plan/EIS in the
A limited number of hard-copies of the Final Plan/EIS may be picked up in-person or may be obtained by making a request in writing to Knife River Indian Villages National Historic Site, PO Box 9, Stanton, North Dakota 58571. The document is also available on the internet at the NPS Planning, Environment, and Public Comment website at:
Superintendent, Brenda Todd, may be reached at this address above, by telephone at (701) 745-3300 or via email at
The NPS announces the availability of the Final Plan/EIS. This process has been conducted pursuant to the National Environmental Policy Act (NEPA) (42 United States Code 4321
The preferred alternative also calls for the relocation of the park maintenance facility. The maintenance facility is located on the edge of the Big Hidatsa Village site, a designated National Historic Landmark and sacred site of the Mandan, Hidatsa, and Arikara Nation (MHA Nation). If off-site space is available and cost effective, the maintenance facility would be relocated outside the park. If suitable property outside the park is unavailable or cost prohibitive the NPS intends to relocate and construct the maintenance facility within the park.
Similarly, the preferred alternative calls for the relocation of the museum collections storage facility if current efforts to stop water infiltration are unsuccessful. The museum collections storage facility, located in the basement of the visitor center, has experienced water leaks since construction was completed in 1992. A project is underway to waterproof the exterior of the building. If efforts fail, the museum collections storage facility would be moved to a suitable location in consultation with the MHA Nation.
Notice of availability of the Draft Plan/EIS was published in the
The authority for publishing this notice is 40 CFR 1506.6.
United States International Trade Commission.
March 23, 2018 at 11:00 a.m.
Room 101, 500 E Street SW, Washington, DC 20436, Telephone: (202) 205-2000.
Open to the public.
1. Agendas for future meetings: None.
2. Minutes.
3. Ratification List.
4. Vote in Inv. Nos. 701-TA-567-569 and 731-TA-1343-1345 (Final)(Silicon Metal from Australia, Brazil, Kazakhstan, and Norway). The Commission is currently scheduled to complete and file its determinations and views of the Commission by April 10, 2018.
5. Outstanding action jackets: None.
In accordance with Commission policy, subject matter listed above, not disposed of at the scheduled meeting, may be carried over to the agenda of the following meeting.
By order of the Commission.
U.S. International Trade Commission.
Notice.
Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on February 2, 2018, under section 337 of the Tariff Act of 1930, as amended, on behalf of Lumencor, Inc. of Beaverton, Oregon. Supplements were filed on February 16, 2018; February 22, 2018; and February 27, 2018. The complaint, as supplemented, 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 light engines and components thereof by reason of infringement of U.S. Patent No. 9,574,722 (“the ’722 patent”), U.S. Patent No. 9,395,055 (“the ’055 patent”), and U.S. Patent No. 8,493,564 (“the ’564 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
Katherine Hiner, The Office of the Secretary, Docket Services, U.S. International Trade Commission, telephone (202) 205-1800.
(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 light engines and components thereof by reason of infringement of one or more of claims 1-6, 10-11, and 16-19 of the ’722 patent, claims 1-3, 5, 7, 9, 11-13, 15, 17 and 20 of the ‘055 patent, and claims 1, 4, 6-7, 9, 16, and 18 of the ‘564 patent; and whether an industry in the United States exists as required by subsection (a)(2) of section 337;
(2) 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: Lumencor, Inc., 14940 NW Greenbrier Parkway, Beaverton, OR 97006.
(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:
(3) For the investigation so instituted, the Chief Administrative Law Judge, U.S. International Trade Commission, shall designate the presiding Administrative Law Judge.
The Office of Unfair Import Investigations will not participate as a party in this investigation.
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
By order of the Commission.
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has determined not to review an initial determination (Order No. 4) granting an unopposed motion to amend the complaint and notice of investigation to add a certain respondent.
Lucy Grace D. Noyola, Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436, telephone 202-205-3438. Copies of non-confidential documents filed in connection with this investigation are or will be 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, Washington, DC 20436, telephone 202-205-2000. General information concerning the Commission may also be obtained by accessing its internet server (
The Commission instituted this investigation on January 22, 2018, based on a complaint filed by Newpark Mats & Integrated Services LLC of The Woodlands, Texas (“Newpark”). 83 FR 3022 (Jan. 22, 2018). The complaint alleges violations of section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, in the importation into the United States, the sale for importation, and the sale within the United States after importation of certain load supporting systems, including composite mat systems, and components thereof by reason of infringement of certain claims of U.S. Patent Nos. 6,511,257 and 6,695,527. The notice of investigation named as respondents Checkers Industrial Products, LLC of Broomfield, Colorado; Checkers Safety Group UK LTD of Cheshire, United Kingdom; and Zigma Ground Solutions LTD of Essex, United Kingdom (collectively, “Respondents”). The Office of Unfair Import Investigations was not named as a party to the investigation.
On February 14, 2018, Newpark filed a motion to amend the complaint and notice of investigation to add Isokon d.o.o. of Slovenske Konjice, Slovenia (“Isokon”) as a respondent. Respondents do not oppose the motion.
On February 20, 2018, the presiding administrative law judge (“ALJ”) issued an initial determination (“ID”) (Order No. 4), granting the motion to amend the complaint and notice of investigation. The ALJ found good cause for the amendment. The ALJ found that Newpark recently learned through discovery of Isokon's role in the sale for importation of products accused in this investigation and that Newpark did not know of Isokon's role when it filed the original complaint. The ALJ found that the amendment will not prejudice the public interest or the parties. The ALJ also found the amendment is in the public interest because it would permit development of a record that identifies the correct entities that import into the United States, sell for importation, and/or sell within the United States after importation the products accused in the investigation. No petitions for review of the ID were filed.
The Commission has determined not to review the subject ID.
The authority for the Commission's determination is contained in section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in part 210 of the Commission's Rules of Practice and Procedure (19 CFR part 210).
By order of the Commission.
U.S. International Trade Commission.
Notice.
Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on February 9, 2018, under section 337 of the Tariff Act of 1930, as amended, on behalf of Tektronix, Inc. of Beaverton, Oregon. 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 multi-domain test and measurement instruments by reason of infringement of certain claims of U.S. Patent No. 8,521,460 B2 (“the '460 patent”) and U.S. Patent No. 8,675,719 B2 (“the '719 patent”). The complaint further alleges that an industry in the United States exists, or is in the process of being established, 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
Katherine Hiner, Office of the Secretary, Docket Services Division, U.S. International Trade Commission, telephone (202) 205-1802.
(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 multi-domain test and measurement instruments by reason of infringement of one or more of claims 1-14 of the '460 patent and claims 1-10 and 12-15 of the '719 patent; and whether an industry in the United States exists, or is in the process of being established, as required by subsection (a)(2) of section 337;
(2) 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: Tektronix, Inc., 14150 SW Karl Braun Drive, Beaverton, OR 97077.
(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:
(3) 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.
United States International Trade Commission.
April 3, 2018 at 11:00 a.m.
Room 101, 500 E Street SW, Washington, DC 20436, Telephone: (202) 205-2000.
Open to the public.
1. Agendas for future meetings: None.
2. Minutes.
3. Ratification List.
4. Vote in Inv. Nos. 731-TA-1347 and 1348 (Final) (Biodiesel from Argentina and Indonesia). The Commission is currently scheduled to complete and file its determinations and views of the Commission by April 16, 2018.
5. Vote in Inv. No. 731-TA-893 (Third Review) (Honey from China). The Commission is currently scheduled to complete and file its determination and views of the Commission by April 16, 2018.
6. Outstanding action jackets: None.
In accordance with Commission policy, subject matter listed above, not disposed of at the scheduled meeting, may be carried over to the agenda of the following meeting.
By order of the Commission.
U.S. International Trade Commission.
Notice.
Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on February 8, 2018, under section 337 of the Tariff Act of 1930, as amended, on behalf of Rovi Corporation of San Jose, California, Rovi Guides, Inc. of San Jose, California, Rovi Technologies Corporation of San Jose, California, and Veveo, Inc. of Andover, Massachusetts. Supplements to the Complaint were filed on February 13 and 28, 2018. 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 digital video receivers and related hardware and software components by reason of infringement of certain claims of U.S. Patent No. 7,779,011 (“the '011 patent”); U.S. Patent No. 7,937,394 (“the '394 patent”); U.S. Patent No. 7,827,585 (“the '585 patent”); U.S. Patent No. 9,294,799 (“the '799 patent”); U.S. Patent No. 9,396,741 (“the '741 patent”); U.S. Patent No. 9,578,363 (“the '363 patent”); U.S. Patent No. 9,621,956 (“the '956 patent”); and U.S. Patent No. 9,668,014 (“the '014 patent”). The complaint further alleges that an industry in the United States exists or is in the process of being established as required by the applicable Federal Statute.
The complainants request 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.
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 digital video receivers and related hardware and software components by reason of infringement of one or more of claims 1-3, 5-11, 13-19, and 21-24 of the '011 patent; claims 1, 2, 4-6, and 8-11 of the '394 patent; claims 1, 3, 4, 8, 10, 11, 15, 17, 18, 22, 24, and 25 of the '585 patent; claims 1-3, 5, 7, 9-12, 14, 16, 18, and 28 of the '799 patent; claims 1-3, 5-10, 12, 14-17, 19, and 20 of the '741 patent; claims 1-8, 10-18, and 20 of the '363 patent; claims 1, 2, 4-6, 11, 12, and 14-16 of the '956 patent; and claims 1-4, 7-13, and 17-20 of the '014 patent, and whether an industry in the United States exists or is in the process of being established as required by subsection (a)(2) of section 337;
(2) 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 complainants are: Rovi Corporation, 2160 Gold Street, San Jose, CA 95002; Rovi Guides, Inc., 2160 Gold Street, San Jose, CA 95002; Rovi Technologies Corporation, 2160 Gold Street, San Jose, CA 95002; Veveo, Inc., 40 Shattuck Road, Suite 303, Andover, MA 01810.
(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: Comcast Corporation, One Comcast Center, 1701 John F. Kennedy Boulevard, Philadelphia, PA 19103; Comcast Cable Communications, LLC, One Comcast Center, 1701 John F. Kennedy Boulevard, Philadelphia, PA 19103; Comcast Cable Communications Management, LLC, One Comcast Center, 1701 John F. Kennedy Boulevard, Philadelphia, PA 19103; Comcast Business Communications, LLC, One Comcast Center, 1701 John F. Kennedy Boulevard, Philadelphia, PA 19103; Comcast Holdings Corporation, One Comcast Center, 1701 John F. Kennedy Boulevard, Philadelphia, PA 19103; Comcast Shared Services, LLC, 330 N Wabash Avenue 22, Chicago, IL 60611-3586.
(c) The Office of Unfair Import Investigations, U.S. International Trade Commission, 500 E Street SW, Suite 401, Washington, DC 20436; and
(3) 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.
On March 12, 2018, the Department of Justice lodged a proposed Consent Decree and Environmental Settlement Agreement (“Settlement Agreement”) with the United States Bankruptcy Court for the District of Delaware in
The United States, on behalf of the United States Environmental Protection Agency, filed this Settlement Agreement with PES Holdings, LLC and its Debtor Affiliates (collectively the Debtors),
The publication of this notice opens a period for public comment on the
During the public comment period, the Settlement Agreement may be examined and downloaded at this Justice Department website:
Please enclose a check or money order for $5.25 (25 cents per page reproduction cost) payable to the United States Treasury.
On March 9, 2018, the Department of Justice lodged a proposed Consent Decree with the United States District Court for District of Utah in the lawsuit entitled
The proposed Consent Decree resolves the claims alleged in the Complaint, and requires the defendants to take specified actions designed to achieve and maintain compliance with the Clean Air Act and the applicable regulations. The proposed Consent Decree requires the defendants to perform audits to identify non-compliance at four facilities and to correct any violations identified. In addition, the defendants must pay a civil penalty of $179,099 and must complete a Supplemental Environmental Project designed to reduce volatile organic compound emissions at the Rabbit Gulch compressor station, located near the Altamont gas processing plant in Duchesne County, Utah.
The publication of this notice opens a period for public comment on the Consent Decree. Please address comments to the Assistant Attorney General, Environment and Natural Resources Division and refer to
During the public comment period, the Consent Decree may be examined and downloaded at this Justice Department website:
Please enclose a check or money order for $ 15.25 (25 cents per page reproduction cost) payable to the United States Treasury.
The Members of the National Council on Disability (NCD) will meet by phone on Thursday, March 29, 2018, 11:00 a.m.-12:30 p.m., ET.
The meeting will occur by phone. NCD staff will participate in the call from the NCD conference room, 1331 F Street NW, Suite 850, Washington, DC. Interested parties may join the meeting in person at the NCD conference room or may join the phone line in a listening-only capacity using the following call-in information: Call-in number: 1-888-855-5838; Passcode: 5101128; Host Name: Neil Romano.
The Council will discuss and vote on the slate of projects it will move forward for external funding opportunities and internal work of staff.
The times provided below are approximations for when each agenda item is anticipated to be discussed (all times Eastern):
Anne Sommers, NCD, 1331 F Street NW, Suite 850, Washington, DC 20004; 202-272-2004 (V).
A CART streamtext link has been arranged for this meeting. The web link to access CART on Thursday, March 29, 2018 is:
Those who plan to attend the meeting in-person and require accommodations should notify NCD as soon as possible to allow time to make arrangements. To help reduce exposure to fragrances for those with multiple chemical sensitivities, NCD requests that all those attending the meeting in person refrain from wearing scented personal care products such as perfumes, hairsprays, and deodorants.
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 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.
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This Notice will be published in the
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
The Exchange proposes to amend its Fees Schedule to adopt the Select Customer Options Reduction (“SCORe”) program. The text of the proposed rule change is also available on the Exchange's website (
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 adopt the Select Customer Options Reduction program (“SCORe”).
The SCORe program is available to any Trading Permit Holder (“TPH”) Originating Clearing Firm or non-TPH Originating Clearing Firm. For this program, an “Originating Clearing Firm” will be defined as either (a) the executing clearing Options Clearing Corporation (“OCC”) number on any transaction which does not also include a Clearing Member Trading Agreement (“CMTA”) OCC clearing number or (b) the CMTA in the case of any transaction which does include a CMTA OCC clearing number. In order to participate, an Originating Firm must complete the SCORe Registration Form by the second to last business day of the month preceding the month in which their participation in the SCORe program will commence. The Exchange will aggregate an Originating Firm's volume with volume of their OCC clearing affiliates if such affiliates are reported to the Exchange via the SCORe Registration Form and there is at least 75% common ownership between the firms as reflected on each firm's Form BD, Schedule A. “Originating Firm” will refer to both an Originating Clearing Firm and any applicable affiliates.
The SCORe program will utilize two measures for participation and discounts: (1) The Qualifying Tiers, which determine whether a firm qualifies for the discounts in either Tier A or Tier B and (2) the Discount Tiers, which determine the Originating Firm's applicable discount tiers and corresponding discounts, as further described below.
To determine an Originating Firm's Qualifying Tier, the Originating Firm's total Retail volume in the Qualifying Classes will be divided by the Originating Firm's total Customer volume, Retail and non-Retail, in the Qualifying Classes. If an Originating Firm's Retail volume is between 35.00% and 69.99%, the Originating Firm will qualify for Tier B discounts. If an Originating Firm's Retail volume is at or above 70.00%, the Originating Firm will qualify for Tier A discounts. The Qualifying Tier that is applied in a given month is based on an Originating Firm's Retail volume in the prior month (
For the Discount Tier, an Originating Firm's Retail volume in the Qualifying Classes will be divided by total Retail volume in the Qualifying Classes executed on the Exchange. Additionally, SCORe will employ the use of “product multipliers” for the Discount Tier only. Multipliers will be applied to MXEF, MXEA, RUT and XSP volume only, as reflected below. Specifically, Retail volume in these products will be multiplied by the values indicated below so that any volume executed by an Originating Firm in these classes will be increased for purposes of the Discount Tier calculation, but not for purposes of calculating the Qualifying Tiers. Additionally, discounts will be applied to executed volume only, not on multiplied volume. If an Originating Firm's volume in a given month includes volume from MXEF, MXEA,
In that month, Originating Firm A executes 900,000 contracts from orders which qualify as Customer Retail volume, none of which were in product multiplier classes (
In the same month, Originating Firm B executes 900,000 contracts from orders which qualify as Customer Retail volume, of which 10,000 contracts were in XSP. The XSP volume of Originating Firm B is multiplied by 99 (
The Clearing TPH(s) that is billed for an Originating Firm's transactions will receive the applicable discounts. If more than one Clearing TPH was billed transaction fees for an Originating Firm's transactions subject to the SCORe program, the discounts will be applied pro-rata to the Clearing TPHs.
The Exchange believes the proposed rule change is consistent with the Securities Exchange Act of 1934 (the “Act”) and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of Section 6(b) of the Act.
The adoption of SCORe is reasonable because it will allow Customers orders from Originating Firms that register for the program an opportunity to receive certain discounts for reaching certain trading volume thresholds. The Exchange notes that SCORe provides an incremental incentive for Originating Firms to strive for the highest tier level, which provides increasingly higher discounts. The Exchange notes that it is voluntary for Originating Firms to choose whether or not to register for the program.
The Exchange believes it's equitable and not unfairly discriminatory to establish the program for Originating Firms only because this is designed to attract a greater number of customer orders in the Qualifying Classes. This increased volume creates greater trading opportunities that benefit all market participants by providing more trading opportunities and tighter spreads. Additionally, the Exchange notes that incentive programs based on Customer volume already exist elsewhere within the industry.
The Exchange believes limiting the SCORe program to the Qualifying Classes is equitable and not unfairly discriminatory because the Exchange has expended considerable time and resources in developing these products. The SCORe program is designed to encourage greater customer options trading in the Qualifying Classes, which, along with bringing greater options trading opportunities to all market participants, would bring in more fees to the Exchange, and such fees can be used to recoup the Exchange's costs and expenditures from developing and maintaining the Qualifying Classes.
The Exchange believes limiting the SCORe program to Retail orders is equitable and not unfairly discriminatory because the Exchange wants to encourage more Retail Customer volume in the Qualifying classes, which as noted above will bring greater volume and liquidity, which benefit all market participants by providing more trading opportunities and tighter spreads. Additionally, the Exchange notes other incentive programs already exist for non-Retail Customer orders.
The Exchange believes it's reasonable, equitable and not unfairly discriminatory to adopt a product multiplier because the Exchange wishes to support and encourage customers to provide greater order flow in these particular classes, which allows for price improvement in these products and has a number of positive impacts on the market system. The Exchange also believes however, that it's reasonable, equitable and not unfairly discriminatory to base the discount paid off the amount of transaction fees that would be assessed pursuant to the Fees Schedule (as opposed to being based off the “theoretical” number of contracts using the product multiplier) because the Exchange does not want to provide discount on contracts for which it is not also collecting transaction fees.
The Exchange also believes it's reasonable, equitable and not unfairly discriminatory to provide that it will aggregate the volume of affiliated Originating Firms to determine whether and what volume thresholds are met as the entities being aggregated share more than majority ownership. Particularly, the Exchange notes multiple incentive programs allow for aggregation between affiliates provided there is at least 75% common ownership between the firms as reflected on each firm's Form BD, Schedule A.
Lastly, the Exchange believes it's reasonable, equitable and not unfairly discriminatory to provide the discount to the executing Clearing TPH (or if more than one Clearing TPH, than on a pro-rata basis to the Clearing TPHs) because the executing Clearing TPH is the entity that is assessed transactions fees on the SCORe eligible volume.
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act because, while the discounts apply only to Customer orders from Originating Firms, the Program is designed to encourage increased Customer options volume in the Qualifying Classes, which provides greater trading opportunities for all market participants. Additionally, there is a history in the options markets of providing preferential treatment to Customers orders. The Exchange believes that the proposed rule change will not cause an unnecessary burden on intermarket competition because the Qualifying Classes are products that only trade on Cboe Options. To the extent that the proposed changes make the Exchange a more attractive marketplace for market participants at other exchanges, such market participants are welcome to become Cboe Options market participants.
The Exchange neither solicited nor received comments on the proposed rule change.
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 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1)
The Exchange proposes to expand the Short Term Options Series (“STOS”) Program to allow Monday expirations for SPDR S&P 500 ETF Trust (“SPY”) options. The proposed rule change is available on the Exchange's website at
In its filing with the Commission, the self-regulatory organization 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 those 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 parts of such statements.
The Exchange proposes to expand the STOS Program to allow Monday expirations for SPY options. In
Currently Rule 6.1-O(b)(41) provides that a STOS is a series in an option class that is approved for listing and trading on the Exchange in which the series is opened for trading on any Tuesday, Wednesday, Thursday or Friday that is a business day and that expires on the Wednesday or Friday of the next business week. The Exchange proposes to amend Rule 6.1-O(b)(41) to permit the listing of options series that expire on Mondays. Specifically, the Exchange is proposing that it may open for trading series of options on any Monday that is a business day and that expires on the Monday of the next business week. The Exchange is also proposing to list Monday expirations series on Fridays that precede the expiration Monday by one business week, plus one business day. Since Rule 6.1-O(b)(41) already provides for the listing of STOS on Fridays, the Exchange is not modifying this provision to allow for Friday listing of Monday expiration series. However, the Exchange proposes to amend Rule 6.1-O(b)(41) to clarify that, in the case of a STOS that is listed on a Friday and expires on a Monday, that STOS must be listed one business week and one business day prior to that expiration (
As part of this proposal, the Exchange is also amending Rule 6.1-O(b)(41) to address the expiration date of Monday expiration series when the Monday is not a business day. In that case, the rule would provide that the series shall expire on the first business day immediately following that Monday. This procedure differs from the expiration date of Wednesday expiration series that are scheduled to expire on a holiday. In that case, the Wednesday expiration series expire on the first business day immediately prior to that Wednesday,
The Exchange also proposes to make corresponding changes to Rule 6.4-O, Commentary .07, which sets forth the requirements for SPY options that are listed pursuant to the STOS Program, to permit Monday SPY expirations (“Monday SPY Expirations”). Accordingly, the Exchange proposes to amend Commentary .07(a) and (f) to Rule 6.4-O to state that, with respect to Monday SPY Expirations, the Exchange may open for trading on any Friday or Monday that is a business day series of options on the SPY to expire on any Monday of the month that is a business day and is not a Monday in which Quarterly Options Series expire, provided that Monday SPY Expirations that are listed on a Friday must be listed at least one business week and one business day prior to the expiration. As with the current rules for Wednesday SPY Expirations, the Exchange would also amend Commentary .07(a) and (f) to state that it may list up to five consecutive Monday SPY Expirations at one time, and may have no more than a total of five Monday SPY Expirations (and no more than a total of five STOS expirations for SPY expiring on Friday and no more than a total of five Wednesday SPY Expirations). The Exchange would also clarify that, as with Wednesday SPY Expirations, Monday SPY Expirations would be subject to the provisions of this Rule. The interval between strike prices for the proposed Monday SPY Expirations would be the same as those for the current STOS for Wednesday and Friday SPY Expirations. Specifically, the Monday SPY Expirations would have a $0.50 strike interval minimum. As is the case with other options series listed pursuant to the STOS, the Monday SPY Expiration series would be P.M.-settled.
Currently, for each option class eligible for participation in the STOS Program, the Exchange is limited to opening thirty (30) series for each expiration date for the specific class. The thirty (30) series restriction does not include series that are open by other securities exchanges under their respective short term option rules; the Exchange may list these additional series that are listed by other exchanges.
Finally, the Exchange proposes to amend Commentary .07 to Rule 6.4-O to address the listing of STOS that expire in the same week as monthly or quarterly options series. Currently, that rule states that no STOS may expire in the same week in which monthly option series on the same class expire (with the exception of Wednesday SPY Expirations) or, in the case of Quarterly Options Series, on an expiration that coincides with an expiration of Quarterly Option Series on the same class. The Exchange proposes to extend this exemption to Monday SPY Expirations.
The Exchange does not believe that any market disruptions would be encountered with the introduction of P.M.-settled Monday expirations. The Exchange has the necessary capacity and surveillance programs in place to support and properly monitor trading in the proposed Monday expiration series, including Monday SPY Expirations. The Exchange currently trades P.M.-settled STOS that expire almost every
The Exchange seeks to introduce Monday expirations to, among other things, expand hedging tools available to market participants and to continue the reduction of the premium cost of buying protection. The Exchange believes that Monday expirations, similar to Wednesday and Friday expirations, would allow market participants to purchase an option based on their timing as needed and allow them to tailor their investment and hedging needs more effectively.
As noted above, Phlx recently received approval to list Monday expirations for SPY options pursuant to its Short Term Options Series program. In addition, other exchanges currently permit Monday expirations for other options. For example, Cboe lists options on the SPX with a Monday expiration as part of its Nonstandard Expirations Pilot Program.
The Exchange believes the proposed rule change is consistent with Section 6(b) of the Act
In particular, the Exchange believes the STOS Program has been successful to date and that Monday expirations, including Monday SPY Expirations, would expand the ability of investors to hedge risk against market movements stemming from economic releases or market events that occur throughout the month in the same way that the STOS Program has expanded the landscape of hedging. Similarly, the Exchange believes Monday expirations, including Monday SPY Expirations, should create greater trading and hedging opportunities and flexibility, and would provide customers with the ability to tailor their investment objectives more effectively.
With the exception of Monday expiration series that are scheduled to expire on a holiday, the Exchange does not believe there are any material differences between Monday SPY Expirations and Wednesday or Friday SPY Expirations. The Exchange notes that it has been listing Wednesday expiration pursuant to Rule 6.4-O and Rule 6.1-O(b)(41) since 2016.
Given the similarities between Monday SPY Expiration series and Wednesday and Friday SPY Expiration series, the Exchange believes that applying the provisions in Rule 6.4-O, Commentary .07 that currently apply to Wednesday SPY Expirations, to Monday SPY Expirations, is justified. For example, the Exchange believes that allowing Monday SPY Expirations and monthly SPY expirations in the same week would benefit investors and minimize investor confusion by providing Monday SPY Expirations in a continuous and uniform manner. The Exchange also believes that it is appropriate to amend Rule 6.4-O, Commentary .07 to clarify that no STOS may expire on the same day as an expiration of Quarterly Option Series on the same class. This change would make that provision more consistent with the existing language in Rule 6.4-O, Commentary .07 that prohibits Wednesday SPY Expirations from expiring on a Wednesday in which Quarterly Options Series expire.
The Exchange represents that it has an adequate surveillance program in place to detect manipulative trading in Monday expirations, including Monday SPY Expirations, in the same way that it monitors trading in the current STOS Program.
With regard to the impact of this proposal on system capacity, the Exchange believes it and OPRA have the necessary systems capacity to handle any potential additional traffic associated with this proposed rule change. The Exchange believes that its members will not have a capacity issue as a result of this proposal.
The Exchange does not believe that the proposed rule change would impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The Exchange notes that having Monday expirations is not a novel proposal, as Cboe currently lists and trades short-term SPX options with a Monday expiration, and Phlx has recently received approval from the Commission to list Monday SPY expirations.
No written comments were solicited or received with respect to the proposed rule change.
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, the proposed rule change has become effective pursuant to Section 19(b)(3)(A) of the Act
A proposed rule change filed under Rule 19b-4(f)(6) normally does not become operative for 30 days from the date of filing. However, Rule 19b-4(f)(6)(iii)
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 Brent J. Fields, Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1)
The Exchange proposes to expand the Short Term Options Series (“STOS”) Program to allow Monday expirations for SPDR S&P 500 ETF Trust (“SPY”) options. The proposed rule change is available on the Exchange's website at
In its filing with the Commission, the self-regulatory organization 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 those statements may be examined at
The Exchange proposes to expand the STOS Program to allow Monday expirations for SPY options. In particular, the Exchange proposes to amend Rule 900.2NY (Definitions) and Rule 903 (Series of Options Open for Trading) to permit the listing and trading of options series with Monday expirations that are listed pursuant to the STOS Program. This is a competitive filing based on a filing submitted by Nasdaq PHLX LLC (“Phlx”), which the Securities and Exchange Commission (“Commission”) recently approved.
Currently Rule 900.2NY(50) provides that a STOS is a series in an option class that is approved for listing and trading on the Exchange in which the series is opened for trading on any Tuesday, Wednesday, Thursday or Friday that is a business day and that expires on the Wednesday or Friday of the next business week. The Exchange proposes to amend Rule 900.2NY(50) to permit the listing of options series that expire on Mondays. Specifically, the Exchange is proposing that it may open for trading series of options on any Monday that is a business day and that expires on the Monday of the next business week. The Exchange is also proposing to list Monday expirations series on Fridays that precede the expiration Monday by one business week, plus one business day. Since Rule 900.2NY(50) already provides for the listing of STOS on Fridays, the Exchange is not modifying this provision to allow for Friday listing of Monday expiration series. However, the Exchange proposes to amend Rule 900.2NY(50) to clarify that, in the case of a STOS that is listed on a Friday and expires on a Monday, that STOS must be listed one business week and one business day prior to that expiration (
As part of this proposal, the Exchange is also amending Rule 900.2NY(50) to address the expiration date of Monday expiration series when the Monday is not a business day. In that case, the rule would provide that the series shall expire on the first business day immediately following that Monday. This procedure differs from the expiration date of Wednesday expiration series that are scheduled to expire on a holiday. In that case, the Wednesday expiration series expire on the first business day immediately prior to that Wednesday,
The Exchange also proposes to make corresponding changes to Rule 903, which sets forth the requirements for SPY options that are listed pursuant to the STOS Program, to permit Monday SPY expirations (“Monday SPY Expirations”). Accordingly, the Exchange proposes to amend Rule 903(h) and Rule 903 Commentary .10(e) to state that, with respect to Monday SPY Expirations, the Exchange may open for trading on any Friday or Monday that is a business day series of options on the SPY to expire on any Monday of the month that is a business day and is not a Monday in which Quarterly Options Series expire, provided that Monday SPY Expirations that are listed on a Friday must be listed at least one business week and one business day prior to the expiration. As with the current rules for Wednesday SPY Expirations, the Exchange would also amend Rule 903(h) and Rule 903, Commentary .10(e) to state that it may list up to five consecutive Monday SPY Expirations at one time, and may have no more than a total of five Monday SPY Expirations (and no more than a total of five STOS expirations for SPY expiring on Friday and no more than a total of five Wednesday SPY Expirations). The Exchange would also clarify that, as with Wednesday SPY Expirations, Monday SPY Expirations would be subject to the provisions of this Rule. The interval between strike prices for the proposed Monday SPY Expirations would be the same as those for the current STOS for Wednesday and Friday SPY Expirations. Specifically, the Monday SPY Expirations would have a $0.50 strike interval minimum. As is the case with other options series listed pursuant to the STOS, the Monday SPY Expiration series would be P.M.-settled.
Currently, for each option class eligible for participation in the STOS Program, the Exchange is limited to opening thirty (30) series for each expiration date for the specific class. The thirty (30) series restriction does not include series that are open by other securities exchanges under their respective short term option rules; the Exchange may list these additional series that are listed by other exchanges.
Finally, the Exchange proposes to amend Rule 903 to address the listing of STOS that expire in the same week as monthly or quarterly options series. Currently, that rule states that no STOS may expire in the same week in which monthly option series on the same class expire (with the exception of Wednesday SPY Expirations) or, in the case of Quarterly Options Series, on an expiration that coincides with an expiration of Quarterly Option Series on the same class. The Exchange proposes to extend this exemption to Monday SPY Expirations.
The Exchange does not believe that any market disruptions would be encountered with the introduction of P.M.-settled Monday expirations. The Exchange has the necessary capacity and surveillance programs in place to support and properly monitor trading in the proposed Monday expiration series, including Monday SPY Expirations. The Exchange currently trades P.M.-settled STOS that expire almost every Wednesday and Friday, which provide market participants a tool to hedge special events and to reduce the premium cost of buying protection. Moreover, the Exchange has been listing Wednesday expirations pursuant to Rule 903 and Rule 900.2NY(50) since 2016.
The Exchange seeks to introduce Monday expirations to, among other things, expand hedging tools available to market participants and to continue the reduction of the premium cost of buying protection. The Exchange believes that Monday expirations, similar to Wednesday and Friday expirations, would allow market participants to purchase an option based on their timing as needed and allow them to tailor their investment and hedging needs more effectively.
As noted above, Phlx recently received approval to list Monday expirations for SPY options pursuant to its Short Term Options Series program. In addition, other exchanges currently permit Monday expirations for other options. For example, Cboe lists options on the SPX with a Monday expiration as part of its Nonstandard Expirations Pilot Program.
The Exchange believes the proposed rule change is consistent with Section 6(b) of the Act
In particular, the Exchange believes the STOS Program has been successful to date and that Monday expirations, including Monday SPY Expirations, would expand the ability of investors to hedge risk against market movements stemming from economic releases or market events that occur throughout the month in the same way that the STOS Program has expanded the landscape of hedging. Similarly, the Exchange believes Monday expirations, including Monday SPY Expirations, should create greater trading and hedging opportunities and flexibility, and would provide customers with the ability to tailor their investment objectives more effectively.
With the exception of Monday expiration series that are scheduled to expire on a holiday, the Exchange does not believe there are any material differences between Monday SPY Expirations and Wednesday or Friday SPY Expirations. The Exchange notes that it has been listing Wednesday expiration pursuant to Rule 903 and Rule 900.2NY(50) since 2016.
Given the similarities between Monday SPY Expiration series and Wednesday and Friday SPY Expiration series, the Exchange believes that applying the provisions in Rule 903 Commentary .10 that currently apply to Wednesday SPY Expirations, to Monday SPY Expirations, is justified. For example, the Exchange believes that allowing Monday SPY Expirations and monthly SPY expirations in the same week would benefit investors and minimize investor confusion by providing Monday SPY Expirations in a continuous and uniform manner. The Exchange also believes that it is appropriate to amend Rule 903 Commentary .10 to clarify that no STOS may expire on the same day as an expiration of Quarterly Option Series on the same class. This change would make that provision more consistent with the existing language in Rule 903 Commentary .10 that prohibits Wednesday SPY Expirations from expiring on a Wednesday in which Quarterly Options Series expire.
The Exchange represents that it has an adequate surveillance program in place to detect manipulative trading in Monday expirations, including Monday SPY Expirations, in the same way that it monitors trading in the current STOS Program.
With regard to the impact of this proposal on system capacity, the Exchange believes it and OPRA have the necessary systems capacity to handle any potential additional traffic associated with this proposed rule change. The Exchange believes that its members will not have a capacity issue as a result of this proposal.
The Exchange does not believe that the proposed rule change would impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The Exchange notes that having Monday expirations is not a novel proposal, as Cboe currently lists and trades short-term SPX options with a Monday expiration, and Phlx has recently received approval from the Commission to list Monday SPY expirations.
No written comments were solicited or received with respect to the proposed rule change.
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, the proposed rule change has become effective pursuant to Section 19(b)(3)(A) of the Act
A proposed rule change filed under Rule 19b-4(f)(6) normally does not become operative for 30 days from the date of filing. However, Rule 19b-4(f)(6)(iii)
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 Brent J. Fields, Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
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 (the “Act”),
The Exchange proposes to establish fees for options that overlie the S&P Select Sector Index options (“Sector Index options”). The text of the
The text of the proposed rule change is also available on the Exchange's website (
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.
On October 4, 2017, the Exchange submitted a proposed rule change to amend certain rules in connection with listing S&P Select Sector Index
By way of background, a specific set of proprietary products are commonly included or excluded from a variety of programs, qualification calculations and transaction fees. In lieu of listing out these products in various sections of the Fees Schedule, the Exchange uses the term “Underlying Symbol List A” to represent these products.
Specifically, like products in Underlying Symbol List A, the Exchange proposes to except Sector Index options from the Volume Incentive Program (“VIP”),
The Exchange does intend to apply to Sector Index options the Liquidity Provider Sliding Scale.
The Exchange next proposes to establish transaction fees for Sector Index options. Particularly, the Exchange proposes to assess the same fees for Sector Index options as apply to OEX Weekly and XEO Weekly options, except for Market-Maker transaction fees, which will be subject to the Liquidity Provider Sliding Scale as described above, and except for Clearing Trading Permit Holder Proprietary transactions, which will be $0.25 rather than subject to the Proprietary Products Sliding Scale for Clearing Trading Permit Holder Proprietary Orders. Transaction fees for Sector Index options will be as follows (all listed rates are per contract):
The Exchange also proposes to apply to Sector Index options
The Exchange currently assesses an Index License Surcharge of $0.10 per contract for all non-customer orders for products in Underlying Symbol A except RUT and SPX. The Exchange proposes to assess a Surcharge of $0.10 per contract in order to recoup the costs associated with the Sector Index license. In order to promote and encourage trading of Sector Index options, the Exchange proposes to waive the Index License Surcharge for Sector Index option transactions through June 30, 2018.
The Exchange believes the proposed rule change is consistent with the Securities Exchange Act of 1934 (the “Act”) and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of Section 6(b) of the Act.
Particularly, the Exchange believes it is reasonable to charge different fee amounts to different user types in the manner proposed because the proposed fees are consistent with the price differentiation that exists today for other index products, including those in Underlying Symbol A. The Exchange also believes that the proposed fee amounts for Sector Index option orders are reasonable because the proposed fee amounts are the same already assessed for other proprietary products (
The Exchange believes that it is equitable and not unfairly discriminatory to assess lower fees to Customers as compared to certain other market participants except Market-Makers and Clearing Trading Permit Holders because Customer order flow enhances liquidity on the Exchange for the benefit of all market participants. Specifically, customer liquidity benefits all market participants by providing more trading opportunities, which attracts Market-Makers. An increase in the activity of these market participants in turn facilitates tighter spreads, which may cause an additional corresponding increase in order flow from other market participants. The fees offered to customers are intended to attract more customer trading volume to the Exchange. Moreover, the options industry has a long history of providing preferential pricing to Customers, and the Exchange's current Fees Schedule currently does so in many places, as do the fees structures of many other exchanges. Finally, all fee amounts listed as applying to Customers will be applied equally to all Customers (meaning that all Customers will be assessed the same amount).
The Exchange believes that it is equitable and not unfairly discriminatory to, [sic] assess lower fees to Market-Makers pursuant to the Liquidity Provider Sliding Scale as compared to other market participants because Market-Makers, unlike other market participants, take on a number of obligations, including quoting obligations, that other market participants do not have. Further, these lower fees offered to Market-Makers are intended to incent Market-Makers to quote and trade more on the Exchange, thereby providing more trading opportunities for all market participants. Additionally, the proposed fee for Market-Makers will be applied equally to all Market-Makers (meaning that all Market-Makers will be subject to the Liquidity Provider Sliding Scale). This concept also applies to orders from all other origins. It should also be noted that all fee amounts described herein are intended to attract greater order flow to the Exchange in Sector Index options, which should therefore serve to benefit all Exchange market participants.
Similarly, it is equitable and not unfairly discriminatory to assess lower fees to Clearing Trading Permit Holder Proprietary orders than those of other market participants (except Market-Makers) because Clearing Trading Permit Holders also have a number of obligations (such as membership with the Options Clearing Corporation), significant regulatory burdens, and financial obligations, that other market participants do not need to take on. The Exchange also notes that the Sector Index option fee amounts for each separate type of market participant will be assessed equally to all such market participants (
The Exchange believes the proposed transaction fees for Brokers Dealers, Non-Trading Permit Holder Market-Makers, Professionals/Voluntary Professionals, JBOs and Customers are reasonable because they are the same as those assessed for transactions in certain other proprietary products.
The Exchange believes that assessing an Index License Surcharge Fee of $0.10 per contract to Sector Index option transactions is reasonable because the Surcharge helps recoup some of the costs associated with the license for Sector Index options. Additionally, the Exchange notes that the Surcharge amount is the same as, and in some cases lower than, the amount assessed as an Index License Surcharge to other index products. The proposed Surcharge is also equitable and not unfairly discriminatory because the amount will be assessed to all market participants to whom the Surcharge applies. Not applying the Sector Index License Surcharge Fee to Customer orders is equitable and not unfairly discriminatory because this is designed to attract Customer Sector Index option orders, which increases liquidity and provides greater trading opportunities to all market participants. The Exchange believes it is reasonable, equitable and not unfairly discriminatory to waive the Index License Surcharge because it promotes and encourages trading of these new products and applies to all Trading Permit Holders.
Similarly, the Exchange believes assessing a CFLEX Surcharge Fee of $0.10 per contract for all Sector Index option orders executed electronically on CFLEX and capping it at $250 (
Excepting VIP, the Marketing Fee, the Fee Cap, exemption from fees for facilitation orders, the AIM Contra Execution Fee, the CFLEX AIM Response Fee, the Clearing Trading Permit Holder Proprietary and/or their Non-Trading Permit Holder Affiliates transaction fee cap for all non-facilitation business executed in AIM or open outcry, or as a QCC or FLEX transaction, the ORS and CORS Programs,
The Exchange does not believe that the proposed rule changes will impose any burden on competition that are not necessary or appropriate in furtherance of the purposes of the Act. The Exchange does not believe that the proposed rule change will impose any burden on intramarket competition that is not necessary or appropriate in furtherance of the purposes of the Act because, while different fees are assessed to different market participants in some circumstances, these different market participants have different obligations and different circumstances as discussed above. For example, Market-Makers have quoting obligations that other market participants do not have. The Exchange does not believe the proposed rule change to waive the Index License Surcharge through June 30, 2018 will impose any burden on intramarket competition because it applies to all Trading Permit Holders and encourages trading in these new products.
The Exchange does not believe that the proposed rule changes will impose any burden on intermarket competition that is not necessary or appropriate in furtherance of the purposes of the Act because Sector Index options will be exclusively listed on Cboe Options. To the extent that the proposed changes make Cboe Options a more attractive marketplace for market participants at other exchanges, such market participants are welcome to become Cboe Options market participants.
The Exchange neither solicited nor received comments on the proposed rule change.
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 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On January 18, 2018, The Options Clearing Corporation (“OCC”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
As stated in the Notice, OCC filed the proposed Fee Policy to reduce the permitted implementation time for proposed changes to its Schedule of Fees.
OCC's By-Laws require OCC to set its fee structure so that it is sufficient to: (1) Cover OCC's operating expenses plus a Business Risk Buffer (“Buffer”);
As stated in the Notice, OCC believes that the current 60-day implementation period under the Fee Policy: (i) Increases the difficulty of projecting appropriate fee levels needed to cover its operating expenses and the Buffer because of the amount of time that passes between OCC's analysis of the data supporting the fee change and the subsequent implementation of the fee change; (ii) increases the risk that by the time the fee change is implemented, the extended delay in implementation may result in revenues that diverge (either higher or lower) further from the target Buffer; and (iii) increases the impact of fee changes on participants due to the delayed implementation timing.
Section 19(b)(2)(C) of the Act
Section 17A(b)(3)(F) of the Act requires that the rules of a clearing agency be designed to promote the prompt and accurate clearance and settlement of securities transactions and the protection of investors and the public interest.
The Commission believes that setting clearing fees based on more current information would allow OCC to more accurately set and collect fees necessary to support its operations, and promote the prompt and accurate clearance and settlement of securities transactions. The Commission further believes that accurate fee calculations supports the protection of investors and the public by protecting participants from large and unexpected swings in fee levels resulting from fee schedules based upon stale and outdated information. While the proposed Fee Policy would shorten the notice period for implementation, the Commission believes that thirty days still provides sufficient notice for Clearing Members to make adjustments to their activity as a result of any impending fee change. Accordingly, the Commission finds that the proposed Fee Policy promotes the prompt and accurate settlement of securities transactions and protection of investors and the public interest, consistent with Section 17A(b)(3)(F) of the Act.
Rule 17Ad-22(e)(21) requires, in part, that a covered clearing agency establish, implement, maintain, and enforce written policies and procedures that are reasonably designed to be efficient and effective in meeting the requirements of its participants and the markets it serves.
The Fee Policy requires OCC to set fees at levels designed to cover its operating expenses and to maintain the Buffer. As discussed above, the proposed Fee Policy would reduce the implementation period for fee changes from sixty to thirty days. The Commission believes the proposed change would enhance the efficiency and effectiveness of OCC's fee calculations by using more current expense and revenue information, thereby leading to more accurate fee projections. Improving the efficiency and effectiveness of OCC's fee calculation process ensures that OCC is able to cover its operating expenses and maintain the Buffer, while also reducing the possibility of large and unexpected swings in fees that could result from using stale and outdated information. Accordingly, the Commission finds that the proposed Fee Policy would enhance OCC's efficiency and effectiveness in setting accurate fees necessary to cover its operating expenses and the Buffer, thereby enhancing its efficiency and effectiveness to meet the requirements of its participants and the markets it serves, consistent with Rule 17Ad-22(e)(21).
On the basis of the foregoing, the Commission finds that the proposed Fee Policy is consistent with the requirements of the Act, and in particular, with the requirements of Section 17A of the Act
For the Commission, by the Division of Trading and Markets, pursuant to delegated Authority.
Notice of request for public comment and submission to OMB of proposed collection of information.
The Department of State has submitted the information collection described below to the Office of Management and Budget (OMB) for approval. In accordance with the Paperwork Reduction Act of 1995 we are requesting comments on this collection from all interested individuals and organizations. The purpose of this Notice is to allow 30 days for public comment.
Submit comments directly to the Office of Management and Budget (OMB) up to April 16, 2018.
Direct comments to the Department of State Desk Officer in the Office of Information and Regulatory Affairs at the Office of Management and Budget (OMB). You may submit comments by the following methods:
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Direct requests for additional information regarding the collection listed in this notice, including requests for copies of the proposed collection instrument and supporting documents, to Patrice Johnson at 3507 International Place NW, Washington DC 20008, who may be reached on 202-895-3504 or at
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We are soliciting public comments to permit the Department to:
• Evaluate whether the proposed information collection is necessary for the proper functions of the Department.
• Evaluate the accuracy of our estimate of the time and cost burden for this proposed collection, including the validity of the methodology and assumptions used.
• Enhance the quality, utility, and clarity of the information to be collected.
• Minimize the reporting burden on those who are to respond, including the use of automated collection techniques or other forms of information technology.
Please note that comments submitted in response to this Notice are public record. Before including any detailed personal information, you should be aware that your comments as submitted, including your personal information, will be available for public review.
Information collection instruments from the foreign mission community, to include the electronic data compilation (e-Gov), have been combined under one information collection request, collectively referred to as the “Foreign Diplomatic Services Applications.” These information collection instruments provide the Office of Foreign Missions and the Office of the Chief of Protocol with the information necessary to provide and administer an effective and efficient benefits, privileges, and immunities program by which foreign missions and eligible applicants may apply for benefits from the U.S. Department of State, to which they are entitled pursuant to the Foreign Missions Act or international agreement.
Information may be received via Email, fax, or electronic submission through eGov at
Notice is hereby given of the following determinations: I hereby determine that a certain object, entitled “Snow-Covered Field with a Harrow (after Millet),” to be exhibited in the Impressionism and the Late Nineteenth Century Gallery of the Harvard Art Museums, imported from abroad for temporary exhibition within the United States, is of cultural significance. The object is imported pursuant to a loan agreement with the foreign owner or custodian. I also determine that the exhibition or display of the exhibit object at the Harvard Art Museums, Cambridge, Massachusetts, from on or about March 23, 2018, until on or about July 10, 2018, and at possible additional exhibitions or venues yet to be determined, is in the national interest.
Elliot Chiu in the 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 certain component objects of a certain work of art entitled “In Pursuit of Bling,” to be included in the exhibition “Otobong Nkanga: To Dig a Hole that Collapses Again,” imported from abroad for temporary exhibition within the United States, are of cultural significance. The component objects are imported pursuant to a loan agreement with the foreign owner or custodian. I also determine that the exhibition or display of the exhibit component objects as configured in the aforesaid work of art, at the Museum of Contemporary Art Chicago, in Chicago, Illinois, from on or about March 31, 2018, until on or about September 2, 2018, and at possible additional exhibitions or venues yet to be determined, is in the national interest.
Elliot Chiu in the 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,
Pursuant to Section 490(b)(1)(A) of the Foreign Assistance Act of 1961, as amended, I hereby determine and certify that the top five exporting and importing countries and economies of pseudoephedrine and ephedrine (Egypt, Germany, Greece, India, Indonesia, Republic of Korea, Singapore, Spain, Switzerland, Turkey, and the United Kingdom) have cooperated fully with the United States, or have taken adequate steps on their own, to achieve full compliance with the goals and objectives established by the 1988 United Nations Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances.
This determination and certification shall be published in the
Federal Aviation Administration (FAA), U.S. Department of Transportation (DOT).
Twenty Seventh RTCA SC-214 Standards for Air Traffic Data Communications Services Plenary.
The FAA is issuing this notice to advise the public of a meeting of Twenty Seventh RTCA SC-214 Standards for Air Traffic Data Communications Services Plenary.
The meeting will be held April 17, 2018 9:00 a.m.-5:00 p.m.
The meeting will be held Virtually:
Karan Hofmann at
Pursuant to section 10(a) (2) of the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.), notice is hereby given for a meeting of the Twenty Seventh RTCA SC-214 Standards for Air Traffic Data Communications Services Plenary. The agenda will include the following:
Attendance is open to the interested public but limited to space availability. With the approval of the chairman, members of the public may present oral statements at the meeting. Persons wishing to present statements or obtain information should contact the person listed in the
The Federal Aviation Administration (FAA), Department of Transportation (DOT) is the lead agency. The National Aeronautics and Space Administration and National Park Service are cooperating agencies.
Notice of availability and request for comment; Notice of public hearings.
The FAA is announcing the availability of and requesting comments on the Spaceport Camden Draft EIS, which is available for public review. The Draft EIS evaluates the potential environmental impacts that may result from the FAA's Proposed Action of issuing a Launch Site Operator License to the Camden County Board of Commissioners (County) to operate a proposed commercial space launch site, called Spaceport Camden. The license would allow the County to offer Spaceport Camden to commercial launch operators to conduct vertical launches.
Comments must be received on or before May 16, 2018.
The FAA will hold two public hearings to solicit comments from the public concerning the content of the Draft EIS. The dates of the hearings are Wednesday, April 11, and Thursday, April 12, 2018, from 5:30 p.m. to 8:30 p.m.
The FAA will hold the two public hearings at the following location: Camden County Public Service Authority Recreation Center Community Room, 1050 Wildcat Drive, Kingsland, GA 31548 (912-729-5600).
A paper copy of the Draft EIS is available for review during regular business hours at the following libraries:
Comments regarding the Draft EIS should be mailed to Ms. Stacey M. Zee, Environmental Specialist, Federal Aviation Administration, c/o Leidos, 2109 Air Park Road SE, Suite 200, Albuquerque, NM 87106. Comments may also be submitted by email to
Ms. Stacey M. Zee, Environmental Specialist, Federal Aviation Administration, 800 Independence Ave. SW, Suite 325, Washington, DC 20591; telephone (202) 267-9305; email
The FAA is announcing the availability of and requesting comments on the Spaceport Camden Draft EIS, in accordance with the National Environmental Policy Act of 1969 as amended (42 United States Code [U.S.C.] §§ 4321
An electronic version of the Draft EIS is available on the FAA Office of Commercial Space Transportation website at:
The FAA encourages all interested agencies, organizations, Native American tribes, and members of the public to submit comments concerning the analysis presented in the Draft EIS by May 16, 2018. Comments should be as specific as possible and address the analysis of potential environmental impacts and the adequacy of the proposed action or merits of alternatives and any mitigations being considered. Reviewers should organize their participation so that it is meaningful and makes the agency aware of the viewer's interests and concerns using quotations and other specific references to the text of the Draft EIS and related documents. Matters that could have been raised with specificity during the comment period on the Draft EIS may not be considered if they are raised for the first time later in the decision process. This commenting procedure is intended to ensure that substantive comments and concerns are made available to the FAA in a timely manner so that the FAA has an opportunity to address them.
Before including your address, phone number, email address, or other personal identifying information in your comment, be advised 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 from public review your personal identifying information, we cannot guarantee that we will be able to do so.
Due to the large turnout during the public scoping meetings, the FAA will hold two public hearings to solicit comments from the public concerning the content of the Draft EIS on Wednesday, April 11 and Thursday, April 12, 2018, from 5:30 p.m. to 8:30 p.m. at the following location: Camden County Public Service Authority Recreation Center Community Room, 1050 Wildcat Drive, Kingsland, GA 31548 (912-729-5600).
At the public hearings, the FAA will present information about the Draft EIS and the environmental review process. Please note the FAA will present identical information at each public hearing. If you are planning to provide oral comments during the hearing, we ask that you speak at only one of the hearings, so that everyone wanting to present comments has the opportunity to do so, as time is limited. The purpose of the public hearings is to afford the public and other interested parties the opportunity to comment on the analysis of the Proposed Action and alternatives presented in the Draft EIS. Members of the public and other interested parties will be provided the opportunity to submit both written and oral comments. The hearings will include a poster information session and an FAA presentation, followed by a public statement period in which members of the public can present up to a three-minute statement. The FAA will transcribe oral comments. All comments received during the comment period will be given equal weight and taken into consideration during preparation of the Final EIS.
Under the Proposed Action, the FAA would issue a Launch Site Operator License to the County. The license would allow the County to offer Spaceport Camden to commercial launch operators to conduct launches of liquid-fueled, small to medium-large lift-class, orbital and suborbital vertical launch vehicles. The license would allow up to 12 vertical launches and up to 12 associated launch vehicle first-stage landings per year. In support of the launches, there would be up to 12 wet dress rehearsals and up to 12 static fire engine tests per year. All vehicles would launch to the east, from between 83 degrees (slightly north of due east) and 115 degrees (approximately east southeast), over the Intracoastal Waterway, Cumberland Island National Seashore and/or Little Cumberland Island, and the Atlantic Ocean. The Proposed Action includes possible recovery of the first stage by either landing the stage at Spaceport Camden or landing the stage on a barge approximately 200 to 300 miles off shore in the Atlantic Ocean and returning it to Spaceport Camden.
Alternatives under consideration in the Draft EIS include the Proposed Action, an Ocean-Landing Only Alternative (similar to the Proposed Action except first-stage landings would only occur on a barge approximately 200 to 300 miles off shore in the Atlantic Ocean), and the No Action Alternative.
The Draft EIS evaluates the potential direct, indirect, and cumulative environmental impacts that may result from the Proposed Action, Ocean-Landing Only Alternative, and the No Action Alternative. The FAA assessed impact categories to provide a context for understanding and assessing the potential environmental impacts of the construction and operation, as well as secondary (induced) impacts associated with the Proposed Action and alternatives. The Draft EIS focuses on the following impact categories: Air quality; biological resources (including fish, wildlife, and plants); climate; coastal resources; Department of Transportation Act, Section 4(f) (including park and recreational lands, wildlife and waterfowl refuges, and historic sites in transportation project development); farmlands; hazardous materials, solid waste, and pollution prevention; historical, architectural, archeological, and cultural resources; land use; natural resources and energy supply; noise and compatible land use; socioeconomics, environmental justice, and children's environmental health and safety risks; visual effects (including light emissions), and water resources (including wetlands, floodplains, surface waters, groundwater, and wild and scenic rivers). The following topics were also analyzed and are appended to the Draft EIS: Health and safety, soils and geology, transportation, and airspace.
Federal Aviation Administration (FAA), U.S. Department of Transportation (DOT).
Thirty Ninth RTCA SC-216 Aeronautical Systems Security Plenary.
The FAA is issuing this notice to advise the public of a meeting of Thirty Ninth RTCA SC-216 Aeronautical Systems Security Plenary.
The meeting will be held April 09-13, 2018 9:00 a.m.-5:00 p.m.
The meeting will be held at: RTCA Headquarters, 1150 18th Street NW, Suite 910, Washington, DC 20036.
Karan Hofmann at
Pursuant to section 10(a) (2) of the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.), notice is hereby given for a meeting of the Thirty Ninth RTCA SC-216 Aeronautical Systems Security Plenary.
The agenda will include the following:
Attendance is open to the interested public but limited to space availability. With the approval of the chairman, members of the public may present oral statements at the meeting. Persons wishing to present statements or obtain information should contact the person listed in the
Maryland Department of Transportation State Highway Administration (MDOT SHA), Federal Highway Administration (FHWA), Department of Transportation (DOT).
Notice of intent to prepare an Environmental Impact Statement (EIS).
The FHWA, as the Lead Federal Agency, and MDOT SHA, as the Local Project Sponsor, are issuing this notice to advise the public of our intention to prepare an EIS for the I-495 & I-270 Managed Lanes Study (Study). The Study is the first element of a broader Traffic Relief Plan as announced by Governor Larry Hogan in September 2017, which considers improvements along the entire length of I-495 (Capital Beltway), as well as the entire length of I-270 (Dwight D. Eisenhower Memorial Highway) up to I-70 in Frederick County, Maryland. This EIS will evaluate the potential environmental impacts of alternatives that address congestion within the specific Study scope of I-495 from south of the American Legion Bridge in Fairfax County, Virginia to east of the Woodrow Wilson Bridge and on I-270 from I-495 to I-370, including the east and west I-270 spurs in Montgomery and Prince George's Counties, Maryland. The EIS will be prepared in accordance with regulations implementing the National Environmental Policy Act (NEPA) and provisions of the Fixing America's Surface Transportation (FAST) Act and will include a range of reasonable alternatives, including a “No Build” alternative.
Jeanette Mar, Environmental Program Manager, Federal Highway Administration, Maryland Division, George H. Fallon Federal Building 31 Hopkins Plaza, Suite 1520, Baltimore MD 21201, (410) 779-7152, or email at
The purpose of this notice is to: (1) Alert interested parties to the FHWA and MDOT SHA plan to prepare the EIS; (2) provide information on the nature of the proposed action; (3) solicit public and agency input regarding the scope of the EIS, including the purpose and need, alternatives to be considered, and impacts to be evaluated; and (4) announce that public and agency scoping meetings will be conducted.
The Study limits extend to areas in Montgomery and Prince George's counties, Maryland along I-495 (Capital Beltway) from south of the American Legion Bridge in Fairfax County, Virginia, to east of the Woodrow Wilson Bridge and on I-270 (Dwight D. Eisenhower Memorial Highway) from I-495 to I-370 including the east and west I-270 spurs.
At the present time, high travel demand from commuter, business, and recreational trips results in severe congestion nearly 10 hours a day in the Study corridors. Travelers place a high value on reaching their destinations in a timely manner, and in recent years, the Study corridors have become so unreliable that uncertain travel times are experienced daily. Managed lanes are needed to provide more dependable travel times and congestion relief. Motorists on I-495 and I-270 do not have an option for efficient travel during extensive periods of congestion. Additional roadway management options are needed to improve travel choices.
Additional capacity and improvements to enhance reliability must be financially viable. MDOT's traditional funding sources would be unable to effectively finance, construct, operate, and maintain highway systems of this magnitude. A revenue source that provides necessary funding, such as tolling options, is needed to provide additional capacity and improvements addressing existing and anticipated high travel demand. A Public-Private Partnership (P3) with the state will be pursued to develop innovative approaches to design, build, finance, operate, and maintain the potential improvements developed through the NEPA Study.
The intent of the proposed action to be assessed in the Study is to accommodate existing traffic and long-term traffic growth, enhance trip reliability, and provide an additional roadway travel choice. Additional roadway options would also accommodate homeland security needs and improve the movement of goods and services throughout the Study corridor. The EIS will include a review of existing and future traffic, existing roadway infrastructure, and existing environmental conditions to establish context for the identification of alternatives and assessment of potential impacts. The analyses undertaken during the EIS will result in identification of the alternative that best meets the Study purpose and need while considering the environmental impacts of that alternative. The alternatives evaluated in the EIS will include build alternatives which provide additional capacity and offer travel choices for travelers on I-495 and I-270. The “No Build” alternative will
The EIS will be prepared by MDOT SHA for FHWA to fulfill the requirements established in NEPA pursuant to current FHWA regulations and guidance. MDOT SHA intends to recommend a preferred alternative in the Draft EIS. The FHWA may issue a single Final EIS and Record of Decision (Final EIS/ROD), unless FHWA determines statutory criteria or consideration precluding issuance of a combined decision document.
Previous analyses which evaluated managed lanes in the Study corridors will be considered and incorporated by reference, as appropriate. The Study will consider relevant resource identification and field investigations from previous studies. To the extent consistent with FHWA NEPA regulations, conclusions reached as part of previous planning studies could inform the initial range of alternatives and focus the alternatives evaluation. Since 1990, several studies have examined various sections of I-495 and I-270 within the current Study limits in an effort to evaluate potential congestion relief and operational improvements. Among other issues, these studies considered the potential to provide additional capacity along I-495 and I-270 that could connect with adjacent transportation facilities. Recommendations resulting from each of these studies included the implementation of managed lanes (including Express Toll Lanes [ETL], High-Occupancy vehicle [HOV] lanes, and High-Occupancy Toll [HOT] lanes) on I-495 and radial facilities, (
The
In July 2017, the National Capital Region Transportation Planning Board at the MWCOG approved a set of ten regional initiatives for further study, which includes analyzing managed lanes on the portions of I-495 and I-270 that are included in the I-495 and I-270 Managed Lanes Study. In September 2017, Maryland Governor Hogan announced the intent to develop additional capacity along sections of I-270, I-495, and the Baltimore-Washington Parkway (MD 295). For I-495 and I-270, the Governor has proposed a P3 to design, build, finance, operate, and maintain this project to accelerate the delivery of improvements for congestion relief.
FHWA and MDOT SHA will undertake a scoping process for the I-495 & I-270 Managed Lanes Study that will solicit input from the public and interested agencies on the issues that will be evaluated in EIS. This public outreach effort will educate and engage stakeholders regarding the nature and extent of the proposed action. FHWA and MDOT SHA will invite all interested individuals, organizations, and public agencies to comment on the scope of the EIS, including the purpose and need, potential alternatives to be studied, environmental impacts to be considered, evaluation methods to be used, and potential mitigation measures.
More information on public outreach activities, including future public workshops, will be available in a project coordination plan on the Study website. All public meetings related to the Study will be held in locations accessible to persons with disabilities. Any person who requires special assistance, such as a language interpreter, should contact the I-495 & I-270 P3 Office at (833) 858-5960 via email at
Letters inviting agencies to be cooperating or participating in the environmental review process are being sent to those agencies that have jurisdiction or may have an interest in the EIS. Additionally, FHWA and MDOT SHA will notify cooperating and participating agencies of a separate agency scoping meeting.
Four initial public workshop presentations will be held in April 2018 to solicit public input regarding the scope of issues that will be included in the EIS. Written comments on the scope of the EIS should be provided to MDOT SHA by May 1, 2018, using the email address or physical mailing address listed below. Comments may also be provided in writing at the public workshops.
The public and other interested parties are encouraged to comment on-line at the Study's website (
23 U.S.C. 315; 49 CFR 1.48; 23 CFR 771.111 and 771.123.
Federal Highway Administration (FHWA), DOT.
Notice and request for comments.
The FHWA has forwarded the information collection request described in this notice to the Office of Management and Budget (OMB) for approval of a new information collection. We published a
Please submit comments by April 16, 2018.
You may send comments within 30 days to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street NW, Washington, DC 20503, Attention DOT Desk Officer. You are asked to comment on any aspect of this information collection, including: (1) Whether the proposed collection is necessary for the FHWA's performance; (2) the accuracy of the estimated burden; (3) ways for the FHWA to enhance the quality, usefulness, and clarity of the collected information; and (4) ways that the burden could be minimized, including the use of electronic technology, without reducing the quality of the collected information. All comments should include the Docket No. FHWA-2018-0015.
Crystal Taylor, 202-366-2907, Office of Human Resources, Corporate Recruitment and Career Entry Division, Federal Highway Administration, Department of Transportation, 1200 New Jersey Avenue, SE, Washington, DC 20590. Office hours are from 9 a.m. to 5 p.m., Monday through Friday, except Federal holidays.
The STIPDG anticipates accepting approximately 500 applications each year and placing an estimated 60-120 undergraduate, graduate, and law students in transportation-related, non-administrative, technical, hands-on assignments with a Federal or State mentor providing on-the- job training. The STIPDG will provide college students with an opportunity to work on current transportation-related topics and issues identified in, or directly pertaining to, the current DOT Strategic Plan. The STIPDG is open to all qualified applicants regardless of race, color, religion, sex, national origin, political affiliation, sexual orientation, marital status, disability, age, membership in an employee organization, or other non-merit factor.
The STIPDG is open to all applicants based on the eligibility requirements that follow and based on the merit of the “Required Documents” listed in bulleted-format below:
1. Applicants must be currently enrolled in degree-granting programs of study at accredited U.S. institutions of higher education recognized by the U.S. Department of Education.
2. Undergraduate applicants must
3. Law Applicants must be
4. Applicants who are scheduled to graduate during the coming spring or summer semesters are not eligible for consideration for the STIPDG
5. Former STIPDG interns may apply but will not receive preferential consideration.
6. Applicants will be evaluated based on the “completeness of the application and the Required Documents” listed below. Priority will be given to those with GPA's of 3.0 or better (for the Major and/or cumulatively).
7. Applicants must be available and able to participate in the entire 10-week program.
The Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended; and 49 CFR 1.48.
Under part 211 of Title 49 of the Code of Federal Regulations (CFR), this document provides the public notice that on November 11, 2017, Brightline (BLF) has petitioned the Federal Railroad Administration (FRA) for a waiver of compliance from certain provisions of the Federal railroad safety regulations contained at 49 CFR part 229,
BLF has purchased ten Siemens SCB-40 locomotives to power Brightline trains between Miami and Orlando, Florida. BLF requests relief from the requirements of 49 CFR 229.61,
A copy of the petition, as well as any written communications concerning the petition, is available for review online at
Interested parties are invited to participate in these proceedings by submitting written views, data, or comments. FRA does not anticipate scheduling a public hearing in connection with these proceedings since the facts do not appear to warrant a hearing. If any interested parties desire an opportunity for oral comment and a public hearing, they should notify FRA, in writing, before the end of the comment period and specify the basis for their request.
All communications concerning these proceedings should identify the appropriate docket number and may be submitted by any of the following methods:
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Communications received by April 30, 2018 will be considered by FRA before final action is taken. Comments received after that date will be considered if practicable.
Anyone can search the electronic form of any written communications and comments received into any of our dockets by the name of the individual submitting the comment (or signing the document, if submitted on behalf of an association, business, labor union, etc.). Under 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its processes. DOT posts these comments, without edit, including any personal information the commenter provides, to
Departmental Offices, U.S. Department of the Treasury.
Request for comment.
The Terrorism Risk Insurance Program Reauthorization Act of 2015 (Reauthorization Act), which extended and amended certain provisions of the Terrorism Risk Insurance Program (TRIP or Program), requires the Secretary of the Treasury (Secretary) to submit a report to Congress by June 30, 2018 concerning, in general, the overall effectiveness of TRIP. To assist the Secretary in formulating the report, the Federal Insurance Office (FIO) within the Department of the Treasury (Treasury) is seeking comments from the industry and other stakeholders on the statutory factors that the report must analyze, as well as any other feedback about the effectiveness of TRIP.
Submit comments on or before April 30, 2018.
Submit comments electronically through the Federal eRulemaking Portal at
Richard Ifft, Senior Insurance Regulatory Policy Analyst, Federal Insurance Office, (202) 622-2922 (this is not a toll-free number) or Lindsey Baldwin, Senior Policy Analyst, Federal Insurance Office, (202) 622-3220 (not a toll free number). Persons who have difficulty hearing or speaking may access these numbers via TTY by calling the toll-free Federal Relay Service at (800) 877-8339.
The Terrorism Risk Insurance Act of 2002, as amended (TRIA), requires participating insurers to make insurance available for losses resulting from acts of terrorism, and provides a federal government backstop for the insurers' resulting financial exposure. TRIA established TRIP within Treasury, and the Program is administered by the Secretary with the assistance of FIO. Section 111 of the Reauthorization Act (Pub. L. 114-1) requires the Secretary to prepare and submit reports to the Committee on Financial Services of the House of Representatives and the Committee on Banking, Housing, and Urban Affairs of the Senate on, among other things, the impact and effectiveness of TRIP. The report which is to be submitted by June 30, 2018 will also include an analysis of information that is being collected by Treasury through the 2018 TRIP Data Call,
The Section 111 factors that must be considered in the report and on which Treasury seeks comments include:
1. The overall effectiveness of TRIP;
2. Any changes or trends you have observed relating to the data Treasury is collecting under Section 111 of the Reauthorization Act;
3. Whether any aspects of TRIP have the effect of discouraging or impeding insurers from providing commercial property casualty insurance coverage or coverage for acts of terrorism; and
4. Any impact of TRIP on workers' compensation insurers in particular. Collecting information and views via this request for comments on the matters that must be addressed in the report will enhance the accuracy and value of the report to Congress, by offering qualitative feedback that may not be otherwise observable through the results of the TRIP Data Calls. Comments from insurers that are otherwise providing data, from other stakeholders, and from the public at large will assist the Secretary in the formulation of the report. In addition to comments on the above statutory factors, Treasury also seeks comments on:
5. The availability and affordability of terrorism risk insurance coverage, both nationally and in particular geographic areas;
6. Whether any lines of insurance or coverages within certain lines of insurance currently subject to the Program do not require the support of TRIP;
7. The market for standalone terrorism risk insurance that is written outside of TRIP, the reasons such coverage is offered and obtained, and whether the existence of such insurance provides any insights into the effectiveness of the Program;
8. The availability and affordability of private reinsurance, or capital markets support, for terrorism risk insurance exposures (both those which are currently subject to support under TRIP as well as those otherwise held by insurers participating in TRIP);
9. The extent to which reinsurance for terrorism risk is being obtained as part of catastrophe reinsurance programs generally, the reasons for this, and how if at all this has affected market capacity for terrorism risk reinsurance generally;
10. Any factors that impede private reinsurance or capital markets support for terrorism risk insurance;
11. The availability of terrorism risk insurance coverage for losses arising from nuclear, biological, chemical, or radiological (NBCR) exposures, and the availability of private reinsurance or capital markets support for such terrorism risk insurance;
12. Terrorism risk insurance issues presented by cyber-related losses, the impact of TRIP in connection with such exposures, and any reforms that would encourage the take up of insurance for cyber-related losses arising from acts of terrorism within the meaning of TRIA;
13. Private reinsurance or capital markets support for cyber-related losses arising from acts of terrorism within the meaning of TRIA; and
14. Any other issues relating to TRIP or terrorism risk insurance or reinsurance that may be relevant to an assessment of the effectiveness of TRIP in the report.
Food and Drug Administration, HHS.
Advance notice of proposed rulemaking.
The Food and Drug Administration (FDA) is issuing this advance notice of proposed rulemaking (ANPRM) to obtain information for consideration in developing a tobacco product standard to set the maximum nicotine level for cigarettes. Because tobacco-related harms ultimately result from addiction to the nicotine in such products, causing repeated use and exposure to toxicants, FDA is considering taking this action to reduce the level of nicotine in these products so they are minimally addictive or nonaddictive, using the best available science to determine a level that is appropriate for the protection of the public health. FDA is using the term “nonaddictive” in this document specifically in the context of a potentially nonaddictive cigarette. We acknowledge the highly addictive potential of nicotine itself depending upon the route of delivery. As discussed elsewhere in this document, questions remain with respect to the precise level of nicotine in cigarettes that might render them either minimally addictive or nonaddictive for specific members or segments of the population. We envision the potential circumstance where nicotine levels in cigarettes do not spur or sustain addiction for some portion of potential smokers. This could give addicted users the choice and ability to quit more easily, and it could help to prevent experimenters (mainly youth) from initiating regular use and becoming regular smokers. The scope of products covered by any potential product standard will be one issue for comment in the ANPRM. Any additional scientific data and research relevant to the empirical basis for regulatory decisions related to a nicotine tobacco product standard is another issue for comment in the ANPRM.
Submit either electronic or written comments on the ANPRM by June 14, 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 June 14, 2018. The
Submit electronic comments in the following way:
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• 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:
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• 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
Gerie Voss, Center for Tobacco Products, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 1-877-CTP-1373,
Tobacco use causes a tremendous toll of death and disease every year, and these effects are ultimately the result of addiction to the nicotine in combustible cigarettes which causes repeated use of such products, thus repeatedly exposing users and non-users to toxicants. This nicotine addiction causes users to engage in compulsive tobacco use, makes quitting less likely, and, thus, repeatedly exposes them to thousands of toxicants in combusted tobacco products. This is especially true with respect to cigarette smoking. Through this ANPRM, FDA indicates that it is considering the issuance of a product standard to set a maximum nicotine level in cigarettes so that they are minimally addictive or nonaddictive, using the best available science to determine a level that is appropriate for the protection of the public health. The Agency seeks information and comment on a number of issues associated with such a potential product standard. Greatly reducing or eliminating the addictiveness of cigarettes would have significant benefits for youth, young adults, and adults. More than half of adult cigarette smokers make a serious quit attempt each year (quit for at least a day), many of whom do not succeed due to the addictive nature of these products (Ref. 1). The establishment of a maximum nicotine level in cigarettes not only could increase the likelihood of successful quit attempts, but it also could help prevent experimenters (mainly youth and young adults) from initiating regular cigarette smoking. Therefore, rendering cigarettes minimally addictive or nonaddictive (however that were achieved) could help current users quit and prevent future users from becoming addicted and escalating to regular use.
In this ANPRM, FDA is seeking information on a variety of issues regarding the development of a tobacco product standard that would limit the amount of nicotine in cigarettes. Specifically, FDA is seeking your comments, evidence, and other information supporting your responses to questions on the following topics:
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Another possible countervailing effect is the potential for increased harm due to continued VLNC smoking with altered smoking behaviors (
Another possible countervailing effect of setting a maximum nicotine level for cigarettes could be users seeking to add nicotine in liquid or other form to their combusted tobacco product. Therefore, FDA is considering whether any action it might take to reduce nicotine in cigarettes should be paired with a provision that would prohibit the sale or distribution of any tobacco product designed for the purposes of supplementing the nicotine content of the combusted tobacco product (or where the reasonably foreseeable use of the product is for the purposes of supplementing the nicotine content). FDA is also considering other regulatory options to address this concern.
FDA is also considering whether illicit trade could occur as a result of a nicotine tobacco product standard and how that could impact the marketplace. In addition, FDA is considering how, if FDA were to issue a nicotine tobacco product standard that prompted an increase in the illicit market, comprehensive interventions could reduce the size of the illicit tobacco market through enforcement mechanisms and collaborations across jurisdictions.
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Further, this ANPRM briefly describes the potential public health benefits that could result from the increased cessation from and decreased initiation to regular use of cigarettes that FDA expects could occur with a nicotine tobacco product standard. FDA references findings from a population-based simulation model that projects the potential public health impact of enacting a regulation lowering nicotine levels in cigarettes and certain other combusted tobacco products to minimally addictive levels, utilizing inputs derived from empirical evidence and expert opinion (eight subject matter experts provided quantitative estimates for the potential outcomes of the policy on smoking cessation, initiation, switching, and dual use rates). Based on the experts' determinations that the reduction in nicotine levels in combusted tobacco products would create substantial reductions in smoking prevalence due to increased smoking cessation and reduced initiation of regular smoking, the model calculates that by the year 2100, more than 33 million youth and young adults who would have otherwise initiated regular smoking would not start as a result of a nicotine tobacco product standard. The model also projected that approximately 5 million additional smokers would quit smoking 1 year after implementation of the product standard, compared to the baseline scenario, which would increase to approximately 13 million additional former smokers within 5 years after policy implementation.
On July 28, 2017, FDA announced a comprehensive approach to the regulation of nicotine that includes the Agency's plan to begin a public dialogue about lowering nicotine levels in combustible cigarettes to minimally addictive or nonaddictive levels through achievable product standards, including the issuance of an ANPRM to seek input on the potential public health benefits and any possible adverse effects of lowering nicotine in cigarettes. Tobacco use causes a tremendous toll of death and disease every year, and these effects are ultimately the result of addiction to the nicotine contained in combustible cigarettes, leading to repeated exposure to toxicants from such cigarettes. This nicotine addiction causes users to engage in compulsive use, makes quitting less likely and, therefore,
Preventing nonsmokers, particularly youth and young adults, from becoming regular smokers due to nicotine addiction would allow them to avoid the severe adverse health consequences of smoking and would result in substantial public health benefits. In 2014, the Surgeon General estimated that, unless this trajectory is changed dramatically, 5.6 million youth aged 0 to 17 years alive today will die prematurely from a smoking-related disease (Ref. 7 at table 12.2.2). In 2009, Congress estimated that a 50 percent reduction in youth smoking would also result in approximately $75 billion in savings
Nicotine is powerfully addictive. The Surgeon General has reported that 87 percent of adult smokers start smoking before the age of 18 and half of adult smokers become addicted before the age of 18, which is before the age at which they can legally buy a pack of cigarettes (Ref. 7). Nearly all smokers begin before the age of 25, which is the approximate age at which the brain has completed development (Ref. 8). Generally, those who begin smoking before the age of 18 are not aware of the degree of addictiveness and the full extent of the consequences of smoking when they begin experimenting with tobacco use (see,
Because it is such a powerful addiction, addiction to nicotine is often lifelong (Ref. 14). Among adolescent tobacco users in 2012, over half (52.2 percent) reported experiencing at least one symptom of tobacco dependence (Ref. 15). FDA expects that making cigarettes minimally addictive or nonaddictive (however that were achieved) may have significant benefits for youth by reducing the risk that youth experimenters progress to regular use of cigarettes as a result of nicotine dependence.
The adolescent brain is more vulnerable to developing nicotine dependence than the adult brain; there are also data from animal studies that indicate that brain changes induced by nicotine may have long-term consequences (
For all these reasons, FDA is considering limiting the addictiveness of cigarettes by setting a product standard establishing a maximum nicotine level of cigarettes, to help prevent experimenters (who are mainly youth) from becoming addicted to tobacco and, thus, prevent them from initiating regular use and from increasing their risk of tobacco-related death and disease.
FDA is also considering this action because age restrictions on the sale of tobacco products, by themselves, are not entirely effective in preventing youth from obtaining cigarettes or other combusted tobacco products. Youth smokers get their cigarettes from a variety of sources, including directly purchasing them from retailers, giving others money to buy them, obtaining them from other youth or adults (with
Similarly, limiting the nicotine in cigarettes could have significant benefits for adult tobacco product users, a large majority of whom want to quit but are unsuccessful because of the highly addictive nature of these products (see,
Although many factors contribute to an individual's initial experimentation with tobacco products, the addictive nature of tobacco is the major reason people progress to regular use, and it is the presence of nicotine that causes youth, young adults, and adult users to become addicted to, and to sustain, tobacco use (see,
Accordingly, FDA is considering whether to issue a tobacco product standard to: (1) Give addicted users of cigarettes the choice and ability to quit more easily by reducing the nicotine to a minimally addictive or nonaddictive level and (2) reduce the risk of progression to regular use and nicotine dependence for persons who experiment with the tobacco products covered by the standard. FDA hypothesizes that making cigarettes minimally addictive or nonaddictive, using the best available science to determine a level that is appropriate for the protection of the public health, could significantly reduce the morbidity and mortality caused by smoking.
The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) was enacted on June 22, 2009, amending the FD&C Act and providing FDA with the authority to regulate tobacco products (Pub. L. 111-31). Section 901 of the FD&C Act (21 U.S.C. 387a), as amended by the Tobacco Control Act, granted FDA authority to regulate the manufacture, marketing, and distribution of cigarettes, cigarette tobacco, RYO tobacco, and smokeless tobacco to protect the public health and to reduce tobacco use by minors. The Tobacco Control Act also gave FDA the authority to issue a regulation deeming other products that meet the statutory definition of tobacco product to be subject to FDA's tobacco product authority under chapter IX of the FD&C Act. On May 10, 2016, FDA issued the deeming rule (81 FR 28973), extending FDA's tobacco product authority to all tobacco products, other than the accessories of deemed tobacco products, that meet the statutory definition of tobacco product.
Among the authorities included in chapter IX of the FD&C Act is the authority to establish tobacco product standards. The Act authorizes FDA to adopt a tobacco product standard under section 907 of the FD&C Act if the Secretary of Health and Human Services (HHS) finds that a tobacco product standard is appropriate for the protection of the public health. In making such a finding, the Secretary of HHS must consider scientific evidence concerning: (1) The risks and benefits of the proposed standard to the population as a whole, including users and nonusers of tobacco products; (2) the increased or decreased likelihood that existing users of tobacco products will stop using such products; and (3) the increased or decreased likelihood that those who do not use tobacco products will start using such products (section 907(a)(3)(B)(i) of the FD&C Act).
Section 907(a)(4) of the FD&C Act states that tobacco product standards must include provisions that are appropriate for the protection of the public health. Section 907(a)(4)(B)(i) provides that a product standard must include, where appropriate for the protection of the public health, provisions respecting the construction, components, ingredients, additives, constituents, including smoke constituents, and properties of the tobacco product. Further, section 907(a)(4)(A)(i) states that provisions in tobacco product standards must include, where appropriate, provisions for nicotine yields. Section 907(a)(4)(B)(ii) also provides that a product standard must, where appropriate for the protection of public health, include “provisions for the testing (on a sample basis or, if necessary, on an individual basis) of the tobacco product.” In addition, section 907(a)(4)(B)(iv) provides that, where appropriate for the protection of public health, a product standard must include provisions requiring that the results of the tests of the tobacco product required under section 907(a)(4)(B)(ii) show that the product is in conformity with the portions of the standard for which the test(s) were required. Finally, section 907(d)(3)(B) of the FD&C Act prohibits the Agency from issuing a regulation that would require the reduction of nicotine yields of a tobacco product to zero.
The FD&C Act also provides FDA with authority to issue regulations establishing restrictions on the sale and distribution of a tobacco product (section 906(d)(1) of the FD&C Act (21 U.S.C. 387f(d)(1))). These restrictions
FDA intends to use the information submitted in response to this ANPRM, its independent scientific knowledge, and other appropriate information, to further inform its thinking about options, including the scope, for a potential product standard that would set a maximum nicotine level for cigarettes, and restrictions prohibiting the sale and distribution of any product that violates such a standard.
Tobacco products are addictive, primarily due to the presence of nicotine, and the magnitude of public health harm caused by tobacco products is inextricably linked to their addictive nature (Ref. 13 at p. xi). Cigarettes are the most widely used tobacco products among adults and are responsible for at least 480,000 premature deaths in the United States each year (Ref. 7). Other combusted tobacco products that are possible targets of product migration (
The Surgeon General has reported that “most people begin to smoke in adolescence and develop characteristic patterns of nicotine dependence before adulthood” (Ref. 36 at p. 29). Adolescents develop physical dependence and experience withdrawal symptoms when they try to quit smoking (id.). The 2014 Surgeon General's Report states that 5.6 million youth currently 0 to 17 years of age are projected to die prematurely from smoking-related illnesses (Ref. 7 at pp. 666-667). Accordingly, using the best available science to determine a level that is appropriate for the protection of the public health, making cigarettes minimally addictive or nonaddictive would limit the number of youth and young adults who progress from experimentation to regular use and who, thereby, increase their risk for dangerous smoking-related diseases.
Researchers have determined that almost one-third of adolescents aged 11 to 18 (31 percent) are “early experimenters,” meaning that they have tried smoking at least one puff of a cigarette (but smoked no more than 25 cigarettes in their lifetime) (Ref. 37). The Centers for Disease Control and Prevention (CDC) and other researchers have estimated that 30 percent or more of experimenters become established smokers (Ref. 37, citing Refs. 38 and 39). Given these past trends, if one applies the 30 percent estimate to the adolescents who were early experimenters in 2000, then 2.9 million of these early experimenters have now or will become established smokers (Ref. 37). Based on the number of persons aged 0 to 17 in 2012, the Surgeon General estimated that 17,371,000 of that group will become future smokers and 5,557,000 will die from a smoking-related disease (Ref. 7 at T. 12.2.1). These high numbers speak to the extreme vulnerability of today's children and adolescents to the health harms of tobacco use resulting from addiction.
Nicotine addiction is a critical factor in the transition of smokers from experimentation to sustained smoking and in the continuation of smoking for those who want to quit (Ref. 7 at p. 113; Ref. 17). Intermittent smokers, even very infrequent smokers, can become addicted to tobacco products (Ref. 40). Longitudinal research has shown that smoking typically begins with experimental cigarette use and the transition to regular smoking can occur relatively quickly by smoking as few as 100 cigarettes (Ref. 8). Other research found that among the 3.9 million middle and high school students who reported current use of tobacco products (including cigarettes and cigars) in 2012, 2 million of those students reported at least one symptom of dependence (Ref. 15).
Although the majority of adolescent daily smokers meet the criteria for nicotine dependence, one study found that the most susceptible youth lose autonomy (
It is clear that many adult cigarette smokers want to quit. Data from the 2015 National Health Interview Survey show that 68 percent of current adult smokers in the United States wanted to quit and 55.4 percent of adult smokers made a past-year quit attempt of at least 1 day (Ref. 22). According to an analysis of this survey, only 7.4 percent of former adult cigarette smokers had recently quit (id.).
For adult smokers who report quit attempts, many of these attempts are unsuccessful. For example, among the 19 million adults who reported attempting to quit in 2005, epidemiologic data suggest that only 4 to 7 percent were successful (Ref. 28 at p. 15). Similarly, the Institute of Medicine (IOM), considering data from 2004, found that although approximately 40.5 percent of adult smokers reported attempting to quit in that year, only between 3 and 5 percent were successful (Ref. 13 at p. 82). Adult smokers may make as many as thirty or more quit attempts before succeeding (Ref. 45). FDA also notes that adults with education levels at or below the equivalent of a high school diploma have the highest smoking prevalence levels but the lowest quit ratios (
Adolescents also experience low success rates when attempting to quit. As we have noted, most Americans who use tobacco products begin using when they are under the age of 18 and become addicted before reaching the age of 18 (Refs. 36 and 47). Although many adolescents believe “they can quit [smoking] at any time and therefore avoid addiction,” nicotine dependence can be rapidly established (Ref. 13 at p. 89; see also Ref. 28 at p. 158). Research has shown that some adolescents report symptoms of withdrawal and craving within days or weeks of beginning to smoke (Ref. 48). As a result, many adolescents are nicotine dependent despite their relatively short smoking histories (Ref. 11). An analysis of data from the 2015 YRBS found that, of those currently smoking cigarettes, 45.4 percent had tried to quit smoking cigarettes during the previous year (Ref. 19). Likewise, an analysis of the 2012 National Youth Tobacco Survey (NYTS) revealed that 51.5 percent of middle and high school student smokers had sought to quit all tobacco use in the previous year (Ref. 49).
Relapse is the principal limiting factor in the transition of smoking to nonsmoking status (Ref. 17). Relapse refers to the point after an attempt to stop smoking when tobacco use becomes ongoing and persistent (Ref. 17, citing Ref. 50). Most smokers who ultimately relapse do so soon after their quit attempt (Ref. 17). One study found that 80 to 90 percent of those individuals who were smoking at 6 months following a quit attempt had resumed smoking within 2 weeks following their quit attempt (Ref. 51). Long-term studies of individuals trying to quit smoking reveal that 30 to 40 percent of those who quit smoking for 1 year eventually relapsed (id.). In fact, one study following 840 participants for more than 8 years found that approximately one-half of smokers who stopped smoking for 1 year relapsed to regular smoking within the subsequent 7 years (Ref. 52). Researchers have found that a higher frequency of smoking predicts more severe withdrawal symptoms and earlier relapse after an attempt to quit smoking and is associated with early lapses after cessation (Ref. 17 at p. 119). FDA specifically requests comment as to whether higher frequency smokers would experience more severe withdrawal symptoms from the use of VLNC cigarettes.
FDA expects that, if cigarettes were minimally addictive or nonaddictive, the nicotine level in cigarettes would be self-limiting (
Nicotine is a powerfully addictive chemical. The effects of nicotine on the central nervous system occur rapidly after absorption (Ref. 25 at p. 12). Users of combusted tobacco products absorb nicotine readily from tobacco smoke through the lungs (id. at p. iii). Nicotine introduced through the lungs is rapidly distributed to the brain (id. at p. 12). With regular use, nicotine levels accumulate in the body during the day from the tobacco product use and then decrease overnight as the body clears the nicotine (id. at p. iii). Mild nicotine intoxication even occurs in first-time smokers (Ref. 25 at pp. 15-16). Tolerance to the effects of nicotine develops rapidly.
The addiction potential of a nicotine delivery system varies as a function of its total nicotine dosing capability, the speed at which it can deliver nicotine, the palatability and sensory characteristics of the system, how easy it is for the user to extract nicotine, and the cost of the delivery system (Ref. 54). A cigarette is an inexpensive and extremely effective nicotine delivery device, which maximizes the cigarette's addicting and toxic effects (id.). The amount of nicotine delivered and the means through which it is delivered can either reduce or enhance a product's potential for abuse and physiological effects (Ref. 17 at p. 113). Quicker delivery, higher rate of absorption, and higher resulting concentration of nicotine increase the potential for addiction (id. at p. 113). The ultimate levels of nicotine absorbed into the blood for different tobacco products (
The significant negative health effects from cigarettes are a consequence of long-term use. Children and adults continue using cigarettes primarily as a result of their addiction to nicotine (
Cigarettes are responsible for hundreds of thousands of premature deaths every year from many diseases, put a substantial burden on the U.S. health care system, and cause massive economic losses to society (Ref. 7 at pp. 659-666; another perspective on this issue is provided by Sloan et al. (Ref. 55)). Cigarette smoking causes more deaths each year than AIDS, alcohol, illegal drug use, homicide, suicide, and motor vehicle crashes combined (Ref. 47). Every year, cigarette smoking is the primary causal factor for 163,700 deaths from cancer, 160,600 deaths from cardiovascular and metabolic diseases, and 131,100 deaths from pulmonary diseases (Ref. 7 at p. 659). In the United States, about 87 percent of all lung cancer deaths, 32 percent of coronary heart disease deaths, and 79 percent of all cases of chronic obstructive pulmonary disease (COPD) are attributable to cigarette smoking (id.). The 2014 Surgeon General's Report states that 5.6 million youth currently 0 to 17 years of age are projected to die prematurely from smoking-related illnesses (id. at pp. 666-667).
Data from the CDC's Smoking-Attributable Mortality, Morbidity, and Economic Costs system for 2005-2009 (the most recent years for which analyses are available) indicate that cigarette smoking and exposure to cigarette smoke are responsible for at least 480,000 premature deaths each year (id. at p. 659). However, this estimate does not include deaths caused by other combusted forms of tobacco, such as cigars and pipes (id. at 665).
Cigarettes also have deadly effects on nonsmokers. From 2005 to 2009, an estimated 7,330 lung cancer and 33,950 heart disease deaths were attributable to exposure to secondhand smoke (Ref. 7 at p. 660). It is also well established that secondhand tobacco smoke causes premature death and disease in children and in adults who do not smoke (see,
Other combusted tobacco products, particularly those that could be cigarette alternatives if users were unable to continue smoking cigarettes, cause similar negative health effects. For example, there is a long-standing body of research, including reports from the Surgeon General and National Cancer Institute (NCI), demonstrating that cigar use can cause serious adverse health effects (Ref. 31 at 119-155; Refs. 60, 61, and 33). NCI's Smoking and Tobacco Control Monograph No. 9 (“Cigars: Health Effects and Trends”), which provides a comprehensive, peer-reviewed analysis of the trends in cigar smoking and potential public health consequences, as well as other research, demonstrates that cigar smoking leads to an increased risk of oral, laryngeal, esophageal, pharyngeal, and lung cancers, as well as coronary heart disease and aortic aneurysm, with the magnitude in risk a function of the amount smoked and depth of inhalation (Ref. 31 at 119-155). Research indicates that most cigar smokers do inhale some amount of smoke, even when they do not intend to inhale, and are not aware of doing so (Refs. 33 and 34). Even when cigar smokers do not breathe smoke into their lungs, they are still subject to the addictive effects of nicotine through nicotine absorption (Refs. 33 and 35). This is because cigar smoke dissolves in saliva, allowing the smoker to absorb sufficient nicotine to create dependence, even if the smoke is not inhaled (Refs. 35 and 62).
Regular cigar smoking (which, in this study, constituted use on at least 15 of the past 30 days) was responsible for approximately 9,000 premature deaths and more than 140,000 years of potential life lost among adults aged 35 years or older in 2010 (Ref. 56). Researchers also have found that the risk of dying from tobacco-related cancers is higher from current exclusive pipe smokers and current exclusive cigar smokers than for those who reported never using combusted tobacco products (Ref. 32).
To aid in its consideration regarding development of a nicotine tobacco product standard, FDA is seeking comments, data, research results, and other information related to questions under the following topics: Scope of products to be covered, maximum nicotine level for a nicotine tobacco product standard, implementation, analytical testing, technical achievability, possible countervailing effects (including the potential for an illicit market), and other considerations. We ask that commenters clearly identify the section and question associated with their responsive comments and information.
A tobacco product standard limiting the nicotine level in cigarettes could address one of our nation's greatest public health challenges: The death and disease caused by cigarette use. Approximately 480,000 people die every year from smoking cigarettes (Ref. 7). Cigarettes are the tobacco product category that causes the greatest burden of harm to public health as a result of the prevalence of cigarette use and the toxicity and addictiveness of these products. FDA hypothesizes that a tobacco product standard limiting the nicotine level in cigarettes could significantly increase the number of successful quit attempts by the majority of smokers seeking to quit smoking every year and potentially prevent experimenters from becoming regular smokers. However, if a standard were to apply to cigarettes only, it could be substantially less effective. Specifically, FDA expects that, to maintain their nicotine dose, some number of addicted cigarette smokers could migrate to other similar, combusted products (or begin to engage in dual use with such other products) after the standard went into effect, reducing the benefits of the product standard. Former smokers that choose to switch completely to a potentially less harmful nicotine delivery product (
FDA is continuing to weigh several factors as it considers the scope of products that should be subject to any potential nicotine tobacco product standard—including the strength and breadth of the available data derived from studies of VLNC cigarettes on the likely effects of reducing nicotine
Based on these considerations, FDA is seeking comment on whether any nicotine tobacco product standard should cover any or all of the following products:
• Combusted cigarettes (which FDA has previously interpreted to include kreteks and bidis),
• Cigarette tobacco,
• RYO tobacco,
• Cigars (some or all categories;
• Pipe tobacco, and
• Waterpipe tobacco.
Please explain your responses and provide any evidence or other information supporting your responses to the following questions:
1. If FDA were to propose a product standard setting a maximum nicotine level, should such a standard cover other combusted tobacco products in addition to cigarettes? If so, which other products? If FDA were to propose to include additional categories of combusted tobacco products in a nicotine tobacco product standard, should the standard be tailored to reflect differences in these products? What criteria should be used to determine whether, and which, products should be covered?
2. Some suggest that large cigars and those cigars typically referred to as “premium” cigars should be regulated differently from other cigars, asserting that they are used primarily by adults and their patterns of use are different from those of regular cigars (81 FR 28973 at 29024). FDA requests information and data on whether large and/or so-called premium cigars should be excluded from a possible nicotine tobacco product standard based on asserted different patterns of use, and whether large and/or so-called premium cigars would be migration (or dual use) candidates if FDA were to issue a nicotine tobacco product standard that excluded premium cigars from its scope. FDA also requests data and information on whether and how there is a way that, if FDA were to exclude premium cigars from the scope of a nicotine tobacco product standard, FDA could define “premium cigar” to include only unlikely migration or dual use products and thereby minimize such consequences.
3. Should waterpipe tobacco products, which are different from regular pipe tobacco, be included in such a standard? Are there data showing different use topographies or that they are not likely to be migration substitutes or dual use candidates? If FDA were to issue a nicotine tobacco product standard that did not include waterpipe tobacco products within the scope, what would be the likelihood that former smokers would switch to waterpipe tobacco to maintain their nicotine addiction? What are the relative risk consequences of switching to waterpipe tobacco?
As discussed throughout this document, nicotine is addictive and is the primary reason why many smokers who want to quit are unable to do so. Accordingly, FDA is considering developing a proposed product standard to make cigarettes minimally addictive or nonaddictive by setting a maximum nicotine level, using the best available science to determine a level that is appropriate for the protection of the public health. FDA has considered several peer-reviewed studies regarding very low nicotine content (VLNC) cigarettes
Early “light” cigarettes achieved a reduction in machine-measured nicotine yield through a variety of means, including through the use of ventilation holes (although the actual nicotine content was not low). This increase in ventilation led to lower yields of nicotine in smoke as measured by smoking machines, and these products were marketed as low nicotine delivery or “light” cigarettes. However, cigarette users could modify their use behaviors to compensate for this increase in ventilation. For example, the vent holes could be easily blocked by users' fingers or mouths, and larger or more frequent puffs could be taken by consumers (Ref. 65). As a result, these products were designed to make them “appear” light to the user but could deliver as much nicotine to the user as high nicotine delivery cigarettes. The compensatory behaviors of the cigarette user were able to overcome the changes in ventilation in these higher ventilated products.
VLNC cigarettes, in contrast, have relied on reducing nicotine content in the tobacco filler rather than engineering changes to the cigarette. Patents reveal that more than 96 percent of nicotine can be successfully extracted while achieving a product that “was subjectively rated as average in smoking characteristics” (Ref. 66) and that up to a 75 percent reduction in the nicotine contained in a tobacco leaf can be achieved with an “effective and economical system for producing tobacco products . . . while maintaining other desirable ingredients for good taste and flavor” (Ref. 67).
In conventional cigarettes manufactured in the United States, nicotine accounts for approximately 1.5 percent of the cigarette weight, or 10-14 mg of nicotine per cigarette (Refs. 68-71) and generally have nicotine yields in the 1.1 mg to 1.7 mg (Ref. 31 at p. 67). Certain VLNC cigarettes have much lower nicotine yields than conventional cigarettes—in the 0.02-0.07 mg nicotine/cigarette range—due to product changes that the user cannot overcome (Ref. 72). Reducing the nicotine in the finished tobacco product places an absolute maximum limit on the amount of nicotine that can be extracted by the user in a given cigarette, unlike modifications such as ventilation holes, which affect nicotine yield in smoke but can be overcome through user behavior. See section IV.C of this document for a discussion of possible compensatory smoking under a single target approach or a stepped down approach to nicotine reduction.
The first VLNC cigarettes studied by researchers were produced by Philip Morris and marketed under the brand name “Next,” which was reported to contain 0.4 mg nicotine/g of tobacco filler (Ref. 73). Later, the National Institute for Drug Abuse (NIDA) contracted with the Ultratech/Lifetech
Researchers also have used Quest cigarettes, produced by Vector Tobacco, to study the impact of reduced nicotine (Ref. 76). To provide consumers with reduced risk tobacco products, companies like 22nd Century are using genetic engineering and plant breeding to produce very low nicotine tobacco for incorporation into cigarettes. In 2014, the company was granted patents for its process to virtually eliminate the nicotine in tobacco plants (Ref. 77). Further, low-nicotine cigarettes are produced and distributed for research purposes by Research Triangle Institute (RTI), under a contract for the NIDA's Drug Supply Program (Ref. 78). 22nd Century is acting as a vendor for RTI for this contract manufacturing Spectrum cigarettes that contain 0.4 mg nicotine/gram (g) of tobacco filler (id). Finally, Philip Morris manufactured cigarettes with varying nicotine levels for research only (Ref. 79). FDA requests data and information regarding the risks to smokers from inhalation of VLNC cigarette smoke.
Table 1 includes a list of VLNC cigarettes used in research studies and their reported nicotine levels.
In 1994, certain scientists proposed the idea of federal regulation of nicotine content, which could result in lower intake of nicotine and a lower level of nicotine dependence (Ref. 81). However, FDA acknowledges that there is individual variability in dose sensitivity to all addictive substances, making it difficult to determine a single addiction threshold which would apply across the population. A proposal to lower the nicotine in conventional cigarettes, or any tobacco product, could merit consideration only if there were a threshold nicotine exposure level below which the nicotine did not produce significant reinforcing effects or sustain addiction in a majority of the population. FDA continues to assess VLNC cigarette studies analyzing addiction threshold levels, as discussed in this section.
Four primary study types speak to the level of nicotine in tobacco that could significantly reduce product addictiveness. The first type uses indirect estimates based on information in humans regarding nicotine intake in smokers who appear not to be addicted to nicotine to estimate a likely threshold level. A second type includes studies of VLNC use by study participants that have reported increased quit attempts and cessation even in smokers not interested in quitting. A third type includes studies that have revealed reduced positive subjective effects and increased negative effects in VLNC smokers. The fourth type includes studies measuring nicotine receptor binding, which indicate that use of VLNC cigarettes yields significantly lower nicotinic acetylcholine receptor (nAChR) occupancy and cerebral response.
a.
In another study seeking to estimate a reinforcement threshold, scientists reviewed several studies, including one in which abstinent smokers received intravenous nicotine injections by pulling a lever in a fixed ratio task (Ref.
b.
Some studies showed that switching to VLNC cigarettes results in a reduced number of cigarettes smoked per day (Ref. 4; Ref. 76), reduced nicotine dependence (Refs. 4, 84, and 85), and minimal evidence of withdrawal distress and increased depression (Ref. 64, Ben 12; Refs. 85-87). On the other hand, other researchers have reported the use of VLNC cigarettes did not change the number of cigarettes smoked per day (Refs. 86 and 88), but they did observe reductions in cotinine and carbon monoxide levels. For example, in the Benowitz et al. 2015 study (Ref. 86), where researchers progressively lowered nicotine content over 7 months, the authors found that, after the 7 months of VLNC cigarette use, nicotine intake remained below baseline (
One of the more recent studies (Ref. 85) on this issue was a double-blind, parallel, randomized clinical trial conducted between June 2013 and July 2014 that evaluated 840 participants (780 completed the 6-week study) who were not interested in quitting smoking. During the sixth week of the study, the average number of cigarettes smoked per day was lower for participants randomly assigned to cigarettes containing 2.4, 1.3, or 0.4 mg of nicotine per gram of tobacco (16.5, 16.3, and 14.9 cigarettes per day, respectively) than for those assigned to their usual cigarette brand or those cigarettes containing 5.2 or 15.8 mg per gram (22.2 and 21.3 cigarettes per day, respectively) (Ref. 85). Those participants using cigarettes with the lowest nicotine content (0.4 mg per gram nicotine/gram of tobacco filler, demonstrated reduced dependence, and use of reduced nicotine cigarettes, including the VLNC cigarettes, with minimal evidence of withdrawal-related discomfort or safety concerns (id.). The authors concluded that this study provides “preliminary-short term data . . . [that] suggest that if nicotine content is adequately reduced, smokers may benefit by smoking fewer cigarettes and experiencing less nicotine dependence, with few negative consequences” (id.).
While these results, taken together with other studies, are promising, FDA acknowledges the inherent limitations of the available research on changes in smoking as a function of VLNC cigarettes use. As noted by the investigators of the 2015 double-blind, parallel, randomized clinical trial, “no large-scale clinical trials of reduced nicotine cigarettes have been conducted. Furthermore, little is known about the dose-related effects of reduced nicotine. Data derived from trials assessing a range of reduced-nicotine cigarettes are critical for providing an empirical basis for regulatory decisions pertaining to nicotine product standards” (Ref. 85). As a result, FDA requests submission of additional data that may be used to explore further the hypotheses presented in this ANPRM (
c.
d.
Please explain your responses and provide any evidence or other information supporting your responses to the following questions:
1. The Tobacco Control Act prohibits FDA from reducing nicotine yields in any combusted tobacco product to zero
2. FDA lists four types of studies to estimate the threshold of nicotine addiction (
3. In addition to nicotine, minor tobacco alkaloids (including nornicotine, cotinine, anabasine, anatabine, and myosamine) and tobacco smoke aldehydes (such as acetaldehyde) are pharmacologically active and may contribute to addiction (see,
4. If FDA were to finalize a nicotine tobacco product standard, what is the potential that adults and adolescents would perceive these VLNC cigarettes as “safe”—and how could youth and adult risk perceptions of these cigarettes impact initiation, use, and cessation habits of combusted tobacco products?
If FDA were to issue a product standard establishing a maximum nicotine level for cigarettes, such a standard would need to either propose a single target (where the nicotine is reduced all at once) or a stepped-down approach (where the nicotine is gradually reduced over time through a sequence of incremental levels and implementation dates) to reach the desired maximum nicotine level. Some have suggested that any maximum nicotine level should be established as a single target (rather than a stepped-down approach) to limit exposure to harmful tobacco while providing similar cessation rates to those that could occur with a stepped-down approach. Some level of compensatory smoking behavior (
In contrast, during a stepped-down approach, tobacco users may attempt to compensate for the loss of nicotine during the early stages of a stepped-down approach by smoking additional tobacco products or by smoking more intensely, since the intermediate-stage products could allow for extraction of nicotine through such efforts in a way that VLNC cigarettes would not (
FDA is aware of several studies that have demonstrated the impact of an immediate (
Nevertheless, some studies have found that both reduction strategies increase a smoker's probability of cessation. For example, in a study of smokers with no strong preference for a quitting method who were randomly assigned to study arms requiring either that they quit immediately or gradually reduce their cigarette consumption over 2 weeks, both the immediate and gradual cessation methods produced similar results (Ref. 110). Likewise, in a meta-analysis of 10 studies to determine the impact of stepped reduction of nicotine versus a single nicotine target in participants interested in quitting smoking, scientists determined that a stepped reduction in nicotine “provides similar quit rates to abrupt quitting with no evidence that one method is significantly superior to the other in adults trying to quit smoking” (Ref. 111 at p. 13) and concluded that there were no additional cessation benefits for the stepped-down approach (Ref. 111 at p. 2).
FDA understands the argument that a stepped-down approach to limiting the nicotine levels in tobacco products
Please explain your responses and provide any evidence or other information supporting your responses to the following questions:
1. What data are available to demonstrate that a single target approach to reach a maximum nicotine level would or would not result in any unintended consequences?
2. In the alternative, what data are available to demonstrate that a stepped-down approach involving a sequence of incremental levels and implementation dates to reach a proposed nicotine level would or would not result in any unintended consequences?
3. If FDA were to select a stepped-down approach for a nicotine tobacco product standard, what scientific evidence exists to support particular interim nicotine levels and the appropriate number of steps that would be needed to reach the target level?
4. Would a single target and a stepped-down approach for implementation result in comparable quit rates or reduced initiation rates?
5. What would be the likely implementation differences, including implementation timelines and transition costs, between a single target approach or a stepped-down approach involving a sequence of incremental levels and implementation dates?
As part of its consideration regarding a potential nicotine tobacco product standard, FDA is also considering whether such a product standard should specify a method for manufacturers to use to detect the level of nicotine in their tobacco products. FDA believes that the results of any test method to measure the nicotine in combusted tobacco products should be comparable across different accredited testing facilities and products. It is critical that the results from the test method demonstrate a high level of specificity, accuracy, and precision in measuring a range of nicotine levels across a wide variety of tobacco blends and products.
A variety of methods have been in development that allows nicotine in tobacco or tobacco product filler to be quantified for various products. For example, two Cooperation Centre for Scientific Research Relative to Tobacco (CORESTA) methods have undergone round-robin method validation studies in accordance with ISO 5725-1 through ISO 5725-2: (1) Continuous flow analysis (CFA) and (2) gas chromatography-flame ionization detector (GC-FID). The CFA method measured a nicotine range of 0.69-3.30 percent (or 6.9-33 mg/g) in burley and flue-cured tobaccos and exhibited a repeatability range of 0.03-0.17 and a reproducibility range of 0.12-0.67, dependent on the mean (Ref. 112). A GC-FID method for determining nicotine in fermented extractions from tobacco leaves was validated in accordance with FDA and International Council for Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use specifications, including specificity, linearity, precision, accuracy, and robustness (Ref. 113). Gas chromatography-mass spectrometry (GC-MS) was used as the confirmation technique in this study, in which a recovery of 117.8 percent was achieved; recovery was within FDA guidelines (<120 percent) (Ref. 113). Nicotine content of 0.43 percent (4.3 mg/g) in the extract was reliably measured and stability testing on this same extract was conducted for 360 days (id.). In addition, the WHO's Tobacco Laboratory Network (TobLabNet) has developed a standard operating procedure for determination of nicotine in cigarette tobacco filler using gas chromatography (Ref. 114). The WHO's TobLabNet determined that this method is suitable for the quantitative determination of nicotine in cigarette tobacco filler by gas chromatography (GC) (id.).
We also note that ISO 10315 and CORESTA Method No. 62 have been used in substantial equivalence reports submitted to the Agency. ISO 10315 is a method for analyzing nicotine in smoke. With this method, conditioned cigarettes are smoked under ISO 4387 conditions and smoke is captured on a Cambridge filter pad and extracted in propan-2-ol containing internal standard such as n-heptadecane or quinaldine (carvone or n-octadecane are other alternatives to internal standards) and analyzed immediately using GC coupled with flame ionization detection (Ref. 115).
CORESTA Method No. 62 is a standard method used to analyze nicotine in tobacco filler and smokeless tobacco products (Ref. 116). This method describes extraction of nicotine in solid tobacco in basified extraction solution (using sodium hydroxide to deprotonate the nicotine in solution) of either hexane containing n-heptadecane or quinaldine internal standards or basified extraction solution (using sodium hydroxide) of methyl-t-butyl ether solution containing quinoline internal standard (id.).
FDA is also aware of other methods that have been used to analyze nicotine levels. Such methods include GC combined with various detectors, GC-MS with solid-phase microextraction as a preconcentration step for low detection, other formats of GC-FID, capillary electrophoresis combined with either ultraviolet (UV) or electrochemical detection, and alternative chromatography techniques including supercritical fluid chromatography-ion mobility detection (Ref. 117), reversed phase ion-pair liquid chromatographic extraction (Ref. 118), and high-pressure liquid chromatography with UV detection (Ref. 119).
Please explain your responses and provide any evidence or other information supporting your responses to the following questions:
1. If FDA were to issue a product standard, should the Agency require a standard method of product testing to analyze the nicotine levels in products subject to the standard? If so, what method or methods should FDA use?
2. Should the Agency require manufacturers to sample their products in a specific manner to ensure that products do not contain excess levels of nicotine? Should manufacturers be required to test each manufactured batch to ensure compliance with a product standard limiting nicotine levels? What criteria should be used to determine if a batch passes or fails testing?
FDA continues to analyze the technical achievability of a maximum nicotine level for cigarettes as part of its overall assessment of how best to implement this authority and is seeking comments from interested parties regarding this issue, including with respect to the technical achievability of such a standard for small cigarette and/or small combusted tobacco product manufacturers.
The industry and consumer product companies have developed versions of denicotinized cigarettes and a range of brands with differing nicotine levels. By blending tobaccos based on nicotine levels, tobacco companies have manufactured their products to specifications that ensure the final product will have precise levels of nicotine and have ensured that nicotine levels vary only minimally within cigarette packs and from pack to pack (60 FR 41453 at 41505, 41509, August 11, 1995). In fact, the tobacco industry has had programs in place since the 1960s to obtain “any level of nicotine desired” (Ref. 120, citing Ref. 121). The industry also has recognized that the techniques it has used to increase nicotine levels can be used to reduce nicotine levels as well (60 FR 41453 at 41722).
As previously described, VLNC cigarettes have been produced since the 1970s. During this time, NCI contracted for production of a line of cigarettes with widely varying nicotine concentrations (Ref. 122, 81 SG). In the late 1980s, a major cigarette manufacturer had plans to develop VLNC cigarettes with a reduction in mainstream nicotine yields of greater than 95 percent (Ref. 123). More recently, 22nd Century, acting as vendor for RTI's contract with NIDA, has developed cigarettes, not currently commercially available, that are similar in many sensory characteristics to conventional cigarettes but with extremely low nicotine levels (Refs. 54, 124, and 125).
Significant reductions of nicotine in combusted tobacco products can be achieved principally through tobacco blending and cross-breeding plants, genetic engineering, and chemical extraction. Agricultural practices (
Most of the cigarettes sold in the United States are blended cigarettes (Ref. 126). A tobacco industry executive previously testified that the main component of a cigarette that contributes to nicotine delivery is the tobacco blend and that year-to-year crop variation does not determine the nicotine content in a cigarette (Ref. 127). The term “leaf blending” describes the selection of tobaccos to be used in a product by tobacco type (
Many tobacco lines are available, including approximately 1,000 different tobacco varieties (Ref. 126). The tobacco industry has used breeding and cultivation practices to develop high nicotine tobacco plants to give manufacturers greater flexibility in blending and in controlling the amount of nicotine to be delivered (60 FR 41453 at 41694). These practices could be used to develop low nicotine plants as well. In fact, tobacco industry documents show that in the 1960s, tobacco companies recognized the increasing demand for low nicotine tobacco and began instituting projects that found that low nicotine cigarettes can be made by selecting grades of tobacco with low nicotine content (Ref. 128; citing Ref. 129; Ref. 130).
Because the nicotine content of tobacco plants varies, manufacturers could replace more commonly used nicotine-rich varieties like
The position of leaves on the plant stalk also affects nicotine levels; tobacco leaves located near the top of the plant can contain higher concentrations of nicotine and lower stalk leaves generally contain lower nicotine levels (Ref. 114; Ref. 120). For example, flue-cured tobacco leaves harvested from the lowest stalk position may contain from 0.08 to 0.65 percent nicotine, whereas leaves from the highest positions may contain between 0.13 and 4.18 percent nicotine (Ref. 126, citing Ref. 134). Therefore, substituting leaves found lower on the plants could reduce the nicotine content of tobacco products (Ref. 131).
A number of internal tobacco industry documents describe the use of leaf blending and tobacco selection to control the nicotine content of cigarettes (Ref. 128 at p. 3). For example, one company project determined that low nicotine cigarettes can be made by selecting grades of tobacco with low nicotine content (Ref. 128 at p. 3, citing Ref. 135). Another observed that the demand for low nicotine tobacco has increased worldwide and necessitated a shift in purchasing standards (Ref. 128 at p. 3, citing Ref. 136).
Nicotine also can be removed from tobacco via chemical extraction technology. By the 1970s, tobacco manufacturers regularly practiced nicotine extraction as a method to control nicotine delivery (Ref. 128, citing Ref. 137; Refs. 138 and 139). Extraction methods include water extraction (coupled with steam or oven drying), solvent extraction, and extractions of nicotine without usable leaf (Ref. 128). Supercritical fluid extraction also yielded success in the 1990s, allowing for optimum extraction times and the elimination of more time-consuming steps (Refs. 140 and 141). FDA notes that there are existing patents for chemical extraction of nicotine in tobacco, which reveal that more than 96 percent of nicotine can be successfully extracted while achieving a product that “was subjectively rated as average in nicotine characteristics” (Refs. 142 and 66).
In addition, a major tobacco manufacturer has used a high-pressure carbon dioxide process similar to the process used to decaffeinate coffee. In this process, tobacco leaf is treated with ammonium salt, then treated with carbon dioxide/water vapor, which has achieved a 95 to 98 percent reduction in nicotine (Ref. 133, citing Ref. 143) Although some manufacturers believe that previous water extraction practices may have rendered the tobacco “unsuitable for use,” other water extraction projects yielded suitable smoking material with sizeable nicotine reductions (80 to 85 percent reduction in leaf nicotine) (Ref. 128, citing Ref. 144; Refs. 145 and 146).
Tobacco industry scientists have long recognized the potential for genetic engineering to control nicotine content (Ref. 147). The first practical application of biotechnology by a major tobacco manufacturer was the development of low nicotine tobacco in the 1980s, which led to the receipt of a patent for biotechnology for altering nicotine in tobacco plants (Refs. 133 and 148). Other tobacco researchers and major manufacturers also recognized the value of biotechnology for developing low nicotine tobacco for cigarettes, including for use as part of a smoking cessation program (Ref. 149).
Several American and international tobacco companies genetically engineered low nicotine varietals in the 1960s and 1970s, including a strain with nicotine levels as low as 0.15 percent (Ref. 128; citing Refs. 150-155). During that time period, the Kentucky Tobacco Research Board worked on genetic strains of low nicotine tobacco (with a nicotine content of 0.2 percent) to be used for experimental studies on the role of nicotine in smoking behavior (Ref. 128, citing Refs. 156-159). In addition, Canadian researchers examined low nicotine strains of tobacco, particularly in association with efforts to develop a strain of flue-cured or air-cured tobacco that would be suitable as the base material for reconstituted tobacco (Ref. 128, citing Refs. 151 and 160). In 2003, Vector Tobacco began marketing the Quest cigarette, which was produced from genetically modified tobacco and contained only trace amounts of nicotine (Ref. 133) (this product is no longer on the market). Genetic engineering has resulted in reductions of nicotine levels in the range of 80 to 98 percent (id.). In 2014, the U.S. Patent and Trademark Office granted two patents for two genes that may be suppressed to achieve a substantial decrease in nicotine in tobacco plants (Ref. 161).
Industry studies have shown that changes to growing and harvesting practices affect the development of tobacco chemistry, including nicotine content (Ref. 128). Some manufacturers have revised their agricultural practices specifically to meet new product development goals, such as the production of low nicotine tobacco (id.). For example, one manufacturer evaluated various experimental agricultural practices that could affect the tobacco's chemistry, including bulk-curing, once-over harvesting, and high plant density (id., citing Ref. 162). In other cases, chemical agents were observed to reduce nicotine content (Ref. 128 citing Refs. 163-165).
After growers harvest tobacco, it is cured and aged before use in tobacco products. The aging process naturally changes the chemistry of the tobacco, including some reduction in nicotine content (Ref. 128). At least one manufacturer has explored efforts to speed up the process of aging tobacco, in part to alter or limit the changes in chemistry that naturally occur (id., citing Ref. 166). Other approaches to curing and fermenting tobacco were explored as a method for altering nicotine content (Ref. 128). For example, in one manufacturer's report, researchers observed that the properties of tobacco, including nicotine content, could be altered without the need for nontobacco additives by modifying curing practices (id., citing Ref. 167). In addition, manufacturers have explored approaches to identify microbial bacteria that actively degraded nicotine while leaving other components of the leaf intact (Ref. 128, citing Refs. 168 and 169). Consumer product testing showed that the “product acceptability” of that tobacco was equal to that of untreated tobacco (Ref. 128, citing Ref. 170).
Researchers have developed novel approaches to reducing the nicotine in tobacco products in recent years. For example, a salivary excretion produced by a caterpillar (containing the enzyme glucose oxidase) is applied to tobacco plant leaves and can reduce the nicotine in tobacco leaf by up to 75 percent and provide an “effective and economical system for producing tobacco products which contain about 0.01 mg nicotine per cigarette or less . . . while maintaining the other desirable ingredients for good taste and flavor” (Ref. 67).
Please explain your responses and provide any evidence or other information supporting your responses to the following questions:
1. What methods are tobacco product manufacturers currently using to maintain consistency of the nicotine in their products, given the variability of nicotine levels over growing seasons and crop type? How could these methods be adapted to ensure that certain combusted tobacco products meet a potential nicotine tobacco product standard?
2. What is the feasibility of using the techniques discussed in this section, or other nicotine reduction techniques, to reduce the nicotine in cigarettes?
3. What is the feasibility of using the techniques discussed in this section, or other nicotine reduction techniques, for non-cigarette combusted tobacco products (
4. If FDA were to propose a tobacco product standard setting a maximum nicotine level, how, if at all, would such a product standard impact tobacco farmers' growing and/or curing practices? If FDA were to finalize a nicotine tobacco product standard, what would be the costs and benefits for tobacco farmers and tobacco processors, particularly regarding how any such rulemaking might affect them in light of new technologies and business opportunities that are foreseeable, but not now in place? In addition, if FDA were to finalize a nicotine tobacco product standard, what would be the costs for farmers in light of such a standard?
5. Section 907(d)(2) of the FD&C Act provides that a tobacco product standard must set forth the effective date of the standard, which may not be less than 1 year after publication of a final rule unless FDA determines that an earlier effective date is necessary for the protection of the public health (and that such effective date be established “to minimize, consistent with the public health, economic loss to, and disruption or dislocation of, domestic and international trade”). This section also provides that the effective date be a minimum of 2 years after publication of a final rule if the tobacco standard can be met only by requiring “substantial changes to the methods of farming the domestically grown tobacco used by the manufacturer.” Therefore, if FDA were to propose a product standard setting a maximum nicotine level, when should this standard become effective? What implementation timeframe would allow adequate time for industry to comply? Should the same timeframe be required for all tobacco product manufacturers, regardless of their number of employees and/or annual revenues?
6. Should the standard include provisions that would allow manufacturers, distributors, or retailers to sell off existing nonconforming inventory of manufactured combusted tobacco products? If so, what would be a reasonable sell-off period?
7. What are the potential outcomes of implementing methods to reduce nicotine content in cigarettes in terms of impact on characteristics of cigarettes (flavor, taste, aroma, etc.) and user experience?
Section IV. B discusses some of the potential benefits that FDA expects could occur as a result of one possible nicotine tobacco product standard. There may be possible countervailing effects that could diminish the population health benefits expected as a result of a nicotine tobacco product standard. As part of any subsequent rulemaking FDA would need to assess these effects in comparison to the expected benefits, including among population subgroups.
One possible countervailing effect is continued combusted tobacco product use. Current smokers of tobacco products covered by a nicotine tobacco product standard could turn to other tobacco products to maintain their nicotine dependence, both in combination with cigarettes (
While FDA believes that some consumers would be satisfied with VLNC cigarettes, the Agency expects that there would be a subset of consumers uninterested in switching to VLNC cigarettes or quitting tobacco products altogether. This subset of consumers may seek to obtain illicit tobacco products after a standard becomes effective (see FDA's Draft Concept Paper). As a result, FDA is considering whether an increase in illicit trade might occur as a result of a nicotine tobacco product standard and how that could impact the marketplace and public health. The analysis of possible illicit trade includes considerations regarding the sources of tobacco, how illicit tobacco products might be manufactured, possible workarounds (such as adding nicotine in liquid or other form to a product with minimally addictive or nonaddictive nicotine levels), the ability to distribute illicit products, the development of consumer awareness, and how illicit trade sales might take place (id.). The capacity to produce illicit tobacco products would depend upon a variety of factors, including the ease of acquiring the raw materials (particularly tobacco), the sophistication required to construct the desired product, and the purpose (whether it is for an individual's personal use, or for wider distribution and sale). Large, commercial, tobacco product manufacturers have the resources, sophistication, and ability to manufacture illicit tobacco products (id.). Illicit tobacco products also may be smuggled and sold through the internet. It is unclear, however, to what extent such companies would be willing to risk their businesses (and resulting profits) to manufacture illicit tobacco products (id.). Tribal manufacturers are an additional source of tobacco products, having relatively high sophistication and machinery in some instances, but they are also subject to the same disincentives as large manufacturers and generally lack widespread distribution and sales capabilities (id.).
The IOM has explored the issue of possible illicit trade if FDA were to issue a tobacco product standard limiting the levels of nicotine in cigarettes. The IOM found that although there is insufficient evidence to draw firm conclusions regarding how the U.S. illicit tobacco market would respond to regulations requiring a reduction in the nicotine content of cigarettes, limited evidence suggests that the demand for illicit conventional cigarettes would be “modest” (Ref. 172). The IOM suggests that demand would be limited, because some smokers may quit and other will use modified products or seek legal alternatives (id.). Although some smokers may seek to purchase illicit products if available and accessible, the IOM finds that this “would require established distribution networks and new sources of product (which would either have to be smuggled from other countries or produced illegally) to create a supply of cigarettes with prohibited features” (id.). Given that individuals have utilized distribution networks to smuggle cigarettes and avoid higher taxes, FDA is considering whether there might be additional incentive to create or obtain the prohibited cigarettes that are not available elsewhere in the United States. In addition, the report explains that comprehensive interventions by several countries show that it is possible to reduce the size of the illicit tobacco market through enforcement mechanisms and collaborations across jurisdictions (id.).
If a nicotine tobacco product standard were to prompt the development of an illicit market, FDA would have the authority to take enforcement actions regarding the sale and distribution of illicit tobacco products. The FD&C Act provides FDA with several tools that it may use against noncompliant parties. For example, FDA could issue a Warning Letter, an advisory action in which FDA notifies a regulated entity that FDA has found evidence that the party violated the law. A Warning Letter is used to achieve prompt voluntary compliance. In a Warning Letter, FDA informs the regulated entity that failure to comply with the requirements of the FD&C Act and its implementing regulations may result in FDA enforcement action. These actions may include initiating administrative actions or referring cases to the Department of Justice for initiation of judicial action. FDA may seek to initiate an administrative legal action against a regulated entity that can result in the imposition of a fine or civil money penalty. Possible judicial actions may include seizures, injunctions, and criminal prosecution.
Another possible countervailing effect is the potential for increased harm due to continued VLNC smoking with altered smoking behaviors. Some studies of VLNC cigarettes with nicotine levels similar to what FDA is considering have not found compensatory smoking behavior and have found reductions in the number of cigarettes smoked per day and, consequently, decreased exposure to harmful constituents (as discussed in
Another possible countervailing effect of setting a maximum nicotine level for cigarettes could be that users would seek to add nicotine in liquid or other form to their combusted tobacco products. Therefore, FDA is considering whether any action it might take to reduce nicotine in combusted tobacco products should be paired with a provision that would prohibit the sale or distribution of any tobacco product designed for the purposes of supplementing the nicotine content of a combusted tobacco product (or any product where the reasonably foreseeable use is for the purposes of supplementing this nicotine content). FDA is also considering what other regulatory options may be available to address this concern and requests comments on such options.
Please explain your responses and provide any evidence or other information supporting your responses to the following questions:
1. In addition to a nicotine tobacco product standard, should FDA consider any additional regulatory action to address the possibility of migration to, or dual use with, other tobacco products?
2. If FDA were to issue a product standard setting a maximum nicotine content for cigarettes, would smokers seek to add liquid nicotine to their VLNC cigarettes? Therefore, should such a regulation include provisions prohibiting the sale or distribution of any tobacco product designed for the purposes of supplementing the nicotine content of a combusted tobacco product (or any product where the reasonably foreseeable use is to supplement this nicotine content)? How could such a provision be structured to efficiently and effectively achieve this purpose? Should FDA consider other means to prevent supplementing the nicotine content of a combusted tobacco product subject to a nicotine tobacco product standard?
3. Would a nicotine tobacco product standard affect the current illicit trade market, and, if so, to what extent? How would users obtain their sources of tobacco in an illicit market? How would manufacturers distribute their illicit products and develop consumer awareness of such products? How would such sales take place?
4. FDA hypothesizes that, based on currently available research, nicotine levels like those levels that FDA would consider with a possible nicotine tobacco product standard would be self-limiting (
5. If a nicotine tobacco product standard were in effect, the following outcomes could occur: (1) Smokers could continue to smoke but use the low nicotine products; (2) smokers could completely switch to, or dual use low nicotine products with, other legal tobacco or nicotine products; (3) smokers could quit using any nicotine or tobacco product; or (4) smokers could seek to buy illegal cigarettes in an illicit market. Are there data that would provide information on which of these outcomes is most likely? Is there some other outcome that could occur?
6. If an illicit market developed, what percentage of current smokers would switch to illicit conventional cigarettes rather than quitting or switching to other legal products? How would this change if illicit conventional cigarettes were more expensive and/or harder to obtain? How would this change with the implementation of improved monitoring and enhanced enforcement by FDA and its partners?
7. If a nicotine tobacco product standard prompted growth of an illicit market, how long would it likely last? Would demand likely decrease over time, stay the same, or increase?
8. If a nicotine tobacco product standard prompted growth of an illicit market, what effect, if any, would this have on the market for illegal drugs? Are there data showing a relationship between illicit tobacco use and illegal drug use?
9. What mechanisms may be used to prevent, control, or contain illicit markets in conventional cigarettes that may develop if FDA establishes a product standard? What State and Federal entities may be responsible for these mechanisms, and how much would they cost?
To aid in its consideration regarding development of a nicotine tobacco product standard, FDA is seeking data, research results, and other information regarding the following:
1. What data may be helpful to assess the universe of tobacco products that are currently available to consumers and their relevant characteristics, such as nicotine levels? How can available sources of information, such as manufacturer registrations and/or product listings with FDA, be used in this assessment?
2. How should potential consumer surplus or utility loss from the removal of nicotine in cigarettes be considered, given the availability of other sources of nicotine such as ENDS and the continued availability of combustible tobacco products?
3. What sources of information could be used to estimate the change in demand for VLNC cigarettes? What factors should we consider in estimating the changes in demand for other tobacco products?
4. What factors should be considered in estimating changes in experimentation and initiation that may occur as a result of a potential nicotine tobacco product standard?
5. In what ways might a change in nicotine levels in cigarettes spur innovation in the market for both combusted and noncombusted tobacco products?
6. What factors should be considered in estimating the impacts of externalities that might exist for VLNC cigarettes, such as secondhand smoke, litter, and pollution? How could the impact of externalities for VLNC cigarettes be compared to the impacts from NNC cigarettes?
7. What factors should we consider in estimating the impact of changes in demand for other tobacco products?
8. If FDA were to finalize a nicotine tobacco product standard, what might be the costs to current smokers?
9. Are there any other relevant comments or information that would be helpful for FDA to consider in analyzing the economic impacts of a proposed nicotine tobacco product standard?
If FDA were to issue a proposed tobacco product standard setting a maximum nicotine level, FDA would provide an analysis explaining how the proposed rule would be appropriate for the protection of the public health (section 907(a)(3)(A) of the FD&C Act). For the purposes of this ANPRM, this section briefly describes the potential public health benefits FDA believes could result from the increased cessation and decreased initiation to regular use that FDA expects could occur if cigarettes and possibly some other combusted tobacco products were minimally addictive or nonaddictive. It also references findings from a
Significant declines in the deaths caused by the use of combusted tobacco products can be achieved by reducing the prevalence of smoking cigarettes and other combusted tobacco products. Smoking cessation has major and immediate health benefits for men and women of all ages, regardless of health status (Ref. 173 at p. i). Smoking cessation decreases the risk of the health consequences of smoking, and former smokers live longer than continuing smokers. For example, persons who quit smoking before age 50 have one-half the risk of dying in the next 15 years compared with continuing smokers (id. at p. v).
Smoking cessation reduces the risk of cancers throughout the body (Ref. 173). For example, although the risk of dying from lung cancer is 22 times higher for male smokers than male nonsmokers (and 12 times higher for female smokers than female nonsmokers), the risk of lung cancer after 10 years of abstinence is 30 to 50 percent that of continuing smokers (id.; Refs. 174 and 175).
Smoking cessation also reduces the risk of other life-threatening illnesses that occur in smokers. In addition to reducing the risk of cancers and the mortality rates of smoking-related diseases, smoking cessation substantially reduces the risk of other dangerous diseases that can lead to death or disability and cause a financial strain on health care resources. For example, smoking cessation substantially reduces risk of peripheral artery occlusive disease (which can cause complications that lead to loss of limbs) (Ref. 173). Former smokers also have half the excess risk of experiencing an abdominal aortic aneurysm compared to current smokers (id.). Cigarette smoking also complicates many diseases (
Youth and young adults would experience the greatest benefits from a nicotine tobacco product standard, because many of them may not progress beyond experimentation and, therefore, may not experience dangerous and deadly tobacco-related health effects. Fetuses and children also would benefit if their parents quit smoking, given the negative health consequences to the fetus of a smoking mother and the dangers of secondhand smoke. In addition, children of parents who smoke, when compared with children of nonsmoking parents, have an increased frequency of respiratory infections like pneumonia and bronchitis (Ref. 173). Smoking cessation reduces the rates of these respiratory symptoms and of respiratory infections (Ref. 176 at p. 467). Children exposed to tobacco smoke in the home also are more likely to develop acute otitis media (middle ear infections) and persistent middle ear effusions (thick or sticky fluid behind the eardrum) (Ref. 173). If parents were more able to quit because these products become minimally addictive or nonaddictive, youth would experience these health problems much less frequently.
Although the health benefits are greater for people who stop smoking at earlier ages (Refs. 173 and 176), researchers estimate that smokers can gain years of additional life expectancy no matter when they quit (Ref. 177). In addition, scientists using data from the Cancer Prevention Study (CPS-II), but accounting for bias caused by smoking cessation after baseline, found that even smokers who quit at age 65 had an expected life expectancy increase of 2 years for men and 3.7 years for women (Ref. 178).
The benefits continue for those who remain smoke free. At year one, an individual's added risk of coronary heart disease becomes half that of a smoker's (Ref. 175). Between 2 and 5 years after cessation, an individual's stroke risk is reduced to that of a nonsmoker (id.). In addition, a former smoker's risk of cancers of the mouth, throat, esophagus, and bladder is halved within five years (id.). By 10-years post cessation, an individual's risk of cancers of the kidney and pancreas decreases (id). The risk of coronary heart disease becomes that of a nonsmoker after 15 years of abstinence (id.).
As stated throughout this document, nicotine at levels currently found in tobacco products is highly addictive, and addiction to nicotine is the “fundamental reason that individuals persist in using tobacco products” (Ref. 17 at p. 105). Although nicotine itself is not the direct cause of most tobacco-attributable disease, addiction to the nicotine in tobacco products is the proximate cause of these conditions because it sustains tobacco use (Refs. 54 and 179). Addiction caused by nicotine in tobacco is critical in the transition of smokers from experimentation to sustained smoking and in the maintenance of smoking for those who want to quit (Ref. 7 at p. 113; Ref. 17). As a result, FDA expects that making cigarettes minimally addictive or nonaddictive would reduce tobacco-related harms by promoting smoking cessation or complete migration to alternative, potentially less harmful noncombusted products and by reducing initiation. In this section, we summarize the approach used to describe the possible impact of a potential nicotine tobacco product standard to the population as a whole and present the findings of this analysis.
As discussed elsewhere in this document, FDA is considering the scope of a potential product standard, and has asked for public comment. To assess the impact of one potential option that might maximize the potential public health impact, it may be appropriate to consider the Apelberg et al. 2018 publication, which presented simulation modeling of a policy scenario in which the scope of a potential product standard restricted the nicotine level in cigarettes, cigarette tobacco, RYO tobacco, cigars (including little cigars, large cigars, and cigarillos, but not so-called “premium” cigars), and pipe tobacco (other than waterpipe/hookah tobacco). As part of a formal expert elicitation process (this process centered around three online conferencing sessions held during January and February 2015, following a written protocol designed to elicit opinions using a structured, standardized approach (see Ref. 181 for more details)), eight subject matter experts were asked to provide their individual estimates of the anticipated impacts of a hypothetical policy (setting a “maximum limit on the amount of nicotine in cigarette tobacco filler” for the purpose of reducing nicotine in cigarettes “to minimally addictive levels”) and to develop subjective probability distributions for parameters of interest.
A more detailed description of the methodology, data sources and inputs, and results from this analysis can be
As described in this document, FDA expects that making cigarettes minimally addictive or nonaddictive (however that were achieved) would impact currently addicted smokers by increasing their ability to quit smoking and affect nonsmokers by reducing the likelihood that they would become established and addicted smokers. Apelberg et al. 2018 updated a previously published discrete system dynamic population model to compare projected outcomes for a status-quo scenario (in which no maximum nicotine level is implemented) with outcomes for a policy scenario in which a hypothetical regulation lowering nicotine in cigarettes, and selected other combusted tobacco products, to minimally addictive was implemented
The model incorporated, based on estimates of subject matter experts, the following tobacco use transitions to estimate the impact of the policy: (1) Cigarette smoking cessation; (2) cigarette smokers switching to noncombusted tobacco products (
The methodology implemented in this analysis has been detailed elsewhere (Refs. 180 and 181). Briefly, the simulation begins with an initial population that reflects the sex, age, and tobacco use distribution (
Quantitative inputs for rates of post-policy smoking cessation, switching, and dual use in the hypothetical policy scenario were obtained through a formal expert elicitation process. The methodology used to identify experts, develop the protocol, conduct the elicitation, and summarize the findings has been described in detail elsewhere (Ref. 181 at Appendix). Briefly, elicitation candidates with expertise in tobacco science and policy were identified, ranked, and recruited in accordance with a pre-specified protocol, based on publication history and accounting for potential conflicts of interest. Candidates were required to self-certify that they were free of any actual, apparent, or potential conflicts of interests. The elicitation process centered around three online conferencing sessions held during January and February 2015, following a written protocol designed to elicit opinions using a structured, standardized approach (see Ref. 181 for more details). Briefing books with key papers on the topics of interest as well as background data on tobacco use and policy were provided to a panel of eight experts prior to the conference sessions. Experts were asked to identify any other relevant information to share with the panel. Detailed written questionnaires were completed by each expert as independent take-home exercises. To maintain the independence of the experts and encourage open discussion, involvement of FDA staff was limited.
To explore the potential impact of a product standard that would maximally benefit population health, the experts were asked to assume that combusted tobacco products that could be viewed as highly likely to serve as substitutes for traditional cigarettes (
The eight experts' judgments about the potential values of these parameters are published in Apelberg et al. 2018 (Ref. 181). While parameter estimates and their probability distributions varied somewhat between participants, most experts had the view that making cigarettes and certain other combusted tobacco products minimally addictive would lead to substantial initial and long-term increases in smoking cessation among cigarette smokers and decreased initiation among nonsmokers. Distributions provided by the eight experts' parameter estimates were substantially broad in range. For example, for both male and female non-smokers, the median minimum and maximum estimates from the eight experts on the “percent of reduction in annual smoking initiation rates” after the first year in response to the policy ranged from 10 percent to 90 percent. For both male and female smokers, the median minimum and maximum estimates from the eight experts on the “percent of current smokers who quit smoking as a result of the policy” within the first year after policy implementation ranged from 4 percent to 50 percent.
To account for uncertainty associated with the expected impact of the policy scenario, Apelberg et al. 2018 used the distributions of the experts' estimates in a Monte Carlo simulation. A Latin Hypercube sampling with 1,000 sample values was performed for each of the expert's response distributions. For each simulation, the policy scenario was compared to the baseline scenario to estimate changes in the outcomes described above. A summary of distribution responses are provided in Apelberg et al. 2018.
As illustrated in Figure 1 (Ref. 181), using the experts' input estimates for the parameters described previously, and assuming that the policy is implemented in 2020, the simulation model projected that cigarette smoking prevalence declines substantially in the policy scenario within the first year of implementation of the hypothetical policy scenario to a median value of 10.8 percent compared with 12.8 percent in the baseline scenario. In subsequent years, the simulation model projects that the difference in cigarette smoking prevalence between the scenarios continues to grow due to the experts' estimates of sustained increases in cessation and decreases in initiation in the policy scenario. The projected smoking prevalence drops to a median value of 1.4 percent (5th and 95th percentile projections range from 0.2 percent to 5.9 percent) under the policy scenario by 2060 compared to 7.9 percent under the baseline. Smoking prevalence estimates for the year 2100 are comparable to those for 2060.
Concurrent with a projected reduction in cigarette smoking is a projected increase in noncombusted product use. Adult noncombusted tobacco product use is higher in the hypothetical policy scenario compared to the baseline scenario within the first year of implementation of the potential product standard (Ref. 181 at Figure 1), due to estimated increases in switching from cigarette smoking and transitions to dual cigarette and noncombusted product use as a result of the hypothetical policy scenario. The prevalence of noncombusted tobacco product use remains higher in the policy scenario over time due to the experts' predictions that there would be both increased uptake among smokers (through either complete switching or dual use) and increased initiation due to some dissuaded cigarette initiators taking up noncombusted products instead.
Table 2 provides a projection of the number of individuals who would not become cigarette smokers over time as a result of the hypothetical policy scenario. Since it is assumed, based on expert input, that there would be a sustained decrease in cigarette smoking initiation rates, the model projects that the cumulative number of dissuaded smoking initiates continues to increase over time. By 2100, the median estimate from the model, based on the experts' estimates of potential initiation rates as a result of the policy, is that more than 33 million youth and young adults who would have otherwise initiated regular smoking would not start as a result of the hypothetical policy scenario (5th and 95th percentile projections range from 8.0 million to 64.1 million).
Using the eight experts' estimates for the percent of current smokers who would quit smoking after implementation of the policy, approximately 5 million additional smokers are estimated to quit smoking within one year after implementation of the product standard (5th and 95th percentile projections range from 110,000 to 19.7 million), compared to the baseline scenario. The number of additional smokers quitting would increase by approximately 13 million within 5 years after policy implementation (5th and 95th percentile projections range from 430,000 to 30.5 million), compared to the baseline scenario.
Table 3 presents the estimated cumulative number of tobacco-attributable deaths potentially avoided and life years gained due to the experts' determinations that smoking rates would decrease as a result of the hypothetical policy scenario. By 2060, it is estimated that a median value of almost 3 million deaths due to tobacco would be avoided (5th and 95th percentile projections range from 0.7 million to 4.3 million), rising to 8.5 million by the end of the century (5th and 95th percentile projections range from 2.2 million to 11.2 million). The reduction in premature deaths attributable to the hypothetical policy scenario would result in approximately 33 million life years gained by 2060 (5th and 95th percentile projections range from 7.8 million to 53.9 million) and over 134 million life years gained by 2100 (5th and 95th percentile projections range from 31.6 million to 183.0 million).
Based on the experts' judgments that reducing nicotine levels in combusted tobacco products would increase smoking cessation and decrease smoking initiation, and calculations from the simulation model describing the potential impact of reducing nicotine to minimally addictive levels in cigarettes and selected other combusted tobacco products, FDA anticipates a significant public health benefit to the United States. This hypothesis is based on the assumption that the reduction in nicotine levels in combusted tobacco products would create substantial reductions in smoking prevalence due to increased smoking cessation and reduced initiation of regular smoking. Given that research studies cannot easily replicate the condition of a nationally enforced restriction on nicotine to minimally addictive levels in cigarettes, FDA sought expert opinion through an established elicitation process to provide the best estimates for the potential values and associated ranges of the likely impact of a hypothetical reduction in cigarettes' nicotine content (to be achieved by a potential product standard) on tobacco use behaviors. FDA requests data, evidence, and other information regarding the potential public health benefits (or risks) if FDA were to move forward in this area. Specifically, FDA is seeking data, evidence, and other information that could inform the following five parameter inputs that would be helpful in determining the public health impact of a nicotine tobacco product standard:
• Percent of current cigarette smokers who would quit cigarette smoking as a result of a standard restricting nicotine to minimally addictive levels.
• Percent of quitters switching to other combusted or noncombusted tobacco products.
• Percent of continuing smokers who become dual product users of cigarettes and noncombusted tobacco products.
• Percent reduction in annual smoking initiation rates.
• Percent of dissuaded smoking initiates who initiate noncombusted tobacco product use instead.
While the projections from the simulation model calculating the potential impact from reducing nicotine to minimally addictive levels in cigarettes suggest a significant public health benefit to the United States resulting from substantial reductions in smoking prevalence (based on the model's inputs, which reflect the experts' assessments that the reduction in nicotine levels in combusted tobacco products would create substantial increases in smoking cessation and reductions in initiation of regular smoking), the analysis does not address certain potential added benefits. First, the model does not account for increased quality of life from decreased tobacco-related morbidity, nor does it account for cost savings from medical care averted. Second, the analysis does not account for the impacts of secondhand smoke exposure on public health in the United States. Third, the analysis does not account for reductions in harms caused by smoking-related fires. Fourth, the potential impact described does not account for the potential impact on population health from use of the other combusted products (
The following references are on display in the Dockets Management Staff (see
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 |