| Page Range | 28977-29434 | |
| FR Document |
| Page and Subject | |
|---|---|
| 83 FR 29144 - Biweekly Notice; Applications and Amendments to Facility Operating Licenses and Combined Licenses Involving No Significant Hazards Considerations | |
| 83 FR 29431 - Ocean Policy To Advance the Economic, Security, and Environmental Interests of the United States | |
| 83 FR 29113 - Proposed Stipulated Order of Partial Dismissal, Endangered Species Act Claims | |
| 83 FR 29136 - Government in the Sunshine Act Meeting Notice | |
| 83 FR 29088 - Sunshine Act Meeting Notice | |
| 83 FR 29121 - Medicare & Medicaid Programs, and Other Program Initiatives, and Priorities; Meeting of the Advisory Panel on Outreach and Education (APOE), June 20, 2018 | |
| 83 FR 29038 - NASA Federal Acquisition Regulation Supplement: Removal of Definitions (NFS Case 2018-N017) | |
| 83 FR 29115 - Formations of, Acquisitions by, and Mergers of Bank Holding Companies | |
| 83 FR 29116 - Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company | |
| 83 FR 29116 - Formations of, Acquisitions by, and Mergers of Savings and Loan Holding Companies | |
| 83 FR 29131 - Crude Helium Auction and Sale for Fiscal Year 2019 Delivery | |
| 83 FR 29114 - Proposed Information Collection Request; Comment Request; Correction | |
| 83 FR 29101 - Proposed Information Collection; Comment Request; Hazard Simplification WFO-Partner Focus Groups | |
| 83 FR 29100 - Proposed Information Collection; Comment Request; Marine Mammal Protection Act Annual Supplemental Data Report | |
| 83 FR 29131 - Notice of Policy Implementing the 2016 Amendments to STCW in Support of the Polar Code | |
| 83 FR 29039 - NASA Federal Acquisition Regulation Supplement: Removal of Reference to the Supplemental Rights in Data Special Works Policy and Associated Clause (NFS Case 2018-N016) | |
| 83 FR 29040 - NASA Federal Acquisition Regulation Supplement: Removal of Reference to the Shared Savings Policy and Associated Clause (NFS Case 2018-N008) | |
| 83 FR 29137 - Meeting of the Public Safety Officer Medal of Valor Review Board | |
| 83 FR 29023 - Acetochlor; Pesticide Tolerances | |
| 83 FR 29014 - Oxirane, 2-methyl-, polymer with oxirane, mono[2-[2-(2-methoxymethylethoxy)methylethoxy]methylether] ether; Tolerance Exemption | |
| 83 FR 29017 - Tolfenpyrad; Pesticide Tolerances | |
| 83 FR 29088 - Information Systems Technical Advisory Committee; Notice of Partially Closed Meeting | |
| 83 FR 29033 - Benzovindiflupyr; Pesticide Tolerances | |
| 83 FR 29028 - Thiencarbazone-methyl; Pesticide Tolerance | |
| 83 FR 29085 - Commonwealth of Pennsylvania; Allegheny County Health Department, Withdrawal of Section 112(l) Delegation Authority for the Chemical Accident Prevention Regulations | |
| 83 FR 29099 - Low Melt Polyester Staple Fiber From Taiwan: Final Determination of Sales at Less Than Fair Value | |
| 83 FR 29094 - Low Melt Polyester Staple Fiber From the Republic of Korea: Final Determination of Sales at Less Than Fair Value and Final Affirmative Determination of Critical Circumstances, in Part | |
| 83 FR 29092 - Certain Tapered Roller Bearings From the Republic of Korea: Final Determination of Sales at Less Than Fair Value | |
| 83 FR 29127 - Prospective Grant of an Exclusive Patent License: Methods of Modulating Erythropoiesis With Arginine Vasopressin Receptor 1B Molecules | |
| 83 FR 29007 - Regulated Navigation Area and Safety Zone, Harlem River and Hudson River, Manhattan, NY | |
| 83 FR 29081 - Anchorage Grounds; Lower Chesapeake Bay, Cape Charles, VA | |
| 83 FR 29143 - Proposed Extension of Existing Collection; Comment Request | |
| 83 FR 29137 - Proposed Information Collection Request | |
| 83 FR 29118 - Medicare and Medicaid Programs; Application by The Compliance Team for Continued CMS Approval of Its Rural Health Clinic Accreditation Program | |
| 83 FR 29120 - Medicare and Medicaid Programs: Application From the American Association for Accreditation of Ambulatory Surgery Facilities, Inc. (AAAASF) for Continued Approval of its Ambulatory Surgical Center Accreditation Program | |
| 83 FR 28996 - Alabama Abandoned Mine Land Reclamation Plan | |
| 83 FR 29011 - Safety Zone; Unexploded Ordnance Detonation, Gulf of Mexico,Pensacola, FL | |
| 83 FR 29134 - Notice of Intent To Amend a Portion of the Arizona Strip Field Office Resource Management Plan Related to the Kanab Creek Area of Critical Environmental Concern, Arizona | |
| 83 FR 29130 - Information Collection Request to Office of Management and Budget; OMB Control Number: 1625-0010 | |
| 83 FR 29048 - Energy Conservation Program: Test Procedure for Water-Source Heat Pumps | |
| 83 FR 29096 - Certain Plastic Decorative Ribbon From the People's Republic of China: Preliminary Affirmative Countervailing Duty Determination and Alignment of Final Determination With Final Antidumping Duty Determination | |
| 83 FR 29003 - Safety Zone; Lavaca Bay, Point Comfort, TX | |
| 83 FR 29104 - Proposed Collection; Comment Request | |
| 83 FR 29140 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Attestation for Employers Seeking To Employ H-2B Nonimmigrant Workers Under Section 543 of the Consolidated Appropriations Act, 2017 | |
| 83 FR 29139 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Fair Labor Standards Act Special Employment Provisions | |
| 83 FR 29088 - Antidumping Duty Investigation of Common Alloy Aluminum Sheet From the People's Republic of China: Affirmative Preliminary Determination of Sales at Less-Than-Fair Value, Preliminary Affirmative Determination of Critical Circumstances, and Postponement of Final Determination | |
| 83 FR 29098 - Cast Iron Soil Pipe From the People's Republic of China: Postponement of Preliminary Determination in the Less-Than-Fair-Value Investigation | |
| 83 FR 29005 - Safety Zone: San Francisco Giants Fireworks Display, San Francisco Bay, San Francisco, CA | |
| 83 FR 29122 - Decisions Related to the Development of a Clearinghouse of Evidence-Based Practices in Accordance With the Family First Prevention Services Act of 2018 | |
| 83 FR 29126 - Office of the Director, National Institutes of Health; Notice of Meeting | |
| 83 FR 29128 - National Institute on Drug Abuse; Notice of Closed Meetings | |
| 83 FR 29125 - National Institute on Drug Abuse; Notice of Closed Meetings | |
| 83 FR 29127 - Government-Owned Inventions; Availability for Licensing | |
| 83 FR 29126 - National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting | |
| 83 FR 29126 - National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings | |
| 83 FR 29128 - National Eye Institute; Notice of Closed Meetings | |
| 83 FR 29104 - Privacy Act of 1974; System of Records | |
| 83 FR 29107 - Charter Renewal of Department of Defense Federal Advisory Committees | |
| 83 FR 29136 - Importer of Controlled Substances Application: Unither Manufacturing LLC | |
| 83 FR 29001 - Disposition of Property | |
| 83 FR 28994 - Medical Devices; Immunology and Microbiology Devices; Classification of the Next Generation Sequencing Based Tumor Profiling Test | |
| 83 FR 29124 - Tobacco Products Scientific Advisory Committee; Notice of Meeting | |
| 83 FR 29144 - Southern Nuclear Operating Company, Inc.; Vogtle Electric Generating Plant, Units 3 and 4; Improvements to Main Control Room Post-Accident Radiological Consequences | |
| 83 FR 29117 - Information Collection; Violations of Arms Control Treaties or Agreements With the United States | |
| 83 FR 29116 - Information Collection; Use of Products and Services of Kaspersky Lab | |
| 83 FR 29041 - Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Reef Fish Fishery of the Gulf of Mexico; Mutton Snapper and Gag Management Measures | |
| 83 FR 29044 - Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Spiny Lobster Fishery of the Gulf of Mexico and South Atlantic Regions; Regulatory Amendment 4 | |
| 83 FR 29154 - Agency Information Collection Activity: Application for Fee or Roster Personnel Designation | |
| 83 FR 29155 - Agency Information Collection Activity Under OMB Review: Application by Insured Terminally Ill Person for Accelerated Benefit | |
| 83 FR 29140 - Petitions for Modification of Application of Existing Mandatory Safety Standard | |
| 83 FR 29002 - Recurring Safety Zone; Wellsburg 4th of July Committee/Wellsburg 4th of July Freedom Celebration, Wellsburg, WV | |
| 83 FR 29002 - Recurring Safety Zone; Monongahela Area Chamber of Congress/Monongahela 4th of July Celebration, Monongahela, PA | |
| 83 FR 29005 - Recurring Safety Zone; EQT 4th of July Celebration, Pittsburgh, PA | |
| 83 FR 28983 - Children's Products, Children's Toys, and Child Care Articles: Determinations Regarding Lead, ASTM F963 Elements, and Phthalates for Engineered Wood Products | |
| 83 FR 29129 - Center for Scientific Review; Notice of Closed Meetings | |
| 83 FR 29056 - Internet Communication Disclaimers and Definition of “Public Communication” | |
| 83 FR 29129 - Center for Scientific Review; Notice of Closed Meeting | |
| 83 FR 29102 - Recall Effectiveness: Announcement of Request for Information Regarding the Use of Direct Notice and Targeted Notices During Recalls | |
| 83 FR 29144 - Crow Butte Resources, Inc. (North Trend Expansion Project); Notice of Atomic Safety and Licensing Board Reconstitution | |
| 83 FR 29001 - Drawbridge Operation Regulation; Cape Fear River, North Carolina, Wilmington, NC | |
| 83 FR 29153 - Agency Information Collection Activities: Information Collection Renewal; Submission for OMB Review; Procedures To Enhance the Accuracy and Integrity of Information Furnished to Consumer Reporting Agencies Under Section 312 of the Fair and Accurate Credit Transactions Act | |
| 83 FR 29152 - Pipeline Safety: Meeting of the Voluntary Information-Sharing System Working Group | |
| 83 FR 29146 - New Postal Products | |
| 83 FR 29148 - Self-Regulatory Organizations; Nasdaq PHLX LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend Exchange Rule 1101A, Terms of Option Contracts | |
| 83 FR 29150 - Self-Regulatory Organizations; Fixed Income Clearing Corporation; Order Approving Proposed Rule Change To Introduce a Floor to the Calculation of the Fails Charges and Make Other Changes | |
| 83 FR 29146 - Self-Regulatory Organizations; LCH SA; Notice of Filing of Proposed Rule Change Relating to Liquidity Risk Management | |
| 83 FR 29065 - Proposed Establishment and Modification of Area Navigation Routes, Atlantic Coast Route Project; Northeastern United States | |
| 83 FR 28978 - Amendment and Removal of VOR Federal Airways in the Vicinity of Lansing, MI, and Pontiac, MI | |
| 83 FR 28981 - Modification to Restricted Area R-5601F and Establishment of Restricted Area R-5601J; Fort Sill, OK | |
| 83 FR 28977 - Amendment of Class E Airspace; Kenansville, NC | |
| 83 FR 28980 - Amendment of Class E Airspace; Altoona, PA | |
| 83 FR 29115 - Environmental Impact Statements; Notice of Availability | |
| 83 FR 29066 - Proposed Amendment of Class E Airspace, Bloomsburg, PA | |
| 83 FR 29064 - Proposed Establishment of Class E Airspace; Chebeague Island, ME | |
| 83 FR 29111 - Boott Hydropower, LLC; Notice of Intent To File License Application, Filing of Pre-Application Document (PAD), Commencement of Pre-Filing Process, and Scoping; Request for Comments on the PAD and Scoping Document, and Identification of Issues and Associated Study Requests | |
| 83 FR 29108 - Combined Notice of Filings #1 | |
| 83 FR 29108 - Goodyear Lake Hydro, LLC; Notice of Settlement Agreement, Soliciting Comments, and Modification of Procedural Schedule | |
| 83 FR 29110 - Woodland Pulp, LLC; Notice of Application Accepted for Filing, Soliciting Comments, Motions To Intervene, and Protests | |
| 83 FR 29115 - Notice to All Interested Parties of Intent To Terminate Receivership | |
| 83 FR 28992 - Extension of Sunset Date for Attorney Advisor Program | |
| 83 FR 29013 - Pesticides; Agricultural Worker Protection Standard; Notification of Availability | |
| 83 FR 29067 - TWIC-Reader Requirements; Delay of Effective Date | |
| 83 FR 29059 - Airworthiness Directives; Bombardier, Inc., Airplanes | |
| 83 FR 29061 - Airworthiness Directives; Bombardier, Inc., Airplanes | |
| 83 FR 29056 - Airworthiness Directives; Dassault Aviation | |
| 83 FR 29312 - SES Positions That Were Career Reserved During CY 2017 | |
| 83 FR 29135 - Notice of Availability of the Final Environmental Impact Statement for the Normally Pressured Lance (NPL) Natural Gas Development Project | |
| 83 FR 29212 - Taking and Importing Marine Mammals; Taking Marine Mammals Incidental to Geophysical Surveys Related to Oil and Gas Activities in the Gulf of Mexico | |
| 83 FR 29158 - Optional Internet Availability of Investment Company Shareholder Reports |
Industry and Security Bureau
International Trade Administration
National Oceanic and Atmospheric Administration
Air Force Department
Army Department
Navy Department
Federal Energy Regulatory Commission
Centers for Medicare & Medicaid Services
Children and Families Administration
Food and Drug Administration
National Institutes of Health
Coast Guard
Land Management Bureau
Surface Mining Reclamation and Enforcement Office
Drug Enforcement Administration
Justice Programs Office
Disability Employment Policy Office
Mine Safety and Health Administration
Workers Compensation Programs Office
Federal Aviation Administration
Pipeline and Hazardous Materials Safety Administration
Comptroller of the Currency
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.
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Federal Aviation Administration (FAA), DOT.
Final rule.
This action amends Class E airspace at Duplin County Airport, Kenansville, NC, to accommodate airspace reconfiguration due to the decommissioning of the Kenan non-directional radio beacon (NDB), and cancellation of the NDB approach. Controlled airspace is necessary for the safety and management of instrument flight rules (IFR) operations at this airport. This action also updates the geographic coordinates of this airport.
Effective 0901 UTC, September 13, 2018. The Director of the Federal Register approves this incorporation by reference action under title 1, Code of Federal Regulations, part 51, subject to the annual revision of FAA Order 7400.11 and publication of conforming amendments.
FAA Order 7400.11B, Airspace Designations and Reporting Points, and subsequent amendments can be viewed on line at
FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.
John Fornito, Operations Support Group, Eastern Service Center, Federal Aviation Administration, P.O. Box 20636, Atlanta, GA 30320; telephone (404) 305-6364.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it amends Class E airspace extending upward from 700 feet above the surface at Duplin County Airport, Kenansville, NC, to support IFR operations at the airport.
The FAA published a notice of proposed rulemaking in the
Class E airspace designations are published in paragraph 6005 of FAA Order 7400.11B dated August 3, 2017, and effective September 15, 2017, which is incorporated by reference in 14 CFR part 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.
This document amends FAA Order 7400.11B, Airspace Designations and Reporting Points, dated August 3, 2017, and effective September 15, 2017. FAA Order 7400.11B is publicly available as listed in the
This amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 amends Class E airspace extending upward from 700 feet above the surface within a 6.8-mile radius of Duplin County Airport, Kenansville, NC, due to the decommissioning of the Kenan NDB and cancellation of the NDB approach. These changes are necessary for continued safety and management of IFR operations at the airport. The geographic coordinates of the airport are amended to coincide with the FAA's aeronautical database.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,”
Airspace, Incorporation by reference, Navigation (air).
In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g); 40103, 40113, 40120, E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
That airspace extending upward from 700 feet above the surface within a 6.8-mile radius of Duplin County Airport.
Federal Aviation Administration (FAA), DOT.
Final rule.
This action modifies VHF Omnidirectional Range (VOR) Federal airways V-2, V-26, V-84, V-218, and V-510 in the vicinity of Lansing, MI, and removes airway V-410 in the vicinity of Pontiac, MI. These modifications are required due to the planned decommissioning of the Lansing, MI, VHF Omnidirectional Range/Tactical Air Navigation (VORTAC) and the Pontiac, MI, VORTAC navigation aids, which provide navigation guidance for portions of the above routes.
Effective date 0901 UTC, September 13, 2018. The Director of the Federal Register approves this incorporation by reference action under Title 1, Code of Federal Regulations, part 51, subject to the annual revision of FAA Order 7400.11 and publication of conforming amendments.
FAA Order 7400.11B, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.
Colby Abbott, Airspace Policy Group, Office of Airspace Services, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-8783.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it modifies the National Airspace System route structure as necessary to preserve the safe and efficient flow of air traffic.
The FAA published a notice of proposed rulemaking (NPRM) in the
VOR Federal airways are published in paragraph 6010(a) of FAA Order 7400.11B, dated August 3, 2017, and effective September 15, 2017, which is incorporated by reference in 14 CFR 71.1. The VOR Federal airways listed in this document will be subsequently published in the Order.
This document amends FAA Order 7400.11B, Airspace Designations and Reporting Points, dated August 3, 2017, and effective September 15, 2017. FAA Order 7400.11B is publicly available as listed in the
The FAA is amending Title 14, Code of Federal Regulations (14 CFR) part 71 by modifying the descriptions of VOR Federal airways V-2, V-26, V-84, V-218, and V-510; and removing V-410, due to the planned decommissioning of the Lansing, MI, and Pontiac, MI,
All radials in the route descriptions are stated relative to True north. Additionally, minor punctuation changes were made for clarity.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under Department of Transportation (DOT) Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
The FAA has determined that this action of modifying five VOR Federal airways and removing one Federal airway qualifies for categorical exclusion under the National Environmental Policy Act and its implementing regulations at 40 CFR part 1500, and in accordance with FAA Order 1050.1F, Environmental Impacts: Policies and Procedures, Paragraph 5-6.5a, which categorically excludes from further environmental impact review rulemaking actions that designate or modify classes of airspace areas, airways, routes, and reporting points (see 14 CFR part 71, Designation of Class A, B, C, D, and E Airspace Areas; Air Traffic Service Routes; and Reporting Points). As such, this action is not expected to cause any potentially significant environmental impacts. In accordance with FAA Order 1050.1F, paragraph 5-2 regarding Extraordinary Circumstances, the FAA has reviewed this action for factors and circumstances in which a normally categorically excluded action may have a significant environmental impact requiring further analysis. The FAA determined that no extraordinary circumstances exist that warrant preparation of an environmental assessment or environmental impact study.
Airspace, Incorporation by reference, Navigation (air).
In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
From Seattle, WA; Ellensburg, WA; Moses Lake, WA; Spokane, WA; Mullan Pass, ID; Missoula, MT; Helena, MT; INT Helena 119° and Livingston, MT, 322° radials; Livingston; Billings, MT; Miles City, MT; 24 miles, 90 miles 55 MSL, Dickinson, ND; 10 miles, 60 miles 38 MSL, Bismarck, ND; 14 miles, 62 miles 34 MSL, Jamestown, ND; Fargo, ND; Alexandria, MN; Gopher, MN; Nodine, MN; to INT Nodine 122° and Waukon, IA, 053° radials. From Buffalo, NY; Rochester, NY; Syracuse, NY; Utica, NY; Albany, NY; INT Albany 084° and Gardner, MA, 284° radials; to Gardner.
From Blue Mesa, CO; Montrose, CO; 13 miles 112 MSL, 131 MSL, Grand Junction, CO; Meeker, CO; Cherokee, WY; Muddy Mountain, WY; 14 miles, 37 miles 75 MSL, 84 miles 90 MSL, Rapid City, SD; Philip, SD; Pierre, SD; Huron, SD; Redwood Falls, MN; Farmington, MN; Eau Claire, WI; Waussau, WI; Green Bay, WI; INT Green Bay 116° and White Cloud, MI, 302° radials; to White Cloud.
From Northbrook, IL; to Pullman, MI. From Buffalo, NY; Geneseo, NY; INT Geneseo 091° and Syracuse, NY, 240° radials; to Syracuse.
From International Falls, MN; Grand Rapids, MN; Gopher, MN; to Waukon, IA.
From Dickinson, ND; INT Dickinson 078° and Bismarck, ND, 290° radials; 28 miles 38 MSL, Bismarck; INT Bismarck 067° and Jamestown, ND, 279° radials; 14 miles, 65 miles 34 MSL, Jamestown; Fargo, ND; INT Fargo 110° and Alexandria, MN, 321° radials; Alexandria; INT Alexandria 110° and Gopher, MN, 321° radials; Gopher; INT Gopher 109° and Nodine, MN, 328° radials; Nodine; to Dells, WI. From Buffalo, NY; INT Buffalo 045° and Rochester, NY, 273° radials; to Rochester.
Federal Aviation Administration (FAA), DOT.
Final rule.
This action amends amend Class E surface area airspace and Class E airspace extending upward from 700 feet or more above the surface at Altoona-Blair County Airport, Altoona, PA. This action accommodates airspace reconfiguration due to the decommissioning of Altoona VHF omnidirectional range navigation system (VOR) and cancellation of the VOR approaches. Controlled airspace is necessary for the safety and management of instrument flight rules (IFR) operations at this airport.
Effective 0901 UTC, September 13, 2018. The Director of the Federal Register approves this incorporation by reference action under title 1, Code of Federal Regulations, part 51, subject to the annual revision of FAA Order 7400.11 and publication of conforming amendments.
FAA Order 7400.11B, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.
John Fornito, Operations Support Group, Eastern Service Center, Federal Aviation Administration, 1701 Columbia Avenue, College Park, GA 30337; telephone (404) 305-6364.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it amends Class E airspace at Altoona-Blair County Airport, Altoona, PA, to ensure the efficient use of airspace within the National Airspace System.
The FAA published a notice of proposed rulemaking in the
Class E airspace designations are published in paragraph 6002 and 6005, respectively, of FAA Order 7400.11B dated August 3, 2017, and effective September 15, 2017, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.
This document amends FAA Order 7400.11B, Airspace Designations and Reporting Points, dated August 3, 2017, and effective September 15, 2017. FAA Order 7400.11B is publicly available as listed in the
This action amends Title 14 Code of Federal Regulations (14 CFR) part 71 by amending Class E surface area airspace, and Class E airspace extending upward from 700 feet or more above the surface due to the decommissioning of the Altoona VOR and cancelation of associated approaches at Altoona-Blair County Airport, Altoona, PA.
The Class E surface area airspace is amended to within a 4.7-mile (from a 4-mile) radius of the airport, with a segment 1.0-mile each side of the 026° bearing from the airport to 8.7 miles northeast. The Altoona VOR segment is removed.
The Class E airspace area extending upward from 700 feet above the surface is amended to within an 11.2-mile (from a 6.5-mile) radius of the airport. These changes enhance the safety and management of IFR operations at the airport.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. Therefore, this regulation: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.5a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.
Airspace, Incorporation by reference, Navigation (air).
In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
Within a 4.7-mile radius of Altoona-Blair County Airport, and within 1.0 mile each side of the 026° bearing from the airport to 8.7 miles northeast of the airport.
That airspace extending upward from 700 feet above the surface within an 11.2-mile radius of Altoona-Blair County Airport.
Federal Aviation Administration (FAA), DOT.
Final rule, technical amendment.
This action amends the restricted areas at Fort Sill, OK, to subdivide R-5601F into two subareas, R-5601F and R-5601J, make a minor correction to one boundary point in R-5601G, and to update and standardize the using agency information for each restricted area in the Fort Sill restricted area complex. The FAA is taking this action to allow for more efficient use of the airspace during periods when military activities only require the eastern portions of the restricted area complex. The airspace modifications are fully contained within the existing lateral and vertical boundaries of the Fort Sill, OK, restricted airspace. The using agency information update to each of the restricted areas in the Fort Sill complex is editorial only.
Effective date 0901 UTC, September 13, 2018.
Colby Abbott, Airspace Policy Group, Office of Airspace Services, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-8783.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it amends existing restricted area R-5601F by subdividing it into R-5601F and R-5601J, and updates the using agency information for each of the restricted areas at Fort Sill, OK.
R-5601F is an irregularly shaped restricted area in the Fort Sill, OK, restricted area complex used to contain hazardous activities. It connects the Military Operations Areas located to the north with the R-5601 gunnery ranges located to the south and stretches the entire length of the Fort Sill restricted area complex laterally from west to east, from 500 feet above ground level (AGL) to Flight Level 400 in altitude. The United States (U.S.) Army normally trains in the eastern restricted areas, R-5601A, R-5601B, and R-5601F, while the U.S. Air Force normally trains in the western areas, R-5601C, R-5601D, R-5601E, R-5601F, and R-5601G. When the using agency only requires the eastern areas to support its hazardous training activities, it results in the R-5601F restricted area being activated across the entire northern boundary of the restricted areas being activated, and creates a 14-mile extension of restricted area airspace that is not needed for the training activities being conducted.
The activation of R-5601F, and the unintended consequences of the 14-mile extension of restricted area airspace extending westward beyond the eastern Fort Sill restricted areas, primarily impacts the high altitude commercial air carriers inbound to the Dallas-Fort Worth metroplex area. Routing aircraft to overfly the R-5601F restricted area results in descent delays that take aircraft off their optimized descent profiles, and vectoring aircraft to circumnavigate the R-5601F restricted area laterally to the west adds miles and flight time to each aircraft. Additionally, these mitigations to overcome the unneeded extension of the R-5601F restricted area when only the eastern Fort Sill restricted areas are required also increases air traffic complexity and controller workload.
In December 2017, the FAA supported a U.S. Army laser air defense exercise conducted at Fort Sill, OK, using existing permanent restricted areas and two temporary restricted areas established overhead the Fort Sill restricted area complex. As part of a lessons learned review of the exercise, the FAA determined that subdividing the existing R-5601F restricted area laterally into two restricted areas, activated independently, would lessen aeronautical impacts to air traffic operating in the central United States.
Further, subdividing the existing R-5601F laterally into two separate restricted areas enhances the efficient
Lastly, while staffing this airspace action to subdivide R-5601F laterally, the FAA also determined that one geographic point in the R-5601G boundary information needed to be adjusted and the using agency information needed to be updated in all of the restricted areas in the R-5601 complex. The minor R-5601G boundary point change was deemed necessary to ensure the accuracy of the shared boundaries with the two new subdivided restricted areas and the using agency editorial updates was necessary for clarity and standardization in all of the restricted areas in the R-5601 complex.
This action amends 14 CFR part 73 by subdividing restricted area R-5601F in the Fort Sill, OK, restricted area complex into two subareas, R-5601F (amended) and R-5601J (new), divided laterally by a shared boundary extending from lat. 34°45′03″ N, long. 98°29′44″ W to lat. 34°43′30″ N, long. 98°35′40″ W. The subarea portion of the current R-5601F established west of the shared boundary will continue to be designated R-5601F, and the subarea portion established east of the shared boundary will be designated R-5601J. This action does not alter the existing lateral or vertical boundaries of the restricted area airspace or the operations currently conducted in that airspace. The subdivision of the current R-5601F restricted area minimizes impacts to high altitude commercial air carriers inbound to the Dallas-Fort Worth metroplex area unnecessarily when only the eastern R-5601 complex restricted areas are required for training by the using agency at Fort Sill, OK.
This action also makes a minor change to one geographic point in the boundaries information listed in the R-5601G description due to improved digital charting capabilities. This change ensures the accuracy of the shared boundaries between restricted areas R-5601F and R-5601J with R-5601G, and that all three restricted areas meet at the same shared boundary point.
Additionally, this action makes editorial changes to the using agency information listed in each of the Fort Sill restricted area descriptions for clarity and standardization. The using agency is unchanged, but simply amended in the descriptions to reflect the military unit responsible for ensuring the restricted areas are used for their designated purpose, scheduling the restricted areas, and coordinating the restricted area airspace use with the controlling agency. The Fort Sill using agency concurs with this editorial update.
These modifications do not change the current lateral boundaries, designated altitudes, times of designation, or activities conducted within the Fort Sill restricted area complex; therefore, notice and public procedure under 5 U.S.C. 553(b) are unnecessary.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under Department of Transportation (DOT) Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
The FAA has determined that this action of amending the internal subdivision of restricted area R-5601F within the Fort Sill, OK, complex qualifies for categorical exclusion under the National Environmental Policy Act and in accordance with FAA Order 1050.1F, Environmental Impacts: Policies and Procedures, paragraph 5-6.5.d, “Modification of the technical description of special use airspace (SUA) that does not alter the dimensions, altitudes, or times of designation of the airspace (such as changes in designation of the controlling or using agency, or correction of typographical errors).” This airspace action is an administrative change to the internal subdivision of an existing restricted area within the Fort Sill, OK, restricted area complex. It does not alter the dimensions, altitudes, time of designation, or use of the airspace. Therefore, this airspace action is not expected to result in any significant environmental impacts. In accordance with FAA Order 1050.1F, paragraph 5-2 regarding Extraordinary Circumstances, this action has been reviewed for factors and circumstances in which a normally categorically excluded action may have a significant environmental impact requiring further analysis, and it is determined that no extraordinary circumstances exist that warrant preparation of an environmental assessment or an environmental impact study.
Airspace, Prohibited areas, Restricted areas.
In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 73 as follows:
49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
By removing “Using agency. U.S. Army, Commanding General, U.S. Army Fires Center of Excellence (USAFCOE) and Fort Sill, Fort Sill, OK,” and adding in its place:
Using agency. U.S. Army, U.S. Army Fires Center of Excellence (USAFCOE), Fort Sill, OK.
By removing “Using agency. U.S. Army, Commanding General, U.S. Army Fires Center of Excellence (USAFCOE) and Fort Sill, Fort Sill, OK,” and adding in its place:
Using agency. U.S. Army, U.S. Army Fires Center of Excellence (USAFCOE), Fort Sill, OK.
By removing “Using agency. U.S. Army, Commanding General, U.S. Army Fires Center of Excellence (USAFCOE) and Fort Sill, Fort Sill, OK,” and adding in its place:
Using agency. U.S. Army, U.S. Army Fires Center of Excellence (USAFCOE), Fort Sill, OK.
By removing “Using agency. U.S. Army, Commanding General, U.S. Army Fires Center of Excellence (USAFCOE)
Using agency. U.S. Army, U.S. Army Fires Center of Excellence (USAFCOE), Fort Sill, OK.
By removing “Using agency. U.S. Army, Commanding General, U.S. Army Fires Center of Excellence (USAFCOE) and Fort Sill, Fort Sill, OK,” and adding in its place:
Using agency. U.S. Army, U.S. Army Fires Center of Excellence (USAFCOE), Fort Sill, OK.
Boundaries. Beginning at lat. 34°46′24″ N, long. 98°52′00″ W; thence clockwise via the 49 NM arc of the Wichita Falls VORTAC to lat. 34°46′39″ N, long. 98°50′53″ W; to lat. 34°43′46″ N, long. 98°49′55″ W; thence clockwise via the 46 NM arc of the Wichita Falls VORTAC to lat. 34°45′03″ N, long. 98°29′44″ W; to lat. 34°43′30″ N, long. 98°35′40″ W; to lat. 34°45′00″ N, long. 98°40′31″ W; to lat. 34°42′15″ N, long. 98°50′01″ W; to the point of beginning. Excluding that airspace below 5,500 feet MSL beginning at lat. 34°44′28″ N, long. 98°46′16″ W; thence clockwise via the 46 NM arc of the Wichita Falls VORTAC to lat. 34°45′03″ N, long. 98°29′44″ W; to lat. 34°43′30″ N, long. 98°35′40″ W; to lat. 34°45′00″ N, long. 98°40′31″ W; to lat. 34°43′09″ N, long. 98°46′56″ W; to the point of beginning.
Designated altitudes. 500 feet AGL to FL 400. Times of designation. Sunrise to 2200 local time, Monday-Friday; other times by NOTAM. Controlling agency. FAA, Fort Worth ARTCC. Using agency. U.S. Army, U.S. Army Fires Center of Excellence (USAFCOE), Fort Sill, OK.
By removing the boundary geographic point “lat. 34°45′03″ N, long. 98°29′46″ W” and adding in its place “lat. 34°45′03″ N, long. 98°29′44″ W.”
By removing “Using agency. U.S. Army, Commanding General, U.S. Army Fires Center of Excellence (USAFCOE) and Fort Sill, Fort Sill, OK,” and adding in its place:
Using agency. U.S. Army, U.S. Army Fires Center of Excellence (USAFCOE), Fort Sill, OK.
By removing “Using agency. U.S. Army, Commanding General, U.S. Army Fires Center of Excellence (USAFCOE) and Fort Sill, Fort Sill, OK,” and adding in its place:
Using agency. U.S. Army, U.S. Army Fires Center of Excellence (USAFCOE), Fort Sill, OK.
Boundaries. Beginning at lat. 34°45′03″ N, long. 98°29′44″ W; to lat. 34°46′15″ N, long. 98°25′01″ W; to lat. 34°47′00″ N, long. 98°17′46″ W; to lat. 34°46′45″ N, long. 98°17′01″ W; to lat. 34°46′06″ N, long. 98°17′01″ W; to lat. 34°46′06″ N, long. 98°21′01″ W; to lat. 34°43′45″ N, long. 98°21′01″ W; to lat. 34°43′30″ N, long. 98°21′21″ W; to lat. 34°43′30″ N, long. 98°35′40″ W; to the point of beginning. Excluding that airspace below 5,500 feet MSL beginning at lat. 34°43′30″ N, long. 98°35′40″ W; to lat. 34°44′48″ N, long. 98°30′45″ W; to lat. 34°43′30″ N, long. 98°30′00″ W; to the point of beginning; and that airspace below 3,500 feet MSL within a 1 NM radius of lat. 34°46′46″ N, long. 98°17′46″ W.
Designated altitudes. 500 feet AGL to FL 400. Times of designation. Sunrise to 2200 local time, Monday-Friday; other times by NOTAM. Controlling agency. FAA, Fort Worth ARTCC. Using agency. U.S. Army, U.S. Army Fires Center of Excellence (USAFCOE), Fort Sill, OK.
U.S. Consumer Product Safety Commission.
Final rule.
The Consumer Product Safety Commission (CPSC) is issuing a final rule determining that certain untreated and unfinished engineered wood products (EWPs), specifically, particleboard, hardwood plywood, and medium-density fiberboard, made from virgin wood or pre-consumer wood waste do not contain lead, the ASTM F963 elements, or specified phthalates that exceed the limits set forth under the CPSC's statutes for children's products, children's toys, and child care articles. Based on these determinations, the specified EWPs would not be required to have third party testing for compliance with the requirements for lead, ASTM F963 elements, or phthalates for children's products, children's toys, and child care articles.
The rule is effective on July 23, 2018.
Stephen Lee, Office of Compliance, U.S. Consumer Product Safety Commission, 4330 East West Hwy., Bethesda, MD 20814; 301-504-7844: email:
Section 14(a) of the Consumer Product Safety Act (CPSA), as amended by the Consumer Product Safety Improvement Act of 2008 (CPSIA), requires that manufacturers of products subject to a consumer product safety rule or similar rule, ban, standard, or regulation enforced by the CPSC, must certify that the product complies with all applicable CPSC-enforced requirements. 15 U.S.C. 2063(a). For children's products, children's toys, and child care articles, certification must be based on testing conducted by a CPSC-accepted third party conformity assessment body (laboratory).
Section 101 of the CPSIA has two requirements associated with lead in children's products. 15 U.S.C. 1278a. First, no accessible part of a children's product may contain more than 100 parts per million (ppm) lead content. Second, paint or other surface coatings on children's products and furniture intended for consumer use may not contain lead in concentrations greater than 90 ppm. Manufacturers of children's products must certify, based on third party testing, that their
To alleviate some of the third party testing burdens associated with lead in the accessible component parts of children's products, the Commission determined that certain materials, including gemstones, precious metals, wood, paper, CMYK process printing inks, textiles, and specified stainless steel, do not exceed the 100 ppm lead content limit under section 101 of the CPSIA. Based on this determination, these materials do not require third party testing for the lead content limits. The determinations regarding lead content for certain materials are set forth in 16 CFR 1500.91.
Section 106 of the CPSIA provides that the provisions of ASTM International
Section 4.3.5 of ASTM F963 requires that surface coating materials and accessible substrates of children's toys that can be sucked, mouthed, or ingested
The
To alleviate some of the third party testing burdens associated with the ASTM F963 elements in the accessible component parts of children's toys, the Commission determined that certain unfinished and untreated trunk wood does not contain ASTM F963 elements that would exceed the limits specified in section 106 of the CPSIA. Based on this determination, unfinished and untreated trunk wood would not require third party testing for the ASTM F963 elements. The determinations regarding the ASTM F963 elements limits for certain materials is set forth in 16 CFR 1251.2.
Section 108(a) of the CPSIA permanently prohibits the manufacture for sale, offer for sale, distribution in commerce, or importation into the United States of any “children's toy or child care article” that contains concentrations of more than 0.1 percent of di-(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), or butyl benzyl phthalate (BBP). 15 U.S.C. 2057c(a). The CPSIA required the Commission to appoint a Chronic Hazard Advisory Panel (CHAP) to “study the effects on children's health of all phthalates and phthalate alternatives as used in children's toys and child care articles.” 15 U.S.C. 2057c(b)(2). The CHAP issued its report in July 2014.
These restrictions apply to any plasticized component part of a children's toy or child care article or any other component part of a children's toy or child care article that is made of other materials that may contain phthalates. The phthalates prohibitions are set forth in 16 CFR part 1307.
Tests for phthalate concentration are among the most expensive certification tests to conduct on a product, and each accessible component part subject to section 108 of the CPSIA must be tested.
To alleviate some of the third party testing burdens associated with plastics in the accessible component parts of
On October 13, 2017, the Commission published a notice of proposed rulemaking (NPR) in the
CPSC contracted with the Toxicology Excellence for Risk Assessment (TERA),
In the Task 9 Report, TERA conducted a literature search on whether unfinished wood and other natural materials could be determined not to contain any of the ASTM F963 elements in concentrations greater than the ASTM F963 solubility limits.
To assess the presence of the ASTM F963 elements' concentrations in the materials, TERA looked at several factors. The factors reviewed included the presence and concentrations of the elements in the environmental media (
In the Task 11 Report, TERA conducted a literature search on the production and use of 11 specified phthalates in consumer products.
• The raw materials used in the production of the specified phthalates;
• The manufacturing processes used worldwide to produce the specified phthalates;
• Estimated annual production of the specified phthalates;
• Physical properties of the specified phthalates (
• Applications for phthalates use in materials and consumer and non-consumer products; and
• Other potential routes by which phthalates can be introduced into an otherwise phthalates-free material (
In the Task 14 Report, TERA conducted a literature search on the production of three EWPs: Particleboard, hardwood plywood, and medium-density fiberboard.
• Lead in concentrations exceeding 100 ppm;
• Any of the specified elements that are included in the safety standard for children's toys, ASTM F963,
• Any of 10 specified phthalates in concentrations greater than 0.1 percent (1000 ppm), listed in Table 3.
TERA reviewed the literature to assess whether the specified EWPs might contain lead or one or more of the other elements at levels that exceed the ASTM solubility limits, or any of the specified phthalates in concentrations greater than the specified limits. TERA reported that no studies found lead, the ASTM F963 elements, or the specified phthalates in concentrations greater than their limits in particleboard, hardwood plywood, or medium-density fiberboard, that are unfinished and untreated, and made from virgin wood or pre-consumer wood waste.
In the Task 14 Report, TERA described an unfinished EWP as one that does not have any surface treatments applied at manufacture, such as factory-applied coatings. An untreated EWP is one that does not have any additional finishes applied at manufacture, such as flame retardants or rot-resistant finishes. TERA described “virgin wood” as wood logs, fibers, chips, or layers that have not been recycled from a previous use. TERA described “pre-consumer wood waste” as wood materials that have been recycled from an industrial process before being made available for consumer use. Examples of this type of waste include trimmings from EWP panel manufacturing, sawdust from cutting logs, or remaining wood pieces from sawing a log into framing lumber.
The TERA report highlighted the potential for lead, the ASTM F963 elements, or the specified phthalates to be present in concentrations greater than those specified through the use of contaminated recycled material in EWPs made from recycled wood waste or EWPs that have post-manufacturing treatments or finishes. Recycled wood waste may be made from reclaimed or post-consumer wood waste. “Post-consumer wood waste” is described as wood waste that is comprised of materials that are recovered from their original use and subsequently used in a new product. Examples of this type of waste include recycled demolition wood, packaging materials, such as pallets and crates, used wood from
The three types of EWPs reviewed by TERA are discussed below.
Particleboard is a composite of wood chips, adhesives, and other additives pressed into a board. Adhesive formulations are used to bond wood chips, which are then formed into mats that are layered to create uniform boards in a range of dimensions. Particleboard is used widely in furniture making and other interior (or nonstructural) uses. The constituent parts of particleboard reported by TERA can include (by weight):
• Wood (60-99+ percent);
• Adhesive formulation (0-17 percent, with 5-11 percent most common);
• Phenol-formaldehyde (uncommon but potential for use), urea-formaldehyde, melamine-urea-formaldehyde, polymeric methylene-diphenyl-diisocyanate (pMDI);
• Waxes (0.3-1 percent);
• Other additives (up to 2 percent); or
• Scavengers or additional unspecified materials.
TERA researched the possibility of lead, the ASTM F963 elements, or the specified phthalates, in concentrations greater than their specified limits in particleboard. TERA identified little information on measurements of lead and the ASTM F963 elements in particleboard, and found no studies that measured the specified phthalates. TERA identified two references where particleboard made from both untreated and copper chromate arsenic-(CCA) treated wood chips was tested. Arsenic and chromium were undetected in the particleboards made from virgin wood chips. However, the particleboard composed of 25 percent wood chips from reclaimed CCA-treated wood products contained 895 and 832 ppm of arsenic and chromium, respectively, without adversely affecting the mechanical performance of the board. Another study that discussed “recycled particleboard” was identified as wood waste obtained from a wood recycling plant.
Apart from the studies on particleboard made from wood waste that may contain post-consumer wood waste or post-manufacturing treatments, TERA reported that no studies found lead, the ASTM F963 elements, or the specified phthalates in concentrations greater than the specified limits in untreated and unfinished particleboard.
Plywood is a layered board of wood veneers, where the layers have alternating, perpendicular wood grain directions. Less commonly, the board might have a core of other EWPs with wood veneers as the outer layers. Hardwood plywood, addressed in this report, is a type of plywood that is composed of angiosperms (
• Wood (75-99+ percent);
• Adhesive formulation (0.02-20 percent, with 1 percent to 5 percent most common);
• Phenol-formaldehyde or phenol-resorcinol-formaldehyde (likely for use in structural plywood but potential for application to hardwood plywood), urea-formaldehyde, melamine-formaldehyde, or melamine-urea-formaldehyde, or polyvinyl acetate (PVAc); or
• Other additives (less than 2 percent).
TERA researched the possibility of lead, the ASTM F963 elements, or the specified phthalates in concentrations greater than those specified in hardwood plywood. TERA identified only one study that measured lead and the ASTM F963 elements in plywood, and found no studies that measured the specified phthalates. Concentrations of cadmium, chromium, and lead were all less than the solubility limits in “plain” plywood. In addition, because hardwood plywood is made from sheets of wood veneer, it is less likely to contain recycled wood content, unless it incorporates a core of some other EWPs, such as particleboard or medium-density fiberboard.
Aside from the studies on recycled wood waste that may contain post-consumer wood waste or post-manufacturing treatments in a particleboard, medium-density fiberboard, or other EWP core, TERA reported that no studies found lead, the ASTM F963 elements, or the specified phthalates in concentrations greater than the specified limits in untreated and unfinished hardwood plywood. However, TERA identified research that indicated that polyvinyl acetate (PVAc) can be used as an adhesive system for hardwood plywood, as discussed in section (d) below.
Medium-density fiberboard (MDF) is a composite of wood fibers, an adhesive formulation, and other additives pressed into a board. MDF is a product similar to particleboard, differing mostly due to the use of fiber rather than chips. It is used primarily in furniture and for other interior (nonstructural) purposes. The constituent parts of MDF reported by TERA can include (by weight):
• Wood (73-99+ percent);
• Adhesive formulation (0-25 percent with most common 5-12 percent);
• Phenol-formaldehyde (uncommon, but potentially used for moisture resistance), urea-formaldehyde (most commonly identified), methylene-diphenyl-diisocyanate (pMDI), melamine-formaldehyde, or melamine-urea-formaldehyde;
• Waxes (less than 1 percent); or
• Other additives (10-30 percent).
TERA researched the possibility of lead, the ASTM F963 elements, or the specified phthalates in concentrations greater than those specified in MDF. TERA did not identify any references that reported the presence of lead, the ASTM F963 elements, or the specified phthalates in MDF made with virgin wood.
Aside from the studies on recycled wood waste that may contain post-consumer wood waste or post-manufacturing treatments, TERA reported that no studies found lead, the ASTM F963 elements, or the specified phthalates in concentrations greater than the specified limits in untreated and unfinished MDF.
Because few references were found directly addressing lead, the ASTM F963 elements, and the specified phthalates in EWPs, TERA also researched the constituent parts that could be used to manufacture EWPs, including wood and adhesives.
According to the manufacturing process information provided by TERA, virgin wood and wood residues are the main sources of wood fiber used in North America to manufacture EWPs. Typically, these sources include low-value logs, industrial wood residues, or scraps and trim from furniture and EWP production. For example, hardwood plywood requires the trunks of trees to obtain the thin layers of veneer used to construct a sheet. TERA relied on the Task 9 Report and Commission findings on unfinished and untreated wood (80 FR 78651 (Dec. 17, 2015)) to determine
Although TERA reported that the majority of EWPs are manufactured with virgin wood or pre-consumer wood waste fiber or chips, the wood component also can originate from recycled material. For EWPs made from recycled wood waste that may contain post-consumer wood waste, the TERA report highlighted the potential for lead, the ASTM F963 elements, or the specified phthalates to be present in concentrations greater than those specified through the use of contaminated recycled material. The TERA report cited multiple examples of the use of reclaimed or post-consumer wood material used to produce EWPs, both domestically and internationally. Specifically, TERA found studies showing that reclaimed lumber and wood waste could contain a myriad of contaminants, such as surface treatments (
TERA also reviewed another study, based in Italy, which evaluated the “recyclability” of used wood, by conducting elemental analysis of wood residues from wood recycling plants using a handheld fast energy dispersive X-ray fluorescence spectroscopy (ED-XRF) device. TERA found that the study provided some indication of the types and levels of contamination in various kinds of post-consumer wood waste. Elemental analysis results were compared to EU Community Ecolabel limits.
TERA concluded that, with an increased interest and use of post-consumer recycled materials in EWP production, potential contamination by the specified elements and phthalates must be considered. To ensure that EWPs made from used wood fibers do not contain ASTM F963 elements or phthalates that exceed the specified limits, TERA indicated that the materials would need to be sorted carefully and tested to ensure that they are not contaminated.
Adhesive formulations hold together the wood chips, layers, or fibers to make EWP mats and sheets. Some of the formulations use a metal catalyst during the curing process. TERA identified a number of references describing the presence of the ASTM F963 elements in adhesive formulations. However, TERA found very few references that would implicate EWPs. Although the use of barium was noted in multiple references, only one study appeared to be relevant to EWPs. This study suggested that barium, when used as a catalyst in an adhesive, could result in an EWP that exceeded the ASTM solubility level for barium.
Although many different adhesive formulations may be used in hardwood plywood, TERA noted that PVAc can be used as an adhesive system for hardwood plywood. The report cited sources (The Handbook of Adhesive Technology, USDA), which mentioned the use of some of the specified phthalates in PVAc adhesive formulations.
The CPSC received seven comments in response to the NPR. Five of the comments did not address any matters regarding EWPs. These comments addressed environmental regulation issues concerning alternative energy, electric cars, and greenhouse gas emissions, among other topics. None of these comments addressed EWPs. Accordingly, these comments do not fall within the scope of the current rulemaking. Two comments addressed the proposed determinations for EWPs.
In addition, to reflect the current list of prohibited phthalates in section 108 of the CPSIA, as required in the Commission's final rule issued on October 27, 2017, § 1252.1(c) is revised to include all of the permanently prohibited phthalates in any children's toy or child care article that contains concentrations of more than 0.1 percent of DEHP, DBP, BBP, DINP, DIBP, DPENP, DHEXP, or DCHP.
As noted above, section 14(a)(2) of the CPSA requires third party testing for children's products that are subject to a children's product safety rule. 15 U.S.C. 2063(a)(2). Children's products must comply with the lead limits in section 101 of the CPSIA. 15 U.S.C. 1278a. Children's toys must comply with the solubility limits for elements under the ASTM toy standard in section 106 of the CPSIA. 15 U.S.C. 2056b. Children's toys and child care articles must comply with the phthalates prohibitions in section 108 of the CPSIA. 15 U.S.C. 2057c. In response to statutory direction, the Commission has investigated approaches that would reduce the burden of third party testing while also assuring compliance with CPSC requirements. As part of that endeavor, the Commission has considered whether certain materials used in children's products, children's toys, and child care articles would not require third party testing.
To issue a determination that an EWP does not require third party testing, the Commission must have sufficient evidence to conclude that the product consistently complies with the CPSC's requirements to which the EWP is subject, so that third party testing is unnecessary to provide a high degree of assurance of compliance. Under 16 CFR part 1107, section 1107.2 defines “a high degree of assurance” as “an evidence-based demonstration of consistent performance of a product regarding compliance based on knowledge of a product and its manufacture.”
For accessible component parts of children's products, children's toys, and child care articles subject to sections 101, 106, and 108 of the CPSIA, compliance to the specified content limits is always required, irrespective of any testing exemptions. Thus, a manufacturer or importer who certifies a children's product, children's toy or child care article, must ensure the product's compliance. The presence of lead, the ASTM F963 elements, or the specified phthalates do not have to be intended to require compliance. The presence of these chemicals, whether for any functional purpose, as a trace material, or as a contaminant, must be in concentrations less than the specified content or solubility limits for the material to be compliant. Additionally, the manufacturer or importer must have a high degree of assurance that the product has not been adulterated or contaminated to an extent that would render it noncompliant. For example, if a manufacturer or importer is relying on a determination that an EWP does not contain lead, ASTM F963 elements, or specified phthalates in concentrations greater than the specified limits in a children's product, children's toy, or child care article, the manufacturer must ensure that the EWP is one on which a determination has been made.
The Commission finds, based on the staff's review of TERA's Task 14 report regarding reclaimed or post-consumer waste assessment in EWPs, that EWPs with post-consumer wood content and post-manufacturing waste could contain unwanted contaminants, such as paint or stains, metals from nails or fasteners, or adhesive formulations. Additionally, based on staff's review of the Task 11 and Task 14 reports, the Commission finds that PVAc used as an adhesive formulation in the manufacture of EWPs could contain at least one of the specified phthalates in hardwood plywood manufacturing that could result in the EWP exceeding the allowable levels of the specified phthalates. Accordingly, the Commission concludes that there is not a high degree of assurance that EWPs made from post-consumer wood waste or post-manufacturing treatments or finishes are compliant with sections 101, 106, or 108 of the CPSIA, or that hardwood plywood that contain PVAc are compliant with 108 of the CPSIA.
Based on the information provided in the TERA Task reports, staff's review of TERA's source references in the Task reports, and with the additional clarification that only products that are subject to one or more of the requirements for lead, ASTM elements, and the specified phthalates must be third party tested, the Commission determines that untreated and unfinished EWPs (particleboard, hardwood plywood, and medium-density fiberboard) made from virgin wood or pre-consumer wood waste, do not contain lead, or any of the specified elements in ASTM F963 in concentrations greater than their specified solubility limits. In addition, with the exception of hardwood plywood that contains PVAc adhesive formulations, the Commission determines that the specified EWPs do
Section 3 of the CPSIA grants the Commission general rulemaking authority to issue regulations, as necessary, to implement the CPSIA. Public Law 110-314, sec. 3, Aug. 14, 2008. Section 14 of the CPSA, which was amended by the CPSIA, requires third party testing for children's products subject to a children's product safety rule. 15 U.S.C. 2063(a)(2). Section 14(d)(3)(B) of the CPSA, as amended by Public Law 112-28, gives the Commission the authority to “prescribe new or revised third party testing regulations if it determines that such regulations will reduce third party testing costs consistent with assuring compliance with the applicable consumer product safety rules, bans, standards, and regulations.”
The determinations for the specified EWPs would relieve children's product certifiers from third party testing burdens, while assuring compliance with sections 101, 106, and 108 of the CPSIA for component parts made from the specified EWPs. However, the determinations would only relieve the manufacturers' obligation to have the specified EWPs tested by a CPSC-accepted third party laboratory. Children's products, children's toys, and child care articles must still comply with the substantive content limits in sections 101, 106, and 108 of the CPSIA, regardless of any relief on third party testing requirements. Finally, even if a determination is in effect and third party testing is not required, a certifier must still issue a certificate.
This rule creates a new part 1252 for
• Section 1252.1(a) of the rule explains the statutorily created requirements that limit lead in children's products under the CPSIA and the third party testing requirements for children's products.
• Section 1252.1(b) of the rule explains the statutorily created requirements for limiting the ASTM F963 elements in children's toys under the CPSIA and the third party testing requirements for children's toys.
• Section 1252.1(c) of the rule explains the statutorily created requirements limiting phthalates for children's toys and child care articles under the CPSIA and the third party testing requirements for children's toys and child care articles. This section is revised to reflect the final rule issued on phthalates that permanently prohibits any children's toy or child care article that contains concentrations of more than 0.1 percent of di-(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), or benzyl butyl phthalate (BBP). In addition, in accordance with section 108(b)(3) of the CPSIA, 16 CFR part 1307 prohibits any children's toy or child care article that contains concentrations of more than 0.1 percent of diisononyl phthalate (DINP), diisobutyl phthalate (DIBP), di-
• Section 1252.2 of the rule provides definitions that apply to part 1252.
• Section 1252.3(a) of the rule establishes the Commission's determinations that specified EWPs do not exceed the lead content limits with a “high degree of assurance,” as that phrase is defined in 16 CFR part 1107.
• Section 1252.3(b) of the rule establishes the Commission's determinations that specified EWPs do not exceed the solubility limits for ASTM F963 elements with a “high degree of assurance,” as that phrase is defined in 16 CFR part 1107.
• Section 1252.3(c) of the rule establishes the Commission's determinations that specified EWPs do not exceed the phthalates content limits, with the exception of hardwood plywood containing PVAc, with a “high degree of assurance,” as that phrase is defined in 16 CFR part 1107.
• Section 1252.3(d) of the rule provides that accessible component parts of children's products, children's toys, and child care articles made with the specified EWPs, are not required to be third party tested pursuant to section 14(a)(2) of the CPSA and 16 CFR part 1107.
• Section 1252.3(e) of the rule is clarified to state that accessible component parts of children's products, children's toys, and child care articles made with engineered wood products not listed in paragraphs (a)-(c) of this section, or with post-consumer wood waste, are required to be third party tested pursuant to section 14(a)(2) of the CPSA and 16 CFR part 1107 and sections 101, 106, or 108 of the CPSIA, as applicable.
The Administrative Procedure Act (APA) generally requires that a substantive rule must be published not less than 30 days before its effective date. 5 U.S.C. 553(d)(1). Because the final rule provides relief from existing testing requirements under the CPSIA, the Commission concludes that 30 days is sufficient. Thus, the effective date is July 23, 2018.
The Regulatory Flexibility Act (RFA), 5 U.S.C. 601-612, requires agencies to consider the impact of proposed and final rules on small entities, including small businesses. Section 604 of the RFA requires that agencies prepare a final regulatory flexibility analysis (FRFA) when promulgating final rules, unless the head of the agency certifies that the rule will not have a significant impact on a substantial number of small entities. The FRFA must describe the impact of the rule on small entities. CPSC staff prepared a FRFA, which is summarized below.
CPSC staff's review shows that comprehensive estimates of the number of children's products, children's toys, and child care articles that contain component parts made from the specified engineered woods are not available. However, based on the number of domestic producers and sellers of these products, staff believes that a substantial number of small entities could be impacted by this regulation. Staff's review indicates that there are approximately 81,505 small firms that manufacture or distribute children's products, children's toy or child care articles (6,976 manufacturers + 26,124 wholesalers + 48,405 retailers). Even if only a small proportion of these firms manufacture or sell products using the EWPs of interest, staff finds that a
• Lead—The cost of lead testing ranges from $50 to more than $100 per component through Inductively Coupled Plasma (ICP) testing. If one uses X-ray fluorescence (XRF) spectrometry, which is an acceptable method for certification of third party testing for lead content, the costs can be greatly reduced to approximately $5 per component. If a component part made with one of the specified engineered woods is painted, the component part would be exempt from the third party testing requirement, but the paint would still require lead testing.
• ASTM F963 Elements—Based on published invoices and price lists, the cost of a third party test for the ASTM F963 elements ranges from around $60 in China, up to around $190 in the United States, using ICP. This cost can be greatly reduced with the use of high definition X-ray fluorescence spectrometry (HDXRF), which is an acceptable method for certification of third party testing for the presence of the ASTM elements. The cost can be reduced to about $40 per component part. It should be noted that lead is one of the ASTM elements, so this testing would also cover the cost of lead testing for component parts.
• Phthalates—The cost of phthalate testing is relatively high: between about $125 and $350 per component, depending upon where the testing is conducted and any discounts that are applicable. Because one product might have multiple components that require testing, the cost of testing a single product for phthalates could exceed $1,000 in some cases. Moreover, more than one sample might have to be tested to provide a high degree of assurance of compliance with the requirements for testing.
To the extent that small businesses have lower production or lower sales volume than larger businesses, these determinations would be expected to have a disproportionately beneficial impact on small businesses. This beneficial impact is due to spreading the costs of the testing over fewer units. However, small entities that need fewer third party tests may not qualify for discounts that some laboratories may offer their larger customers. In addition, the possible benefits associated with the determinations might be somewhat lower to the extent that firms were already taking advantage of component part testing as allowed by 16 CFR part 1109. Additionally, some firms have reduced their testing costs by using XRF or HDXRF technology, which is less expensive than ICP, and would reduce the marginal benefit of these determinations.
The determinations would not impose any new reporting, recordkeeping, or other compliance requirements on small entities. In fact, because the rule would eliminate a testing requirement, there would be a small reduction in some of the recordkeeping burden under 16 CFR parts 1107 and 1109 because manufacturers would no longer have to maintain records of third party tests for the component parts manufactured from these engineered woods for lead, the ASTM F963 elements, or the specified phthalates. Based on staff's review, the Commission finds that the burden reduction from this determination rule could potentially result in significant benefits for a substantial number of manufacturers, importers, or retailers of the relevant product categories.
Under section 604 of the Regulatory Flexibility Act, a FRFA should include a “statement of the factual, policy, and legal reasons for selecting the alternative adopted in the final rule and why each one of the other significant alternatives to the rule considered by the agency which affect the impact on small entities was rejected.” The final rule is itself, the result of CPSC's efforts to reduce third party testing costs consistent with assuring compliance with all applicable consumer product safety rules. Therefore, CPSC considered few alternatives, other than expanding the list of engineered woods for which determinations could be made. CPSC staff identified these three types of EWPs for study, based on stakeholder feedback, the likelihood of being used in products subject to children's product, children's toy, or child care article certification requirements, and available resources. However, the Commission did not receive any other comments or other information on any additional engineered wood materials for further burden-reduction activities.
The Commission's regulations provide a categorical exclusion for most Commission rules from any requirement to prepare an environmental assessment or an environmental impact statement because they “have little or no potential for affecting the human environment.” 16 CFR 1021.5(c)(2). This rule falls within the categorical exclusion, so no environmental assessment or environmental impact statement is required. The Commission's regulations state that safety standards for products normally have little or no potential for affecting the human environment. 16 CFR 1021.5(c)(1). Nothing in this rule alters that expectation.
Business and industry, Consumer protection, Imports, Infants and children, Product testing and certification, Toys.
Sec. 3, Pub. L. 110-314, 122 Stat. 3016; 15 U.S.C. 2063(d)(3)(B).
(a) Section 101(a) of the Consumer Product Safety Improvement Act of 2008 (CPSIA) provides that any children's product, material, or component part or a children's product must comply with a lead content limit that does not exceed 100 parts per million. Materials used in children's products subject to section 101 of the CPSIA must comply with the third party testing requirements of section 14(a)(2) of the Consumer Product Safety Act (CPSA), unless listed in 16 CFR 1500.91.
(b) Section 106 of the CPSIA made provisions of ASTM F963, Consumer Product Safety Specifications for Toy Safety, a mandatory consumer product safety standard. Among the mandated provisions is section 4.3.5 of ASTM F963 which requires that surface coating materials and accessible substrates of children's toys that can be sucked, mouthed, or ingested, must comply with solubility limits that the toy standard establishes for eight elements. Materials used in children's toys subject to section
(c) Section 108(a) of the CPSIA permanently prohibits any children's toy or child care article that contains concentrations of more than 0.1 percent of di-(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), or benzyl butyl phthalate (BBP). In accordance with section 108(b)(3) of the CPSIA, 16 CFR part 1307 prohibits any children's toy or child care article that contains concentrations of more than 0.1 percent of diisononyl phthalate (DINP), diisobutyl phthalate (DIBP), di-
In addition to the definitions given in sections 101, 106, and 108 of the CPSIA, the following definitions apply for this part 1252.
(a) The following engineered wood products do not exceed the lead content limits with a high degree of assurance as that term is defined in 16 CFR part 1107:
(1) Particleboard that is untreated and unfinished made from virgin wood or pre-consumer wood waste;
(2) Hardwood plywood that is untreated and unfinished made from virgin wood or pre-consumer wood waste; and
(3) Medium-density fiberboard that is untreated and unfinished made from virgin wood or pre-consumer wood waste.
(b) The following engineered wood products do not exceed the ASTM F963 elements solubility limits set forth in 16 CFR part 1250 with a high degree of assurance as that term is defined in 16 CFR part 1107:
(1) Particleboard that is untreated and unfinished made from virgin wood or pre-consumer wood waste;
(2) Hardwood plywood that is untreated and unfinished made from virgin wood or pre-consumer wood waste; and
(3) Medium-density fiberboard that is untreated and unfinished made from virgin wood or pre-consumer wood waste.
(c) The following engineered wood products do not exceed the phthalates content limits with a high degree of assurance as that term is defined in 16 CFR part 1107:
(1) Particleboard that is untreated and unfinished made from virgin wood or pre-consumer wood waste;
(2) Hardwood plywood that is untreated and unfinished made from virgin wood or pre-consumer wood waste and does not contain polyvinyl acetate (PVAc) adhesive formulations; and
(3) Medium-density fiberboard that is untreated and unfinished made from virgin wood or pre-consumer wood waste.
(d) Accessible component parts of children's products, children's toys, and child care articles made with EWPs, listed in paragraphs (a) through (c) of this section are not required to be third party tested pursuant to section 14(a)(2) of the CPSA and 16 CFR part 1107.
(e) Accessible component parts of children's products, children's toys, and child care articles made with engineered wood products not listed in paragraphs (a) through (c) of this section, or that contain post-consumer wood waste, are required to be third party tested pursuant to section 14(a)(2) of the CPSA and 16 CFR part 1107 and sections 101, 106, or 108 of the CPSIA, as applicable.
Social Security Administration.
Final rule.
We are extending for one year our rule authorizing attorney advisors to conduct certain prehearing proceedings and to issue fully favorable decisions. The current rule is scheduled to expire on August 3, 2018. In this final rule, we are extending the sunset date to August 2, 2019. We are making no other substantive changes.
This final rule is effective June 22, 2018.
Susan Swansiger, Office of Hearings Operations, Social Security Administration, 5107 Leesburg Pike, Falls Church, VA 22041, (703) 605-8500. For information on eligibility or filing for benefits, call our national toll-free number, 800-772-1213 or TTY 800-325-0778, or visit our internet site, Social Security Online, at
On August 9, 2007, we issued an interim final rule permitting some attorney advisors to conduct certain prehearing proceedings and issue fully favorable decisions when the documentary record warrants doing so. 72 FR 44763. We instituted this practice to provide more timely service to the increasing number of applicants for Social Security disability benefits and Supplemental Security Income payments based on disability. We considered the public comments we received on the interim final rule, and on March 3, 2008, we issued a final rule without change. 73 FR 11349. Under this rule, some attorney advisors may
We originally intended the attorney advisor program to be a temporary modification to our procedures. Therefore, we included in sections 404.942(g) and 416.1442(g) of the interim final rule a provision that the program would end on August 10, 2009, unless we decided to either terminate the rule earlier or extend it beyond that date by publication of a final rule in the
We published the final rule to adopt without change the interim final rule that we published on August 9, 2007. We stated our intent to monitor the program closely and to modify it if it did not meet our expectations. 73 FR 11349.
We explained in the 2008 final rule that the number of requests for hearings had increased significantly in recent years. From 2008 to the present, the number of pending hearing requests has continued to remain at a high level, and we anticipate that we will receive several hundred thousand hearing requests in fiscal year 2018 and in fiscal year 2019.
To preserve the maximum degree of flexibility and manage our hearings-level workloads effectively, we have decided to extend the attorney advisor rule until August 2, 2019. As before, we reserve the authority to end the program earlier, to extend it by publishing a final rule in the
We follow the Administrative Procedure Act (APA) rulemaking procedures specified in 5 U.S.C. 553 when developing regulations. Section 702(a)(5) of the Social Security Act, 42 U.S.C. 902(a)(5). The APA provides exceptions to its notice and public comment procedures when an agency finds there is good cause for dispensing with such procedures because they are impracticable, unnecessary, or contrary to the public interest. We have determined that good cause exists for dispensing with the notice and public comment procedures for this rule. 5 U.S.C. 553(b)(B). Good cause exists because this final rule only extends the expiration date of an existing rule. It makes no substantive changes to the rule. The current regulations expressly provide that we may extend or terminate this rule. Therefore, we have determined that opportunity for prior comment is unnecessary, and we are issuing this rule as a final rule.
In addition, because we are not making any substantive changes to the existing rule, we find that there is good cause for dispensing with the 30-day delay in the effective date of a substantive rule provided by 5 U.S.C. 553(d)(3). To ensure that we have uninterrupted authority to use attorney advisors to address the number of pending cases at the hearing level, we find that it is in the public interest to make this final rule effective on the date of publication.
We consulted with the Office of Management and Budget (OMB) and although we do not believe that this will be a significant regulatory action under Executive Order (E.O.) 12866, as supplemented by E.O. 13563, OMB has reviewed this final rule.
We certify that this final rule will not have a significant economic impact on a substantial number of small entities because it affects individuals only. Therefore, the Regulatory Flexibility Act, as amended, does not require us to prepare a regulatory flexibility analysis.
These rules do not create any new or affect any existing collections and, therefore, do not require Office of Management and Budget approval under the Paperwork Reduction Act.
Administrative practice and procedure, Blind, Disability benefits, Old-age, Survivors and Disability Insurance, Reporting and recordkeeping requirements, Social security.
Administrative practice and procedure, Reporting and recordkeeping requirements, Supplemental Security Income (SSI).
For the reasons stated in the preamble, we are amending subpart J of part 404 and subpart N of part 416 of Chapter III of title 20 of the Code of Federal Regulations as set forth below:
Secs. 201(j), 204(f), 205(a)-(b), (d)-(h), and (j), 221, 223(i), 225, and 702(a)(5) of the Social Security Act (42 U.S.C. 401(j), 404(f), 405(a)-(b), (d)-(h), and (j), 421, 423(i), 425, and 902(a)(5)); sec. 5, Pub. L. 97-455, 96 Stat. 2500 (42 U.S.C. 405 note); secs. 5, 6(c)-(e), and 15, Pub. L. 98-460, 98 Stat. 1802 (42 U.S.C. 421 note); sec. 202, Pub. L. 108-203, 118 Stat. 509 (42 U.S.C. 902 note).
(g)
Secs. 702(a)(5), 1631, and 1633 of the Social Security Act (42 U.S.C. 902(a)(5), 1383, and 1383b); sec. 202, Pub. L. 108-203, 118 Stat. 509 (42 U.S.C. 902 note).
(g)
Food and Drug Administration, HHS.
Final order.
The Food and Drug Administration (FDA or we) is classifying the next generation sequencing based tumor profiling test into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the next generation sequencing based tumor profiling test's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
This order is effective June 22, 2018. The classification was applicable on November 15, 2017.
Scott McFarland, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4676, Silver Spring, MD, 20993-0002, 301-796-6217,
Upon request, FDA has classified the next generation sequencing based tumor profiling test as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. In addition, we believe this action will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens by placing the device into a lower device class than the automatic class III assignment.
The automatic assignment of class III occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device. Any device that was not in commercial distribution before May 28, 1976, is automatically classified as, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (see 21 U.S.C. 360c(f)(1)). We refer to these devices as “postamendments devices” because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act).
FDA may take a variety of actions in appropriate circumstances to classify or reclassify a device into class I or II. We may issue an order finding a new device to be substantially equivalent under section 513(i) of the FD&C Act to a predicate device that does not require premarket approval (see 21 U.S.C. 360c(i)). We determine whether a new device is substantially equivalent to a predicate by means of the procedures for premarket notification under section 510(k) of the FD&C Act and Part 807 (21 U.S.C. 360(k) & 21 CFR part 807, respectively).
FDA may also classify a device through “De Novo” classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act (21 U.S.C. 360c(f)(2)). Section 207 of the Food and Drug Administration Modernization Act of 1997 established the first procedure for De Novo classification (Pub. L. 105-115). Section 607 of the Food and Drug Administration Safety and Innovation Act modified the De Novo application process by adding a second procedure (Pub. L. 112-144). A device sponsor may utilize either procedure for De Novo classification.
Under the first procedure, the person submits a 510(k) for a device that has not previously been classified. After receiving an order from FDA classifying the device into class III under section 513(f)(1) of the FD&C Act, the person then requests a classification under section 513(f)(2).
Under the second procedure, rather than first submitting a 510(k) and then a request for classification, if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence, that person requests a classification under section 513(f)(2) of the FD&C Act.
Under either procedure for De Novo classification, FDA is required to classify the device by written order within 120 days. The classification will be according to the criteria under section 513(a)(1) of the FD&C Act (21 U.S.C. 360c(a)(1)). Although the device was automatically within class III, the De Novo classification is considered to be the initial classification of the device.
We believe this De Novo classification will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens. When FDA classifies a device into class I or II via the De Novo process, the device can serve as a predicate for future devices of that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a result, other device sponsors do not have to submit a De Novo request or PMA in order to market a substantially equivalent device (see 21 U.S.C. 360c(i), defining “substantial equivalence”). Instead, sponsors can use the less-burdensome 510(k) process, when necessary, to market their device.
On September 25, 2017, Memorial Sloan-Kettering Cancer Center Department of Pathology submitted a request for De Novo classification of the MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets). FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act.
We classify devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls. FDA has determined that these special controls, in addition to the general controls, will provide reasonable assurance of the safety and effectiveness of the device.
Therefore, on November 15, 2017, FDA issued an order to the requester classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 866.6080. We have named the generic type of device next generation sequencing (NGS) based tumor profiling test, and it is identified as a qualitative in vitro diagnostic test intended for NGS analysis of tissue
FDA has identified the following risks to health associated specifically with this type of device and the measures required to mitigate these risks in table 1.
FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. In order for a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this order. This device is subject to premarket notification requirements under section 510(k).
The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations and guidance. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in the guidance document “De Novo Classification Process (Evaluation of Automatic Class III Designation)” have been approved under OMB control number 0910-0844; the collection of information in part 814, subparts A through E, regarding premarket approval, have been approved under OMB control number 0910-0231; the collection of information in part 807, subpart E, regarding premarket notification submissions have been approved under OMB control number 0910-0120, and the collections of information in 21 CFR parts 801 and 809, regarding labeling have been approved under OMB control number 0910-0485.
Biologics, Laboratories, Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 866 is amended as follows:
21 U.S.C. 351, 360, 360c, 360e, 360j, 360
(a)
(b)
(1) Premarket notification submissions must include the following information:
(i) A detailed description of all somatic mutations that are intended to be detected by the test and that are adequately supported in accordance with paragraph (b)(1)(v) of this section and reported in the test results in accordance with paragraph (b)(2)(iv) of this section, including:
(A) A listing of mutations that are cancer mutations with evidence of clinical significance.
(B) As appropriate, a listing of mutations that are cancer mutations with potential clinical significance.
(ii) The indications for use must specify the following:
(A) The test is indicated for previously diagnosed cancer patients.
(B) The intended specimen type(s) and matrix (
(C) The mutation types (
(D) The name of the testing facility or facilities, as applicable.
(iii) A detailed device description including the following:
(A) A description of the test in terms of genomic coverage, as follows:
(
(
(B) Specifications for specimen requirements including any specimen collection devices and preservatives, specimen volume, minimum tumor content, specimen handling, DNA extraction, and criteria for DNA quality and quantity metrics that are prerequisite to performing the assay.
(C) A detailed description of all test components, reagents, instrumentation, and software required. Detailed documentation of the device software including but not limited to, software applications and hardware-based devices that incorporate software.
(D) A detailed description of the methodology and protocols for each step of the test, including description of the quality metrics, thresholds, and filters at each step of the test that are implemented for final result reporting and a description of the metrics for run-failures, specimen-failures, invalids, as applicable.
(E) A list of links provided by the device to the user or accessed by the device for internal or external information (
(F) A description of internal and external controls that are recommended or provided and control procedures. The description must identify those control elements that are incorporated into the testing procedure.
(iv) Information demonstrating analytical validity of the device according to analytical performance characteristics, evaluated either specifically for each gene/mutation or, when clinically and practically justified, using a representative approach based on other mutations of the same type, including:
(A) Data that adequately supports the intended specimen type (
(B) A summary of the empirical evidence obtained to demonstrate how the analytical quality metrics and thresholds were optimized.
(C) Device precision data using clinical samples to adequately evaluate intra-run, inter-run, and total variability. The samples must cover all mutation types tested (both positive and negative samples) and include samples near the limit of detection of the device. Precision must be assessed by agreement within replicates on the assay final result for each representative mutation, as applicable, and also supported by sequencing quality metrics for targeted regions across the panel.
(D) Description of the protocols and/or data adequately demonstrating the interchangeability of reagent lots and multiplexing barcodes.
(E) A description of the nucleic acid assay input concentration range and the evidence to adequately support the range.
(F) A description of the data adequately supporting the limit of detection of the device.
(G) A description of the data to adequately support device accuracy using clinical specimens representing the intended specimen type and range of tumor types, as applicable.
(
(
(
(H) Adequate device stability information.
(v) Information that adequately supports the clinical significance of the panel must include:
(A) Criteria established on what types and levels of evidence will clinically validate a mutation as a cancer mutation with evidence of clinical significance versus a cancer mutation with potential clinical significance.
(B) For representative mutations of those designated as cancer mutations with evidence of clinical significance, a description of the clinical evidence associated with such mutations, such as clinical evidence presented in professional guidelines, as appropriate, with method comparison performance data as described in paragraph (b)(1)(iv)(G) of this section.
(C) For all other mutations designated as cancer mutations with potential clinical significance, a description of the rationale for reporting.
(2) The 21 CFR 809.10 compliant labeling and any product information and test report generated, must include the following, as applicable:
(i) The intended use statement must specify the following:
(A) The test is indicated for previously diagnosed cancer patients.
(B) The intended specimen type(s) and matrix (
(C) The mutation types (
(D) The name of the testing facility or facilities, as applicable.
(ii) A description of the device and summary of the results of the performance studies performed in accordance with paragraphs (b)(1)(iii), (b)(1)(iv), and (b)(1)(v) of this section.
(iii) A description of applicable test limitations, including, for device specific mutations validated with method comparison data to a medically established test in the same intended specimen type, appropriate description of the level of evidence and/or the differences between next generation sequencing results and results from the medically established test (
(iv) A listing of all somatic mutations that are intended to be detected by the device and that are reported in the test results under the following two categories or equivalent designations, as appropriate: “cancer mutations panel with evidence of clinical significance” or “cancer mutations panel with potential clinical significance.”
(v) For mutations reported under the category of “cancer mutations panel with potential clinical significance,” a limiting statement that states “For the mutations listed in [cancer mutations panel with potential clinical significance or equivalent designation], the clinical significance has not been demonstrated [with adequate clinical evidence (
(vi) For mutations under the category of “cancer mutations panel with evidence of clinical significance,” or equivalent designation, link(s) for physicians to access internal or external information concerning decision rules or conclusions about the level of evidence for clinical significance that is associated with the marker in accordance with paragraph (b)(1)(v) of this section.
Office of Surface Mining Reclamation and Enforcement, Interior.
Final rule; approval of amendment.
We, the Office of Surface Mining Reclamation and Enforcement
The effective date is July 23, 2018.
William L. Joseph, Acting Director, Birmingham Field Office, Office of Surface Mining Reclamation and Enforcement, 135 Gemini Circle, Suite 215, Homewood, Alabama 35209. Telephone: (205) 290-7282. Email:
The Abandoned Mine Land Reclamation Program was established by Title IV of the Act, (30 U.S.C. 1201
By letter dated June 7, 2016 (Administrative Record No. AL-0670), Alabama sent OSMRE an amendment to its Plan under SMCRA (30 U.S.C. 1201
We announced receipt of the proposed amendment in the April 7, 2017,
During OSMRE's review, several minor deficiencies were noted, including section numbering inconsistencies and the lien language in the “Reclamation of Private Land” section. By letter dated July 17, 2017 (Administrative Record No. AL-0670-02), OSMRE requested that Alabama address these minor deficiencies. Because these requested changes were minor, Alabama was given the option to either incorporate the changes or withdraw the amendment and resubmit the Plan amendment at a later date. By letter dated July 28, 2017 (Administrative Record No. AL-0670-03), Alabama returned a revised Plan amendment correcting the deficiencies and the amendment process resumed.
We are approving the amendment as described below. The following are the findings we made concerning Alabama's amendment under SMCRA and the Federal regulations at 30 CFR 884.14 and 884.15. Any revisions that we do not specifically discuss below concerning non-substantive wording or editorial changes can be found in the full text of the Plan amendment available at
Alabama included a 1979 letter from the Governor designating the Alabama Department of Industrial Relations, now known as the Alabama Department of Labor (ADOL), as the agency responsible for the abandoned mine lands reclamation program in the state of Alabama. This letter was submitted and approved as part of the original proposed reclamation plan and is consistent with the Federal requirements of 30 CFR 884.13(a)(1). Therefore, we are approving its inclusion.
Alabama included a 1981 legal opinion from the Attorney General of Alabama authorizing the Alabama Department of Industrial Relations, under the legal authority of Alabama law, to conduct its reclamation program in accordance with the requirements of Title IV of the Act. This legal opinion was submitted and approved as part of the original proposed reclamation plan and is consistent with the Federal requirements of 30 CFR 884.13(a)(2). Therefore, we are approving its inclusion.
Alabama, in section 884.13(a)(3)(i) of the Plan, stated that the goal of its AMLR Plan is to amend those adverse effects of past coal mining conducted prior to August 3, 1977, which impact public health, safety, or general welfare, and cause environmental degradation. The stated objectives of the AMLR Plan are to identify and prioritize these adverse impacts, provide planning procedures, and affect their ultimate reclamation. Alabama also stated that, although the primary purpose of the program is the reclamation of coal mine lands, any non-coal AML issues will be dealt with in accordance with OSMRE policies. ADOL elected to set aside up to the maximum amount allowed by OSMRE of each year's allocation of AML funds into a separate fund for the abatement of the causes and treatment of the effects of acid mine drainage. These funds are used in accordance with all applicable State and Federal regulations and are used to achieve the priorities of SMCRA. The program purpose, goals, and objectives are consistent with the Federal requirements of 30 CFR 884.13(a)(3)(i). Therefore, we are approving their inclusion.
Alabama, in section 884.13(a)(3)(ii) of the Plan, described the priority system and the specific criteria for identifying and ranking all sites eligible for reclamation under Title IV of the Act. Examples of eligible site problems include: Open and unprotected mine entries; open shafts; hazardous highwalls and other steep embankments; hazardous mine structures; underground mine subsidence; trash dumps on mine lands; water bodies adversely affected by coal mine drainage; dangerous impoundments; and any other mine related danger. The sites given highest priority are those exhibiting extreme danger to public health, safety, and property from adverse effects of coal mining practices. The sites given the second highest priority are those exhibiting adverse effects of coal mining practices that may impact public health and safety. The sites given third priority for restoration are those land and water resources previously degraded by
Alabama, in section 884.13(a)(3)(iii) of the Plan, described ADOL's coordination with other agencies. The ADOL AML Program coordinates with other State divisions such as the Alabama Department of Environmental Management (ADEM), the State Historic Preservation Office (SHPO), and the Alabama Department of Conservation and Natural Resources (ADCNR), to review proposed reclamation projects, provide assistance, and offer expertise to ensure that reclamation activities restore adversely impacted land and water to a productive state while protecting natural and historic/cultural resources. ADOL maintains an annual cooperative agreement with a non-profit organization, the Walker County Soil and Water Conservation District Board (WCB), which funds and oversees a reclamation group that performs reclamation and maintenance on AML sites and responds to AML emergencies. Historically, several major and minor tribes occupied Alabama; however, no tribal reservations were historically or are currently located in the areas where AML reclamation presently takes place within the Alabama Coal Region. Consultations concerning potential cultural resource impacts are conducted through the SHPO's Alabama Historical Commission through the NEPA review process. Alabama also describes the purpose of its AML Emergency Program, which is to stabilize the emergency aspects of an AML problem by eliminating the immediate danger to public health, safety, or general welfare. The AML Emergency Program is discussed further in Section 8, “Rights of Entry.” This description of agency coordination is consistent with the Federal requirements of 30 CFR 884.13(a)(3)(iii). Therefore, we are approving its inclusion.
Alabama, in section 884.13(a)(3)(iv) of the Plan, stated that ADOL may acquire, manage, and dispose of lands that have been adversely affected by coal mining activity, if deemed necessary, pursuant to Section 407 of SMCRA, 30 U.S.C. 1237, and Code of Alabama Section9-16-127. These acquisition, management, and disposition policies and procedures are consistent with the Federal requirements of 30 CFR 884.13(a)(3)(iv). Therefore, we are approving their inclusion.
Alabama, in section 884.13(a)(3)(v) of the Plan, described its policies and procedures for reclamation on private land. Under its Plan, the ADOL State Programs Administrator has the authority to place or waive a lien against private property if the owner has consented to, participated in, or exercised control over the mining operation, and if reclamation will result in a significant increase in property value. If an initial evaluation suggests an increase in property value of $25,000 or more, the land appraisal may be conducted by an independent appraiser. The Administrator will determine whether to place or waive a lien based on both the independent appraisal findings and other relevant facts, in accordance with Code of Alabama Section 9-16-129. During OSMRE's review, it was noted that this section of the Plan, as well as the referenced Alabama state law (Code of Alabama Section 9-16-129), fails to address the full requirements of 30 CFR 882.13(b) in regard to notifying the landowner of the proposed lien and allowing the landowner a reasonable time to pay that amount in lieu of filing the lien. On July 17, 2017 (Administrative Record No. AL-0670-02), OSMRE requested that Alabama add this lien language to its proposed Plan. On July 28, 2017, Alabama returned a revised Plan which incorporated the additional lien language. These revised policies and procedures are consistent with the Federal requirements of 30 CFR 884.13(a)(3)(v) and 882.13(b). Therefore, we are approving this inclusion.
Alabama, in section 884.13(a)(3)(vi) and (iii) of the Plan, stated its policies and procedures regarding rights of entry to lands or property. Pursuant to Code of Alabama Section 9-16-126, ADOL will take all reasonable actions to obtain advance written consent from the property owner for the purposes of reclamation. In the event that permission cannot be obtained on properties where reclamation is needed and there is an immediate danger to public health, safety, or general welfare, police power entry is authorized under the AML Emergency Program. If police power entry is necessary, a written notice must be mailed to the property owner at least 30 days prior to entry. If the property owner's address is not known, the notice must be posted on the property and advertised in the newspaper. These policies and procedures are consistent with the Federal requirements of 30 CFR 884.13(a)(3)(vi). Therefore, we are approving their inclusion.
Alabama, in section 884.13(a)(3)(vii) of the Plan, described its public participation policies in the development and operation of its Plan. The ADOL encourages the public to contact its office with any questions or concerns regarding mining related problems or the AML program, or to visit the ADOL Inspections Division Abandoned Mine Lands Program Office. For future projects, ADOL distributes notifications to Federal, State, and local elected officials, and publishes public notices to news outlets within the county where the proposed activity is located. If sufficient public response is received, a public meeting may be scheduled to provide information on proposed activities and address the concerns of the citizens. Additional public involvement in the preparation of any revisions or amendments to the AML Plan will be coordinated and executed by OSMRE during the public comment and review period. These policies and procedures are consistent with the Federal requirements of 30 CFR 884.13(a)(3)(vii). Therefore, we are approving their inclusion.
Alabama, in section 884.13(a)(4)(i) of the Plan, described the organization of ADOL and its relationship to other State organizations that may become involved in its reclamation program. ADOL also
Alabama, in section 884.13(a)(4)(ii) of the Plan, described the personnel staffing policies that will govern the assignment of personnel to its reclamation program. The program's staff is selected on the basis of applicable academic and professional experience. ADOL will be responsible for complying with all pertinent Federal and State laws. This description of agency personnel policies is consistent with the Federal requirements of 30 CFR 884.13(a)(4)(ii). Therefore, we are approving its inclusion.
Alabama, in section 884.13(a)(4)(iii) of the Plan, stated that the purchasing and procurement systems used by ADOL will be in accordance with the requirements of Office of Management and Budget (OMB) Circular A-102, Attachment 0. Purchasing and procurement program staff is trained in all applicable State and Federal regulations and larger transactions are reviewed, if necessary, by the Alabama Department of Finance, the State Attorney General, the Alabama Department of Examiners of Public Accounts, and the State Auditor. Alabama also described its AML Applicant/Violator System (AVS), which ensures that no company owners, directors, or major shareholders bidding on AML Federally funded projects have any Federal coal mining violations or state cessation orders that would render them ineligible. Emergency program contractors are also required to meet AVS clearance requirements, unless an overriding need to proceed is determined. These systems are consistent with the Federal requirements of 30 CFR 884.13(a)(4)(iii). Therefore, we are approving their inclusion.
Alabama, in section 884.13(a)(4)(iv) of the Plan, described the ADOL's accounting system, including procedures for the operation of the State Abandoned Mine Reclamation Fund. The ADOL Finance Division is responsible for the proper accounting of Federal draws, income, and expenses, including the maintenance of records for annual audits conducted by the Alabama Department of Examiners of Public Accounts. AML projects, including administrative, operational, and construction costs, are grant-funded and detailed financial records are maintained for auditing purposes, in accordance with 30 CFR part 886 and OMB Circular A-102, Attachment 0. This system description is consistent with the Federal requirements of 30 CFR 884.13(a)(4)(iv). Therefore, we are approving its inclusion.
Alabama, in section 884.13(a)(5) and (a)(5)(i) of the Plan, included a list of documents and data sources offering general descriptions of known or suspected eligible lands and waters within the State of Alabama which potentially required reclamation at the time of publication. Alabama also included a list of counties, in order of significance which have either reported coal mining prior to 1978, currently have conditions associated with past surface mining practices, or currently have physical hazards or environmental conditions associated with past underground mining practices. Alabama also included a mine map repository showing the general location of known or suspected eligible lands and waters within the State which require reclamation. These descriptions are consistent with the Federal requirements of 30 CFR 884.13(a)(5) and (a)(5)(i). Therefore, we are approving their inclusion.
Alabama, in section 884.13(a)(5) through (a)(5)(iii) of the Plan, described the problems occurring on known or suspected lands and waters which require reclamation, including a table expressing the percentage of total abandoned mine lands affected by each problem or source. Examples of such problems include: Open shafts and portals; subsidence; highwalls; abandoned structures and equipment; insect or vermin vectors; water impoundments; waste banks; mine-related fires; landslide and flood hazards; pollution of domestic water supplies; erosion; sedimentation; reduced land potential; and aesthetic disamenities. Reclamation techniques to restore the site to an environmentally stable condition will be based on ADOL's site specific assessments, current industry construction standards, and the reclamation cost estimate procedures outlined in OSMRE Directive AML-1. These descriptions are consistent with the Federal requirements of 30 CFR 884.13(a)(5)(ii) and (iii). Therefore, we are approving their inclusion.
Alabama, in section 884.13(a)(6)(i) of the Plan, described the economic base for the state's primary coal producing region, including population size, market accessibility, economic activities, such as agricultural products and manufacturing, and available mining resources. This description is consistent with the Federal requirements of 30 CFR 884.13(a)(6)(i). Therefore, we are approving its inclusion.
Alabama, in section 884.13(a)(6)(ii) of the Plan, described the aesthetic, historic, and recreational values of Alabama. Alabama stated that, to ensure that all potential impacts of the reclamation process are mitigated, ADOL's Planning and Maintenance Branch will consult with the SHPO's Alabama Historical Commission. This statement is consistent with the Federal requirements of 30 CFR 884.13(a)(6)(ii). Therefore, we are approving its inclusion.
Alabama, in section 884.13(a)(6)(iii) of the Plan, stated that, during the planning stages of proposed AML reclamation projects, evaluations are conducted by the Planning and Maintenance Branch to determine the presence of wetlands, endangered species, and other environmental concerns. Recommendations are provided to enhance or improve wildlife habitat, and to preserve wetlands and other critical wildlife habitat during construction. During this process, ADOL consults with the U.S. Fish and Wildlife
Alabama included a mine map repository showing the general location of known or suspected eligible lands and waters within the State which require reclamation. This map repository is consistent with the Federal requirements of 30 CFR 884.13(a)(5)(i). Therefore, we are approving its inclusion.
We asked for public comments on the amendment but did not receive any.
On June 27, 2016, under 30 CFR 884.14(a), we requested comments on the amendment from various Federal agencies with an actual or potential interest in the Alabama plan (Administrative Record No. AL-0670). We did not receive any comments.
Under 30 CFR 884.14(a)(2), we are required to request comments from the SHPO and ACHP on amendments that may have an effect on historic properties. On June 27, 2016, we requested comments on Alabama's amendment (Administrative Record No. AL-0670), but neither the SHPO nor ACHP responded to our request.
Based on the above findings, we approve the revised amendment Alabama sent us on July 28, 2017 (Administrative Record No. AL-0670-03).
To implement this decision, we are amending the Federal regulations at 30 CFR part 901, that codify decisions concerning the Alabama Plan. In accordance with the Administrative Procedure Act, this rule will take effect 30 days after the date of publication. Section 405 of SMCRA requires that each state with an abandoned mine reclamation program must have an approved State regulatory program pursuant to Section 503 of the Act. Section 503(a) of the Act requires that the State's program demonstrate that the State has the capability of carrying out the provisions of the Act and meeting its purposes. SMCRA requires consistency of State and Federal standards.
This rulemaking does not have takings implications. This determination is based on the analysis performed for the counterpart Federal regulation.
Pursuant to Office of Management and Budget (OMB) guidance, dated October 12, 1993, the approval of state program amendments is exempted from OMB review under Executive Order 12866.
The Department of the Interior has reviewed this rule as required by Section 3 of Executive Order 12988. The Department determined that this
This rule is not a “[p]olicy that [has] Federalism implications” as defined by Section 1(a) of Executive Order 13132 because it does 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.” Instead, this rule approves an amendment to the Alabama Plan submitted and drafted by that State. OSMRE reviewed the submission with fundamental federalism principles in mind as set forth in Sections 2 and 3 of the Executive Order and with the principles of cooperative federalism as set forth in SMCRA. See,
In accordance with Executive Order 13175, we have evaluated the potential effects of this rulemaking on Federally-recognized Indian tribes and have determined that the rulemaking does not have substantial direct effects 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. The basis for this determination is that our decision is on a State AML program and does not involve Federal regulations involving Indian lands.
Executive Order 13211 of May 18, 2001, requires agencies to prepare a Statement of Energy Effects for a rulemaking that is (1) considered significant under Executive Order 12866, and (2) likely to have a significant adverse effect on the supply, distribution, or use of energy. Because this rule is exempt from review under Executive Order 12866 and is not expected to have a significant adverse effect on the supply, distribution, or use of energy, a Statement of Energy Effects is not required.
This rulemaking does not require an environmental impact statement because it falls within a categorical exclusion within the meaning of the National Environmental Policy Act (42 U.S.C. 4332(2)(C)). It is documented in the DOI Departmental Manual, 516 DM 13.5(B)(29), that agency decisions on approval of state reclamation plans for abandoned mine lands do not constitute major Federal Actions.
This rulemaking does not contain information collection requirements that require approval by OMB under the Paperwork Reduction Act (44 U.S.C. 3507
The Department of the Interior certifies that this rulemaking will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
This rulemaking is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. This rulemaking: (a) Does not have an annual effect on the economy of $100 million; (b) Will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; and (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 determination is based upon the fact that the State submittal, which is the subject of this rulemaking, is based upon counterpart Federal regulations for which an analysis was prepared and a determination made that the Federal regulation was not considered a major rulemaking.
This rulemaking will not impose an unfunded mandate on State, local, or tribal governments or the private sector of $100 million or more in any given year. This determination is based upon the fact that the State submittal, which is the subject of this rulemaking, is based upon counterpart Federal regulations for which an analysis was prepared and a determination made that the Federal regulation did not impose an unfunded mandate.
Intergovernmental relations, Surface mining, Underground mining.
For the reasons set out in the preamble, 30 CFR part 901 is amended as set forth below:
30 U.S.C. 1201
Department of the Navy, Department of Defense.
Final rule.
This final rule removes Department of the Navy regulations governing disposition of property, including surplus real property, warships, other surface vessels, personal property, and strategic materials. The disposal of surplus property is governed by standing authorities found within the U.S. Code. Further, disposal of surplus property is also governed by Department of Defense regulations entitled “Defense Material Disposition.” Therefore, this rule can be removed from the CFR.
This rule is effective on June 22, 2018.
James Omans at 703-614-5848.
It has been determined that publication of this CFR part removal for public comment is impracticable, unnecessary, and contrary to public interest since it is based on removing a duplicative CFR part.
Removal of this part does not add or reduce the burden or cost on the public in any way. The cost of disposal of surplus property will remain the same with removal of the part.
This rule is not significant under Executive Order (E.O.) 12866, “Regulatory Planning and Review,” therefore, E.O. 13771, “Reducing Regulation and Controlling Regulatory Costs” does not apply.
Surplus Government property.
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. Route 76 (Cape Fear Memorial) Bridge across the Cape Fear River, mile 26.8, in Wilmington, NC. The deviation is necessary to facilitate routine maintenance. This deviation allows the bridge to remain in the closed-to-navigation position.
This deviation is effective without actual notice from June 22, 2018 through 5 p.m. on November 30, 2018. For the purposes of enforcement, actual notice will be used from 12:01 a.m. on June 15, 2018, until June 22, 2018.
The docket for this deviation, [USCG-2018-0541] is available at
If you have questions on this temporary deviation, call or email Mr. Mickey Sanders, Bridge Administration Branch, Fifth District, Coast Guard; telephone (757) 398-6587, email
The North Carolina Department of Transportation, owner and operator of the U.S. Route 76 (Cape Fear Memorial) Bridge across the Cape Fear River, mile 26.8, in Wilmington, NC, has requested a temporary deviation from the current operating schedule to accommodate routine maintenance.
Under this temporary deviation, the bridge will require a four hour advanced notice to open from 12:01 a.m. on June 15, 2018, to 5 p.m. on November 30, 2018. The current operating schedule is set out in 33 CFR 117.822.
The Cape Fear River is used by a variety of vessels including small commercial vessels, recreational vessels and tug and barge traffic. The Coast Guard has carefully considered the restrictions with waterway users in publishing this temporary deviation.
Vessels able to pass through the bridge in the closed position may do so at any time. The bridge will not be able to open for emergencies and there is no immediate alternate route for vessels unable to pass through the bridge in the closed position. The Coast Guard will also inform the users of the waterways through our Local and Broadcast Notice 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 this temporary deviation.
In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of this effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.
Coast Guard, DHS.
Notice of enforcement of regulation.
The Coast Guard will enforce the safety zone for the Monongahela Area Chamber of Congress/Monongahela 4th of July Celebration, to provide for the safety of persons, vessels, and the marine environment on the Monongahela River during this event. Our regulation for marine events within the Eighth Coast Guard District identifies the regulated area for this event in Monongahela, PA. During the enforcement periods, entry into this zone is prohibited unless authorized by the Captain of the Port Marine Safety Unit Pittsburgh or a designated representative.
The regulations in 33 CFR 165.801, Table 1, Line 45, will be enforced from 9 p.m. through 11 p.m. on July 4, 2018, with a rain date of July 5, 2018.
If you have questions about this notice of enforcement, call or email Petty Officer Jennifer Haggins, Marine Safety Unit Pittsburgh, U.S. Coast Guard; telephone 412-221-0807, email
The Coast Guard will enforce a safety zone for the Monongahela Area Chamber of Congress/Monongahela 4th of July Celebration in 33 CFR 165.801, Table 1, Line 45, from 9 p.m. through 11 p.m. on July 4, 2018, with a rain date of July 5, 2018. This action is being taken to provide for the safety of persons, vessels, and the marine environment on the Monongahela River during this event. Our regulation for marine events within the Eighth Coast Guard District, § 165.801, specifies the location of the safety zone for the Monongahela Area Chamber of Congress/Monongahela 4th of July Celebration, which covers a one-mile stretch of the Monongahela River. Entry into the safety zone is prohibited unless authorized by the Captain of the Port Marine Safety Unit Pittsburgh (COTP) or a designated representative. Persons or vessels desiring to enter into or pass through the area must request permission from the COTP or a designated representative. They can be reached on VHF FM channel 16. If permission is granted, all persons and vessel shall comply with the instructions of the COTP or designated representative.
In addition to this notice of enforcement in the
Coast Guard, DHS.
Notice of enforcement of regulation.
The Coast Guard will enforce the safety zone for the Wellsburg 4th of July Committee/Wellsburg 4th of July Freedom Celebration, to provide for the safety of persons, vessels, and the marine environment on the navigable waters of Ohio River during this event. Our regulation for marine events within
The regulations in 33 CFR 165.801, Table 1, Line 68, will be enforced from 9:30 p.m. through 11 p.m. on July 4, 2018.
If you have questions about this notice of enforcement, call or email Petty Officer Jennifer Haggins, Marine Safety Unit Pittsburgh, U.S. Coast Guard; telephone 412-221-0807, email
The Coast Guard will enforce a safety zone for the Wellsburg 4th of July Committee/Wellsburg 4th of July Freedom Celebration in 33 CFR 165.801, Table 1, Line 68, from 9:30 p.m. through 11 p.m. on July 4, 2018. This action is being taken to provide for the safety of persons, vessels, and the marine environment on the navigable waters of the Ohio River during this event. Our regulation for marine events within the Eighth Coast Guard District, § 165.801, specifies the location of the safety zone for the Wellsburg 4th of July Committee/Wellsburg 4th of July Freedom Celebration, which covers a one-mile stretch of the Ohio River. Entry into the safety zone is prohibited unless authorized by the Captain of the Port Marine Safety Unit Pittsburgh (COTP) or a designated representative. Persons or vessels desiring to enter into or pass through the area must request permission from the COTP or a designated representative. They can be reached on VHF FM channel 16. If permission is granted, all persons and vessel shall comply with the instructions of the COTP or designated representative.
In addition to this notice of enforcement in the
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing a temporary safety zone for certain navigable waters of Lavaca Bay, Point Comfort, TX. This action is necessary to provide for the safety of life on these navigable waters near Point Comfort Bayfront Park during a fireworks display. Entry of vessels or persons into this zone is prohibited unless authorized by the Captain of the Port Sector Corpus Christi or a designated representative.
This rule is effective from 7:30 p.m. through 9:30 p.m. on June 30, 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 Kevin Kyles, Waterways Management Division, U.S. Coast Guard; telephone 361-939-5125, 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)(3)(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 would be impracticable. This safety zone must be established by June 30, 2018 and we lack sufficient time to provide a reasonable comment period and then consider those comments before issuing this rule. The NPRM process would delay the establishment of the safety zone until after the scheduled date of the fireworks and compromise public safety.
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 Corpus Christi (COTP) has determined that potential hazards associated with the fireworks display occurring on June 30, 2018 will be a safety concern for anyone within a 500-foot radius of the fireworks display. This rule is necessary to ensure the safety of life before, during, and after the scheduled firework displays.
This rule establishes a temporary safety zone from 7:30 p.m. through 9:30 p.m. on June 30, 2018. The safety zone will cover all navigable waters within 500 feet of the fireworks launch location at Point Comfort Bayfront Park in the approximate position 28°40′52.93″ N, 096°33′47.723″ W, Point Comfort, TX. The duration of the zone is intended to protect the public from the fireworks display before, during, and after the scheduled fireworks display. The duration of the zone is intended to protect personnel, vessels, and the marine environment before, during, and after the scheduled firework displays.
Entry of vessels or persons into this zone is prohibited unless authorized by the COTP or a designated representative. A designated representative is a commissioned, warrant, or petty officer of the U.S. Coast Guard assigned to units under the operational control of USCG Sector Corpus Christi. Persons or vessels seeking to enter the safety zone must request permission from the COTP or a designated representative on VHF-FM
We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders, and we discuss First Amendment rights of protestors.
Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13771 directs agencies to control regulatory costs through a budgeting process. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.
This regulatory action determination is based on the size, location, duration, and time-of-day of the safety zone. Vessel traffic will be able to safely transit around this safety zone, which will impact a small designated area of Lavaca Bay for about two hours on one evening when vessel traffic is normally low. Moreover, the Coast Guard will issue BNMs (via VHF-FM marine channel 16), Local Notices to Mariners (LNMs), and/or Marine Safety Information Bulletins (MSIBs), about the zone. In addition, 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 with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.
While some owners or operators of vessels intending to transit the temporary safety zone may be small entities, for the reasons stated in section IV.A above, this rule would 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 an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this rule under Department of Homeland Security Directive 023-01 and Commandant Instruction M16475.1D, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone lasting two hours that would prohibit entry within 500 feet of the fireworks launch location. 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 supporting this determination is available in the docket where indicated under
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:
33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 0170.1.
(a)
(b)
(c)
(d)
(2) Persons or vessels seeking to enter the safety zone must request permission from the COTP or a designated representative on VHF-FM channel 16 or by telephone at 361-939-0450.
(3) All persons and vessels permitted to enter this safety zone must transit at the slowest safe speed and comply with all lawful directions issued by the COTP or the designated representative.
(e)
Coast Guard, DHS.
Notice of enforcement of regulation.
The Coast Guard will enforce the safety zone for the EQT 4th of July Celebration to provide for the safety of persons, vessels, and the marine environment on the navigable waters of the Ohio, Allegheny, and Monongahela Rivers during this event. Our regulation for marine events within the Eighth Coast Guard District identifies the regulated area for this event in Pittsburgh, PA. During the enforcement periods, entry into this zone is prohibited unless authorized by the Captain of the Port Marine Safety Unit Pittsburgh or a designated representative.
The regulations in 33 CFR 165.801, Table 1, Line 47, will be enforced from 9 p.m. through 11 p.m. on July 4, 2018.
If you have questions about this notice of enforcement, call or email Petty Officer Charles Morris, Marine Safety Unit Pittsburgh, U.S. Coast Guard; telephone 412-221-0807, email
The Coast Guard will enforce a safety zone for the EQT 4th of July Celebration in 33 CFR 165.801, Table 1, Line 47, from 9 p.m. through 11 p.m. on July 4, 2018. This action is being taken to provide for the safety of persons, vessels, and the marine environment on navigable waters of the Ohio, Allegheny, and Monongahela Rivers during this event. Our regulation for marine events within the Eighth Coast Guard District, § 165.801, specifies the location of the safety zone for the EQT 4th of July Celebration, which covers a less than one-mile stretch of the Ohio, Allegheny, and Monongahela Rivers. Entry into the safety zone is prohibited unless authorized by the Captain of the Port Marine Safety Unit Pittsburgh (COTP) or a designated representative. Persons or vessels desiring to enter the safety zone must request permission from the COTP or a designated representative. They can be reached on VHF FM channel 16. If permission is granted, all persons and vessels shall comply with the instructions of the COTP or designated representative.
In addition to this notice of enforcement in the
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing a temporary moving safety zone in the navigable waters of the San Francisco Bay near AT&T Park in support of the San Francisco Giants Fireworks Display on June 22, 2018. This safety zone is established to ensure the safety of participants and spectators from the dangers associated with pyrotechnics. Unauthorized persons or vessels are prohibited from entering into, transiting through, or remaining in the safety zone without permission of the Captain of the Port or their designated representative.
This rule is effective from 11:00 a.m. to 10:45 p.m. on June 22, 2018.
Documents mentioned in this preamble are part of docket USCG-2018-0507. 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 Lieutenant Junior Grade Emily
The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule. Since the Coast Guard received notice of this event on May 26, 2018, notice and comment procedures would be impracticable in this instance.
For similar reasons as those stated above, under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the
The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The Captain of the Port (COTP) San Francisco has determined that potential hazards associated with the planned fireworks display on June 22, 2018, will be a safety concern for anyone within a 100-foot radius of the fireworks barge and anyone within a 700-foot radius of the fireworks firing site. This rule is needed to protect spectators, vessels, and other property from hazards associated with pyrotechnics.
This rule establishes a temporary safety zone during the loading and transit of the fireworks barge, until after completion of the fireworks display. During the loading of the pyrotechnics onto the fireworks barge, scheduled to take place from 11:00 a.m. to 5:00 p.m. on June 22, 2018, at Pier 50 in San Francisco, CA, the safety zone will encompass the navigable waters around and under the fireworks barge within a radius of 100 feet.
The fireworks barge will remain at Pier 50 until the start of its transit to the display location. Towing of the barge from Pier 50 to the display location is scheduled to take place from 8:30 p.m. to 9:00 p.m. on June 22, 2018, where it will remain until the conclusion of the fireworks display.
At 9:30 p.m. on June 22, 2018, 30 minutes prior to the commencement of the 15-minute fireworks display, the safety zone will increase in size and encompass the navigable waters around and under the fireworks barge within a radius of 700 feet in approximate position 37°46′36″ N, 122°22′56″ W (NAD 83) for the San Francisco Giants Fireworks Display. The safety zone shall terminate at 10:45 p.m. on June 22, 2018.
The effect of the temporary safety zone is to restrict navigation in the vicinity of the fireworks loading, transit, and firing site. Except for persons or vessels authorized by the COTP or the COTP's designated representative, no person or vessel may enter or remain in the restricted areas. These regulations are needed to keep spectators and vessels away from the immediate vicinity of the fireworks firing sites to ensure the safety of participants, spectators, and transiting vessels.
We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders, and we discuss First Amendment rights of protestors.
Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13771 directs agencies to control regulatory costs through a budgeting process. This rule has not been designated a “significant 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 limited duration and narrowly tailored geographic area of the safety zone. Although this rule restricts access to the waters encompassed by the safety zone, the effect of this rule will not be significant because the local waterway users will be notified via public Broadcast Notice to Mariners to ensure the safety zone will result in minimum impact. The entities most likely to be affected are waterfront facilities, commercial vessels, and pleasure craft engaged in recreational activities.
The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as amended, requires federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.
This rule may affect the following entities, some of which may be small entities: Owners and operators of waterfront facilities, commercial vessels, and pleasure craft engaged in recreational activities and sightseeing, if these facilities or vessels are in the vicinity of the safety zone at times when this zone is being enforced. This rule will not have a significant economic impact on a substantial number of small entities for the following reasons: (i) This rule will encompass only a small portion of the waterway for a limited period of time, and (ii) the maritime public will be advised in advance of these safety zones via Broadcast Notice to Mariners.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's
This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.
Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.1D, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone of limited size and duration. It is categorically excluded from further review under Categorical Exclusion L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A Record of Environmental Consideration supporting this determination is available in the docket where indicated under
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:
33 U.S.C 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 0170.1
(a)
(b)
(c)
(d)
(2) The safety zone is closed to all vessel traffic, except as may be permitted by the COTP or a designated representative.
(3) Vessel operators desiring to enter or operate within the safety zone must contact the COTP or a designated representative to obtain permission to do so. Vessel operators given permission to enter or operate in the safety zone must comply with all directions given to them by the COTP or a designated representative. Persons and vessels may request permission to enter the safety zones on VHF-23A or through the 24-hour Command Center at telephone (415) 399-3547.
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing a temporary regulated navigation area and safety zone for waters of the Harlem and Hudson Rivers in the vicinity of the Amtrak Spuyten Duyvil Railroad Bridge at mile 7.9 over the Harlem River. The regulated navigation area and safety zone are needed to protect personnel, vessels, and the marine environment from potential hazards created by the removal and reinstallation of the swing span portion of the Spuyten Duyvil Railroad Bridge. During heavy lift operations this regulated navigation area will establish speed restrictions on vessels transiting the Hudson River to eliminate vessel wake. During heavy lift operations entry of vessel or persons into this safety zone is prohibited unless specifically authorized by the First District Commander or a designated representative.
This rule is effective without actual notice from June 22, 2018 through September 30, 2018. For the purposes of enforcement, actual notice will be used from June 12, 2018 through June 22, 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 Mr. Craig Lapiejko, Waterways Management, First Coast Guard District; telephone (617) 223-8351, email
On May 1, 2018, Amtrak sent the U.S. Coast Guard a letter describing work it would be conducting to remove and replace the moveable portion of the Spuyten Duyvil Railroad Bridge over the Harlem River at mile 7.9. On May 7, 2018, the U.S. Coast Guard District One Bridge Administration notified Amtrak, the bridge owner, that it had no objections to the proposed project.
From May 27 to September 29, 2018, Amtrak will be repairing the Spuyten Duyvil Railroad Bridge. This repair project includes the removal and reinstallation of the swing span of the bridge.
During the removal of the swing span a crane barge and support vessels will be staged near the bridge. The swing span will be lifted from the bridge by a heavy lift crane barge and then secured to another barge. The barge with the swing span will then be towed away and moored west of the bridge, in the Hudson River. These operations, from preparing for the removal of the swing span, removing and securing the swing span to the waiting barge, to mooring the barge with the secured swing span in the Hudson River, will take approximately 72 hours. Amtrak anticipates this work will be conducted over a three-day period between June 12 and June 17, 2018.
During the reinstallation of the swing span a barge and support vessels will again be staged near the bridge. The swing span will be lifted from a support barge by a heavy lift crane barge and reinstalled. The preparation for and reinstallation of the swing span will take approximately 72 hours. Amtrak anticipates this work will be conducted over a three-day period between July 15 and July 28, 2018.
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)(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 the schedule for the removal and reinstallation of the swing span was only recently finalized and provided to the Coast Guard, and timely action is needed to respond to the potential safety hazards associated with this bridge project. The schedule for the repairs and notification to the Coast Guard was delayed by the late finalization of project details, including coordinating the two heavy lift operations with the schedules of known waterway users, and writing a Maintenance of Waterway Traffic Plan. It is impracticable and contrary to the public interest to publish an NPRM because we must establish this RNA and safety zone by June 12, 2018, to allow for timely repairs to the bridge's swing span and promote the safety of the public.
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 First District Commander has determined that potential hazards associated with the bridge swing span removal and reinstallation will be a safety concern for anyone within approximately 300 yards of the center of the Spuyten Duyvil Railroad Bridge. The RNA and safety zone are needed to ensure the safety of personnel, vessels, and the marine environment from hazards associated with the removal and replacement of Spuyten Duyvil Railroad Bridge. The Coast Guard anticipates that crane lifting operations may create the potential for falling debris into the waterway. The RNA is needed to limit vessel speed and wake of all vessels operating in the Hudson River in the vicinity to minimize the unexpected or uncontrolled movement of water. Construction operations utilizing a crane barge are sensitive to water movement and wake from passing vessels could pose significant risk of injury or death to construction workers.
This rule establishes a RNA and safety zone from noon on Monday, June 12, 2018, to 11:59 p.m. on Sunday, September 30, 2018.
The RNA covers all waters of the Hudson River, approximately 500 yards upstream, and downstream, of the Spuyten Duyvil Railroad Bridge from surface to bottom bound by the following approximate positions starting south of a line drawn from 40°53′15.67″ N, 073°56′29.22″ W, thence to 40°52′56.48″ N, 073°55′21.57″ W, and all waters north of a line drawn from 40°52′47.97″ N, 073°56′42.85″ W, thence to 40°52′31.58″ N, 073°55′45.06″ W (NAD 83), excluding the portion of the safety zone surrounding the Spuyten Duyvil Railroad Bridge as discussed in the following paragraph.
The safety zone covers all waters of the Hudson River and Harlem River
During operations involving the removal and reinstallation of the swing span a safety zone will prohibit the transit of vessels in the Hudson River and Harlem River within approximately 300 yards of the center of the Spuyten Duyvil Railroad Bridge. This safety zone will protect personnel, vessels, and the marine environment from potential hazards created by the Spuyten Duyvil Railroad Bridge swing span removal and reinstallation project.
Additionally, during the removal and reinstallation of the swing span all vessels transiting the Hudson River within the regulated navigation area (RNA) will be required to follow a “Slow-No Wake” speed limit. When this RNA is enforced, no vessel may produce a wake nor attain speeds greater than five (5) knots unless a higher minimum speed is necessary to maintain bare steerageway. The heavy lift operations involving the removal and reinstallation of the bridge swing span are currently scheduled to take place in June and July 2018. The Coast Guard is publishing this rule to be effective, and enforceable, through September 30, 2018, in case the project is delayed due to unforeseen circumstances.
We anticipate enforcing the RNA and safety zone during the two periods of heavy lift operations, one occurring between June 12 and approximately June 17, 2018 and the other between approximately July 15 and July 28, 2018. The RNA and safety zone is expected to be enforced for approximately two 72-hour periods when vessels are preparing for, and conducting, the swing span removal and reinstallation operations. The duration of enforcement for both the RNA and safety zone is intended to protect personnel, vessels, and the marine environment in these waters while the bridge span is being removed and reinstalled. During the enforcement periods, all vessels and persons must obtain permission from the First District Commander or a designated representative before entering the safety zone.
The Coast Guard will notify the public and local mariners of this RNA and safety zone through the Local Notice to Mariners (LNM) and Broadcast Notice to Mariners via VHF-FM marine channel 16 in advance of any enforcement period. The regulatory text we are enforcing appears at the end of this document.
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 following reasons: (1) The RNA and safety zone only impact a small designated area of the Harlem and Hudson Rivers; (2) the RNA and safety zone will only be enforced during heavy lift operations tentatively scheduled to occur between June 12-17, 2018, for the swing span removal, and between July 15-28, 2018, for the swing span reinstallation; (3) persons or vessels may transit the RNA at any time, subject to a speed restriction during any periods of enforcement; (4) persons or vessels desiring to enter the safety zone may do so when the heavy lift operations are not in progress; (5) the Coast Guard previously published the approximate project dates in the LNM #18-2018 dated May 2, 2018, LNM #19-2018 dated May 9, 2018, LNM #20-2018 dated May 17, 2018, LNM #21-2018 dated May 23, 2018, LNM #22 dated May 30, 2018, and also requested impacted mariners to contact the contractor to discuss their schedules and receive email schedule updates; (6) the contractor contacted known waterway users to discuss the project and waterway impacts. Although the heavy lift operations will result in two periods of enforcement of a safety zone, closing the Harlem River in the vicinity of the Spuyten Duyvil Railroad Bridge, these operations are scheduled to accommodate sight-seeing vessels and marine events to the greatest extent possible.
The Coast Guard will also notify the public of the enforcement of this rule via appropriate means, such as the LNM and Broadcast Notice to Mariners.
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.
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 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, call1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.
Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this rule under Department of Homeland Security Directive 023-01 and Commandant Instruction M16475.1D, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves the creation of an RNA and a safety zone, both of which are expected to be enforced for two periods each lasting approximately 72 hours. The RNA is will restrict the speed of vessels transiting the Hudson River within approximately 500 yards upstream and downstream of the Spuyten Duyvil Railroad Bridge while heavy lift operations are conducted. The safety zone will prohibit vessels on the Hudson and Harlem Rivers from coming within approximately 300 yards of the center of the Spuyten Duyvil Railroad Bridge during heavy lift operations. 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 supporting this determination will be 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)
(2)
(b)
(c)
(ii) During periods of enforcement, entry and movement within the RNA is subject to a “Slow-No Wake” speed limit. No vessel may produce a wake nor attain speeds greater than five (5) knots unless a higher minimum speed is necessary to maintain bare steerageway.
(iii) During periods of enforcement, any vessel transiting within this RNA must comply with all directions given to them by the First District Commander or the First District Commander's designated representative.
(2)
(ii) Entry into, anchoring, loitering, or movement within the safety zone is prohibited during any periods of enforcement, including preparations for the heavy lift operations, the heavy lift operations, and necessary follow-on actions. This prohibition does not apply to vessels authorized to be within the zone by the District Commander or the
(iii) During periods of enforcement, any vessel or person transiting through the safety zone must comply with all orders and directions from the District Commander or the District Commander's designated representative.
(d)
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing a temporary safety zone for certain navigable waters of the Gulf of Mexico near Fort Pickens in Pensacola, FL. This temporary safety zone is necessary to protect persons, vessels, and the marine environment from potential hazards associated with the detonation of unexploded ordnance. Entry into this zone is prohibited to all vessels and persons unless authorized by the Captain of the Port Sector Mobile or a designated representative.
This rule is effective without actual notice from June 22, 2018 through June 30, 2018. For purposes of enforcement, actual notice will be used from June 14, 2018 through June 22, 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 Lieutenant Kyle D. Berry, Sector Mobile Waterways Management Division, U.S. Coast Guard; telephone 251-441-5940, email
The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(3)(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 and contrary to the public interest. It is impracticable to publish an NPRM because we must enforce this safety zone starting June 14, 2018 and lack sufficient time to provide a reasonable comment period and then consider those comments before issuing the rule. It is also contrary to the public interest as it would delay the safety measures necessary to protect persons, vessels, and the marine environment from the potential hazards associated with the detonation of unexploded ordnance.
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 United States Army Corps of Engineers is conducting a Remedial Investigation/Feasibility Study for the Fort Pickens Munitions Response Site 01—Range Complex, located in Escambia County, Florida. The site, which is located along the western tip of Santa Rosa Island and extends south into the Gulf of Mexico, was used for coastal defense from before the Civil War until after World War II. There is a potential that the marine investigation may encounter munitions that will require in-water detonation to address potential explosive hazards. The safety zone will encompass a 1,000 yard square area detonation area surrounded by a 1,200 yard buffer area. The United States Army Corps of Engineers will be responsible for the detonation of ordnance within the safety zone.
The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The Captain of the Port Sector Mobile (COTP) has determined that potential hazards associated with the detonation of unexploded ordnance beginning on June 14, 2018 will be a safety concern for any vessels or persons on the Gulf of Mexico near Fort Pickens in Pensacola, FL. This rule is necessary to protect persons, vessels, and the marine environment from the potential hazards associated with the detonation of unexploded ordnance.
This rule establishes a temporary safety zone from June 14, 2018 through June 30, 2018. The safety zone will cover all navigable waters of the Gulf of Mexico within the approximate positions 30°17′47.65″ N, 87°21′36.5″ W; 30°17′47.65″ N, 87°19′39.8″ W; 30°16′6.35″ N, 87°19′39.8″ W; and 30°16′6.35″ N, 87°21′36.5″ W near Fort Pickens in Pensacola, FL. The safety zone will encompass a 1,000 yard square area detonation area surrounded by a 1,200 yard buffer area. A chart depicting the area is included in the docket where indicated under
The duration of this safety zone is intended to protect persons, vessels, and the marine environment, and will only be enforced if and when the detonation of unexploded ordnance is necessary. No person or vessel will be permitted to enter or transit within the safety zone during periods of enforcement unless authorized by the COTP or a designated representative. The periods of
Entry into the temporary safety zone is prohibited unless authorized by the COTP or a designated representative. A designated representative is a commissioned, warrant, or petty officer of the U.S. Coast Guard assigned to units under the operational control of USCG Sector Mobile. Vessels requiring entry into this safety zone must request permission from the COTP or a designated representative. They may be contacted on VHF-FM channel 16 or by telephone at 251-441-5976. The COTP or a designated representative will inform the public of the enforcement periods of this safety zone through BNMs, LNMs, and/or MSIBs as appropriate.
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 protectors.
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 determination is based on the size, location, and duration of the temporary safety zone. Vessel traffic will be able to safely transit around this safety zone which would impact a small designated area of the Gulf of Mexico only as necessary for the detonation of ordnance during a two and half week period. Moreover, the Coast Guard will issue a BNMs 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 with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.
While some owners or operators of vessels intending to transit the temporary 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 Directive 023-01 and Commandant Instruction M16475.1D, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a temporary safety zone that will prohibit entry on a small designated area of the Gulf of Mexico near Fort Pickens in Pensacola, FL only as necessary for the detonation of ordnance. It is categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction
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) Persons or vessels seeking to enter into or transit through the zone must request permission from the COTP or a designated representative. They may be contacted on VHF-FM channel 16 or by telephone at 251-441-5976.
(3) Persons and vessels permitted to enter this safety zone must transit at their slowest safe speed and comply with all lawful directions issued by the COTP or the designated representative.
(e)
Environmental Protection Agency (EPA).
Notification of availability.
EPA is announcing the availability of training materials covering the expanded training content required by the Federal Insecticide, Fungicide and Rodenticide Act Worker Protection Standard (WPS) for both agricultural workers and pesticide handlers. The publication of this notification of availability triggers the WPS requirement that training programs must include all of the topics specified in the 2015 revisions to the WPS.
Training programs must include all of the topics specified in 40 CFR 170.401(c)(3)(i)-(xxiii) and 170.501(c)(3)(i)-(xiv) no later than December 19, 2018.
EPA is not requesting, and does not expect to receive, comments on this notification of availability. Questions should be directed to: Jennifer Park, Field and External Affairs Division (7506P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (703) 347-0121; email address:
You may be potentially affected by this action if you work in or employ persons working in crop production agriculture where pesticides are applied. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
• Agricultural Establishments (NAICS code 111000),
• Nursery and Tree Production (NAICS code 111421),
• Timber Tract Operations (NAICS code 113110),
• Forest Nurseries and Gathering of Forest Products (NAICS code 113210),
• Farm Workers (NAICS codes 11511, 115112, and 115114),
• Pesticide Handling on Farms (NAICS code 115112),
• Farm Labor Contractors and Crew Leaders (NAICS code 115115),
• Pesticide Handling in Forestry (NAICS code 115310),
• Pesticide Manufacturers (NAICS code 325320),
• Farm Worker Support Organizations (NAICS codes 813311, 813312, and 813319),
• Farm Worker Labor Organizations (NAICS code 813930),
• Crop Advisors (NAICS codes 115112, 541690, 541712)
On November 2, 2015, EPA published a final rule making changes to the WPS, 40 CFR part 170, referred to as the “2015 revised WPS” (80 FR 67496) (FRL-9931-81). The WPS is a regulation primarily intended to reduce the risks of injury or illness resulting from agricultural workers' and handlers' use of and contact with agricultural pesticides on farms, forests, nurseries and greenhouses. The rule primarily seeks to protect workers (those who perform hand-labor tasks on pesticide-treated crops, such as harvesting, thinning or pruning) and handlers (those who mix, load and apply pesticides). The 2015 revised WPS requirements retained many of the 1992 WPS requirements, while increasing the stringency of some standards and adding new requirements.
Sections 170.401 and 170.501 of the 2015 revised WPS allowed employers to omit certain topics from training materials until 180 days after EPA publishes in the
EPA is currently reconsidering three requirements of the 2015 revised WPS and plans to solicit comments on potential changes to the designated representative provision, the minimum age for handlers and early-entry workers, and the application exclusion zone. If those requirements are changed through a final rulemaking, training materials may need to be amended to reflect such changes.
The publication of this notification of availability of the training materials specified in 40 CFR 170.401(c)(3) and 170.501(c)(3) commences the 180-day period provided in those provisions. Per §§ 170.401(c)(3) and 170.501(c)(3), WPS training programs must include all of the topics specified in §§ 170.401(c)(3)(i)-(xxiii) and 170.501(c)(3)(i)-(xiv) no later than December 19, 2018.
Environmental protection, Agricultural worker, Employer, Farms, Forests, Greenhouses, Nurseries, Pesticide handler, Pesticides, Worker protection standard.
Environmental Protection Agency (EPA).
Final rule.
This regulation establishes an exemption from the requirement of a tolerance for residues of oxirane, 2-methyl-, polymer with oxirane, mono[2-[2-(2-methoxymethylethoxy)methylethoxy]methylether] ether, number average molecular weight 1900 daltons; when used as an inert ingredient in a pesticide chemical formulation. SciReg, Inc. on behalf of Solvay USA Inc., submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of oxirane, 2-methyl-, polymer with oxirane, mono[2-[2-(2-methoxymethylethoxy)methylethoxy]methylether] ether on food or feed commodities.
This regulation is effective June 22, 2018. Objections and requests for hearings must be received on or before August 21, 2018, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2018-0071, is available at
Michael Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address:
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).
You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR site at
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2018-0071 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before August 21, 2018. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2018-0071, by one of the following methods.
•
•
•
Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at
In the
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is “safe.” Section 408(c)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and use in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing an exemption from the requirement of a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue . . .” and specifies factors EPA is to consider in establishing an exemption.
EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be shown that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established.
Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness and reliability and the relationship of this information to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. In the case of certain chemical substances that are defined as polymers, the Agency has established a set of criteria to identify categories of polymers expected to present minimal or no risk. The definition of a polymer is given in 40 CFR 723.250(b) and the exclusion criteria for identifying these low-risk polymers are described in 40 CFR
1. The polymer is not a cationic polymer nor is it reasonably anticipated to become a cationic polymer in a natural aquatic environment.
2. The polymer does contain as an integral part of its composition at least two of the atomic elements carbon, hydrogen, nitrogen, oxygen, silicon, and sulfur.
3. The polymer does not contain as an integral part of its composition, except as impurities, any element other than those listed in 40 CFR 723.250(d)(2)(ii).
4. The polymer is neither designed nor can it be reasonably anticipated to substantially degrade, decompose, or depolymerize.
5. The polymer is manufactured or imported from monomers and/or reactants that are already included on the Toxic Substances Control Act (TSCA) Chemical Substance Inventory or manufactured under an applicable TSCA section 5 exemption.
6. The polymer is not a water absorbing polymer with a number average molecular weight (MW) greater than or equal to 10,000 daltons.
Additionally, the polymer also meets as required the following exemption criteria specified in 40 CFR 723.250(e).
7. The polymer does not contain certain perfluoroalkyl moieties consisting of a CF3- or longer chain length as listed in 40 CFR 723.250(d)(6)
Additionally, the polymer also meets as required the following exemption criteria: Specified in 40 CFR 723.250(e):
The polymer's number average MW of polymer's number average MW is greater than 1,000 and less than 10,000 daltons. The polymer contains less than 10% oligomeric material below MW 500 and less than 25% oligomeric material below MW 1,000, and the polymer contains only reactive functional groups listed in 40 CFR 723.250(e)(1)(ii)(A).
Thus, oxirane, 2-methyl-, polymer with oxirane, mono[2-[2-(2-methoxymethylethoxy)methylethoxy]methylether] ether meets the criteria for a polymer to be considered low risk under 40 CFR 723.250. Based on its conformance to the criteria in this unit, no mammalian toxicity is anticipated from dietary, inhalation, or dermal exposure to oxirane, 2-methyl-, polymer with oxirane, mono[2-[2-(2-methoxymethylethoxy)methylethoxy]methylether] ether.
For the purposes of assessing potential exposure under this exemption, EPA considered that oxirane, 2-methyl-, polymer with oxirane, mono[2-[2-(2-methoxymethylethoxy)methylethoxy]methylether] ether could be present in all raw and processed agricultural commodities and drinking water, and that non-occupational non-dietary exposure was possible. The number average MW of oxirane, 2-methyl-, polymer with oxirane, mono[2-[2-(2-methoxymethylethoxy)methylethoxy]methylether] ether is 1900 daltons. Generally, a polymer of this size would be poorly absorbed through the intact gastrointestinal tract or through intact human skin. Since oxirane, 2-methyl-, polymer with oxirane, mono[2-[2-(2-methoxymethylethoxy)methylethoxy]methylether] ether conform to the criteria that identify a low-risk polymer, there are no concerns for risks associated with any potential exposure scenarios that are reasonably foreseeable. The Agency has determined that a tolerance is not necessary to protect the public health.
Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”
EPA has not found oxirane,2-methyl-, polymer with oxirane, mono[2-[2-(2-methoxymethylethoxy)methylethoxy]methylether] ether to share a common mechanism of toxicity with any other substances, and oxirane, 2-methyl-, polymer with oxirane, mono[2-[2-(2-methoxymethylethoxy)methylethoxy]methylether] ether does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that oxirane, 2-methyl-, polymer with oxirane, mono[2-[2-(2-methoxymethylethoxy)methylethoxy]methylether] ether does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at
Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base unless EPA concludes that a different margin of safety will be safe for infants and children. Due to the expected low toxicity of oxirane, 2-methyl-, polymer with oxirane, mono[2-[2-(2-methoxymethylethoxy)methylethoxy]methylether] ether, EPA has not used a safety factor analysis to assess the risk. For the same reasons the additional tenfold safety factor is unnecessary.
Based on the conformance to the criteria used to identify a low-risk polymer, EPA concludes that there is a reasonable certainty of no harm to the U.S. population, including infants and children, from aggregate exposure to residues of oxirane, 2-methyl-, polymer with oxirane, mono[2-[2-(2-methoxymethylethoxy)methylethoxy]methylether] ether.
There are no existing exemptions from a tolerance for oxirane,2-methyl-, polymer with oxirane, mono[2-[2-(2-methoxymethylethoxy)methylethoxy]methylether] ether polymers.
An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation.
Accordingly, EPA finds that exempting residues of oxirane, 2-methyl-, polymer with oxirane, mono[2-[2-(2-methoxymethylethoxy)methylethoxy]methylether] ether from the requirement of a tolerance will be safe.
This action establishes a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types
Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501
This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).
Pursuant to the Congressional Review Act (5 U.S.C. 801
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
Therefore, 40 CFR chapter I is amended as follows:
21 U.S.C. 321(q), 346a and 371.
Environmental Protection Agency (EPA).
Final rule.
This regulation establishes tolerances for residues of tolfenpyrad in or on multiple commodities which are identified and discussed later in this document. Nichino America, Inc. requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
This regulation is effective June 22, 2018. Objections and requests for hearings must be received on or before August 21, 2018, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2017-0156, is available at
Michael Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address:
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).
You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2017-0156 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before August 21, 2018. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2017-0156, by one of the following methods:
•
•
•
Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at
In the
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .”
Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for tolfenpyrad including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with tolfenpyrad follows.
EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.
A variety of toxic effects were noted in the toxicology database for tolfenpyrad. However, the most consistent finding across species and studies was decreased body weight and/or body weight gain, which were observed in adults of all species (rat, mice, rabbit, and dog) in the majority of the subchronic oral and dermal toxicity studies, and all chronic toxicity studies.
The rat is the species most sensitive to body weight changes, with effects observed at much lower doses than in other species. In rats, significant decreases in body weight and body weight gain were observed in
The body weight changes observed in the database were most often seen in the presence of decreased food consumption and in some studies, additional toxicity including liver/kidney effects and clinical signs. Increased liver and kidney weights, liver and kidney hypertrophy, hyaline droplets in the kidney, and color change in the kidney were seen after subchronic exposure in rats. Chronic exposure resulted in similar effects along with color changes in the liver and liver histopathology at slightly lower doses than in the subchronic studies. Other effects noted in rats were effects on the harderian gland and lymph nodes. In dogs, both changes in liver and kidney histopathology, along with testicular atrophy and clinical signs (emaciation, decreased movement, and staggering gait) were seen in short-term studies. Long-term exposure resulted in histopathological changes in the liver, along with increased liver enzymes. No treatment-related effects were noted in the liver or kidney in mice. However, rough coats, hunched posture, ataxia, and hypoactivity were seen in subchronic studies.
Moribundity and/or mortality were noted in at least one study in all tested species at ≥3 milligrams/kilogram/day (mg/kg/day). Moribundity and mortality were noted in two dams in a rat reproduction study. Mortality was also noted in one dam in a rabbit developmental toxicity study, as well as in two rats from an inhalation toxicity study (range-finding only). In mice and dogs, mortality was observed in both subchronic and chronic toxicity studies. In all cases, these effects were observed only after repeat-dose exposures, and the current points of departure (PODs) for the relevant exposure durations are protective of the observed mortality.
There is no evidence of increased quantitative or qualitative susceptibility in the guideline rat and rabbit developmental studies, or the rat reproduction study. Although several adverse effects were noted in young animals in these studies, the effects were observed in the presence of significant maternal toxicity (significant body weight changes and/or moribundity/mortality). In a non-guideline rat developmental immunotoxicity (DIT) study, decreased survival, body weight, body weight gain, increased blackish abdominal cavity, and dark green abnormal intestinal contents were observed in offspring animals at 3 mg/kg/day. At the same dose, decreased body weight (up to 10%), body weight gain (up to 36%) and food consumption were seen in maternal animals. This is consistent with the other developmental toxicity studies in the database, in which offspring toxicity is observed at the same dose as significant maternal toxicity. There was no evidence of immunotoxicity observed in the study.
No evidence of neurotoxicity was observed in acute and subchronic neurotoxicity studies for tolfenpyrad. Although hunched posture, ataxia, and hypoactivity were seen in mice in a 28-day toxicity study, these effects were not seen in a 90-day study or after chronic exposure. In dogs, decreased spontaneous movement and staggering gait were observed after 13 weeks. In rats, decreased motor activity and prone position (lying face down) prior to death were noted in a reproduction study. Overall, the effects noted in the database were agonal effects mainly seen at high doses, not associated with neuropathology, and not noted in long-term studies. The effects observed are consistent with the mode of action for tolfenpyrad (mitochondrial inhibitor) and are not considered evidence of neurotoxicity.
No evidence of carcinogenicity was observed in cancer studies with mice and rats. Therefore, in accordance with EPA's Final Guidelines for Carcinogen Risk Assessment (March 2005), tolfenpyrad is classified as “not likely to be carcinogenic to humans.” Specific information on the studies received and the nature of the adverse effects caused by tolfenpyrad as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at
Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see
A summary of the toxicological endpoints for tolfenpyrad used for human risk assessment is shown in Table 1 of this unit.
1.
i.
ii.
iii.
iv.
2.
Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-GROW) models, the estimated drinking water concentrations (EDWCs) of tolfenpyrad for acute exposures are estimated to be 26.9 parts per billion (ppb) for surface water and 11.0 ppb for ground water, for chronic exposures for non-cancer assessments are estimated to be 12.2 ppb for surface water and 11.0 ppb for ground water.
Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 26.9 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 12.2 ppb was used to assess the contribution to drinking water.
3.
4.
EPA has not found tolfenpyrad to share a common mechanism of toxicity with any other substances, and tolfenpyrad does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that tolfenpyrad does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at
1.
2.
3.
i. The toxicity database for tolfenpyrad is complete.
ii. There is no indication that tolfenpyrad is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.
iii. Although there is some evidence that tolfenpyrad may result in increased susceptibility, the concern for developmental or reproductive effects is low for the reasons contained in Unit III.D.2., and thus, a 10X FQPA safety factor is not necessary to protect infants and children.
iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100% CT and tolerance-level residues for the acute dietary exposure and average residue levels from crop field trials for the chronic dietary exposure. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to tolfenpyrad in drinking water. These assessments will not underestimate the exposure and risks posed by tolfenpyrad.
EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate margin of exposure (MOE) exists.
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Adequate enforcement methodologies, utilizing high-performance liquid chromatography with tandem mass spectrometric detection (LC/MS/MS), are available for enforcement of tolfenpyrad residue tolerances in/on plant commodities (Morse Laboratories Analytical Method #Meth-183, Revision #2). For livestock, a method described in PTRL West Study No. 1841W is available. The livestock method adequately determines residues of tolfenpyrad and its metabolites, PT-CA,
In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.
The Codex has not established any MRLs for tolfenpyrad in commodities in this action.
EPA's tolerance levels are expressed to provide sufficient precision for enforcement purposes, and this may include the addition of trailing zeros (such as 0.30 ppm rather than 0.3 ppm). This is done to avoid the situation where rounding of an observed violative residue to the level of precision of the tolerance expression would result in a residue considered non-violative (such as 0.34 ppm being rounded to 0.3 ppm). EPA added additional zeros for fruiting vegetables group 8-10 and cucurbit vegetables group 9. EPA is establishing tolerances for residues in or on fruit, citrus, group 10-10 at 0.80 ppm instead of 0.9 ppm; citrus, oil at 30 ppm instead of 28.0 ppm; and citrus, dried pulp at 4.0 ppm instead of 3.0 ppm, based on the previously reviewed orange processing study, and the newly submitted lemon field trial residues as the input dataset for the Organization for Economic Cooperation and Development (OECD) MRL calculation procedure. In addition, the tolerances in fruits, pome, group 11-10 and apple wet pomace are based on the petitioner's revision of the proposed maximum annual use rate on pome fruits, from 0.42 lb ai per acre (lb ai/A) to 0.57 lb ai/A.
In this rule, EPA is reducing the existing tolerances for citrus commodities as follows: Fruit, citrus, group 10-10 from 1.5 ppm to 0.80 ppm; citrus, dried pulp from 8.0 ppm to 4.0 ppm; and citrus, oil from 70 ppm to 30 ppm. The Agency is reducing these tolerances because these reductions requested by the petitioner are supported by available data. This reduction in tolerance levels is not discriminatory; the same food safety standard contained in the FFDCA applies equally to domestically produced and imported foods.
In accordance with the World Trade Organization's (WTO) Sanitary and Phytosanitary Measures (SPS) Agreement, EPA will notify the WTO of its tolerance revision. In addition, the SPS Agreement requires that Members provide a “reasonable interval” between the publication of a regulation subject to the Agreement and its entry into force in order to allow time for producers in exporting Member countries to adapt to the new requirement. At this time, EPA is establishing an expiration date for the existing tolerances to allow those tolerances remain in effect for a period of six months after the effective date of this final rule, in order to address this requirement. Prior to the expiration date, residues of tolfenpyrad up to the existing tolerance levels will be permitted; after the expiration date, residues will need to comply with the reduced tolerance levels.
Therefore, tolerances are established for residues of tolfenpyrad, 4-chloro-3-ethyl-1-methyl-
This action establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001); Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997); or Executive Order 13771, entitled “Reducing Regulations and Controlling Regulatory Costs” (82 FR 9339, February 3, 2017). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501
Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10,
This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).
Pursuant to the Congressional Review Act (5 U.S.C. 801
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
Therefore, 40 CFR chapter I is amended as follows:
21 U.S.C. 321(q), 346a and 371.
The revision reads as follows:
(a) * * *
(1) * * *
Environmental Protection Agency (EPA).
Final rule.
This regulation establishes tolerances for residues of acetochlor in or on alfalfa and related animal commodities which are identified and discussed later in this document. Monsanto Company requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
This regulation is effective June 22, 2018. Objections and requests for hearings must be received on or before August 21, 2018, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2017-0235, is available at
Michael L. Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address:
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).
You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2017-0235 in the subject line on the first page of your submission. All objections and requests for a hearing
In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2017-0235, by one of the following methods:
•
•
•
Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at
In the
Based upon review of the data supporting the petition, EPA has revised the proposed 8 ppm tolerance for alfalfa forage to 8.0 ppm. The reason for this change is explained in Unit IV.D.
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .”
Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for acetochlor including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with acetochlor follows.
EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.
Acetochlor has low acute toxicity by the oral, dermal, and inhalation routes of exposure and is minimally irritating to the eyes. A dermal irritation study indicates that it is a severe skin irritant. Acetochlor is also a strong dermal sensitizer. Evidence of neurotoxicity was observed in acute and subchronic neurotoxicity screening studies in rats, developmental toxicity studies in rats, and subchronic and chronic studies in dogs. In addition to the nervous system, the major target organs affected in subchronic and chronic studies in rats, dogs, and mice exposed to acetochlor are the liver, thyroid (secondary to liver), kidney, testes, and erythrocytes. Species-specific target organs include the nasal olfactory epithelium in rats and the lungs in mice.
There is no evidence of increased qualitative or quantitative susceptibility of fetuses or offspring to acetochlor exposure in the developmental and reproduction toxicity studies in rats and rabbits. In two developmental toxicity studies in rats, fetal effects (increased early resorptions, post-implantation loss, and decreased fetal weight) occurred at doses that also resulted in maternal toxicity (mortality, clinical signs of toxicity, and decreased maternal body weight). In two rabbit developmental toxicity studies, there were no adverse fetal effects at the highest doses tested (190 mg/kg/day and 300 mg/kg/day); whereas maternal toxicity (body weight loss) was seen at 190 mg/kg/day in one study. In three reproduction toxicity studies in rats, offspring effects (decreased pup weights in the first two studies; decreased pup weights, decreased F2 litter size at birth, and focal hyperplasia and polypoid adenomata in nasal epithelium of adult F1 offspring at study termination in the third study) occurred at the same or higher doses than those resulting in parental toxicity (decreased body weight or weight gain in the first two studies; focal hyperplasia and polypoid adenomata in nasal epithelium of adult F1 offspring at study termination in the third study). There was no evidence of reproductive toxicity observed at any
There was evidence of carcinogenicity in studies conducted with acetochlor in rats and mice. A 23-month mouse carcinogenicity study showed weak evidence for increased benign lung tumors in females, and a 78-week study showed weak evidence for increased benign lung tumors in males. The increases were considered equivocal, based on increases in benign tumors only, inconsistent dose-responses between the two studies, inconsistencies in the responses of males and females between the two studies, lack of pre-neoplastic lung lesions in the 23-month study (while the 78-week study showed an increase in bronchiolar hyperplasia), and the variable incidence of lung tumors known to occur in older mice.
Two carcinogenicity studies in rats showed an increase in nasal epithelial tumors and thyroid follicular cell tumors. Thyroid tumor incidence was relatively low, and there was evidence that the tumors were due to disruption of thyroid-pituitary homeostasis. There are acceptable mode of action data for the rat tumors (nasal olfactory epithelial tumors and thyroid follicular cell tumors) which are adequate to support a non-linear, margin of exposure (MOE), approach for assessment of cancer risk. The data show that, like the related compounds, alachlor and butachlor, tumor formation is dependent upon local cytotoxicity secondary to oxidative damage by a reactive quinone imine intermediate. The mechanistic data on nasal tumorigenesis of acetochlor in the rat, when considered together with the mutagenicity data on acetochlor and consistent findings in mechanistic and mutagenicity studies on the closely related compound alachlor, are considered adequate to demonstrate a cytotoxic, non-mutagenic mode of tumor induction.
Because a clear mode of action was demonstrated for the rat tumors, EPA based the cancer classification on the data from the mouse. EPA classified acetochlor as “Suggestive Evidence of Carcinogenic Potential” based on weak evidence for benign lung tumors in male and female mice and histiocytic sarcomas in female mice, and determined that linear quantification of carcinogenic potential would not be appropriate for the mouse tumors. The rat nasal tumors, with a point of departure (POD) of 10 mg/kg/day, are the most sensitive effect for cancer risk. The chronic population adjusted dose (cPAD), based on the no observed adverse effect level (NOAEL) of 2.0 mg/kg/day from the chronic dog study, will be protective of both non-cancer and cancer effects, including rat nasal tumors, thyroid tumors, and mouse tumors.
Specific information on the studies received and the nature of the adverse effects caused by acetochlor as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at
Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see
A summary of the toxicological endpoints for acetochlor used for human risk assessment is discussed in Unit III.B. of the final rule published in the
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Such effects were identified for acetochlor. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture's (USDA) National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). As to residue levels in food, EPA assumed tolerance level residues except for livestock commodities where anticipated residues were used, and 100 percent crop treated (PCT) for all commodities.
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Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Pesticide Root Zone Model Ground Water (PRZM GW), the estimated drinking water concentrations (EDWCs) of acetochlor for acute exposures are estimated to be 74.9 parts per billion (ppb) for surface water and 129 ppb for ground water. EDWCs for chronic exposures for non-cancer assessments are estimated to be 4.84 ppb for surface water and 82.6 ppb for ground water.
Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 129.0 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value of 82.6 ppb was used to assess the contribution to drinking water.
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The chloroacetanilides have been evaluated by the Agency and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) as a related group of chemicals for this purpose. Acetochlor is included in a Cumulative Assessment Group of chloroacetanilide pesticides. For purposes of a cumulative risk assessment, it was determined that the common mechanism of toxicity group consists of alachlor, acetochlor, and butachlor. Butachlor is excluded from the group for risk assessment purposes at present because there are no registered uses or tolerances for this chemical in the U.S. The group was selected based on common endpoints of:
i. Nasal turbinate tumors in rats, and a known mechanism of toxicity for development of these tumors.
ii. Induction of hepatic uridine diphosphate-glucuronosyl transferase (UDPGT), which results in increased incidence of thyroid follicular cell tumors secondary to disruption of pituitary-thyroid homeostasis.
Thyroid effects were not included in the final cumulative assessment of the chloroacetanilide herbicides because they were determined to occur at excessively toxic dose levels, and therefore were not considered relevant to human risk assessment. Nasal tumors represent the most sensitive endpoint for both compounds.
A cumulative risk assessment of the chloroacetanilide pesticides acetochlor and alachlor was conducted in April 2007 and did not identify any cumulative risks of concern. A revised quantitative cumulative assessment was not conducted because the proposed new use on alfalfa would not affect the cumulative risk results. The new use on alfalfa is not anticipated to affect the cumulative risk results for the following reasons: The major risk driver in the cumulative assessment was alachlor in drinking water, domestic alachlor uses are being phased out (tolerances are being maintained for imported foods), cumulative dietary exposure was not of concern when accounting for the contribution from alachlor, acetochlor is a very minor contributor to chloroacetanilide cumulative risk when compared to alachlor, and acetochlor is less toxic than alachlor. No further cumulative evaluation is necessary for acetochlor use on alfalfa.
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i. The toxicity database for acetochlor is complete for the purpose of evaluating this tolerance petition.
ii. Evidence of neurotoxicity from exposure to acetochlor was observed in several oral studies. However, these effects were typically observed at high doses. The points of departure selected for risk assessment are protective of the potential neurotoxicity observed in the database.
iii. There is no evidence that acetochlor results in increased susceptibility in
iv. There are no residual uncertainties identified in the exposure databases. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to acetochlor in drinking water. The acute dietary exposure analysis used tolerance level residues except for livestock commodities where anticipated residues were used and 100 PCT. The chronic dietary exposure analysis used anticipated residues from field trial data and livestock feeding studies, while 100% crop treated assumptions (including feed items) were made for all commodities and 100 PCT. These assessments will not underestimate the exposure and risks posed by acetochlor.
EPA determines whether acute and chronic dietary pesticide exposures are
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An Enforcement Analytical Method is available to enforce the proposed tolerances. The method is a high performance liquid chromatography/oxidative coulometric electrochemical detector (HPLC/OCED) method and is listed as Method I in the Pesticide Analytical Manual (PAM) Vol. II (§ 180.470).
In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.
The Codex has not established a MRL for acetochlor on alfalfa commodities, but there are Codex MRLs established for livestock commodities at 0.02 ppm. The tolerances established in this rulemaking are harmonized with the Codex MRLs for livestock commodities, except for the U.S. kidney tolerances, which are being established at 0.03 ppm.
EPA has revised the 8 ppm tolerance for alfalfa forage to 8.0 ppm, in accordance with policy. No other revisions were needed.
Therefore, tolerances are established for residues of acetochlor, in or on Alfalfa, forage at 8.0 ppm, Alfalfa, hay at 20 ppm, Cattle, fat at 0.02 ppm, Cattle, kidney at 0.03 ppm, Cattle, meat at 0.02 ppm, Cattle, meat byproducts, except kidney at 0.02 ppm, Goat, fat at 0.02 ppm, Goat, kidney at 0.03 ppm, Goat, meat at 0.02 ppm, Goat, meat byproducts, except kidney at 0.02 ppm, Hog, kidney at 0.02 ppm, Horse, fat at 0.02 ppm, Horse, kidney at 0.03 ppm, Horse, meat at 0.02 ppm, Horse, meat byproducts, except kidney at 0.02 ppm, Milk at 0.02 ppm, Sheep, fat at 0.02 ppm, Sheep, kidney at 0.03 ppm, Sheep, meat at 0.02 ppm, Sheep, meat byproducts, except kidney at 0.02 ppm, and to amend 40 CFR part 180.470 (d) Indirect or inadvertent residues., by adding alfalfa as an exception in the description of the commodities as follows: Animal feed, nongrass, group 18, except alfalfa, forage, and Animal feed, nongrass, group 18, except alfalfa, hay.
This action establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001); Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997); or Executive Order 13771, entitled “Reducing Regulations and Controlling Regulatory Costs” (82 FR 9339, February 3, 2017). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501
Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
This action directly regulates growers, food processors, food handlers, and food
This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).
Pursuant to the Congressional Review Act (5 U.S.C. 801
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
Therefore, 40 CFR chapter I is amended as follows:
21 U.S.C. 321(q), 346a and 371.
The additions and revisions read as follows:
(a) * * *
(d) * * *
Environmental Protection Agency (EPA).
Final rule.
This regulation establishes a tolerance for residues of thiencarbazone-methyl in or on wheat forage. Bayer CropScience requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA).
This regulation is effective June 22, 2018. Objections and requests for hearings must be received on or before August 21, 2018, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2017-0448, is available at
Michael L. Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address:
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).
You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2017-0448 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before August 21, 2018. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2017-0448, by one of the following methods:
•
•
•
Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at
In the
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue . . . .”
Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for thiencarbazone-methyl including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with thiencarbazone-methyl follows.
EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.
Thiencarbazone-methyl has low acute toxicity via the oral, dermal, and inhalation routes of exposure. Thiencarbazone-methyl is not an eye nor a skin irritant and it is not a skin sensitizer.
The most toxicologically significant effect of thiencarbazone-methyl occurs in the urothelial system including the kidney, bladder, and urinary tract. Across species, the dog is more sensitive than the rat or the mouse. Common effects observed throughout the database included sulfonamide crystals in the urine, eosinophilic urolithiasis (kidney, ureter and bladder stones), pelvic dilation, thickening of the kidney, bladder, or ureter, collecting duct hyperplasia, urothelial hyperplasia, submucosal inflammatory cell infiltration, bladder hemorrhage, inflammation, and ulceration.
There is no evidence of susceptibility in the thiencarbazone-methyl database. Offspring effects occurred at the same doses as those which caused maternal toxicity. In rats, maternal toxicity was indicated by decreased body and placenta weight and yellowish sediment in the urinary bladder. Developmental toxicity was indicated by delayed ossification of several locations. In rabbits, maternal toxicity consisted of decreased body weight, deaths, reduced food consumption and sediment in the kidney and urinary bladder. Developmental toxicity consisted of more runt fetuses and lower body weight in female offspring. There were no effects on reproductive parameters in either males or females in a reproductive study in rats. Systemically, there were effects on the urothelial system at the high dose in the parents and decreases in body weight in females
There is no evidence of immunotoxicity, neurotoxicity, or mutagenicity in the thiencarbazone-methyl database. There were no treatment-related increases in neoplasia in the rat carcinogenicity study. In mice, calculi in the urothelial system as well as transitional cell epithelium tumors in the urinary bladder (1 male/3 females) and in the prostatic urethra (1 male) were observed at the highest dose tested (599 mg/kg/day in males and 758 mg/kg/day in females). Since the neoplasia occurred only in the high dose group, thiencarbazone-methyl was classified as “not likely to be a carcinogen to humans at doses that do not cause urothelial cytotoxicity.” The formation of the tumors is considered to be related to the secondary effects of the urothelial toxicity (irritation) and regenerative proliferation associated with the formation of urinary tract crystals/calculi.
Specific information on the studies received and the nature of the adverse effects caused by thiencarbazone-methyl as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at
Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see
A summary of the toxicological endpoints for thiencarbazone-methyl used for human risk assessment is shown in Table 1 of this unit.
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No such effects were identified in the toxicological studies for thiencarbazone-methyl; therefore, a quantitative acute dietary exposure assessment is unnecessary.
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iv.
2.
Based on the First Index Reservoir Screening Tool (FIRST) and Screening Concentration in Ground Water (SCI-GROW) models, the estimated drinking water concentrations (EDWCs) of thiencarbazone-methyl for chronic exposures for non-cancer assessments are estimated to be 0.36 ppb for surface water and 0.00079 ppb for ground water.
Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For chronic dietary risk assessment, the water concentration of value 0.36 ppb was used to assess the contribution to drinking water.
3.
• Residential handler exposure is expected to be short-term in duration. Intermediate-term exposures are not likely because of the intermittent nature of applications by homeowners. There is a potential for inhalation and dermal exposure for adult handlers.
• Post-application exposure is expected to be short-term in nature. There is a potential for dermal exposure to adults and children and incidental oral exposure to children ages 1 <2 years old through contact with treated areas after treatment.
Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at
4.
EPA has not found thiencarbazone-methyl to share a common mechanism of toxicity with any other substances, and thiencarbazone-methyl does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that thiencarbazone-methyl does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at
1.
2.
3.
i. The toxicity database for thiencarbazone-methyl is considered complete. There are available developmental studies in rats and rabbits, a reproductions study in rats, and acute and subchronic neurotoxicity battery studies. The requirement for a subchronic inhalation study was waived because thiencarbazone-methyl has low volatility, low acute inhalation toxicity and the use of a POD from an oral study to estimate inhalation exposures results in MOEs that are >100 times higher than the MOEs of concern.
ii. There is no indication that thiencarbazone-methyl is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.
iii. There is no evidence that thiencarbazone-methyl results in increased susceptibility in
iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100% CT and
EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists.
1.
2.
3.
Thiencarbazone-methyl is currently registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to thiencarbazone-methyl. Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in aggregate MOEs of 9,200 to adults, 140,000 for children 11-16 years old, 13,000 for children 6-11 years old, and 7,500 for children 1-2 years old. Because EPA's level of concern for thiencarbazone-methyl is a MOE of 100 or below, these MOEs are not of concern.
4.
5.
6.
Adequate enforcement methodology (LC/MS/MS) is available to enforce the tolerance expression.
In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.
The Codex has not established a MRL for thiencarbazone-methyl.
Therefore, the tolerance is amended for residues of thiencarbazone-methyl, methyl 4-[[[(4,5-dihydro-3-methoxy-4-methyl-5-oxo-1H-1,2,4-triazol-1-yl)carbonyl] amino]sulfonyl]-5-methyl-3-thiophenecarboxylate, in or on wheat forage at 0.15 ppm. In addition, EPA is revising the tolerance expression to clarify (1) that, as provided in FFDCA section 408(a)(3), the tolerance covers metabolites and degradates of thiencarbazone-methyl not specifically mentioned; and (2) that compliance with the specified tolerance levels is to be determined by measuring only the specific compounds mentioned in the tolerance expression. EPA has determined that it is reasonable to make this change final without prior proposal and opportunity for comment, because public comment is not necessary, in that the change has no substantive effect on the tolerance, but rather is merely intended to clarify the existing tolerance expression.
This action amends a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), nor is it considered a regulatory action subject to Executive Order 13771, entitled “Reducing Regulations and Controlling Regulatory Costs” (82 FR 9339, February 3, 2017). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501
Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not
This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501
This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).
Pursuant to the Congressional Review Act (5 U.S.C. 801
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
Therefore, 40 CFR chapter I is amended as follows:
21 U.S.C. 321(q), 346a and 371.
The revisions read as follows:
(a)(1)
(2) Tolerances are established for residues of thiencarbazone-methyl, including its metabolites and degradates, in or on the commodities in the table below. Compliance with the tolerance levels specified below is to be determined by measuring only the sum of thiencarbazone-methyl [methyl 4-[[[(4,5-dihydro-3-methoxy-4-methyl-5-oxo-1
(d)
Environmental Protection Agency (EPA).
Final rule.
In response to a petition filed by Syngenta Crop Protection, LLC under the Federal Food, Drug, and Cosmetic Act (FFDCA), this regulation establishes tolerances for residues of benzovindiflupyr in or on bluegrass, forage at 0.15 parts per million (ppm), bluegrass, hay at 7.0 ppm, bluegrass, straw at 6.0 ppm, bromegrass, forage at 0.15 ppm, bromegrass, hay at 7.0 ppm, bromegrass, straw at 6.0 ppm, fescue, forage at 0.15 ppm, fescue, hay at 7.0 ppm, fescue, straw at 6.0 ppm, orchardgrass, forage at 0.15 ppm, orchardgrass, hay at 7.0 ppm, orchardgrass, straw at 6.0 ppm, and ryegrass, forage at 0.15 ppm, ryegrass, hay at 7.0 ppm, and ryegrass, straw at 6.0 ppm.
This regulation is effective June 22, 2018. Objections and requests for hearings must be received on or before August 21, 2018, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2017-0167, is available at
Michael Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address:
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).
You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2017-0167 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before August 21, 2018. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2017-0167, by one of the following methods:
•
•
•
Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at
In the
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue . . . .”
Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for benzovindiflupyr including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with benzovindiflupyr follows.
EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.
The rat is the most sensitive species tested, and the target organs of benzovindiflupyr are the liver, thyroid, and kidneys in rats. Hepatotoxicity was manifested as changes in liver weights, liver hypertrophy, and decreased triglycerides. The kidney effects were tubular cell pigment deposits, changes in the tubular basophilia, and increased urea. Enlargement and focal c-cell hyperplasia of the thyroid were observed. An increased incidence of cell hypertrophy in the pituitary pars distalis was noted in the F1 generation males and females in the 2-generation
There are no concerns for developmental or reproductive toxicity following benzovindiflupyr exposure. Decreased fetal weight and ossification in the rat developmental toxicity studies occurred at maternally toxic doses. There were no maternal or fetal adverse effects in the rabbit developmental study. In rat reproduction studies, offspring effects (decreased body weight, liver and pituitary effects) occurred at doses higher than those causing parental effects, thus there was no quantitative increase in sensitivity in rat pups. There were no single-dose developmental effects identified in the developmental toxicity studies in rats or rabbits. Although decreases in growing follicle counts were noted in the 2-generation reproduction toxicity study, this effect did not result in reduced fertility in the rat. Furthermore, the antral follicle counts at a later stage in development were not decreased, so the decreased growing follicle count effect is not considered adverse.
No evidence of specific neurotoxicity was observed in the acute oral (gavage) and sub-chronic oral (dietary) neurotoxicity (ACN and SCN) studies in rats, conducted on the benzovindiflupyr technical product. Although benzovindiflupyr caused decreased activity and decreased grip strength in the neurotoxicity studies, there was no supportive neuro-histopathology in any study to indicate a specific neurotoxic effect.
The mouse immunotoxicity study was negative by the T-cell Dependent Antigen Response (TDAR) assay in the mouse.
No systemic effects were noted at the limit dose of 1000 mg/kg/day in the 28-day dermal rat study.
The Agency classified benzovindiflupyr as showing “
Specific information on the studies received and the nature of the adverse effects caused by benzovindiflupyr as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at
Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see
A summary of the toxicological endpoints for benzovindiflupyr used for human risk assessment is discussed in Unit III.B. of the final rule published in the
1.
i.
Such effects were identified for benzovindiflupyr. In estimating acute dietary exposure, EPA used 2003-2008 food consumption information from the U.S. Department of Agriculture's (USDA's) National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). As to residue levels in food, EPA assumed 100 percent crop treated (PCT) and tolerance-level residues.
ii.
iii.
iv.
2.
Based on the Surface Water Concentration Calculator (SWCC) model and the Pesticide Root Zone Model Ground Water (PRZM-GW) model, the estimated drinking water concentrations (EDWCs) of benzovindiflupyr for acute exposures are estimated to be 8.41 parts per billion (ppb) for surface water and 0.14 ppb for ground water and for chronic exposures for non-cancer assessments are estimated to be 5.41 ppb for surface water and 0.14 ppb for ground water.
Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 8.41 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 5.41 ppb was used to assess the contribution to drinking water.
3.
Benzovindiflupyr is currently registered for the following uses that could result in residential exposures: Turf and ornamentals. EPA assessed residential exposure using the following assumptions: The residential uses of benzovindiflupyr will result in short-term residential handler and post-application exposure in residential settings. Only residential handler inhalation and post-application incidental oral exposure scenarios have been quantitatively assessed since no dermal hazard was identified. Residential handler short-term inhalation MOEs are well above the LOC of 100 for all scenarios assessed and are not of concern (inhalation MOEs are ≥180,000). Residential post-application (incidental oral) MOEs for children ranged from 8,000 to 3,600,000 on the day of application, using default input values, and are not of concern.
The residential scenarios for the benzovindiflupyr aggregate assessments are as follows: Adults: Inhalation exposures from treating ornamentals with a manually pressurized hand-wand or backpack sprayer; children 1 to <2 years old: Post-application hand-to-mouth exposures from treated turf. These scenarios resulted in the highest residential exposures and are considered protective of other exposure scenarios.
Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at
4.
EPA has not found benzovindiflupyr to share a common mechanism of toxicity with any other substances, and benzovindiflupyr does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that benzovindiflupyr does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at
1.
2.
3.
i. The toxicity database for benzovindiflupyr is complete.
ii. There is no indication that benzovindiflupyr is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional uncertainty factors (UFs) to account for neurotoxicity.
iii. There is no evidence that benzovindiflupyr results in increased susceptibility in
iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to benzovindiflupyr in drinking water. EPA used similarly conservative assumptions to assess post-application exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by benzovindiflupyr.
EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate food and water exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists.
1.
2.
3.
Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in aggregate MOEs of 2100 for adults and 510 for children. Because EPA's LOC for benzovindiflupyr is an MOE of 100 or below, these MOEs are not of concern.
4.
An intermediate-term adverse effect was identified; however, benzovindiflupyr is not registered for any use patterns that would result in intermediate-term residential exposure. Intermediate-term risk is assessed based on intermediate-term residential exposure plus chronic dietary exposure. Because there is no intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess intermediate-term risk), no further assessment of intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating intermediate-term risk for benzovindiflupyr.
5.
6.
An adequate analytical method is available to enforce the proposed tolerances for benzovindiflupyr in the specified grass commodities. A Quick, Easy, Cheap, Effective, Rugged, and Safe (QuEChERS) multi-residue method (EN15662:2009) was developed for the determination of residues of benzovindiflupyr via liquid chromatography-mass spectrometry/mass spectrometry (LC-MS/MS)
The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address:
In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.
The Codex has not established a MRL for benzovindiflupyr.
The registrant petitioned for the use of benzovindiflupyr in or on grasses grown for seed, forage at 0.15 parts per million (ppm), grasses grown for seed, hay at 7 ppm and grasses grown for seed, straw at 6 ppm. The Agency has not established a crop group for “grasses grown for seed” or otherwise defined what commodities are included in the category of “grasses grown for seed”. The closest group tolerance to the commodity category requested is a crop group tolerance on grasses (
Therefore, tolerances are established for residues of benzovindiflupyr, including its metabolites and degradates, in or on bluegrass, forage at 0.15 ppm, bluegrass, hay at 7.0 ppm, bluegrass, straw at 6.0 ppm, bromegrass, forage at 0.15 ppm, bromegrass, hay at 7.0 ppm, bromegrass, straw at 6.0 ppm, fescue, forage at 0.15 ppm, fescue, hay at 7.0 ppm, fescue, straw at 6.0 ppm, orchardgrass, forage at 0.15 ppm, orchardgrass, hay at 7.0 ppm, orchardgrass, straw at 6.0 ppm, and ryegrass, forage at 0.15 ppm, ryegrass, hay at 7.0 ppm, and ryegrass, straw at 6.0 ppm.
This action establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001); Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997); or Executive Order 13771, entitled “Reducing Regulations and Controlling Regulatory Costs” (82 FR 9339, February 3, 2017). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501
Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501
This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).
Pursuant to the Congressional Review Act (5 U.S.C. 801
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
Therefore, 40 CFR chapter I is amended as follows:
21 U.S.C. 321(q), 346a and 371.
(a) * * *
National Aeronautics and Space Administration.
Direct final rule.
NASA is issuing a final rule to amend the NASA Federal Acquisition Regulation (FAR) Supplement (NFS) to remove definitions which affect only the internal Agency administrative procedures and have no cost or administrative impact on contractors or prospective contractors.
This final rule is effective August 21, 2018. Comments due on or before July 23, 2018. If adverse comments are received, NASA will publish a timely withdrawal of the rule in the
Submit comments identified by NFS Case 2018-N017, using any of the following methods:
•
•
Geoffrey S. Sage, NASA Headquarters, Office of Procurement, Contract and Grant Policy Division, Suite 5K32, 300 E Street SW, Washington, DC 20456-0001. Telephone 202-358-2420.
NFS part 1802, Definitions of Words and Terms, contains the following definitions that affect only the internal Agency administrative procedures and have no cost or administrative impact on contractors or prospective contractors: Administrator, Contracting activity, Head of the agency or agency head, Head of the contracting activity (HCA), NASA Acquisition internet Service (NAIS), Procurement officer, and Senior Procurement Executive. Pursuant to Executive Order 13563, Improving Regulation and Regulatory
NASA does not anticipate opposition to the changes or significant adverse comments. However, if the Agency receives significant adverse comment, it will withdraw this final rule by publishing a document in the
Publication of proposed regulations, 41 U.S.C. 1707, is the statute which applies to the publication of the Federal Acquisition Regulation (FAR). Paragraph (a)(1) of the statute requires that a procurement policy, regulation, procedure or form (including an amendment or modification thereof) must be published for public comment if it relates to the expenditure of appropriated funds, and has either a significant effect beyond the internal operating procedures of the agency issuing the policy, regulation, procedure or form, or has a significant cost or administrative impact on contractors or offerors. This final rule is not required to be published for public comment because it makes nonsubstantive changes to Agency regulations that has no impact on contractors or prospective offerors as the definitions being removed affect only the internal Agency administrative procedures.
Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.
This rule is not subject to Executive Order (E.O.) 13771, Reducing Regulation and Controlling Regulatory Costs, because this rule is not a significant regulatory action under E.O. 12866.
The Regulatory Flexibility Act does not apply to this rule because this final rule does not constitute a significant NFS revision within the meaning of FAR 1.501-1 and 41 U.S.C. 1707 and therefore does not require publication for public comment.
The rule does not contain any information collection requirements that require the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. chapter 35).
Government procurement.
National Aeronautics and Space Administration.
Direct final rule.
NASA is issuing a final rule to amend the NASA Federal Acquisition Regulation (FAR) Supplement (NFS) to remove reference to the supplemental rights in data special works policy and associated clause.
This final rule is effective August 21, 2018. Comments due on or before July 23, 2018. If adverse comments are received, NASA will publish a timely withdrawal of the rule in the
Submit comments identified by NFS Case 2018-N016, using any of the following methods:
○
○
John Brett, NASA Headquarters, Office of Procurement, Contract and Grant Policy Division, Suite 5G25, 300 E Street SW, Washington, DC 20456-0001. Telephone 202-358-0687.
NFS 1827.409(i), and associated clause 1852.227-17, Rights in Data-Special Works, require that whenever the words “establish” and “establishment” are used in clause 52.227-17, Rights in Data, those words shall be construed to mean “assert” and “assertion”, respectively. In 2007, 52.227-17 was modified. As a result of the modification, the words “establish” and “establishment” no longer appear in the clause. With the modification of 52.227-17, the requirement for NFS 1827.409(i), and associated clause 1852.227-17, Rights in Data-Special Works, is rendered unnecessary. Pursuant to Executive Order 13563, Improving Regulation and Regulatory Review, and Executive Order 13777, Enforcing the Regulatory Reform Agenda, NASA is continually reviewing existing regulations with the objective of reducing or removing any unnecessary, outdated and burdensome requirements that have outlived their intended purpose, NFS 1827.409(i), and associated clause 1852.227-17, Rights in Data-Special Works, were reviewed and recommended for removal from the NFS since they are no longer applicable under any circumstance.
NASA does not anticipate opposition to the changes or significant adverse
Publication of proposed regulations, 41 U.S.C. 1707, is the statute which applies to the publication of the Federal Acquisition Regulation (FAR). Paragraph (a)(1) of the statute requires that a procurement policy, regulation, procedure or form (including an amendment or modification thereof) must be published for public comment if it relates to the expenditure of appropriated funds, and has either a significant effect beyond the internal operating procedures of the agency issuing the policy, regulation, procedure or from, or has a significant cost or administrative impact on contractors or offerors. This final rule is not required to be published for public comment because it makes nonsubstantive changes to Agency regulations. The rule merely removes from the NFS policy and an associated clause that are outdated.
Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.
This rule is not subject to Executive Order (E.O.) 13771, Reducing Regulation and Controlling Regulatory Costs, because this rule is not a significant regulatory action under E.O. 12866.
The Regulatory Flexibility Act does not apply to this rule because this final rule does not constitute a significant NFS revision within the meaning of FAR 1.501-1 and 41 U.S.C. 1707 and therefore does not require publication for public comment.
The rule does not contain any information collection requirements that require the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. chapter 35).
Government procurement.
Accordingly, 48 CFR parts 1827 and 1852 are amended as follows:
51 U.S.C. 20113(a) and 48 CFR chapter 1.
National Aeronautics and Space Administration.
Direct final rule.
NASA is issuing a final rule to amend the NASA Federal Acquisition Regulation (FAR) Supplement (NFS) to remove reference to the Shared Savings policy and associated clause.
This final rule is effective August 21, 2018. Comments due on or before July 23, 2018. If adverse comments are received, NASA will publish a timely withdrawal of the rule in the
Submit comments identified by NFS Case 2018-N008, using any of the following methods:
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Marilyn J. Seppi, NASA Headquarters, Office of Procurement, Contract and Grant Policy Division, Suite 5H35, 300 E. Street SW, Washington, DC 20456-0001. Telephone 202-358-0447.
NFS subpart 1843.71, Shared Savings, and associated clause 1852.243-71, Shared Savings, were added to the NFS in 1997. The intent of the clause was to provide an incentive for contractors to identify and implement significant cost reduction programs. In return, they would be eligible for a share of the realized savings which resulted from those cost-cutting projects once they were approved by the contracting officer. Pursuant to Executive Order 13563, Improving Regulation and Regulatory Review, and Executive Order 13777, Enforcing the Regulatory Reform Agenda, NASA is continually reviewing existing regulations with the objective of reducing or removing any unnecessary, outdated and burdensome requirements that have outlived their intended purpose, NFS 1843.71, Shared Savings, and associated clause 1852.243-71, Shared Savings were reviewed and recommended for removal from the NFS since they are duplicative of the FAR part 48, Value Engineering Change Proposal (VECP) program and associated clauses implemented under OMB Circular A-131, Value Engineering. The FAR VECP clauses provide the same
NASA does not anticipate opposition to the changes or significant adverse comments. However, if the Agency receives significant adverse comment, it will withdraw this final rule by publishing a document in the
Publication of proposed regulations, 41 U.S.C. 1707, is the statute which applies to the publication of the Federal Acquisition Regulation (FAR). Paragraph (a)(1) of the statute requires that a procurement policy, regulation, procedure or form (including an amendment or modification thereof) must be published for public comment if it relates to the expenditure of appropriated funds, and has either a significant effect beyond the internal operating procedures of the agency issuing the policy, regulation, procedure or form, or has a significant cost or administrative impact on contractors or offerors. This final rule is not required to be published for public comment because it makes nonsubstantive changes to Agency regulations that has minimal impact on contractors or offerors as there are value engineering proposal clauses prescribed in FAR part 48 that may be utilized in lieu of the NFS clause. The rule merely removes from the NFS policy and an associated clause that is outdated and redundant to policy that is already provided for in the FAR.
Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.
This rule is not subject to Executive Order (E.O.) 13771, Reducing Regulation and Controlling Regulatory Costs, because this rule is not a significant regulatory action under E.O. 12866.
The Regulatory Flexibility Act does not apply to this rule because this final rule does not constitute a significant NFS revision within the meaning of FAR 1.501-1 and 41 U.S.C. 1707 and therefore does not require publication for public comment.
The rule does not contain any information collection requirements that require the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. chapter 35).
Government procurement.
Accordingly, 48 CFR parts 1843 and 1852 are amended as follows:
51 U.S.C. 20113(a) and 48 CFR chapter 1.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Final rule.
NMFS issues regulations to implement management measures described in a framework action to the Fishery Management Plan for the Reef Fish Resources of the Gulf of Mexico (FMP), as prepared by the Gulf of Mexico (Gulf) Fishery Management Council (Council). This final rule revises the mutton snapper commercial and recreational minimum size limits, the recreational bag limit, and the stock annual catch limit (ACL). In addition, this final rule revises the gag commercial minimum size limit. The purposes of this final rule are to reduce harvest of mutton snapper to prevent overfishing while also achieving optimum yield (OY), and streamline management measures to help increase compliance with the fishing regulations for mutton snapper and gag in the exclusive economic zone (EEZ) of the Gulf off Florida.
This final rule is effective July 23, 2018.
Electronic copies of the framework action, which includes an environmental assessment, a regulatory impact review, and a Regulatory Flexibility Act (RFA) analysis may be obtained from the Southeast Regional Office website at
Rich Malinowski, NMFS SERO, telephone: 727-824-5305, email:
The Gulf reef fish fishery includes mutton snapper and gag and is managed under the FMP. The FMP was prepared by the Council and is implemented by NMFS through regulations at 50 CFR part 622 under the authority of the Magnuson-
On February 15, 2018, NMFS published a proposed rule for the framework action and requested public comment (83 FR 6830). The proposed rule and framework action outlined the rationale for the actions contained in this final rule. A summary of the management measures described in the framework action and implemented by this final rule is provided below.
For mutton snapper, this final rule revises the stock ACL (given in round weight), the commercial and recreational minimum size limits, and the recreational bag limit. This final rule also revises the gag commercial minimum size limit.
This final rule sets the Gulf mutton snapper stock ACL at 134,424 lb (60,974 kg) for the 2018 fishing year, 139,392 lb (63,227 kg) for the 2019 fishing year, and 143,694 lb (65,179 kg) for the 2020 fishing year and subsequent fishing years. The ACLs are consistent with the current apportionment between the Gulf and South Atlantic and are equal to the Gulf's portion of the acceptable biological catch recommended by the Council's Scientific and Statistical Committee (SSC).
This final rule reduces the recreational bag limit applicable to the Gulf EEZ to 5 mutton snapper per person per day within the 10-snapper aggregate bag limit to be consistent with the Florida state bag limit and South Atlantic EEZ bag limit. NMFS and the Council expect consistent mutton snapper recreational bag limits across the Gulf and South Atlantic EEZs and Florida state waters to improve regulatory compliance and decrease the burden for law enforcement.
This final rule revises the mutton snapper commercial and recreational minimum size limits to 18 inches (45.7 cm), total length (TL), in the Gulf EEZ to be consistent with the state of Florida and South Atlantic EEZ minimum size limits. As with the change to the recreational bag limit, this revision increases regulatory consistency to improve compliance and decrease the burden for law enforcement.
Because more than 95 percent of mutton snapper landings from the Gulf are from the commercial sector and 95 percent of the commercially landed mutton snapper are larger than 20 inches (50.8 cm), NMFS expects little effect on the spawning population and harvest rates as a result of this change.
This final rule increases the Gulf gag commercial minimum size limit to 24 inches (60.9 cm), TL, to make the commercial minimum size limit consistent with the Gulf EEZ recreational minimum size limit, as well as consistent with the South Atlantic EEZ and state of Florida commercial and recreational size limits. Over 98 percent of Gulf commercial gag landings come from waters adjacent to Florida and 94.5 percent of commercially harvested gag in the Gulf waters are at least 24 inches. Therefore, NMFS and the Council expect increasing the commercial minimum size limit to improve compliance and decrease the burden for law enforcement by increasing regulatory consistency, but do not expect an increase in regulatory discards of gag.
NMFS received three comments related to the proposed rule for the framework action. These comments either agreed with the proposed changes or suggested additional modifications to management measures such as prohibiting commercial harvest of gag or modifying the recreational closed seasons, which were beyond the scope of the proposed rule. No changes were made to this final rule based on public comment.
The Regional Administrator for the NMFS Southeast Region has determined that this final rule is consistent with the framework action, the FMP, the Magnuson-Stevens Act, and other applicable law.
This final rule has been determined to be not significant for purposes of Executive Order (E.O.) 12866. This rule is not an Executive Order 13771 regulatory action because this rule is not significant under E.O. 12866.
In compliance with section 604 of the Regulatory Flexibility ACT (RFA), NMFS prepared a final regulatory flexibility analysis (FRFA) for this final rule. The FRFA follows.
The Magnuson-Stevens Act provides the statutory basis for this final rule. A description of the final rule, why it is being considered, and the objectives of, and legal basis for this final rule are contained in the
No public comments were received relating to the socio-economic implications and potential impacts on small business entities, therefore no changes to this final rule were made in response to public comments. No comments were received from the Office of Advocacy for the Small Business Administration.
NMFS agrees that the Gulf Council's preferred alternatives will best achieve their objectives for the framework action while minimizing, to the extent practicable, the adverse effects on fishers, support industries, and associated communities.
NMFS expects this final rule to directly affect all commercial vessels that harvest Gulf mutton snapper and/or gag under the FMP. Changes to ACLs, recreational minimum size limits, or recreational bag limits in this framework and final rule will not directly apply to or regulate charter vessel and headboat (for-hire) businesses. Any impact to the profitability or competitiveness of for-hire fishing businesses will be the result of changes in for-hire angler demand and will therefore be indirect in nature. The RFA does not consider recreational anglers, who will be directly affected by this final rule, to be small entities, so they are outside the scope of this analysis and only the effects on commercial vessels were analyzed. For RFA purposes only, NMFS has established a small business size standard for businesses, including their affiliates, whose primary industry is commercial fishing (see 50 CFR 200.2). A business primarily engaged in commercial fishing (NAICS code 11411) is classified as a small business if it is independently owned and operated, is not dominant in its field of operation (including affiliates), and has combined annual receipts not in excess of $11 million for all its affiliated operations worldwide.
As of April 5, 2018, there were 842 vessels with valid or renewable Federal Gulf reef fish commercial vessel permits. From 2010 through 2015, an average of 119 vessels per year landed mutton snapper in state and Federal waters of the Gulf. These vessels, combined, averaged 429 trips per year in the Gulf on which mutton snapper were landed and 1,594 other trips taken in the Gulf on which no mutton snapper were landed or were taken in the South Atlantic. The average annual total
Because all entities expected to be directly affected by this final rule are assumed to be small entities, NMFS has determined that this final rule will affect a substantial number of small entities; however, the issue of disproportionate effects on small versus large entities does not arise in the present case.
Relevant to commercial vessels, the final rule modifies the 2018-2020, and subsequent years', ACLs for the Gulf apportionment of mutton snapper; increases the minimum size limit for commercial mutton snapper in the Gulf to 18 inches (45.7 cm) TL; and, increases the commercial minimum size limit for gag in the Gulf to 24 inches (60.9 cm) TL.
Modifying the ACLs for mutton snapper will result in ACL reductions each year from 2018 through 2020. Vessel revenue reductions corresponding to these reduced ACLs will be approximately $166,000 in 2018, $154,000 in 2019, and $143,000 in 2020, or an annual average of approximately $160,000 for the four-year period. If distributed equally among the 119 vessels, average annual revenue loss will be approximately $1,350 per vessel. This annual revenue loss per vessel will be approximately 1 percent of average per vessel revenues from all species.
Increasing the Gulf mutton snapper minimum size limit from 16 inches (40.6 cm), TL, to 18 inches (45.7 cm), TL, affects approximately 0.2 percent of commercial landings, or approximately $495 annually in total vessel revenues. This revenue reduction is minimal, and it is also unlikely to be in addition to the estimated revenue losses from the reductions in ACLs, because NMFS expects fishermen to catch the full amount of the ACLs even with an increase in the minimum size limit for mutton snapper.
Increasing the commercial gag minimum size limit in the Gulf from 22 inches (55.8 cm), TL, to 24 inches (60.9 cm), TL, could potentially reduce commercial gag landings by 12,207 lb (5,537 kg) annually, or approximately $61,890 in total vessel revenues. These landings and revenue loss, however, appear unlikely because gag are managed under an individual fishing quota (IFQ) program, and IFQ participants will likely adjust their trip level catch composition throughout the year or sell a portion of their annual gag allocation to other fishers, rather than suffer a loss in revenues.
The following discussion analyzes the alternatives that were considered by the Council, including those that were not selected as preferred by the Council.
Three alternatives, including the preferred alternative described in this final rule, were considered for establishing ACLs for Gulf mutton snapper. The first alternative, the no-action alternative, would maintain the current economic benefits to all participants in the mutton snapper component of the reef fish fishery. This alternative, however, would be inconsistent with the best scientific information available and would allow more harvest than is recommended by the SSCs based on the most recent stock assessment.
The second alternative, which is the preferred alternative, includes two options, one of which is the preferred option. The non-preferred option would apply the Gulf's ACL/annual catch target (ACT) control rule, with the resultant ACT being 12 percent less than the ACL. Because the ACT is not currently used for management purposes, the economic effects of this option would be the same as that of the preferred option.
The third alternative would establish ACLs that would be lower than the ACLs in the preferred alternative, and thus would be expected to result in larger revenue losses than the preferred alternative.
Three alternatives, one of which includes the preferred alternative described in this final rule, were considered for modifying the mutton snapper minimum size limit. The first alternative, the no-action alternative, would maintain the 16-inch (40.6 cm), TL, minimum size limit for commercial and recreational mutton snapper, and thus would not be expected to change the economic benefits from fishing for mutton snapper. However, this alternative would not achieve one of the stated goals of changing the minimum size limit, which is to establish consistent size limit regulations between the Gulf EEZ, the South Atlantic EEZ, and Florida state waters.
The second alternative would increase the minimum size limit for commercial and recreational mutton snapper to 20 inches (50.8 cm), TL. This alternative would be expected to result in larger revenue reductions to commercial vessels than the preferred alternative.
Two alternatives, including the preferred alternative described in this final rule, were considered for modifying the commercial gag minimum size limit. The only alternative to the preferred action is the no-action alternative which would retain the 22-inch (55.8 cm), TL, minimum size limit for gag. However, this alternative would not establish consistent size limit regulations between the Gulf EEZ, the South Atlantic EEZ, and Florida state waters. Furthermore, although the preferred alternative is expected to reduce vessel revenues by approximately $61,890 relative to the no-action alternative, as previously noted, such revenue reduction is deemed unlikely under an IFQ program.
Commercial, Fisheries, Fishing, Gag, Gulf of Mexico, Mutton snapper, Recreational, Reef fish.
For the reasons set out in the preamble, 50 CFR part 622 is amended as follows:
16 U.S.C. 1801
(a) * * *
(5)
(b) * * *
(1)
(b) * * *
(4)
(o) * * * The stock ACL for mutton snapper, in round weight, is 134,424 lb (60,974 kg) for 2018, 139,392 lb (63,227 kg) for 2019, and 143,694 lb (65,179 kg) for 2020 and subsequent fishing years.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Final rule.
NMFS implements management measures described in Regulatory Amendment 4 to the Fishery Management Plan for Spiny Lobster in the Gulf of Mexico (Gulf) and South Atlantic (FMP), as prepared and submitted by the Gulf and South Atlantic Fishery Management Councils (Councils). This final rule increases the annual catch limit (ACL) for spiny lobster based on updated landings information and revised scientific recommendations. This final rule also prohibits the use of traps for recreational harvest of spiny lobster in the South Atlantic exclusive economic zone (EEZ) off Georgia, South Carolina, and North Carolina. The purposes of this final rule are to ensure catch levels for spiny lobster are based on the best scientific information available, to prevent overfishing, and to minimize potential negative effects of traps on habitat and protected species interactions in the South Atlantic EEZ.
This final rule is effective on July 23, 2018.
Electronic copies of Regulatory Amendment 4, which includes an environmental assessment and a regulatory flexibility analysis, and a regulatory impact review, may be obtained from the Southeast Regional Office website at
Nikhil Mehta, NMFS Southeast Regional Office, telephone: 727-824-5305, or email:
The spiny lobster fishery of the Gulf and the South Atlantic is managed under the FMP. The FMP was prepared by the Councils and implemented through regulations at 50 CFR part 622 under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) (16 U.S.C. 1801
On February 2, 2018, NMFS published a proposed rule for Regulatory Amendment 4 in the
This final rule modifies the stock ACL and annual catch target (ACT) for spiny lobster and prohibits the use of traps for the recreational harvest of spiny lobster in the South Atlantic EEZ.
This final rule revises the stock ACL and ACT based on the new acceptable biological catch (ABC) recommendation provided by the Councils' Scientific and Statistical Committees (SSCs). This final rule sets the ACL equal to the recommended ABC of 9.60 million lb (4.35 million kg), which is based on the mean landings from the years 1991/1992-2015/2016 plus 1.5 standard deviations. This final rule sets the ACT at 8.64 million lb (3.92 million kg), which is 90 percent of the ACL. As established in Amendment 10 to the FMP (Amendment 10), the optimum yield (OY) equals the ACT. NMFS does not expect the increase in the ACT and ACL to result in negative biological effects on the stock because current fishing effort is limited by several variables. These variables include the number of trap tags issued by the state of Florida, commercial and recreational bag and possession limits in the Gulf and South Atlantic EEZ, and the duration of the fishing season, which varies depending on the area where spiny lobsters are harvested.
This final rule prohibits the use of traps for recreational harvest of spiny lobster in all of the South Atlantic EEZ.
The Councils are concerned that using these traps for recreational harvest may become more popular and result in potential negative impacts on essential fish habitat and an increase in the use of vertical lines that may interact with protected species, for example, by creating entanglement issues, continuing to fish after a trap is lost, or creating bycatch.
As established in Amendment 10, the maximum sustainable yield (MSY) proxy and maximum fishing mortality threshold (MFMT) are equal to the OFL, which was set at 7.9 million lb (3.58 million kg). Consistent with Amendment 10, Regulatory Amendment 4 would modify the MSY proxy and MFMT values, so that they are equal to the revised OFL of 10.46 million lb (4.74 million kg).
In addition to implementing the measures associated with Regulatory Amendment 4, this final rule corrects regulatory language that was mistakenly included in the final rule implementing Amendment 10. This final rule changes 50 CFR 622.407(c) to remove the phrase “whichever is greater” and the first occurrence of a duplicative sentence. This final rule also makes a minor
A total of 14 comments were received on the proposed rule to implement Regulatory Amendment 4. Comments that were beyond the scope of the proposed rule and comments that agreed with the proposed actions are not responded to in this final rule. Other comments that relate to the actions contained in Regulatory Amendment 4 and the proposed rule are grouped as appropriate and summarized below, followed by NMFS' respective responses.
This final rule revises a reference to a boundary point coordinate for the Tortugas shrimp sanctuary in 50 CFR 622.55(c)(2)(iii), which incorrectly refers to paragraph (d)(1) rather than paragraph (c)(1).
The Regional Administrator, Southeast Region, NMFS has determined that this final rule is consistent with Regulatory Amendment 4, the FMP, the Magnuson-Stevens Act, and other applicable law.
This final rule has been determined to be not significant for purposes of Executive Order 12866.
The Magnuson-Stevens Act provides the statutory basis for this rule. No duplicative, overlapping, or conflicting Federal rules have been identified. In addition, no new reporting, record-keeping, or other compliance requirements are introduced by this final rule.
The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration during the proposed rule stage that this final rule would not have a significant economic impact on a substantial number of small entities. The factual basis for this determination was published in the proposed rule and is not repeated here.
One public comment (
No changes were made to the final rule in response to public comments, and NMFS has not received any new information that would affect its previous determination. As a result, a final regulatory flexibility analysis is not required and none was prepared.
The Assistant Administrator for NOAA Fisheries finds that with respect to the change to 50 CFR 622.55(c)(2)(iii) there is good cause to waive the requirements to provide prior notice and opportunity for public comment pursuant to the authority set forth in 5 U.S.C. 553(b)(B), as such procedures are unnecessary. Such procedures are unnecessary because the rule implementing the provision has been subject to notice and comment and the revision corrects only a typographical error.
Fisheries, Fishing, Gulf, South Atlantic, Spiny lobster, Trap.
For the reasons set out in the preamble, 50 CFR parts 600 and 622 are amended as follows:
5 U.S.C. 561 and 16 U.S.C. 1801
(v) * * *
16 U.S.C. 1801
(c) * * *
(2) * * *
(iii) Effective from May 26 through July 31, each year, that part of the Tortugas shrimp sanctuary seaward of rhumb lines connecting the following points is open to trawling: From point F, as specified in paragraph (c)(1) of this section, to point Q at 24°46.7′ N lat., 81°52.2′ W long. (on the line denoting the seaward limit of Florida's waters); thence along the seaward limit of Florida's waters, as shown on the current edition of NOAA chart 11439, to point U and north to point T, both points as specified in paragraph (c)(2)(i) of this section.
(d) Except for black sea bass pots and golden crab traps as allowed in § 622.188 and § 622.248, respectively, the possession of all other traps is prohibited onboard a vessel in the South Atlantic EEZ when spiny lobster subject to the recreational bag and possession limits specified in § 622.408 is also onboard the vessel. The recreational harvest of spiny lobster using a trap is prohibited in the South Atlantic EEZ.
(c)
For recreational and commercial spiny lobster landings combined, the ACL is 9.60 million lb (4.35 million kg), whole weight. The ACT is 8.64 million lb, (3.92 million kg) whole weight.
Office of Energy Efficiency and Renewable Energy, Department of Energy.
Request for information (RFI).
The U.S. Department of Energy (“DOE”) is initiating a data collection process through this RFI to consider whether to amend DOE's test procedure for commercial water-source heat pumps (“WSHPs”). To inform interested parties and to facilitate this process, DOE has gathered data, identifying several issues associated with the currently applicable test procedure on which DOE is interested in receiving comment. The issues outlined in this document mainly concern: Methods that are incorporated by reference by the applicable industry standard; efficiency metrics and calculations; additional specifications for the test methods; and any additional topics that may inform DOE's decisions in a future test procedure rulemaking, including methods to reduce regulatory burden while ensuring the test procedure's accuracy. DOE welcomes written comments from the public on any subject within the scope of this document (including topics not raised in this RFI).
Written comments and information are requested and will be accepted on or before July 23, 2018.
Interested persons are encouraged to submit comments using the Federal eRulemaking Portal at
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No telefacsimilies (faxes) will be accepted. For detailed instructions on submitting comments and additional information on the rulemaking process, see section III of this document.
The docket web page can be found at:
Mr. Antonio Bouza, 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) 586-4563. Email:
Mr. Eric Stas, U.S. Department of Energy, Office of the General Counsel, GC-33, 1000 Independence Avenue SW, Washington, DC 20585. Telephone: (202) 586-9507. Email:
For further information on how to submit a comment, or review other public comments and the docket, contact the Appliance and Equipment Standards Program staff at (202) 287-1445 or by email:
WSHPs are included in the list of “covered equipment” for which DOE is authorized to establish and amend energy efficiency standards and test procedures. (42 U.S.C. 6311(1)(B)-(D)) DOE's test procedure for WSHPs is prescribed at title 10 of the Code of Federal Regulations (“CFR”) § 431.96. The following sections discuss DOE's authority to establish and amend test procedures for WSHPs, as well as relevant background information regarding DOE's consideration of test procedures for this equipment.
The Energy Policy and Conservation Act of 1975 (“EPCA” or “the Act”),
Under EPCA, DOE's energy conservation program consists essentially of four parts: (1) Testing, (2) labeling, (3) Federal energy conservation standards, and (4) certification and enforcement procedures. Relevant provisions of the Act include definitions (42 U.S.C. 6311), energy conservation standards (42 U.S.C. 6313), test procedures (42 U.S.C. 6314), labeling provisions (42 U.S.C. 6315), and the authority to require information and reports from manufacturers (42 U.S.C. 6316).
Federal energy efficiency requirements for covered equipment established under EPCA generally supersede State laws and regulations concerning energy conservation testing, labeling, and standards. (42 U.S.C. 6316(a) and (b); 42 U.S.C. 6297) DOE may, however, grant waivers of Federal preemption for particular State laws or regulations, in accordance with the procedures and other provisions of EPCA. (42 U.S.C. 6316(b)(2)(D))
The DOE 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. 6316(b); 42 U.S.C. 6296), and (2) making representations about the efficiency of that equipment (42 U.S.C. 6314(d)). Similarly, DOE must use these test procedures to determine whether the equipment complies with relevant standards promulgated under EPCA.
Under 42 U.S.C. 6314, EPCA sets forth the criteria and procedures DOE is required to follow when prescribing or amending test procedures for covered equipment. 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 covered equipment 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. 6314(a)(2))
In addition, if DOE determines that a test procedure amendment is warranted, it must publish proposed test procedures and offer the public an opportunity to present oral and written comments on them. (42 U.S.C. 6314(b))
As discussed, WSHPs are a category of commercial package air conditioning and heating equipment. EPCA requires that the test procedures for commercial package air conditioning and heating equipment be those generally accepted industry testing procedures or rating procedures developed or recognized by the Air-Conditioning, Heating, and Refrigeration Institute (AHRI) or by the American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE), as referenced in ASHRAE Standard 90.1, “Energy Standard for Buildings Except Low-Rise Residential Buildings” (ASHRAE Standard 90.1). (42 U.S.C. 6314(a)(4)(A)) Further, if such an industry test procedure is amended, DOE must amend its test procedure to be consistent with the amended industry test procedure, unless DOE determines, by rule published in the
EPCA also requires that, at least once every 7 years, DOE evaluate test procedures for each type of covered equipment, including WSHPs, to determine whether amended test procedures would more accurately or fully comply with the requirements for the test procedures to not be unduly burdensome to conduct and be reasonably designed to produce test results that reflect energy efficiency, energy use, and estimated operating costs during a representative average use cycle. (42 U.S.C. 6314(a)(1)) In addition, if DOE determines that a test procedure amendment is warranted, it must publish proposed test procedures and offer the public an opportunity to present oral and written comments on them. (42 U.S.C. 6314(b)) If DOE determines that test procedure revisions are not appropriate, DOE must publish its determination not to amend the test procedures. (42 U.S.C. 6314(a)(1)(A)(ii)) DOE is publishing this RFI to collect data and information to inform its decision in satisfaction of the 7-year review requirement specified in EPCA. (42 U.S.C. 6314(a)(1))
DOE sets forth the test procedure for WSHPs with a cooling capacity less than 135,000 Btu/h at 10 CFR 431.96. The DOE test procedure currently incorporates by reference International Organization for Standardization (ISO) Standard 13256-1 (1998), “Water-source heat pumps-Testing and rating for performance-Part 1: Water-to-air and brine-to-air heat pumps,” (ISO 13256-1:1998) and includes additional provisions for equipment set-up at 10 CFR 431.96(e). Paragraph (e) of 10 CFR 431.96 provides specifications for addressing key information typically found in the installation and operation manuals.
DOE initially incorporated ISO 13256-1:1998 as the referenced test procedure for WSHPs on October 21, 2004 (69 FR 61962), and DOE last reviewed the test procedure for WSHPs as part of a final rule for test procedures for commercial package air conditioners and heat pumps published on May 16, 2012 (77 FR 28928). Since then, the relevant industry standards have undergone a reevaluation process which did not result in substantive changes to the referenced standards. (See section II.C.1 of this RFI for a more complete explanation of the industry update process.) Because these actions by the relevant industry standard-setting bodies contained no substantive changes to the industry standard already incorporated by reference, DOE has tentatively concluded that the statutory trigger provisions of 42 U.S.C. 6314(a)(4)(B) do not provide a basis for DOE to review its WSHP test procedure at this time. Therefore, if DOE determines, based upon its assessment of the information submitted in response to this RFI, that a rulemaking is necessary for a reevaluation of the WSHP test procedure, DOE would conduct such review under EPCA's 7-year-lookback authority. (42 U.S.C. 6314(a)(1))
In the following sections, DOE has identified a variety of issues on which it seeks input to aid in the development of the technical and economic analyses regarding whether amended test
Additionally, DOE welcomes comments on other issues relevant to the conduct of this process that may not specifically be identified in this document. In particular, DOE notes that under Executive Order 13771, “Reducing Regulation and Controlling Regulatory Costs,” Executive Branch agencies such as DOE are directed to manage the costs associated with the imposition of expenditures required to comply with Federal regulations. See 82 FR 9339 (Feb. 3, 2017). Pursuant to that Executive Order, DOE encourages the public to provide input on measures DOE could take to lower the cost of its regulations applicable to WSHPs consistent with the requirements of EPCA.
This RFI covers WSHPs, which DOE defines at 10 CFR 431.92, as a single-phase or three-phase reverse-cycle heat pump that uses a circulating water loop as the heat source for heating and as the heat sink for cooling. The main components are a compressor, refrigerant-to-water heat exchanger, refrigerant-to-air heat exchanger, refrigerant expansion devices, refrigerant reversing valve, and indoor fan. Such equipment includes, but is not limited to, water-to-air water-loop heat pumps.
DOE notes that while the current Federal test procedure and energy conservation standards at 10 CFR 431.96 and 431.97 apply only to those WSHPs with a rated cooling capacity below 135,000 Btu/h (
For WSHPs, the cooling metric currently specified by DOE is the energy efficiency ratio (EER). 10 CFR 431.96. EER is the ratio of the produced cooling effect of the WSHP to its net work input, expressed in Btu/watt-hour, and measured at standard rating conditions. The heating mode metric currently specified by DOE for WSHPs is the coefficient of performance (COP).
DOE is aware that the energy use of field-installed fans will vary based on the use of the fan for various functions (
ISO 13256-1:1998 uses a fan power adjustment calculation to exclude fan power used for overcoming external resistance on ducted equipment. As a result, the calculation of efficiency only includes the fan power required to overcome the internal resistance of the unit. Similarly, only liquid pump power required to overcome the internal resistance of the unit is included in the effective power input used for efficiency calculation for WSHPs.
ISO 13256-1:1998 does not provide minimum external static pressure (ESP) requirements for ducted equipment; however, Table 9 of ISO 13256-1:1998 includes an operating tolerance (
DOE is aware that some WSHPs may be installed with or without indoor air distribution ducts in the field. Depending on the type of installation, the test method specified in ISO 13256-1:1998 differs; section 4.1.2 of ISO 13256-1:1998 specifies provisions for WSHPs installed without ducts, and section 4.1.3 of that standard specifies provisions for WSHPs installed with ducts. DOE's preliminary research has not revealed any physical characteristics of WSHPs that distinguish them as being suitable for installation with ducts, without ducts, or both. ISO 13256-1:1998 does not specify how to determine whether a WSHP is to be tested using the ducted or non-ducted provisions.
ISO 13256-1:1998 provides requirements for airflow rates in section 4.1.5, including that: (a) Non-ducted heat pumps shall be tested at airflow rates obtained at zero ESP; (b) ducted heat pumps with internal fans or with designated air movers be tested at the airflow rates obtained at zero ESP or the manufacturer-specified airflow rate, whichever is lower, and (c) ducted heat pumps without internal fans shall be tested at the manufacturer-specified airflow rate subject to a maximum internal pressure drop. Additionally, paragraph (e)(2) of 10 CFR 431.96 requires that the airflow rate used for testing must be specified by the manufacturer in the installation and operation manuals being shipped to the commercial customer. ISO 13256-1:1998 does not indicate what speed setting should be used to achieve specified airflow for a fan with more than one speed setting. Also, in some cases, the airflow rate and pressure conditions specified by ISO 13256-1:1998 for a given ducted heat pump without an internal fan may not be achievable simultaneously. For example, the manufacturer-specified airflow may not be achievable below the maximum internal pressure drop specified in section 4.1.5.3 of ISO 13256-1:1998. ISO 13256-1:1998 does not provide an approach for simultaneously achieving the specified airflow rate and pressure conditions for such a case.
ISO 13256-1:1998 uses a fan efficiency value of 0.3 × 10
DOE notes that all of the issues considered in this section address potential changes to the test procedure for WSHPs that could be reflected in the cooling and/or heating efficiency metrics (
DOE's test procedure for WSHPs does not include part-load conditions nor a seasonal metric that includes part-load performance. A seasonal metric is a weighted average of the performance of cooling or heating systems at different rating points intended to represent average efficiency over a full cooling or heating season. Several categories of commercial package air conditioning and heating equipment are rated using a seasonal metric, such as the IEER for air cooled commercial unitary air conditioners as discussed in section 6.2 of AHRI Standard 340/360-2015, “2015 Standard for Performance Rating of Commercial and Industrial Unitary Air-Conditioning and Heat Pump Equipment,” (“AHRI 340/360-2015”). IEER is a weighted average of efficiency at the four load levels representing 100, 75, 50, and 25 percent of full-load capacity, each measured at an outdoor air condition representative of field operation at the given load level.
At this time, ISO 13256-1:1998 is still the most current industry standard relevant to water-source heat pumps. In 2012, AHRI and ASHRAE reaffirmed ISO 13256-1:1998, and published a version denoted as ISO 13256-1:1998 (RA 2012). DOE tentatively determined that there are no changes to ISO 13256-1:1998 in the reaffirmed 2012 version. ISO 13256-1:1998 is also referenced in ASHRAE Standard 90.1 as the test procedure for testing and rating WSHPs. ASHRAE Standard 90.1 was updated on October 26, 2016, and this update references the reaffirmed version of ISO 13256-1:1998 that DOE tentatively determined contains no changes from the version of ISO 13256-1:1998 referenced in the previous version of ASHRAE Standard 90.1. Because neither of these actions by the relevant industry standard-setting bodies contained substantive changes to the industry standards already incorporated by reference, DOE has tentatively concluded that the statutory trigger
The test method used in ISO 13256-1:1998 is similar to the American National Standards Institute (ANSI)/ASHRAE 37-2009, “Methods of Testing for Rating Electrically Driven Unitary Air-Conditioning and Heat Pump Equipment” (ANSI/ASHRAE 37-2009). ANSI/ASHRAE 37-2009 is the method referenced by the 2007 and 2015 versions of AHRI 340/360, “Standard for Performance Rating of Commercial and Industrial Unitary Air-Conditioning and Heat Pump Equipment” (AHRI 340/360). The 2015 version of AHRI 340/360 is referenced by ASHRAE Standard 90.1 for testing water-cooled commercial unitary air conditioners (WCUACs). DOE is considering whether using the same method of test for WSHPs and WCUACs is appropriate, given the similarities in the design of WSHPs and WCUACs.
ISO 13256-1:1998 determines total cooling and heating capacities by averaging the results obtained using two test methods: The liquid enthalpy test method for the liquid side tests and the indoor air enthalpy test method for the air side tests. For non-ducted equipment, ISO 13256-1:1998 includes an option for conducting the air-side tests using the calorimeter room test method instead of the air enthalpy test method. The test standard also specifies that, for a test to be valid, the results obtained by the two methods used must agree within 5 percent. ANSI/ASHRAE 37-2009 requires two capacity measurements as well (
DOE has identified split-system WSHPs available on the market. For at least one of these split-system WSHP, the unit containing the compressor is intended for either indoor or outdoor installation. Where the compressor is installed in relation to the conditioned space and other system components impacts the capacity of the WSHP system and the provisions necessary for accurately measuring system capacity. DOE is considering whether the test procedure needs to provide additional specifications for split systems in order to properly account for compressor heat during testing of such WSHPs.
ISO 13256-1:1998 requires use of two methods to measure space-conditioning capacity provided by a WSHP. One of these methods, the indoor air enthalpy method (see normative annex B of ISO 13256-1:1998), measures capacity directly by measuring mass flow and enthalpy change of the indoor air.
For testing of single-package WSHPs, ISO 13256-1:1998 provides specific instructions to ensure that all energy flows (including heat transfer) are accounted for appropriately. Specifically, section F7.5 of ISO 13256-1:1998 indicates that an enclosure as shown in Figure F-3 should be used when the compressor is in the indoor section and separately ventilated (
As discussed previously, for split-system WSHPs with the compressor in the liquid coil section, some of the compressor heat may be transferred to the ambient air surrounding the compressor/coil section and, therefore, may not be captured in the space-conditioning measurement. Under ISO 13256-1:1998, if a separate compressor/liquid coil section is placed in the indoor room (as shown in Figure F-1 of ISO 13256-1:1998), the compressor heat would not be captured by the indoor air enthalpy method, even though it does add heat to the indoor room. For a split-system WSHP for which the compressor/liquid coil section is always installed indoors, this issue might be remedied by using an arrangement similar to Figure F-3 and installing both the compressor/liquid coil section and the indoor air section (
In contrast, for a split-system WSHP for which the compressor/liquid coil section is always installed outdoors, the air that absorbs compressor heat would not directly affect the conditioned space. For such a case, the arrangement of Figure F-1 of the test standard and avoiding adjustments that assume that the compressor heat that is absorbed by outdoor air is combined with supply air would be appropriate. However, for such a case, ambient temperature conditions surrounding the outdoor section in field installations would likely be warmer than the indoor conditions specified in ISO 13256-1:1998 (or cooler than indoor conditions when operating in heating mode), which might affect system performance in a different way. In addition, adding or subtracting the entire compressor input power to or from the capacity calculated based on liquid temperature change likely overestimates the impact of compressor power input on the indoor-side capacity that is calculated using the liquid enthalpy-based method. ANSI/ASHRAE 37-2009 also includes a capacity measurement method for systems with outdoor coils that reject or absorb heat from a flowing liquid. However, this “outdoor liquid coil method” may not be used if the compressor is cooled (ventilated) by outdoor air (see ANSI/ASHRAE 37-2009, table 1 and section 7.6.1.2). This restriction applies because determination of cooling or heating capacity for a system with outdoor-air cooling of the compressor requires accounting for the compressor heat transferred to the outdoor air, the measurement of which is not specified in the outdoor liquid coil method. In contrast, ISO 13256-1:1998 does not include any restrictions on use of the liquid enthalpy test method—in fact, it is required for testing all WSHPs. The approach may have to be modified to be suitable for split-system WSHPs for which the compressor is housed in a section located outdoors.
Split-system WSHPs have refrigerant lines that can transfer heat to and from their surroundings, which can incrementally affect measured capacity. ISO 13256-1:1998 indicates, for both the indoor air enthalpy test method (annex B) and the liquid enthalpy test method (annex C), in sections B4.2 and C3.3 of the industry standard, that if line loss corrections are to be made, they shall be included in the capacity calculations. DOE believes that these procedures may benefit from additional specificity, specifically regarding what circumstances require line loss corrections and what method to use to determine an appropriate correction.
DOE notes that sections 7.3.3.4 and 7.3.4.4 of ANSI/ASHRAE 37-2009 prescribe methods for calculating and including line losses for both heating and cooling capacity calculations in the outdoor air enthalpy method, in order to obtain an energy balance with results from the indoor air enthalpy method; these procedures and calculations are for air-cooled split systems in which the “outdoor unit” is generally located outdoors. In contrast, the “outdoor unit” for a split-system WSHP (
For the liquid enthalpy test method in annex C of ISO 13256-1:1998, the variables used to calculate the heating and cooling capacity include liquid mass flow rate, specific heat capacity of the liquid, liquid temperatures entering and leaving the unit, and total unit power. The test standard requires the use of water as the liquid medium when testing water-loop heat pumps; however, no value or method for calculating the specific heat capacity of water is provided. Specification of a standard value or calculation method for the specific heat capacity of water may improve the repeatability of the WSHP test procedure.
ISO 13256-1:1998 section D.1 requires airflow measurements to be made in accordance with the provisions specified in several different industry test standards, “as appropriate.”
Some of the airflow measurement approaches specified in ISO 13256-1:1998 use a nozzle apparatus. Airflow can be derived from measuring the change in pressure across a nozzle of known geometry. Airflow derivations using this approach often include a discharge coefficient (
ISO 13256-1:1998 section F8.9 uses a second lookup table that specifies the temperature factor, used to calculate the Reynolds number, based on eight different air temperatures. For measured air temperature and calculated Reynolds numbers, ISO 13256-1:1998 does not specify what approach should be applied to determine the coefficient of discharge for air temperatures and Reynolds numbers that fall between the values specified in the look-up tables.
In the calculations for cooling and heating capacities for the indoor air enthalpy test method of ISO 13256-1: 1998, the test standard includes a footnote in sections B3 and B4 of annex B stating that the equations do not provide allowances for heat leakage in the test equipment (
Section 4.1.6 of ISO 13256-1:1998 indicates that WSHPs shall be tested using the water flow rate specified by the manufacturer, with a few exceptions depending on whether the WSHP includes an integral pump and whether the flow rate is automatically adjusted. DOE has reviewed publicly-available WSHP product literature and notes that manufacturers often list multiple water flow rates in performance data.
In contrast, the test method for WCUACs (AHRI 340/360-2007) specifies both the water inlet and outlet temperatures to be 85 °F and 95 °F, respectively, which determines the water flow rate setting. ISO 13256-1:1998 does not include water outlet temperature rating conditions for WSHPs, so the water flow rate cannot be set by adjusting to match the prescribed test conditions.
Indoor air temperature and humidity are key parameters that affect WSHP performance, and for this reason, ISO 13256-1:1998 requires accurate indoor air condition measurements. However, DOE has tentatively determined that the method set forth in ISO 13256-1:1998 would benefit from additional specification as to indoor air temperature measurement. For air-cooled and evaporatively-cooled commercial unitary air conditioners, Appendix C of AHRI 340/360-2015 provides details on entering outdoor air temperature measurement, including air sampling tree and aspirating psychrometer requirements, but AHRI 340/360-2015 does not state that these provisions apply for measurement of entering indoor air temperature and leaving indoor air temperature. DOE is considering whether the requirements contained in Appendix C of AHRI 340/360-2015 (excluding the temperature uniformity requirements in Table C2) would be appropriate for indoor air measurements for testing WSHPs.
ISO 13256-1:1998 does not provide any specific guidance on setting and verifying the refrigerant charge of a unit. In a test procedure final rule for central air conditioners (CACs) and heat pumps (HPs) published on June 8, 2016 (“June 2016 CAC TP final rule”), DOE established a comprehensive approach for refrigerant charging that improves test reproducibility. 81 FR 36992, 37030-37031. The approach specifies which set of installation instructions to use for charging, explains what to do if there are no instructions, specifies that target values of parameters are the centers of the ranges allowed by installation instructions, and specifies tolerances for the measured values.
ISO 13256-1:1998 requires that for units rated with dual nameplate voltages, the test be performed at both voltages or at the lower voltage if only a single rating is to be published. DOE understands that voltage can affect the measured efficiency of air conditioners and is, therefore, considering adding provisions to its test procedure that specify at which nameplate voltage to conduct the test for dual nameplate voltage units.
In addition to the issues identified earlier in this document, DOE welcomes comment on any other aspect of the existing test procedures for WSHPs not already addressed by the specific areas identified in this document. DOE particularly seeks information that would improve the repeatability, reproducibility of the test procedures, as well as the ability of the test procedure to provide results that are representative of actual use. DOE also requests information that would help DOE create a procedure that would limit manufacturer test burden through streamlining or simplifying testing requirements. Comments regarding the repeatability and reproducibility are also welcome.
DOE also requests feedback on any potential amendments to the existing test procedure that could be considered to address impacts on manufacturers, including small businesses. Regarding the DOE test method, DOE seeks comment on the degree to which the DOE test procedure should consider and be harmonized with the most recent relevant industry standards for WSHPs, and whether there are any changes to the DOE test method that would provide additional benefits to the public. DOE also requests comment on the benefits and burdens of adopting any industry/voluntary consensus-based or other appropriate test procedure, without modification. As discussed, the current DOE test procedure relies on ISO 13256-1:1998, with some additional provisions specified for equipment set-up. 10 CFR 431.96(e).
Additionally, DOE requests comment on whether the existing test procedures limit a manufacturer's ability to provide additional features to consumers of WSHPs. DOE particularly seeks information on how the test procedures could be amended to reduce the cost of new or additional features and make it more likely that such features are included on WSHPs.
DOE invites all interested parties to submit in writing by July 23, 2018, comments and information on matters addressed in this notice and on other matters relevant to DOE's consideration of amended test procedures for WSHPs. These comments and information will aid in the development of a test procedure NOPR for WSHPs if DOE determines that amended test procedures may be appropriate for this equipment.
Submitting comments via
However, your contact information will be publicly viewable if you include it in the comment or in any documents attached to your comment. Any information that you do not want to be publicly viewable should not be included in your comment, nor in any document attached to your comment. Persons viewing comments will see only first and last names, organization names, correspondence containing comments, and any documents submitted with the comments.
Do not submit to
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Submitting comments via email, hand delivery, or mail. Comments and documents submitted via email, hand delivery, or mail also will be posted to
Include contact information each time you submit comments, data, documents, and other information to DOE. If you submit via mail or hand delivery, please provide all items on a CD, if feasible. It is not necessary to submit printed copies. No facsimiles (faxes) will be accepted.
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Campaign form letters. Please submit campaign form letters by the originating organization in batches of between 50 to 500 form letters per PDF or as one form letter with a list of supporters' names compiled into one or more PDFs. This reduces comment processing and posting time.
Confidential Business Information. According to 10 CFR 1004.11, any person submitting information that he or she believes to be confidential and exempt by law from public disclosure should submit via email, postal mail, or hand delivery two well-marked copies: One copy of the document marked confidential including all the information believed to be confidential, and one copy of the document marked “non-confidential” with the information believed to be confidential deleted. Submit these documents via email or on a CD, if feasible. DOE will make its own determination about the confidential status of the information and treat it according to its determination.
Factors of interest to DOE when evaluating requests to treat submitted information as confidential include (1) a description of the items, (2) whether and why such items are customarily treated as confidential within the industry, (3) whether the information is generally known by or available from other sources, (4) whether the information has previously been made available to others without obligation concerning its confidentiality, (5) an explanation of the competitive injury to the submitting person which would result from public disclosure, (6) when such information might lose its confidential character due to the passage of time, and (7) why disclosure of the information would be contrary to the public interest.
It is DOE's policy that all comments may be included in the public docket, without change and as received, including any personal information provided in the comments (except information deemed to be exempt from public disclosure).
DOE considers public participation to be a very important part of the process for developing test procedures and energy conservation standards. DOE actively encourages the participation and interaction of the public during the comment period in each stage of a rulemaking process. Interactions with and between members of the public provide a balanced discussion of the issues and assist DOE in a rulemaking process. Anyone who wishes to be added to the DOE mailing list to receive future notices and information about this proceeding should contact Appliance and Equipment Standards Program staff at (202) 287-1445 or via email at
Federal Election Commission.
Notice of proposed rulemaking; public hearing.
The Federal Election Commission is adding a second day to the already-announced public hearing on the proposed rules for disclaimers on public communications on the internet.
The public hearing will be held on June 27-28, 2018, and will begin at 9:30 a.m. on June 27, continuing the next day.
The hearing will be held in the Commission's 12th floor hearing room at 1050 First St. NE, Washington, DC.
Mr. Neven F. Stipanovic, Acting Assistant General Counsel, or Ms. Jessica Selinkoff, Attorney, (202) 694-1650 or (800) 424-9530.
On March 26, 2018, the Commission published a Notice of Proposed Rulemaking (“NPRM”) proposing to revise its regulations at 11 CFR 100.26 and 110.11 regarding disclaimers on communications placed for a fee on the internet that contain express advocacy, solicit contributions, or are made by political committees. Internet Communication Disclaimers and Definition of “Public Communication,” 83 FR 12864 (Mar. 26, 2018). In the NPRM, the Commission announced that it would hold a hearing on June 27, 2018, and that anyone wishing to testify at the hearing must file timely written comments including a request to testify.
Accordingly, the Commission is extending the hearing to a second day: June 28, 2018. Witnesses will be limited to those persons who included a request to testify in their timely comments on the NPRM.
Individuals who plan to attend and require special assistance, such as sign language interpretation or other reasonable accommodations, should contact Dayna Brown, Commission Secretary, at (202) 694-1040 at least 72 hours prior to the date of attendance. Individuals who cannot attend in person may view the hearing via webcast; on the hearing day, visit
On behalf of the Commission,
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to adopt a new airworthiness directive (AD) for all Dassault Aviation Model MYSTERE-FALCON 200 airplanes. This proposed AD was prompted by a determination that more restrictive maintenance requirements and airworthiness limitations are necessary. This proposed AD would require revising the maintenance or inspection program, as applicable, to incorporate new or more restrictive maintenance requirements and airworthiness limitations. We are proposing this AD to address the unsafe condition on these products.
We must receive comments on this proposed AD by August 6, 2018.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
For service information identified in this NPRM, contact Dassault Falcon Jet Corporation, Teterboro Airport, P.O. Box 2000, South Hackensack, NJ 07606; telephone 201-440-6700; internet
You may examine the AD docket on the internet at
Tom Rodriguez, Aerospace Engineer, International Section, Transport Standards Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone and fax 206-231-3226.
We invite you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under the
We will post all comments we receive, without change, to
The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2018-0009, dated January 15, 2018 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for all Dassault Aviation Model MYSTERE-FALCON 200 airplanes. The MCAI states:
The airworthiness limitations for Dassault Mystère Falcon 200 aeroplanes, which are approved by EASA, are currently defined and published in AMM [aircraft maintenance manual] ALS [airworthiness limitations section] Chapter 5-40. These instructions have been identified as mandatory for continued airworthiness.
Failure to accomplish these instructions could result in an unsafe condition.
EASA previously issued AD 2008-0221 (later corrected), requiring the actions described in Dassault Mystère Falcon 200 AMM Chapter 5-40 (DMD 18740A) at Revision 14. Since that [EASA] AD was issued, Dassault published the ALS, containing new and/or more restrictive maintenance tasks.
For the reason described above, this [EASA] AD takes over the requirements for Mystère Falcon 200 aeroplanes from EASA AD 2008-0221 and requires accomplishment of the actions specified in the ALS.
You may examine the MCAI in the AD docket on the internet at
Dassault Aviation has issued Falcon 200 Maintenance Manual, Airworthiness Limitations, Chapter 5-40-00, Revision 17, dated December 20, 2017. The service information describes mandatory maintenance tasks that operators must perform at specified intervals. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all pertinent information and determined an unsafe condition exists and is likely to exist or develop on other products of the same type design.
This AD requires revisions to certain operator maintenance documents to include new actions (
The MCAI specifies that if there are findings from the airworthiness limitations section (ALS) inspection tasks, corrective actions must be accomplished in accordance with Dassault maintenance documentation. However, this proposed AD does not include that requirement. Operators of U.S.-registered airplanes are required by general airworthiness and operational regulations to perform maintenance using methods that are acceptable to the FAA. We consider those methods to be adequate to address any corrective actions necessitated by the findings of ALS inspections required by this proposed AD.
We estimate that this proposed AD affects 9 airplanes of U.S. registry. We estimate the following costs to comply with this proposed AD:
We have determined that revising the maintenance or inspection program takes an average of 90 work-hours per operator, although we recognize that this number may vary from operator to operator. In the past, we have estimated that this action takes 1 work-hour per airplane. Since operators incorporate maintenance or inspection program changes for their affected fleet(s), we have determined that a per-operator estimate is more accurate than a per-
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
This proposed AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to transport category airplanes to the Director of the System Oversight Division.
We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have 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.
For the reasons discussed above, I certify this proposed regulation:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);
3. Will not affect intrastate aviation in Alaska; and
4. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
We must receive comments by August 6, 2018.
None.
This AD applies to all Dassault Aviation Model MYSTERE-FALCON 200 airplanes, certificated in any category.
Air Transport Association (ATA) of America Code 05, Time Limits/Maintenance Checks.
This AD was prompted by a determination that more restrictive maintenance requirements and airworthiness limitations are necessary. We are issuing this AD to address fatigue cracking, damage, and corrosion in principal structural elements; such fatigue cracking, damage, and corrosion could result in reduced structural integrity of the airplane.
Comply with this AD within the compliance times specified, unless already done.
Within 90 days after the effective date of this AD, revise the maintenance or inspection program, as applicable, to incorporate Falcon 200 Maintenance Manual, Airworthiness Limitations, Chapter 5-40-00, Revision 17, dated December 20, 2017. The initial compliance time for accomplishing the actions is at the applicable time specified in Falcon 200 Maintenance Manual, Airworthiness Limitations, Chapter 5-40-00, Revision 17, dated December 20, 2017; or within 90 days after the effective date of this AD; whichever occurs later.
After the maintenance or inspection program has been revised as required by paragraph (g) of this AD, no alternative actions (
The following provisions also apply to this AD:
(1)
(2)
(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA AD 2018-0009, dated January 15, 2018, for related information. This MCAI may be found in the AD docket on the internet at
(2) For more information about this AD, contact Tom Rodriguez, Aerospace Engineer, International Section, Transport Standards Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone and fax 206-231-3226.
(3) For service information identified in this AD, contact Dassault Falcon Jet Corporation, Teterboro Airport, P.O. Box 2000, South Hackensack, NJ 07606; telephone 201-440-6700; internet
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to adopt a new airworthiness directive (AD) for certain Bombardier, Inc., Model DHC-8-400 series airplanes. This proposed AD was prompted by a report of broken P-clamps on the pressure relief line and the motive flow line in the left and right fuel tanks, and fouling conditions between the motive flow line and the collector tank partition wall in both fuel tanks. This proposed AD would require, depending on airplane configuration: Increasing the hole size in the collector tank partition wall, inspecting the motive flow line for damage, and replacing the associated grommet and motive flow line; replacing the affected single nut plate brackets and standoffs at the affected stations on the motive flow line and pressure relief line; and inspecting the motive flow line and vent line at certain wing stations, and inspecting the fuel tubes, to verify that an appropriate clearance has been maintained between the fuel tubes and their support brackets, and applicable corrective actions. We are proposing this AD to address the unsafe condition on these products.
We must receive comments on this proposed AD by August 6, 2018.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
For service information identified in this NPRM, contact Bombardier, Inc., Q-Series Technical Help Desk, 123 Garratt Boulevard, Toronto, Ontario M3K 1Y5, Canada; telephone 416-375-4000; fax 416-375-4539; email
You may examine the AD docket on the internet at
Joseph Catanzaro, Aerospace Engineer, Propulsion Section, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-7300; fax 516-794-5531.
We invite you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under the
We will post all comments we receive, without change, to
Transport Canada Civil Aviation (TCCA), which is the aviation authority for Canada, has issued Canadian AD CF-2017-05R1, dated September 20, 2017 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Bombardier, Inc., Model DHC-8-400 series airplanes. The MCAI states:
Some operators have reported broken P-clamps on the pressure relief line and the motive flow line in the left and right fuel tanks. Fouling conditions were also reported to exist between the motive flow line and the collector tank partition wall in both fuel tanks. These issues affect the integrity of the electrical bonding paths throughout the fuel lines, which in turn may lead to lightning strike induced fuel tank ignition.
The initial issue of this [Canadian] AD mandated design changes that mitigate the risk of lightning strike induced fuel tank ignition.
Since the initial issue of this [Canadian] AD, Transport Canada has become aware that Bombardier (BA) Service Bulletin (SB) 84-28-19 Revision A, dated 4 November 2016, and the initial issue of BA SB 84-28-19, dated 16 August 2016, do not instruct operators to support the motive flow line and vent line at wing stations −371.019 and 371.019 in the left-hand and right-hand fuel tanks, respectively, and do not instruct operators to maintain appropriate clearance between the fuel tubes and their support brackets at wing stations −371.019 and −209.019 in the left-hand fuel tank and wing stations 371.019 and 209.019 in the right-hand fuel tank. Revision 1 of this [Canadian] AD introduces Part III, which requires operators to inspect and correct the fuel tube installation on affected aeroplanes, as required, to maintain fuel tube support and clearance between the fuel tubes and their support brackets. Revision 1 of this [Canadian] AD also updates SB references.
Required actions include, depending on airplane configuration, increasing the hole size in the collector tank partition wall, inspecting the motive flow line for damage, and replacing the associated grommet and motive flow line; replacing the affected single nut plate brackets and standoffs at the affected stations on the motive flow line and pressure relief line; and inspecting the motive flow line and vent line at certain wing stations, and inspecting the fuel tubes, to verify that an appropriate clearance has been maintained between the fuel tubes and their support brackets, and applicable corrective actions. Corrective actions include reworking the replaced parts. You may examine the MCAI in the AD docket on the internet at
Bombardier has issued Service Bulletin 84-28-18, Revision B, dated April 20, 2017. This service information describes procedures to increase the hole size in the collector tank partition wall, inspect the motive flow line for damage, and replace the associated grommet and motive flow line.
Bombardier has also issued Service Bulletin 84-28-19, Revision C, dated September 1, 2017. This service information describes procedures to replace the affected single nut plate brackets and standoffs at the affected stations on the motive flow line and pressure relief line, inspect the motive flow line and vent line at certain wing stations, and inspect the fuel tubes to verify that an appropriate clearance has been maintained between the fuel tubes and their support brackets, and applicable corrective actions.
The service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all pertinent information and determined an unsafe condition exists and is likely to exist or develop on other products of the same type design.
We estimate that this proposed AD affects 52 airplanes of U.S. registry.
We estimate the following costs to comply with this proposed AD:
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
This proposed AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to transport category airplanes to the Director of the System Oversight Division.
We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have 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.
For the reasons discussed above, I certify this proposed regulation:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);
3. Will not affect intrastate aviation in Alaska; and
4. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
We must receive comments by August 6, 2018.
None.
This AD applies to Bombardier, Inc., Model DHC-8-400, -401, and -402 airplanes, certificated in any category, having serial numbers 4001, and 4003 through 4533 inclusive.
Air Transport Association (ATA) of America Code 28, Fuel.
This AD was prompted by a report of broken P-clamps on the pressure relief line and the motive flow line in the left and right fuel tanks, and fouling conditions between the motive flow line and the collector tank partition wall in both fuel tanks. We are issuing this AD to address fouling or chafing conditions that affect the integrity of the electrical bonding paths throughout the fuel lines, which could lead to lightning strike induced fuel tank ignition.
Comply with this AD within the compliance times specified, unless already done.
For airplanes having serial numbers (S/Ns) 4001, and 4003 through 4525 inclusive: Within 6,000 flight hours or 36 months, whichever occurs first, from the effective date of this AD, increase the hole size in the collector tank partition wall, do a detailed inspection of the motive flow line for damage, including chafing, and replace the associated grommet and motive flow line, as applicable, before further flight in accordance with the Accomplishment Instructions of Bombardier Service Bulletin 84-28-18, Revision B, dated April 20, 2017.
For airplanes, having S/Ns 4001, and 4003 through 4533 inclusive, on which Bombardier Service Bulletin 84-28-19, dated August 16, 2016; or Bombardier Service Bulletin 84-28-19, Revision A, dated November 4, 2016; has not been incorporated: Within 6,000 flight hours or 36 months, whichever occurs first, from the effective date of this AD, replace the affected single nut plate brackets and standoffs at the affected left and right wing stations on the motive flow line and pressure relief line, in accordance with the Accomplishment Instructions of Bombardier Service Bulletin 84-28-19, Revision C, dated September 1, 2017. Where Bombardier Service Bulletin 84-28-19, Revision C, dated September 1, 2017, specifies to contact Bombardier for appropriate action: Before further flight, accomplish corrective actions in accordance with the procedures specified in paragraph (k)(2) of this AD.
For airplanes, having S/Ns 4001, and 4003 through 4533 inclusive, on which Bombardier Service Bulletin 84-28-19, dated August 16, 2016; or Bombardier Service Bulletin 84-28-19, Revision A, dated November 4, 2016; have been incorporated: Within 6,000 flight hours or 36 months, whichever occurs first, from the effective date of this AD, inspect the motive flow line and vent line at wing stations −371.019 and 371.019 in the left-hand and right-hand fuel tanks, respectively, to ensure that these fuel tubes are adequately supported, inspect the fuel tubes to verify that an appropriate clearance has been maintained between the fuel tubes and their support brackets, and before further flight do all applicable corrective actions, in accordance with Section 3.A., Section 3.B.(13), and Section 3.C. of Bombardier Service Bulletin 84-28-19, Revision C, dated September 1, 2017. Where Bombardier Service Bulletin 84-28-19, Revision C, dated September 1, 2017, specifies to contact Bombardier for appropriate action: Before further flight, accomplish corrective actions in accordance with the procedures specified in paragraph (k)(2) of this AD.
(1) This paragraph provides credit for actions required by paragraph (g) of this AD, if those actions were performed before the effective date of this AD using Bombardier Service Bulletin 84-28-18, dated April 20, 2016; or Bombardier Service Bulletin 84-28-18, Revision A, dated November 14, 2016.
(2) This paragraph provides credit for actions required by paragraph (h) of this AD, if those actions were performed before the effective date of this AD using Bombardier Service Bulletin 84-28-19 Revision B, dated July 28, 2017.
(3) This paragraph provides credit for actions required by paragraph (i) of this AD, if those actions were performed before the effective date of this AD using Section 3.A., Section 3.B.(13), and Section 3.C. of Bombardier Service Bulletin 84-28-19, Revision B, dated July 28, 2017.
The following provisions also apply to this AD:
(1)
(2)
(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) Canadian AD CF-2017-05R1, dated September 20, 2017, for related information. This MCAI may be found in the AD docket on the internet at
(2) For more information about this AD, contact Joseph Catanzaro, Aerospace Engineer, Propulsion Section, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-7300; fax 516-794-5531.
(3) For service information identified in this AD, contact Bombardier, Inc., Q-Series Technical Help Desk, 123 Garratt Boulevard, Toronto, Ontario M3K 1Y5, Canada; telephone 416-375-4000; fax 416-375-4539; email
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to adopt a new airworthiness directive (AD) for certain Bombardier, Inc., Model CL-600-2B16 (CL-604 Variants) airplanes. This proposed AD was prompted by reports of floodlight lamps found burned and the corresponding circuit breaker tripped as a result of fluid entering the cockpit floodlight fixtures. This proposed AD would require installation of a new gasket seal on floodlight fixtures. We are proposing this AD to address the unsafe condition on these products.
We must receive comments on this proposed AD by August 6, 2018.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
For service information identified in this NPRM, contact Bombardier, Inc.,
You may examine the AD docket on the internet at
Assata Dessaline, Aerospace Engineer, Avionics and Administrative Services Section, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-7301; fax 516-794-5531; email
We invite you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under the
We will post all comments we receive, without change, to
Transport Canada Civil Aviation (TCCA), which is the aviation authority for Canada, has issued Canadian AD CF-2016-40, dated December 15, 2016; and Canadian AD CF-2018-06, dated February 19, 2018; to correct an unsafe condition for certain Bombardier, Inc., Model CL-600-2B16 (CL-604 Variants) airplanes. Canadian AD CF-2016-40 and Canadian AD CF-2018-06 are referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI.”
Canadian AD CF-2016-40 states:
Several operators have reported a burning odor and smoke emanating from the cockpit floodlights. Bombardier Aerospace (BA) has determined the cause to be fluid entering into the cockpit floodlight fixtures causing short circuits and damage to electrical components. If not corrected, this condition may result in a fire in the cockpit.
This [Canadian] AD is issued to mandate the installation of a new gasket seal on the floodlight fixture.
Canadian AD CF-2018-06 states:
[Canadian] AD CF-2016-40, applicable to Bombardier Inc. model CL-600-2B16 (604 [CL-604 Variants serial numbers 5301 through 5665 inclusive] and 605 [CL-604 Variants serial numbers 5701 through 5988 inclusive] variants) aeroplanes, was issued to address the potential of water penetrating into cockpit floodlight fixtures. A similar condition exists on the CL-600-2B16 (650 variant [CL-604 Variants serial numbers 6050 through 6070 inclusive]) aeroplanes. This condition can cause short circuits and damage to electrical components, which may result in a fire in the cockpit.
This [Canadian] AD mandates the installation of gasket seals on the pilot and co-pilot floodlight fixtures to prevent fluid from entering them.
You may examine the MCAI in the AD docket on the internet at
Bombardier has issued the following service information:
• Bombardier Service Bulletin 604-33-007, Revision 02, dated October 2, 2017.
• Bombardier Service Bulletin 605-33-005, Revision 02, dated October 2, 2017.
• Bombardier Service Bulletin 650-33-001, Revision 03, dated October 2, 2017.
The service information describes procedures to install a new gasket seal on floodlight fixtures. These documents are distinct since they apply to different configurations of the same airplane model. The service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all pertinent information and determined an unsafe condition exists and is likely to exist or develop on other products of these same type design.
We estimate that this proposed AD affects 123 airplanes of U.S. registry. We estimate the following costs to comply with this proposed AD:
According to the manufacturer, some or all of the costs of this proposed AD may be covered under warranty, thereby reducing the cost impact on affected individuals. We do not control warranty coverage for affected individuals. As a result, we have included all known costs in our cost estimate.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in Subtitle VII,
This proposed AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to transport category airplanes to the Director of the System Oversight Division.
We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have 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.
For the reasons discussed above, I certify this proposed regulation:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);
3. Will not affect intrastate aviation in Alaska; and
4. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
We must receive comments by August 6, 2018.
None.
This AD applies to certain Bombardier, Inc., Model CL-600-2B16 (CL-604 Variants) airplanes, certificated in any category, serial numbers 5301 through 5665 inclusive, 5701 through 5988 inclusive, and 6050 through 6070 inclusive.
Air Transport Association (ATA) of America Code 33, Lights.
This AD was prompted by reports of floodlight lamps found burned and the corresponding circuit breaker tripped as a result of fluid entering the cockpit floodlight fixtures. We are issuing this AD to prevent fluid from entering the cockpit floodlight fixtures, which could cause short circuits and damage to electrical components, which may result in a fire in the cockpit.
Comply with this AD within the compliance times specified, unless already done.
(1) For airplanes identified in Bombardier Service Bulletin 604-33-007, Revision 02, dated October 2, 2017: Within 38 months after the effective date of this AD, install new gasket seals in accordance with the Accomplishment Instructions of Bombardier Service Bulletin 604-33-007, Revision 02, dated October 2, 2017.
(2) For airplanes identified in Bombardier Service Bulletin 605-33-005, Revision 02, dated October 2, 2017: Within 38 months after the effective date of this AD, install new gasket seals in accordance with the Accomplishment Instructions of Bombardier Service Bulletin 605-33-005, Revision 02, dated October 2, 2017.
(3) For airplanes identified in Bombardier Service Bulletin 650-33-001, Revision 03, dated October 2, 2017: Within 38 months after the effective date of this AD, install new gasket seals in accordance with the Accomplishment Instructions of Bombardier Service Bulletin 650-33-001, Revision 03, dated October 2, 2017.
(1) This paragraph provides credit for actions required by (g)(1), if those actions were performed before the effective date using Bombardier Service Bulletin 604-33-007, dated September 29, 2015; or Bombardier Service Bulletin 604-33-007, Revision 01, dated November 30, 2015.
(2) This paragraph provides credit for actions required by (g)(2), if those actions were performed before the effective date using Bombardier Service Bulletin 605-33-005, dated September 29, 2015; or Bombardier Service Bulletin 605-33-005, Revision 01, dated November 30, 2015.
(3) This paragraph provides credit for actions required by (g)(3), if those actions were performed before the effective date using the service information specified in paragraphs (h)(3)(i), (h)(3)(ii), or (h)(3)(iii) of this AD.
(i) Bombardier Service Bulletin 650-33-001, dated October 1, 2015.
(ii) Bombardier Service Bulletin 650-33-001, Revision 01, dated November 30, 2015.
(iii) Bombardier Service Bulletin 650-33-001, Revision 02, dated March 11, 2016.
The following provisions also apply to this AD:
(1)
(2)
(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) Canadian AD CF-2016-40, dated December 15, 2016; and Canadian AD CF-2018-06, dated February 19, 2018, for related information. This MCAI may be found in the AD docket on the internet at
(2) For more information about this AD, contact Assata Dessaline, Aerospace Engineer, Avionics and Administrative Services Section, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-7301; fax 516-794-5531; email
(3) For service information identified in this AD, contact Bombardier, Inc., 400 Côte-
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
This action proposes to establish Class E airspace extending upward from 700 feet above the surface at Chebeague Island Heliport, Chebeague Island, ME, to accommodate new area navigation (RNAV) global positioning system (GPS) standard instrument approach procedures serving the heliport. Controlled airspace is necessary for the safety and management of instrument flight rules (IFR) operations at this heliport.
Comments must be received on or before August 6, 2018.
Send comments on this rule to: U.S. Department of Transportation, Docket Operations, 1200 New Jersey Avenue SE, West Bldg. Ground Floor Rm. W12-140, Washington, DC 20590; telephone: 1-800-647-5527, or (202)-366-9826. You must identify the Docket No. FAA-2018-0475; Airspace Docket No. 18-ANE-4, at the beginning of your comments. You may also submit and review received comments through the internet at
FAA Order 7400.11B, Airspace Designations and Reporting Points, and subsequent amendments can be viewed on line at
FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.
John Fornito, Operations Support Group, Eastern Service Center, Federal Aviation Administration, 1701 Columbia Ave, College Park, GA 30337; telephone (404) 305-6364.
The FAA's authority to issue rules regarding aviation safety is found in title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This proposed rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority, as it would establish Class E airspace extending upward from 700 feet above the surface at Chebeague Island Heliport, Chebeague Island, ME, to support standard instrument approach procedures for IFR operations at this heliport.
Interested persons are invited to comment on this proposed rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers (Docket No. FAA-2018-0475 and Airspace Docket No. 18-ANE-4) and be submitted in triplicate to DOT Docket Operations (see
Persons wishing the FAA to acknowledge receipt of their comments on this action must submit with those comments a self-addressed stamped postcard on which the following statement is made: “Comments to FAA Docket No. FAA-2018-0475; Airspace Docket No. 18-ANE-4.” The postcard will be date/time stamped and returned to the commenter.
All communications received before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this document may be changed in light of the comments received. All comments submitted will be available for examination in the public docket both before and after the comment closing date. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket. All communications received on or before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this notice may be changed in light of the comments received. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket.
An electronic copy of this document may be downloaded through the internet at
You may review the public docket containing the proposal, any comments received and any final disposition in person in the Dockets Office (see the
This document proposes to amend FAA Order 7400.11B, Airspace Designations and Reporting Points, dated August 3, 2017, and effective September 15, 2017. FAA Order 7400.11B is publicly available as listed in the
The FAA is considering an amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 to establish Class E airspace extending upward from 700 feet above the surface within a 6-mile radius of Chebeague Island Heliport, Chebeague Island, ME, providing the controlled airspace required to support the new Copter RNAV (GPS) standard instrument approach procedures for IFR operations at Chebeague Island Heliport.
Class E airspace designations are published in Paragraph 6005 of FAA Order 7400.11B, dated August 3, 2017, and effective September 15, 2017, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.
The FAA has determined that this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this proposed rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
This proposal would be subject to an environmental analysis in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.
Airspace, Incorporation by reference, Navigation (air).
In consideration of the foregoing, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
That airspace extending upward from 700 feet above the surface within a 6-mile radius of Chebeague Island Heliport.
Federal Aviation Administration (FAA) DOT.
Notice of proposed rulemaking (NPRM); withdrawal.
The FAA is withdrawing the NPRM published in the
Effective as of 0901 UTC, June 22, 2018, the proposed rule published January 5, 2017 (82 FR 1276), is withdrawn.
Paul Gallant, Airspace Policy Group, Office of Airspace Services, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-8783.
The FAA published a NPRM in the
Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal. No comments were received.
The FAA has reviewed project scoping and determined that additional planning is warranted to ensure a more efficient implementation and integration with other ongoing program activities; therefore, the NPRM is withdrawn.
Airspace, Incorporation by reference, Navigation (air).
49 U.S.C. 106(f), 106(g), 40103, 40113, 40120; E.O. 10854; 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
This action proposes to amend Class E airspace extending upward from 700 feet or more above the surface at Bloomsburg, PA, due to the decommissioning of the Milton very high frequency omni-directional range collocated tactical air navigation aid (VORTAC) which requires airspace reconfiguration at Bloomsburg Municipal Airport. Controlled airspace is necessary for the safety and management of instrument flight rules (IFR) operations at the airport. This action also would update the geographic coordinates of the airport.
Comments must be received on or before August 6, 2018.
Send comments on this proposal to: U.S. Department of Transportation, Docket Operations, 1200 New Jersey Avenue SE, West Bldg. Ground Floor Rm. W12-140, Washington, DC 20590; Telephone: (202) 366-9826. You must identify the Docket No. FAA-2017-1043; Airspace Docket No. 17-AEA-18, at the beginning of your comments. You may also submit and review received comments through the internet at
FAA Order 7400.11B, Airspace Designations and Reporting Points, and subsequent amendments can be viewed on line at
FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.
John Fornito, Operations Support Group, Eastern Service Center, Federal Aviation Administration, P.O. Box 20636, Atlanta, Georgia 30320; telephone (404) 305-6364.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would amend Class E airspace at Bloomsburg Municipal Airport, Bloomsburg, PA, to support IFR operations at the airport.
Interested persons are invited to comment on this proposed rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers and be submitted in triplicate to DOT Docket Operations (see
Persons wishing the FAA to acknowledge receipt of their comments on this action must submit with those comments a self-addressed stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2017-1043; Airspace Docket No. 17-AEA-18.” The postcard will be date/time stamped and returned to the commenter.
All communications received before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this notice may be changed in light of the comments received. All comments submitted will be available for examination in the public docket both before and after the comment closing date. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket.
An electronic copy of this document may be downloaded through the internet at
You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office (see the
This document proposes to amend FAA Order 7400.11B, Airspace Designations and Reporting Points, dated August 3, 2017, and effective September 15, 2017. FAA Order 7400.11B is publicly available as listed in the
The FAA is considering an amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 to amend Class E airspace extending upward from 700 feet or more above the surface within a 11.8-mile radius of Bloomsburg Municipal Airport, Bloomsburg, PA. and for continued safety and management of IFR operations at the airport. The geographic coordinates of the airport also would be adjusted to coincide with the FAAs aeronautical database.
Class E airspace designations are published in Paragraph 6005 of FAA Order 7400.11B, dated August 3, 2017, and effective September 15, 2017, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.
The FAA has determined that this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this proposed rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.
Airspace, Incorporation by reference, Navigation (air).
In consideration of the foregoing, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
That airspace extending upward from 700 feet above the surface within an 11.8-mile radius of Bloomsburg Municipal Airport.
Coast Guard, DHS.
Notice of proposed rulemaking.
The Coast Guard proposes delaying the effective date for certain facilities affected by the final rule entitled “Transportation Worker Identification Credential (TWIC)—Reader Requirements,” published in the
Comments and related material must be received by the Coast Guard on or before July 23, 2018.
You may submit comments identified by docket number USCG-2017-0711 using the Federal eRulemaking Portal at
For information about this document, call or email LCDR Yamaris Barril, Coast Guard CG-FAC-2; telephone 202-372-1151, email
The Coast Guard views public participation as essential to effective rulemaking and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.
We encourage you to submit comments through the Federal eRulemaking Portal at
We accept anonymous comments. All comments received will be posted without change to
Pursuant to the Maritime Transportation Security Act of 2002 (MTSA),
On May 22, 2006, the Coast Guard and the Transportation Security Administration (TSA) jointly published a notice of proposed rulemaking (NPRM) entitled “Transportation
Worker Identification Credential (TWIC) Implementation in the Maritime Sector; Hazardous Materials Endorsement for a Commercial Driver's License.”
Although the May 22, 2006, NPRM proposed certain TWIC reader requirements, after reviewing the public comments, the Coast Guard decided not to include the proposed TWIC reader requirements in the 2007 final rule. Instead, the Coast Guard addressed TWIC reader requirements in a separate rulemaking after conducting a pilot program to address the feasibility of reader requirements.
On March 27, 2009, the Coast Guard published an advanced notice of proposed rulemaking (ANPRM) on the topic of TWIC reader requirements.
On August 23, 2016, we published a final rule entitled “Transportation Worker Identification Credential (TWIC)—Reader Requirements”
In this NPRM, we propose to delay the effective date of the TWIC Reader final rule, until August 23, 2021, for two categories of facilities. The rationale for the proposed delay is to consider industry input asking us to reconsider the scope of the TWIC Reader final rule and to re-evaluate the underlying methodology used to determine the facilities subject to the electronic TWIC inspection requirements. For these reasons, and to provide appropriate context necessary to understand the purpose of this NPRM, we have included background information in this NPRM that details: (1) Why the electronic TWIC inspection requirements were originally proposed
The TWIC Reader final rule was promulgated to fulfill the Congressional mandate found in section 104 of the SAFE Port Act.
Inspection of the TWIC, whether electronic or visual, provides a baseline of information to determine who may be provided unescorted access to secure areas of MTSA-regulated vessels and facilities. While not every person who possesses a TWIC is authorized for unescorted access, the TWIC inspection process ensures that facility security personnel do not grant unescorted access to individuals who have not been vetted or who have been adjudicated unfit for unescorted access to secure areas.
Electronic TWIC inspection is the process by which the TWIC is authenticated and validated, and by which the individual presenting the TWIC is matched to the stored biometric template. This process consists of three discrete parts: (1) Authentication, in which the TWIC presented is identified as an authentic credential issued by TSA; (2) validity check, in which the TWIC presented is compared to the TSA-supplied list of cancelled TWICs to ensure that it has not been revoked and is not expired; and (3) identity verification, in which biometric data stored on the TWIC presented is matched to the person presenting it using a fingerprint scan. Electronic TWIC inspection strengthens the inspection of TWIC, as compared to visual TWIC inspection, resulting in increased security at high-risk facilities. While visual TWIC inspection can accomplish the same three goals as electronic inspection (authentication, validation, and identify verification), visual inspection is not as thorough or reliable.
Electronic TWIC inspection improves on visual inspection by adding additional benefits. With electronic inspection, the authenticity of the TWIC is verified by issuing a challenge/response to the unique electronic identifier of the TWIC, called a Card Holder Unique Identifier. The validity of the TWIC is determined by electronically checking the TWIC against a database with the most recently updated list of cancelled TWICs. Finally, the identity of the person presenting the TWIC is verified by matching the biometric template stored on the TWIC with the presenter's biometrics though use of a fingerprint scan. These three aspects of electronic inspection represent improvements over visual inspection because they are not easily counterfeited or altered within the TWIC.
The Coast Guard based its decision about which vessels and facilities to include in Risk Group A on a study entitled “Analysis of Transportation Worker Identification Credential (TWIC) Electronic Reader Requirements in the Maritime Sector,”
To develop the Coast Guard TWIC Report, the Coast Guard assembled a panel of maritime security subject matter experts (SMEs) from the Coast Guard and TSA to conduct a risk-based analysis of MTSA-regulated vessels and facilities. The panel determined that the Analytical Hierarchy Process (AHP) would provide an effective basis for applying the panel's judgment to weigh and apply several key factors to the assessment of types of vessels and facilities.
The Coast Guard's panel of SMEs identified 68 distinct types of vessels and facilities (referred to as “asset categories”) based on their purpose or operational description. The panel then assessed each of the 68 asset categories using three factors: (1) Maximum consequences to the vessel or facility resulting from a terrorist attack; (2) criticality to the health and economy of the Nation, and to national security; and (3) utility of the TWIC in reducing risk. The panel used this methodology to develop the framework discussed in the 2009 ANPRM and proposed in the 2013 TWIC Reader NPRM, in which the Coast Guard required vessels and facilities that had the highest vulnerabilities, and that could derive benefits from TWIC readers, to use electronic inspection procedures. The Coast Guard TWIC Report recognized that, while “security measures are not implemented in a `one size fits all' fashion . . . Coast Guard regulations also need to be prescriptive to ensure appropriate implementation in a uniform manner nationally.”
The HSI Report was designed to determine the validity of the Coast Guard methodology for analyzing the underlying risk to vessels and facilities outlined in the Coast Guard TWIC Report and the effectiveness of the overall TWIC program in mitigating that risk. As stated in the HSI Report, its purpose was to “strengthen the USCG's TWIC reader requirements development efforts by evaluating (1) the validity of the risk assessment methodology, (2) the extent to which the conclusions follow from the analysis, and (3) the overall strengths and limitations of the risk analysis.”
The HSI Report validated the Coast Guard's risk assessment methodology. Specifically, the report's foremost conclusion was that HSI “
While the Coast Guard TWIC Report and the HSI Report ranked the relative risk of facilities based on asset category, the HSI Report did not unequivocally state that asset categorization was the best methodology to use. Indeed, in the executive summary, the report noted that “[t]he 68 asset categories considered in the well-established MSRAM were ranked based on their risk scores. The list is considered comprehensive based upon its widespread use. Nevertheless, we also point out that there might still be
Furthermore, the HSI Report identified several recommendations that could have been used to improve the methodology to develop the Coast Guard's risk analysis. Most fundamentally, the HSI Report suggested that further analysis on risk grouping of asset categories—that is, which categories should be included in Risk Group A—could help to ensure that the results were more defensible. The HSI Report also suggested that the Coast Guard better define TWIC utility and add mechanisms that allow more flexibility in applying TWIC reader requirements. Finally, noting that the electronic TWIC inspection requirements discussed in the Coast Guard TWIC Report (and, in part, ultimately promulgated in the TWIC Reader final rule) were developed based on the 2006 MSRAM data, the HSI Report stated that “there is probably a need to reassess reader requirements using recently updated MSRAM data.
After reviewing the methodology used in the TWIC Reader final rule, we believe that the information the methodology contained was generally
To ensure that the TWIC reader requirement was applied only to those facilities where the readers could enhance security the most, the Coast Guard designated certain facilities as high risk, putting them into Risk Group A. The TWIC Reader final rule requires that facilities in Risk Group A conduct electronic TWIC inspection to identify that a person seeking unescorted access to a secure area has undergone a biometric identification check, a card authentication check, and a card validation check to ensure that the person is authorized to have access. To determine which vessels and facilities should be included in Risk Group A, we relied on MSRAM. MSRAM is a risk-analysis tool used to analyze vulnerabilities and risk-mitigation measures in a wide variety of scenarios.
MSRAM identified three hypothetical scenarios in which a TWIC reader could be useful in preventing or mitigating terrorist attacks: (1) A truck bomb; (2) a terrorist assault team; and (3) an explosive attack carried out by a passenger or passerby (with the specific stipulation that the terrorist is not an “insider”).
Using the asset categories identified in the HSI Report and the risk analysis conducted under MSRAM, the Coast Guard found that three discrete classes of facilities could experience security benefits that are significant enough to warrant the requirement for electronic TWIC inspection. These included: (1) Facilities that handle CDC in bulk;
In the TWIC Reader final rule, our goal was to apply the requirements for electronic TWIC inspection only to those high-risk facilities that could most benefit from its use. Because the asset categories identified in this NPRM contained a vulnerable target, and the threat to that vulnerability could be mitigated by electronic TWIC inspection, we believe that the security benefits justify the cost of the upgraded security. As reported in the Regulatory Analysis section of the TWIC Reader final rule, we estimated that the electronic TWIC inspection provision would extend to 290 bulk liquid facilities, 16 break bulk and solid facilities, 3 container facilities, 61 “mixed use” facilities, and 165 passenger facilities, for a total of 525 facilities.
After publication of the TWIC Reader final rule in August 2016, we received several questions from the public about our risk analysis, as well as a rulemaking petition to reconsider the scope of the TWIC Reader final rule.
Furthermore, even though bulk CDC could be attacked by the identified attack methods from the Coast Guard's risk analysis no matter where it is located in the facility,
At this time, we are not issuing a grant or denial for the petition for rulemaking, but we do wish to
In the NPRM, the Coast Guard addressed the issue of bulk CDC located outside of areas related to maritime transportation. In response to a comment suggesting that facility owners should not be required to use TWIC readers for certain portions of their facilities, we noted that facilities already had an “option to redefine their `secure area' as only that portion of their access control area that is directly related to maritime transportation . . .” and that “facilities whose footprint includes portions that are not directly related to maritime transportation can submit a [Facility Security Plan] for Coast Guard approval that removes those areas from the definition of the facility's `secure area' for Coast Guard regulatory purposes.”
In the TWIC Reader final rule, we also addressed the issue of bulk CDC located outside of the maritime nexus of the facility. We noted that a facility where bulk CDC is stored and handled away from the maritime nexus would be a Risk Group A facility (because the bulk CDC would still be protected by the facility's security plan and, thus, would present a vulnerability), and stated that “when the bulk CDC is not a part of the maritime transportation activities, it may be that a facility could define its MTSA footprint in such a way as to exclude that area . . . [with the result that] the TWIC reader requirements . . . would not apply in that area.”
In summary, we believe that the manner in which the TWIC Reader final rule defines Risk Group A may be overbroad. While some facilities that handle bulk CDC that is not transferred to or from a vessel present a serious risk of a TSI, the fact that it was evident that exceptions and waivers would be necessary to implement the program indicates that there may be a need for more refinement of the Risk Group A category. The petitioners and others, such as owners and operators of facilities that would have to comply with the TWIC Reader final rule and members of Congress who represent this interests of those persons, who have discussed the TWIC Reader final rule with the Coast Guard have raised valid issues about whether the risk groupings established in the TWIC Reader final rule represent the best definition of high-risk facilities that can benefit from the requirement of electronic TWIC inspection. Because it is our goal to impose a requirement only where there is clear evidence that the benefits will justify the costs, we believe that these issues warrant additional study.
Based on industry input, the recommendations outlined in the HSI Report, and the length of time that has passed since the development of the original risk analysis, we are proposing in this NPRM a temporary, partial delay in implementing the requirements for electronic TWIC inspection for certain facilities. Specifically, we are proposing to delay for 3 years implementation of the requirements for electronic TWIC inspection at facilities that handle bulk CDC but do not transfer it to or from a vessel and facilities that receive vessels that carry bulk CDC but, during that vessel-to-facility interface, do not transfer bulk CDC to or from the vessel. All other vessels and facilities subject to the electronic TWIC inspection requirements, including facilities that receive large passenger vessels and facilities regulated under 33 CFR 105.295 that handle bulk CDC and transfer it to or from a vessel, would still be required to comply on the August 23, 2018, compliance date.
We are proposing this delay because we believe that we can better consider the risk methodology used in the TWIC Reader final rule. When we determined that the presence of CDC in bulk within the MTSA footprint was enough justification for a facility to be considered Risk Group A (
The items raised by the petitioners and recommendations provided by the HSI Report establish the parameters of what the Coast Guard plans to study and reevaluate during the proposed delay period. Specifically, we would analyze whether we can divide the general asset category of “facilities that handle CDC
The goals of the additional study would be to prevent situations where electronic TWIC inspection requirements would provide little or no protection and, conversely, to capture situations where the existing Risk Group A may not cover the full range of necessary facilities. As an example, a 1,000 lb. propane tank remotely located in a large facility away from a population center may have a relatively low risk of causing a TSI. That same propane tank located in a small facility in an urban environment may have a much higher risk of causing a TSI, and therefore may warrant designation of the facility as Risk Group A. The current asset categorization methodology used by the Coast Guard cannot make such distinctions.
We believe that a 3-year delay period is needed to allow time for the Coast Guard to attain and analyze data from individual MTSA facilities that contain hazardous chemicals, and implement electronic TWIC inspection for those facilities that would benefit from electronic TWIC inspection requirements. The first 18 months of the delay would be dedicated to physical analysis of individual facilities, during which we would develop the specific data entry requirements for field inspectors, analyze data from facility inspections, and, potentially, develop a new risk methodology based on that analysis. After the data entry requirements are established, Coast Guard inspectors would incorporate any additional data gathering as part of the annual or spot inspection of each facility. As data are gathered, they would be entered into and analyzed through a risk analysis tool to score for operational risks. This process would require several months to collate and analyze data to determine the risk values of MTSA facilities with regard to electronic TWIC inspection, verify whether the new risk values coincide with previous parameters of Risk Group A, and determine which facilities have the highest risk of a TSI.
Based on the information collected and analyzed during the first half of the proposed 3-year delay period, we would take one of two next steps. If the new data indicates that the risk groupings in the TWIC Reader final rule were appropriate, we would not make any changes to the existing requirements for electronic TWIC inspection, and would publish a document in the
During the proposed delay period, facilities that receive large passenger vessels and facilities that transfer bulk CDC to or from a vessel will be required to implement electronic TWIC inspection. We believe that, unlike situations where CDC is not transferred to or from a vessel, these two categories of facilities present a clear risk of a TSI. Facilities that transfer CDCs to or from a vessel typically transfer large quantities. Similarly, large passenger facilities present an inherent risk of a TSI. Unlike the scenarios described above involving bulk CDC, the loss of human life that could occur as a result of an attack at a large passenger facility is not related to the location of the facility (
This proposed rule would delay implementation of the TWIC Reader final rule by 3 years, until August 23, 2021, for two types of Risk Group A facilities: (1) Those that handle CDCs in bulk, but do not transfer CDCs to or from a vessel, and (2) those that receive vessels carrying bulk CDC but, during the vessel-to-facility interface, do not transfer bulk CDC to or from the vessel. Other facilities and vessels would still be required to comply with the TWIC Reader final rule by August 23, 2018.
Below, we provide an updated Regulatory Analysis of the TWIC Reader final rule that presents the impacts of delaying the effective date of the final rule for the two types of Risk Group A facilities defined in the preceding paragraph. For this updated analysis, we estimated the impact of delaying the final rule by calculating the 10-year cost of this proposed rule, where only certain facilities will incur costs starting in year one and other facilities will incur no costs in the first 3 years, and compare it to the 10-year cost presented in the Regulatory Analysis for the TWIC Reader final rule. We then calculated the difference between the two costs to estimate the impact of this proposed rule. To properly compare the costs and benefits of this proposed rule and the TWIC Reader final rule, we first updated the costs of the final rule from 2012 dollars to 2016 dollars.
Executive Orders 12866 (Regulatory Planning and Review) and 13563 (Improving Regulation and Regulatory Review) 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 (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. This proposed rule is expected to be an Executive Order 13771 (Reducing Regulation and Controlling Regulatory Costs) deregulatory action. Details on the estimated cost savings of this proposed rule can be found in the rule's economic analysis.
This proposed rule is a significant regulatory action under section 3(f) of Executive Order 12866. The Office of Management and Budget (OMB) has reviewed it under that Order. It requires an assessment of potential costs and
In the 2016 final rule Regulatory Analysis, we estimated that 525 facilities and 1 vessel out of the MTSA-regulated entities (13,825 vessels and more than 3,270 facilities) will have to comply with the final rule's electronic TWIC inspection requirements using MSRAM's risk-based tiered approach.
Table 1 summarizes the costs and benefits of the TWIC Reader final rule as well as this proposed rule, which would delay the final rule. We do not anticipate any new costs to industry if the final rule is implemented, because this proposed rule would not change the applicability of the 2016 final rule. This proposed rule would result in no other changes to the final rule. The impact to the one affected vessel, along with the qualitative costs and benefits, remain the same. Because this proposed rule would delay the implementation of the final rule by 3 years for 122 facilities, it would result in cost savings to both industry and the government of $8.1 million (discounted at 7 percent) over a 10-year period of analysis ($162.9 million minus $154.8 million). At a 7-percent discount rate, we estimate the total annualized cost savings to be $1.2 million ($23.2 million minus $22.0 million). Using a perpetual period of analysis, we estimated the total annualized cost savings of the proposed rule to be $0.552 million in 2016 dollars, using a 7-percent discount rate.
As shown in table 1, we updated the annualized cost of the 2016 final rule from 2012 dollars to 2016 dollars (over a 10-year period), which is approximately $23.2 million at a 7-percent discount rate. We performed this update to compare them to this proposed rule's total industry costs on the same basis.
To do this, we used an inflation factor from the annual GDP deflator data . We calculated the inflation factor of 1.059 by dividing the annual 2016 index number (111.445) by the annual 2012 index number (105.214).
We then applied this inflation factor to the costs for vessels and additional costs, which include additional delay costs, travel costs, and the cost to replace TWIC readers that fail (Table 4.38 of the final rule RA). These inflated costs are shown in table 2.
For facilities, we applied this inflation factor to the total cost-by-cost component (table 4.17 of the final rule RA) because the proposed rule would apply only to some of these cost elements. Facility costs include capital costs, maintenance costs, and operational costs. Capital costs consist of the cost to purchase and install TWIC readers, as well as the cost to fully replace TWIC readers 5 years after the original installation. Maintenance costs account for the costs to maintain TWIC readers every year after the original installation. Operational costs include costs that occur only at the time of the TWIC reader installation, such as those for amending security plans, creating a recordkeeping system, and initial training. Operational costs also include ongoing costs, such as those for keeping and maintaining records, downloading the canceled card list, and ongoing annual training. Table 3 presents a comparison of the facility costs in 2012 and 2016 dollars, as well as an estimate of the total number of facilities complying with the regulation each year.
Table 4 summarizes the total costs to industry of the final rule in 2016 dollars. We estimated the annualized cost to be $23.2 million at a 7-percent discount rate.
This proposed rule would delay the effective date of the final rule by 3 years (until August 23, 2021) for 122 facilities that handle bulk CDC, but do not transfer it to or from a vessel, and an unestimated number of facilities that receive vessels carrying bulk CDC, but do not transfer it to or from the vessel during that vessel-to-facility interface. To allow for a consistent comparison between the baseline estimates and the costs of this proposed rule, we maintain the assumption that 50 percent of facilities will comply each year of the implementation period. Therefore, we expect that 50 percent of the 403 facilities unaffected by the delayed implementation will comply in year 1 (202 facilities), and the remaining 50 percent will comply in year 2 (201 facilities). For the 122 facilities with the 3-year implementation delay, we assume that 50 percent will comply in year 3 (61 facilities), and 50 percent will comply in year 4 (61 facilities).
The costs are separated into three categories: Capital costs, maintenance costs, and operating costs. To estimate the capital costs in a given year, we multiplied the total baseline capital costs for all facilities by the percentage of facilities incurring costs in a given year.
Table 6 summarizes the total costs to industry of this proposed rule, which would delay the TWIC Reader final rule, in 2016 dollars.
Table 7 presents the estimated change in total costs to industry from delaying the implementation of the TWIC Reader final rule by 3 years (until August 23, 2021) for facilities that handle bulk CDC, but do not transfer it to or from a vessel, and facilities that receive vessels carrying bulk CDC, but do not transfer it to or from the vessel during that vessel-to-facility interface. We estimated an annualized cost savings to industry of $1.15 million at a 7-percent discount rate.
Qualitative costs are as shown in table 1. This proposed rule would delay the cost to retrieve or replace lost PINs for use with TWICs for the facilities with delayed implementation.
We expect that this proposed rule would also generate a cost savings to the government from delaying the review of the revised security plans for 122 Risk Group A facilities that handle bulk CDC, but do not transfer it to or from a vessel, and facilities that receive vessels carrying bulk CDC. There is no change in cost to the government resulting from TWIC inspections, because inspections are already required under MTSA and
To estimate the cost to the government we followed the same approach as the industry cost analysis and adjusted the cost estimate presented in the final rule Regulatory Analysis from 2012 dollars to 2016 dollars. For the government analysis, we used the fully loaded 2016 wage rate for an E-5 level staff member, $51 per hour, from Commandant Instruction 7310.1R: Reimbursable Standard Rates, in place of the 2012 wage of $49 per hour.
Table 9 presents the government cost under the proposed rule. We estimated the annualized government cost to be $13,047 at a 7-percent discount rate. To estimate government costs in year 1 and year 2, we used the same approach as the baseline cost estimates.
Table 10 presents the estimated change in government costs from delaying the implementation of the TWIC Reader final rule by 3 years (until August 23, 2021) for facilities that handle bulk CDC, but do not transfer it to or from a vessel, and facilities that receive vessels carrying bulk CDC, but do not transfer it to or from the vessel during that vessel-to-facility interface. We estimated an annualized cost savings to the government of $738 at a 7-percent discount rate.
Using a perpetual period of analysis, we estimated the total annualized cost savings of the proposed rule to be $0.552 million in 2016 dollars, using a 7-percent discount rate.
As noted, this proposed rule would delay the effective date of the TWIC reader requirement for two categories of facilities: (1) Facilities that handle bulk CDC, but do not transfer it to or from a vessel (to comply by Aug. 23, 2021), and (2) facilities that receive vessels carrying bulk CDC but do not transfer bulk CDC to or from the vessel during that vessel-to-facility interface. The facilities for which the TWIC Reader final rule would be delayed will not realize the enhanced benefits of electronic inspection, such as ensuring that only individuals who hold valid TWICs are granted unescorted access to secure areas, enhanced verification of personal identity, and a reduction in potential vulnerability by establishing earlier the intent of perpetrators who attempt to bypass or thwart the TWIC readers, until August 23, 2021.
We do not anticipate any new costs to the industry and government if this proposed rule is implemented and the effective date of the TWIC Reader final rule is delayed by 3 years. Therefore, this proposed rule is expected to be an Executive Order 13771 deregulatory action. Table 11 summarizes the cost savings of this rule by comparing and subtracting the costs of this proposed rule from the TWIC Reader final rule costs. Because this proposed rule would delay the implementation of the final rule by 3 years for 122 facilities, it would result in cost savings of $8.1 million for industry, $0.005 million for government, and $8.1 million total (all discounted at 7 percent) over a 10-year period of analysis. At a 7-percent discount rate, we estimate the annualized cost savings to be $1.15 million to the industry, $0.0007 to the government, and $1.15 million total. Using a perpetual period of analysis, we found total annualized cost savings of the proposed rule to be $0.552 million to industry and the government.
One regulatory alternative to this proposed rule is for the Coast Guard to take no action. Under this alternative, the TWIC Reader final rule would become effective on August 23, 2018, and all 122 facilities we identified in our final rule Regulatory Analysis, in addition to the unknown number of facilities, would be expected to comply with the final rule. These entities would be required to implement the requirements for the electronic inspection of TWICs and would incur the costs we estimated in our final rule Regulatory Analysis unless a waiver was granted by the Coast Guard.
Another alternative the Coast Guard considered was a waiver approach. However, because we currently lack a comprehensive risk analysis on the level of individualized facilities, we do not believe this approach maximizes benefits. In the absence of a new comprehensive risk analysis, the Coast Guard might issue blanket waivers that include facilities that may indeed warrant the additional security of electronic inspection. For example, take 2 facilities with a 5,000 gallon tank of a CDC each. The tank in the first facility is placed near enough to the perimeter fence in a populated area that, if the tank explodes, it would kill enough people to cause a TSI and therefore should require electronic TWIC inspection. That same tank on the other facility is located away from the water in an isolated area within the MTSA footprint (not near a population). If it explodes it does not cause a TSI and therefore should not need to conduct electronic TWIC inspection. If the Coast Guard issued a blanket waiver for those facilities with a storage tank of CDC with 5,000 gallons or less, then we would not be properly implementing these requirements to mitigate the risks as intended.
We rejected both alternatives (`no action' and `waiver approach') because
Under the Regulatory Flexibility Act, 5 U.S.C. 601-612, we have considered whether this proposed rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.
The Coast Guard proposes to delay the effective date of the TWIC Reader final rule (August 23, 2018) by 3 years, until August 23, 2021, for facilities that handle bulk CDC, but do not transfer it to or from a vessel, and facilities that receive vessels carrying bulk CDC but, during that vessel-to-facility interface, do not transfer it to or from the vessel. These facilities will experience a cost savings. Therefore, we estimate that this proposed rule would provide cost savings to 122 facilities.
Given this information, the Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule would not have a significant economic impact on a substantial number of small entities. If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this proposed rule would have a significant economic impact on it, please submit a comment to the docket at the address listed in the
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996, Public Law 104-121, we want to assist small entities in understanding this proposed rule so that they can better evaluate its effects on them and participate in the rulemaking. If this proposed 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 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).
This proposed rule would call for no new collection of information under the Paperwork Reduction Act of 1995, 44 U.S.C. 3501-3520.
A rule has implications for Federalism under E.O. 13132 (Federalism) if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this proposed rule under that order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in E.O. 13132. Our analysis is explained below.
This proposed rule would delay the implementation of existing regulations that create a risk-based set of security measures for MTSA-regulated facilities. Based on this analysis, each facility is classified according to its risk level, which then determines whether the facility will be required to conduct electronic TWIC inspection. As this proposed rule would not impose any new requirements, but simply delay the implementation of existing requirements, it would not have a preemptive impact. Please refer to the Coast Guard's federalism analysis in the final rule entitled “Transportation Worker Identification Credential (TWIC)—Reader Requirements,” (81 FR 57652, 57706) for additional information.
While it is well settled that States may not regulate in categories in which Congress intended the Coast Guard to be the sole source of a vessel's obligations, States and local governments have traditionally shared certain regulatory jurisdiction over waterfront facilities. Therefore, MTSA standards contained in 33 CFR part 105 (Maritime security: Facilities) are not preemptive of State or local law or regulations that do not conflict with them (
The Coast Guard recognizes the key role that State and local governments may have in making regulatory determinations. Additionally, for rules with federalism implications and preemptive effect, Executive Order 13132 specifically directs agencies to consult with State and local governments during the rulemaking process. If you believe this rule has implications for federalism under Executive Order 13132, 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 million (adjusted for inflation) or more in any one year. Although this proposed rule would not result in such expenditure, we discuss the effects of this NPRM elsewhere in this preamble.
This proposed rule would not cause a taking of private property or otherwise have taking implications under Executive Order 12630 (Governmental Actions and Interference with Constitutionally Protected Property Rights).
This proposed rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988 (Civil Justice Reform) to minimize litigation, eliminate ambiguity, and reduce burden.
We have analyzed this proposed rule under Executive Order 13045 (Protection of Children from Environmental Health Risks and Safety Risks). This proposed rule is not an economically significant rule and will not create an environmental risk to health or risk to safety that might disproportionately affect children.
This proposed rule does not have tribal implications under Executive
We have analyzed this proposed rule under Executive Order 13211 (Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use). We have determined that it is not a “significant energy action” under that order because although it is a “significant regulatory action” under Executive Order 12866, it is not likely to have a significant adverse effect on the supply, distribution, or use of energy, and the Administrator of OMB's Office of Information and Regulatory Affairs has not designated it as a significant energy action.
The National Technology Transfer and Advancement Act, codified as a note to 15 U.S.C. 272, directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through OMB, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (
This proposed rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.
We have analyzed this proposed rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made a preliminary determination that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. A preliminary Record of Environmental Consideration (REC) supporting this determination is available in the docket where indicated under the “Public Participation and Request for Comments” section of this preamble. This proposed rule would be categorically excluded under paragraph L54 of Appendix A, Table 1 of DHS Instruction Manual 023-01(series). Paragraph L54 pertains to regulations that are editorial or procedural. We seek any comments or information that may lead to the discovery of a significant environmental impact from this proposed rule.
Maritime security, Reporting and recordkeeping requirements, Security measures.
For the reasons listed in the preamble, the Coast Guard proposes to amend 33 CFR part 105 as follows:
33 U.S.C. 1226, 1231; 46 U.S.C. 70103; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-11, 6.14, 6.16, and 6.19; Department of Homeland Security Delegation No. 0170.1.
(a) * * *
(1) Beginning August 23, 2018: Facilities that receive vessels certificated to carry more than 1,000 passengers.
(2) Beginning August 23, 2018: Facilities that handle Certain Dangerous Cargoes (CDC) in bulk and transfer such cargoes from or to a vessel.
(3) Beginning August 23, 2021: Facilities that handle CDC in bulk, but do not transfer it from or to a vessel.
(4) Beginning August 23, 2021: Facilities that receive vessels carrying CDC in bulk but, during the vessel-to-facility interface, do not transfer it from or to the vessel.
Coast Guard, DHS.
Notice of proposed rulemaking; notice of public meetings.
The Coast Guard proposes to amend the regulations for Hampton Roads, Virginia and adjacent water anchorage grounds by establishing a new, deep-water anchorage ground and relocating an existing anchorage ground near Cape Charles, VA on the Lower Chesapeake Bay. Maritime infrastructure improvements and growth in both size and volume of vessel traffic entering the port, including large and deep-draft vessels have prompted this proposed rulemaking to ensure that the Hampton Roads Anchorage Grounds continue to safely and effectively support current and future deep-draft vessel anchorage demands. We moved the proposed locations of the anchorage grounds in this notice of proposed rulemaking (NPRM) further offshore than the potential locations we identified in an advance notice of proposed rulemaking (ANPRM) we published in 2016. We did so based on our review and analysis of public comments on the ANPRM and the results of an environmental study referenced in our preliminary Record of Environmental Consideration for this NPRM. We propose to establish an Anchorage R that is further offshore of Cape Charles, VA, and to relocate the existing Anchorage Q (Quarantine Anchorage) south of its current location to a more secluded location on the southern Chesapeake Bay. The intended effect of this proposed rulemaking is to protect the environment, facilitate the safe navigation of maritime commerce and national defense assets, and more safely and effectively support commercial vessel anchoring requirements on the Lower Chesapeake Bay. We invite your comments on this proposed rulemaking.
Comments and related material must be received by the Coast Guard on or before July 17, 2018. Additionally, the Coast Guard will hold several public meetings to allow the public the opportunity to provide comment. The first public meeting will be held on
You may submit comments identified by docket number USCG-2015-1118 using the Federal eRulemaking Portal at
If you have questions about this proposed rulemaking, call or email CDR Ken Kostecki, Sector Hampton Roads Prevention Chief, 757-668-5536, email
On April 19, 2016, the Coast Guard published an advance notice of proposed rule-making (ANPRM) in the
• Norfolk, VA, on July 19, 2016;
• Melfa, VA, on July 20, 2016; and
• Cape Charles, VA, on August 17, 2016.
At the three public meetings, we heard from 20 speakers and we received a total of 35 individual comment letters. On December 16, 2016, the Coast Guard issued a news release to inform the public that a review of comments and the environmental study would be conducted. In November 2017, the Coast Guard completed its environmental review. In January 2018, the Center for Disease Control, the U.S. Navy Fleet Forces Command, and the U.S. Army Corps of Engineers, North Atlantic provided comments identifying and addressing adverse impacts from the proposed anchorage establishment.
The purpose of this NPRM is to solicit comments on proposed rulemaking for establishing a federal commercial anchorage ground, Anchorage R, 3 nautical miles (NM) west of Cape Charles, VA and relocating the existing quarantine anchorage ground currently off Cape Charles, VA to a more secluded location in the lower Chesapeake Bay that is 6 NM southwest of Fishermans Island, VA. With the increasing trend of larger and deeper-draft ships calling within Virginia and Maryland, our efforts to improve navigation safety of both national defense and commercial vessels and to protect the environment can be accomplished by providing an anchorage of adequate size, depth and capacity.
The legal basis and authorities for this notice of proposed rulemaking are found in 33 U.S.C. 471, 33 CFR 1.05-1, DHS Delegation No. 0170.1, which collectively authorize the Coast Guard to propose, establish, and define regulatory anchorage grounds.
This section provides a detailed discussion of the public comments received during the ANPRM's comment period and public meeting. We received 35 comment letters in response to the ANPRM. In addition, we hosted three public meetings to provide another forum for obtaining public feedback on the ANRPM.
Twenty-three comments were received from the public meetings. Comments submitted to the online docket and received at the public meeting aligned into five categories: Environmental concerns, local economy and tourism, safety and security compliance concerns, view shed concerns, and anchorage proponent. Copies of the public meeting sign-in sheets and written comments received are available for viewing in the public docket for this rulemaking. Commenters represented a wide range of individuals and entities, including State and local government officials, port authorities, representatives of affected industries, such as maritime, port, and other facilities, and private citizens. The comments received from these parties helped to inform the proposal in this NPRM.
We received 22 comments opposing the anchorage location due to environmental concerns, such as light and noise pollution and potential vessel discharge. In the ANPRM, we inquired about the possible establishment of a deep-water anchorage ground west of Cape Charles, VA on the Chesapeake Bay. These comments on the ANPRM combined with the results of our environmental study caused us to move the anchorages we are proposing in this NPRM further offshore. The Coast Guard has prepared a preliminary Record of Environmental Consideration (REC) for this NPRM and has made a preliminary determination that the proposed Anchorage R and new Quarantine Anchorage do not cumulatively or individually have a significant effect on the human environment.
Also, we noted that there are existing laws and regulations in place to govern behavior of mariners and vessels related to these concerns about the release of pollutants. In terms of the discharge of pollutants, our regulations in 33 CFR part 151 and the Act to Prevent Pollution from Ships implement provisions of the International Convention for Prevention of Pollution from Ships and subject violators to penalties. Also, the Ports and Waterways Safety Act (PWSA) of 1972, (33 U.S.C. 1221, 1223, 1228, 1232
Under 33 CFR 110.168(c)(8) and (9), the COTP may prescribe specific
To further enhance the safety of the waters of the Chesapeake Bay, the Quarantine Anchorage was relocated to a more secluded location to provide an additional layer of protection should a hazardous condition exist onboard the vessel.
Sixteen comments received were opposed to the anchorage due to the proximity to the shore and its impact to the commercial and recreational boaters that use the Cape Charles City Channel, also known as the Cherrystone Inlet Channel. In this NPRM, the Coast Guard shifted the anchorage 3 NM from the coastline and into deeper water keeping Cherry Stone Channel Inlet, connected to Cape Charles, VA, open to workboats, fishing vessels, and recreational boats transiting this inlet to support the local economy and tourism. Also, by moving the anchorage north of an existing regulated navigation area, 33 CFR 165.501, this will direct vessels to no longer routinely anchor offshore Bulters Bluff, Kiptopeke State Park Beach, Jackspot at the Sunset Beach and Chesapeake Bay Resort and Beach Club but instead to use a dedicated anchorage ground. This will move the lights from ships anchored there further offshore.
Although boaters would be allowed to fish in the proposed anchorage ground, we would strongly discourage crab pot fishing as we would around any places vessels anchor because lines may get caught or cut by the anchors and propellers of vessels anchoring. Mariners deciding to fish in the anchorage ground would do so at the risk of their lines or other fishing gear getting snagged or cut by anchor lines or propellers. Fishing vessels would also need to comply with the provisions outlined in the Navigation Rules of the Road (see 33 CFR part 83).
An additional commenter opposed the anchorage contemplated in the ANPRM requesting that if the ships could not anchor closer to Norfolk than they should anchor at sea until they are called to port. The Coast Guard cannot direct vessels to anchor greater than 12 NM offshore or to stay at sea where they could become exposed to unsafe environmental weather conditions. However, in this NPRM, the proposed anchorage is being shifted further west from Cape Charles, VA and will now be regulated, enhancing the overall safety and security of both vessels and the public.
Ten comments were received regarding vessel safety and crewmember security. Under 33 CFR part 160, subpart C, in general, U.S. vessels in commercial service and foreign vessels entering port must provide a Notice of Arrival to the Coast Guard. The vessel's Notice of Arrival is vetted by numerous federal agencies to ensure compliance with applicable safety and security laws prior to the vessel and its crews entering U.S. waters. Speaking specifically to foreign crewmembers, U.S. Customs and Border Protection (CBP) screen and provide escort protocol for those individuals who are seeking to go ashore. All crewmembers must remain onboard the vessel unless clearance from CBP has been obtained prior to going ashore.
A total of six comments were received opposing the anchorage due to the negative impact anchored vessels could have on the view from shore and diminished property values. The Coast Guard considered these comments to find an alternate anchorage area. Based on exposure to weather, tug and barge traffic density, and navigational safety concerns for areas west of Chesapeake Channel due to drafts between 25 feet and 35 feet with numerous shoals, the proposed alternative areas were considered unsafe for deep draft vessels to anchor. To mitigate the issues associated with the view shed, the Coast Guard moved the anchorage to 3 NM offshore vice the original 1.5 NM and as far west as 500 yards from the Chesapeake Channel. Directly east of Cape Charles heading north towards the Cherry Stone Camp Grounds, the anchorage gets progressively narrower to reduce the overall number of vessels offshore that would be viewed on the horizon.
Three responses were received in support of a new, deep-water anchorage due to the growing maritime infrastructure in the Commonwealth of Virginia. With the support of the anchorage, there were also recommendations to review the existing anchorages within the lower Chesapeake Bay, to maintain the original anchorage proposal, and to expand the boundaries of the anchorage proposal. The existing anchorages will not be reviewed for this rulemaking. The need to adjust the anchorage to include deep water to the north of the proposed area was suggested and incorporated into this adjusted proposal. Various mariner subject matter experts were consulted to ensure navigation safety of both anchored vessels and vessels transiting near the proposed Anchorage R and the proposed Quarantine Anchorage. With limited availability of a deep draft anchorage in the existing naval anchorages, this anchorage proposal is anticipated to enhance the navigation safety of the port and more safely and effectively support commercial vessel anchoring requirements on the Lower Chesapeake Bay.
The Coast Guard proposes to establish a new Anchorage R and relocate the existing Quarantine Anchorage. This proposal reflects our consideration of all comments received from the ANPRM and the Record of Environmental Consideration. We believe this will more effectively establish a new deep-water anchorage ground for commercial vessels to support the new and projected growth in maritime commerce vessel traffic throughout the Port of Virginia. The approximate depths of the proposed new Anchorage R will be located in naturally deep water with charted depths between 25 and 101 feet. The average depth of the northern half of the anchorage is between 45 and 101 feet. The average depth of the southern half of the anchorage is between 25 and 45 feet.
The 7.9 NM long eastern boundary of the proposed Anchorage R is located 3 NM to the west of landside Cape Charles, VA on the Lower Chesapeake Bay. The southernmost boundary is 3.9 NM, and runs parallel with, and 500 yards north of the existing Regulated Navigation Area (33 CFR 165.501) connected along the SE to S coordinates
The Coast Guard proposes moving the existing Quarantine Anchorage (Anchorage Q), from the current location 3.5 NM to the west of landside of Cape Charles, VA, and east of York Spit Channel between lighted buoys 36 to 38, relocating it 6 NM southwest of Fishermans Point, VA. The new location runs 625 yards west of York Spit Channel between buoys 16 and 18. The eastern boundary of proposed Anchorage Q runs parallel to York Spit Channel for 2.2 NM, connected by the NE and SE coordinates as outlined in the proposed regulatory language. The southernmost boundary is 1.3 NM from the emergency restricted area outside the Chesapeake Bay Bridge Tunnel, connected by the listed SE and SW coordinates. The westernmost boundary is 2.2 NM, connected by the listed SW and NW coordinates. The northernmost boundary is 450 yards southwest of York River Entrance Channel and runs for 1.3 NM, connected by the listed NW and NE coordinates.
The regulatory text we are proposing, including the coordinates mention above, appears at the end of this document. You may find a drawing of the proposed anchorage grounds in the docket. Look for Illustration of Contemplated Anchorage “R” and “Quarantine” Anchorage.
We developed this proposed rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders and we discuss First Amendment rights of protestors.
Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13771 directs agencies to control regulatory costs through a budgeting process. This NPRM has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, the NPRM has not been reviewed by the Office of Management and Budget (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.
This regulatory action determination is based on the size, location, and historical vessel traffic data pertaining to the proposed anchorage locations. The regulation would ensure approximately 18 square miles of anchorage grounds are designated to provide a necessary commercial deep draft anchorage and enhance the navigational safety of large naval and commercial vessels transiting within the lower Chesapeake Bay. In reviewing historical Automated Information System (AIS) track line data of vessel transits, the proposed Anchorages Quarantine and R areas are safe locations for vessels to anchor in a minimally trafficked section of the Chesapeake Bay while maintaining a more appropriate safe distance from shore.
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule would not have a significant economic impact on a substantial number of small entities.
While some owners or operators of vessels intending to use the anchorage may be small entities, for the reasons stated in section IV.A above, this proposed rule would not have a significant economic impact on any vessel owner or operator. The towns and communities along the western coast of Eastern Shore of Virginia have an economy based on tourism and numerous small entities and businesses. The anchorage will regulate and move vessels who are currently anchoring in the general vicinity away from the shore and beaches, lessening impacts these small entities may currently experience.
If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment explaining why you think it qualifies and how and to what degree this rule would economically affect it.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this proposed rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
This proposed rule would not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this proposed rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.
Also, this proposed rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it would not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this proposed rule has implications for federalism or Indian tribes, please contact the person listed in the
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this proposed rule would not result in such an expenditure, we do discuss the
We have analyzed this proposed rule under Department of Homeland Security Directive 023-01 and Commandant Instruction M16475.1 (series) OM, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made a preliminary determination that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This proposed rule involves amending the regulations for Hampton Roads and adjacent water anchorages by establishing an anchorage, Anchorage R, 3 NM west of Cape Charles, VA and relocating the existing Quarantine Anchorage, Anchorage Q, to a more secluded position that is 6 NM southwest of Fishermans Point, VA. Normally, such actions are categorically excluded from further review under paragraphs L59(a) and L59(b) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A preliminary Record of Environmental Consideration supporting this determination is available in the docket where indicated under
We view public participation as essential to effective rulemaking and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.
We encourage you to submit comments through the Federal eRulemaking Portal at
We accept anonymous comments. All comments received will be posted without change to
Documents mentioned in this NPRM as being available in the docket, and all public comments, will be in our online docket at
We plan to hold three public meetings to receive oral comments on this NPRM, one in Norfolk, VA and two in Cape Charles, VA. The first public meeting will be held on Monday, June 25, 2018, from 5 p.m. to 7 p.m. at Slover Public Library Meeting Room, 235 E. Plume Street, Norfolk, VA 23510. Two public meetings will be held on July 10, 2018 at Cape Charles Civic Center, 500 Tazwell Avenue, Cape Charles, VA; the first meeting will be held from 1 p.m. to 3 p.m. and the second meeting will be held from 6 p.m. to 8 p.m. For information on facilities or services for individuals with disabilities or to request special assistance at the public meeting, contact the person named in the
Anchorage grounds.
For the reasons discussed in the preamble, the Coast Guard proposes to amend 33 CFR part 110 as follows:
33 U.S.C., 471, 1221 through 1236, 2071; 33 CFR 1.05-1; Department Homeland Security Delegation No 0170.1.
(a)
(6)
(7)
Environmental Protection Agency (EPA).
Proposed rule.
Environmental Protection Agency (EPA) is notifying the public that Allegheny County Health Department (ACHD) has completed the regulatory process for voluntary withdrawal from EPA's delegation of authority to enforce the chemical accident prevention regulations, and EPA is proposing to modify amendments indicating that ACHD does not have delegated authority to implement and enforce the regulatory requirements. EPA is also notifying the public that each facility subject to the previously approved ACHD delegated chemical accident prevention program is required to maintain continuous compliance with applicable requirements. This action is being taken under the Clean Air Act (CAA).
Written comments must be received on or before July 23, 2018.
Submit your comments, identified by Docket ID No. EPA-R03-OAR-2018-0304 at
Mary Cate Opila, (215) 814-2041, or by email at
Section 112(l) of the Clean Air Act (CAA) and 40 CFR part 63, subpart E, authorizes EPA to approve of State, and local, rules and programs to be implemented and enforced in place of certain CAA requirements, including the chemical accident prevention provisions set forth at 40 CFR part 68 (Chemical Accident Prevention Regulations). EPA promulgated the Chemical Accident Prevention Regulations (or risk management program (RMP) regulations) (RMP regulations) pursuant to CAA Section 112(r)(7). By letter dated June 15, 2001, ACHD requested delegation of authority to implement and enforce the RMP regulations for all sources, among other requests for delegation of other programs. On January 30, 2002, EPA issued a direct final rule, which became effective on April 1, 2002, approving ACHD's request for delegation of authority to implement and enforce EPA's RMP regulations, which had been adopted by reference from 40 CFR part 68, for all sources within Allegheny County, Pennsylvania, subject to such regulations.
The procedures for a State, or local authority, to voluntarily withdraw from a CAA approved rule, program or portion of a rule or program are set forth at 40 CFR 63.96(b)(7). In summary, these regulations and relevant EPA guidance provide that a State, or local authority, may unilaterally and voluntarily withdraw from an approved delegated program by notifying EPA and all affected sources of its intent to withdraw and the specific requirements subject to such withdrawal. Any such withdrawal is not effective sooner than 180 days after such notification to EPA. The State, or local authority, must also provide notice and opportunity for comment to the public. To the extent that any source that is affected by the withdrawal is also subject to a CAA operating permit issued pursuant to 40 CFR part 70, the State, or local authority, must reopen and revise such permit to the extent necessary.
By letter dated July 28, 2017, ACHD notified EPA Region III of its intent to voluntarily withdraw from EPA's delegation of authority to enforce the RMP regulations. By letter dated November 9, 2017, ACHD notified EPA Region III that ACHD announced a public comment period to take comment on ACHD's voluntary withdrawal from EPA's delegation of authority to enforce the RMP regulations. The public comment period extended from November 10, 2017 to December 10, 2017. During this public comment period, ACHD did not receive any comments in response to the public comment notification. ACHD provided all applicable facilities with written notice that ACHD is voluntarily withdrawing from EPA's delegation of authority to enforce the RMP regulations set forth at 40 CFR part 68.
Pursuant to 40 CFR 63.96(b)(7), ACHD has determined which facilities, located in Allegheny County, are subject to the RMP regulations and have effective CAA Title V operating permits in accordance with 40 CFR part 70. Sixteen facilities within Allegheny County have submitted risk management plans to EPA and ACHD has issued Title V operating permits to 28 currently operating facilities. ACHD Title V operating permits incorporate the RMP regulations, set forth at 40 CFR part 68, by reference. Therefore, each facility, located in Allegheny County, Pennsylvania, that is subject to the RMP regulations and has an effective Title V operating permit has been issued a Title V permit which includes the proper citation to any applicable RMP regulation.
Upon a State's or local authority's voluntary withdrawal of a delegated program, in accordance with 40 CFR 63.96(b)(7), EPA is required to publish a time for sources subject to the previously approved State, or local, rule or program to come into compliance with applicable Federal requirements. Because, as part of its previously approved delegated program, ACHD incorporated the RMP regulations by reference, there is no distinction between ACHD's previously approved delegated program for implementing the requirements set forth at 40 CFR part 68 and the applicable Federal requirements set forth at 40 CFR part 68. Furthermore, EPA's delegation of authority to implement the requirements set forth at 40 CFR part 68 to ACHD stated in relevant part: “Although ACHD has primary authority and responsibility to implement and enforce the . . . chemical accident prevention provisions, nothing shall preclude, limit, or interfere with the authority of EPA to exercise its enforcement, investigatory, and information gathering authorities concerning this part of the Act.”
EPA's review of this material indicates that ACHD has completed the regulatorily mandated process, set forth at 40 CFR 63.96(b)(7), for voluntary withdrawal from EPA's delegation of authority to enforce the Chemical Accident Prevention regulations set forth at 40 CFR part 68. EPA is proposing to modify 40 CFR 63.99(a)(39)(v) to indicate ACHD's withdrawal from EPA's delegation of authority to enforce the chemical accident prevention provisions set forth at 40 CFR part 68. EPA is soliciting public comments on the issues discussed in this document. These comments will be considered before taking final action.
This action notifies the public that ACHD has completed the process for voluntary withdrawal from EPA's delegation of authority to enforce the chemical accident prevention provisions set forth at 40 CFR part 68, and the action proposes to update 40 CFR 63.99(a)(39)(v) to indicate the withdrawal. The proposed action does not impose additional requirements beyond those imposed by state and federal law. For that reason, this proposed action:
• Is not a “significant regulatory action” subject to review by the Office
• is not an Executive Order 13771 regulatory action because this action is not significant under Executive Order 12866.
• does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and
• does not provide 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 proposed rule to modify 40 CFR 63.99(a)(39)(v) to indicate ACHD's voluntary withdrawal from EPA's delegation of authority to enforce the chemical accident prevention provisions set forth at 40 CFR part 68, does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the action does to apply in Indian country located in the state, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law.
Environmental protection, Administrative practice and procedure, Air pollution control, Hazardous substances, Incorporation by reference, Intergovernmental relations, Paper and paper products industry, Reporting and recordkeeping requirements.
42 U.S.C. 7401
United States Commission on Civil Rights.
Notice of commission telephonic business meeting.
Tuesday, June 26, 2018, at 1:00 p.m. ET.
Meeting to take place by telephone.
Brian Walch, (202) 376-8371,
This business meeting is open to the public by telephone only.
The Information Systems Technical Advisory Committee (ISTAC) will meet on July 25 and 26, 2018, 9:00 a.m., at Qualcomm Incorporated, 5665 Morehouse Drive, QRC Building, San Diego, California 92121. The Committee advises the Office of the Assistant Secretary for Export Administration on technical questions that affect the level of export controls applicable to information systems equipment and technology.
The open session will be accessible via teleconference to 20 participants on a first come, first serve basis. To join the conference, submit inquiries to Ms. Yvette Springer at
A limited number of seats will be available for the public session. Reservations are not accepted. If attending in person, forward your Name (to appear on badge), Title, Citizenship, Organization name, Organization address, Email, and Phone to Ms. Springer. To the extent time permits, members of the public may present oral statements to the Committee. The public may submit written statements at any time before or after the meeting. However, to facilitate distribution of public presentation materials to Committee members, the Committee suggests that public presentation materials or comments be forwarded before the meeting to Ms. Springer.
The Assistant Secretary for Administration, with the concurrence of the delegate of the General Counsel, formally determined on January 4, 2018, pursuant to Section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. app. 2 § (10)(d))), that the portion of the meeting concerning trade secrets and commercial or financial information deemed privileged or confidential as described in 5 U.S.C. 552b(c)(4) and the portion of the meeting concerning matters the disclosure of which would be likely to frustrate significantly implementation of an agency action as described in 5 U.S.C. 552b(c)(9)(B) shall be exempt from the provisions relating to public meetings found in 5 U.S.C. app. 2 §§ 10(a)(1) and 10(a)(3). The remaining portions of the meeting will be open to the public.
For more information, call Yvette Springer at (202) 482-2813.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Commerce) preliminarily determines that common alloy aluminum sheet (aluminum sheet) from the People's Republic of China (China) is being, or is likely to be, sold in the United States at less-than-fair value (LTFV). We invite interested parties to comment on this preliminary determination.
Applicable June 22, 2018.
Deborah Scott or Scott Hoefke, 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) 482-2657 and (202) 482-4947, respectively.
Commerce published the notice of initiation of this LTFV investigation on December 4, 2017.
For a complete description of the events that followed the initiation of this investigation,
The period of investigation (POI) is April 1, 2017, through September 30, 2017.
The product covered by this investigation is aluminum sheet from China. For a complete description of the scope of this investigation,
In accordance with the preamble to Commerce's regulations,
We are conducting this investigation in accordance with section 731 of the Tariff Act of 1930, as amended (the Act). We calculated export prices in accordance with section 772 of the Act. Because China is a non-market economy within the meaning of section 771(18) of the Act, we calculated normal value (NV) in accordance with section 773(c) of the Act. For a full description of the methodology underlying our conclusions,
On March 23, 2018, the Domestic Industry timely filed a critical circumstances allegation, pursuant to section 733(e)(1) of the Act and 19 CFR 351.206, alleging that critical circumstances exist with respect to imports of aluminum sheet from China.
In the
The preliminary weighted-average antidumping margins are as follows:
In accordance with section 733(d)(2) of the Act, we will direct U.S. Customs and Border Protection (CBP) to suspend liquidation of all entries of aluminum sheet from China as described in the scope of the investigation section entered, or withdrawn from warehouse, for consumption on or after the date of publication of this notice in the
Section 733(e)(2) of the Act provides that, given an affirmative determination of critical circumstances, any suspension of liquidation shall apply to unliquidated entries of merchandise entered, or withdrawn from warehouse, for consumption on or after the later of (a) the date which is 90 days before the date on which the suspension of liquidation was first ordered, or (b) the date on which notice of initiation of the investigation was published. Commerce preliminarily finds that critical circumstances exist for imports of subject merchandise from Nanjie Resources Co., Limited/Yong Jie New Material Co., Ltd./Zhejiang Yongjie Aluminum Co., Ltd.; Zhejiang GKO Aluminium Stock Co., Ltd.; the companies eligible for a separate rate; and the China-wide entity, as discussed above.
In accordance with section 733(e)(2)(A) of the Act, the suspension of liquidation shall apply to all unliquidated entries of merchandise from the producer/exporter combinations identified in this paragraph that were entered, or withdrawn from warehouse, for consumption on or after the date which is 90 days before the publication of this notice.
The suspension of liquidation will remain in effect until further notice.
We will disclose to interested parties the calculations performed in this proceeding within five days of the date of announcement of this preliminary determination in accordance with 19 CFR 351.224(b). Case briefs or other written comments on the preliminary determination described above may be submitted to the Assistant Secretary for Enforcement and Compliance no later than seven days after the date on which the last verification report is issued in this proceeding.
Parties who submit case briefs or rebuttal briefs in this proceeding are encouraged to submit with each
Interested parties who wish to request a hearing must do so in writing within 30 days after the publication of this preliminary determination in the
Parties must file their case and rebuttal briefs, and any requests for a hearing, electronically using ACCESS.
Section 735(a)(2) of the Act provides that a final determination may be postponed until not later than 135 days after the date of the publication of the preliminary determination if, in the event of an affirmative preliminary determination, a request for such postponement is made by exporters who account for a significant proportion of exports of the subject merchandise, or in the event of a negative preliminary determination, a request for such postponement is made by the petitioner. Section 351.210(e)(2) of Commerce's regulations requires that requests by respondents for postponement of a final determination be accompanied by a request for extension of provisional measures from a four-month period to a period not more than six months in duration.
Respondents Mingtai and Yongjie Companies requested that, in the event of an affirmative preliminary determination in this investigation, Commerce postpone its final determination,
In accordance with section 735(a)(2)(A) of the Act and 19 CFR 351.210(b)(2)(ii), because: (1) Our preliminary determination is affirmative; (2) the requesting exporters account for a significant proportion of exports of the subject merchandise; and (3) no compelling reasons for denial exist, we are postponing the final determination until no later than 135 days after the publication of this notice in the
In accordance with section 733(f) of the Act, we will notify the International Trade Commission (ITC) of our preliminary determination of sales at LTFV. If our final determination is affirmative, the ITC will determine before the later of 120 days after the date of this preliminary determination or 45 days after our final determination whether these imports are materially injuring, or threaten material injury to, the U.S. industry.
This determination is issued and published in accordance with sections 733(f) and 777(i)(I) of the Act and 19 CFR 351.205(c).
The merchandise covered by this investigation is aluminum common alloy sheet (common alloy sheet), which is a flat-rolled aluminum product having a thickness of 6.3 mm or less, but greater than 0.2 mm, in coils or cut-to-length, regardless of width. Common alloy sheet within the scope of this investigation includes both not clad aluminum sheet, as well as multi-alloy, clad aluminum sheet. With respect to not clad aluminum sheet, common alloy sheet is manufactured from a 1XXX-, 3XXX-, or 5XXX-series alloy as designated by the Aluminum Association. With respect to multi-alloy, clad aluminum sheet, common alloy sheet is produced from a 3XXX-series core, to which cladding layers are applied to either one or both sides of the core.
Common alloy sheet may be made to ASTM specification B209-14, but can also be made to other specifications. Regardless of specification, however, all common alloy sheet meeting the scope description is included in the scope. Subject merchandise includes common alloy sheet that has been further processed in a third country, including but not limited to annealing, tempering, painting, varnishing, trimming, cutting, punching, and/or slitting, or any other processing that would not otherwise remove the merchandise from the scope of the investigations if performed in the country of manufacture of the common alloy sheet.
Excluded from the scope of this investigation is aluminum can stock, which is suitable for use in the manufacture of aluminum beverage cans, lids of such cans, or tabs used to open such cans. Aluminum can stock is produced to gauges that range from 0.200 mm to 0.292 mm, and has an H-19, H-41, H-48, or H-391 temper. In addition, aluminum can stock has a lubricant
Where the nominal and actual measurements vary, a product is within the scope if application of either the nominal or actual measurement would place it within the scope based on the definitions set for the above.
Common alloy sheet is currently classifiable under HTSUS subheadings 7606.11.3060, 7606.11.6000, 7606.12.3090, 7606.12.6000, 7606.91.3090, 7606.91.6080, 7606.92.3090, and 7606.92.6080. Further, merchandise that falls within the scope of this investigation may also be entered into the United States under HTSUS subheadings 7606.11.3030, 7606.12.3030, 7606.91.3060, 7606.91.6040, 7606.92.3060, 7606.92.6040, 7607.11.9090. Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the scope of this investigation is dispositive.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Commerce) determines that imports of certain tapered roller bearings (TRBs) from the Republic of Korea (Korea) for the period of investigation (POI) of April 1, 2016 through March 31, 2017, are being, or are likely to be, sold in the United States at less than fair value (LTFV).
Applicable June 22, 2018.
Blaine Wiltse and Manuel Rey, AD/CVD Operations, Office II, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-6345 and (202) 482-5518, respectively.
On February 2, 2018, Commerce published the
The product covered by this investigation is TRBs from Korea. For a full description of the scope of this investigation,
All issues raised in the case and rebuttal briefs by parties in this investigation are addressed in the Issues and Decision Memorandum accompanying this notice. A list of the issues addressed in the Issues and Decision Memorandum is attached to this notice as Appendix II. The Issues and Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at
As provided in section 782(i) of the Tariff Act of 1930, as amended, (the Act) from February through April 2018, we conducted verification of the sales and cost information submitted by Iljin Group
Based on our analysis of the comments received and our findings at verification, we made certain changes to the margin calculations for each of the respondents. For a discussion of these changes,
Section 735(c)(5)(A) of the Act provides that the estimated weighted-average dumping margin for all other producers and exporters shall be equal to the weighted average of the estimated weighted-average dumping margins established for exporters and producers individually examined, excluding rates that are zero,
The final estimated weighted-average dumping margins are as follows:
We will disclose the calculations performed within five days of the date of publication of this notice to parties in this proceeding in accordance with 19 CFR 351.224(b).
In accordance with section 735(c)(1)(B) of the Act, for this final determination, we will direct U.S. Customs and Border Protection (CBP) to continue to suspend liquidation of all entries of TRBs from Korea, as described in Appendix I of this notice, which are entered, or withdrawn from warehouse, for consumption on or after February 2, 2018, the date of publication in the
In accordance with section 735(d) of the Act, we will notify the International Trade Commission (ITC) of the final affirmative determination of sales at LTFV. Because Commerce's final determination is affirmative, in accordance with section 735(b)(2) of the Act, the ITC will make its final determination as to whether the domestic industry in the United States is materially injured, or threatened with material injury, by reason of imports, or sales (or the likelihood of sales) for importation of TRBs from Korea no later than 45 days after this final determination. If the ITC determines that such injury does not exist, this proceeding will be terminated and all cash deposits will be refunded or canceled. If the ITC determines that such injury does exist, Commerce will issue an antidumping duty order directing CBP to assess, upon further instruction by Commerce, antidumping duties on all imports of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the effective date of the suspension of liquidation, as discussed above in the “Continuation of Suspension of Liquidation” section.
This notice serves as a reminder to parties subject to an 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.
This determination and this notice are issued and published pursuant to sections 735(d) and 777(i)(1) of the Act and 19 CFR 351.210(c).
The scope of this investigation is certain tapered roller bearings. The scope covers all tapered roller bearings with a nominal outside cup diameter of eight inches and under, regardless of type of steel used to produce the bearing, whether of inch or metric size, and whether the tapered roller bearing is a thrust bearing or not. Certain tapered roller bearings include: Finished cup and cone assemblies entering as a set, finished cone assemblies entering separately, and finished parts (cups, cones, and tapered rollers). Certain tapered roller bearings are sold individually as a set (cup and cone assembly), as a cone assembly, as a finished cup, or packaged as a kit with one or several tapered roller bearings, a seal, and grease. The scope of the investigation includes finished rollers and finished cones that have not been assembled with rollers and a cage. Certain tapered roller bearings can be a single row or multiple rows (
Finished cups, cones, and rollers differ from unfinished cups, cones, and rollers in that they have undergone further processing after heat treatment, including, but not limited to, final machining, grinding, and/or polishing. Mere heat treatment of a cup, cone, or roller (without any further processing after heat treatment) does not render the cup, cone, or roller a finished part for the purpose of this investigation. Finished tapered roller bearing parts are understood to mean parts which, at the time of importation, are ready for assembly (if further assembly is required) and require no further finishing or fabrication, such as grinding, lathing, machining, polishing, heat treatment,
Tapered roller bearings that have a nominal outer cup diameter of eight inches and under that may be used in wheel hub units, rail bearings, or other housed bearings, but entered separately, are included in the scope to the same extent as described above. All tapered roller bearings meeting the written description above, and not otherwise excluded, are included, regardless of coating.
Excluded from the scope of this investigation are:
(1) Unfinished parts of tapered roller bearings (cups, cones, and tapered rollers);
(2) cages, whether finished or unfinished;
(3) the non-tapered roller bearing components of subject kits (
(4) tapered roller bearing wheel hub units, rail bearings, and other housed tapered roller bearings (flange, take up cartridges, and hanger units incorporating tapered rollers).
Tapered roller bearings subject to this investigation are primarily classifiable under subheadings 8482.20.0040, 8482.20.0061, 8482.20.0070, 8482.20.0081, 8482.91.0050, 8482.99.1550, and 8482.99.1580 of the Harmonized Tariff Schedule of the United States (HTSUS).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Commerce) determines that imports of low melt polyester staple fiber (low melt PSF) from the Republic of Korea (Korea) are being, or are likely to be, sold in the United States at less than fair value (LTFV) during the period of investigation (POI) April 1, 2016, through March 31, 2017. In addition, we determine that critical circumstances exist with respect to certain imports of the subject merchandise. The final dumping margins of sales at LTFV are listed below in the “Final Determination” section of this notice.
Applicable June 22, 2018.
Alice Maldonado or Brittany Bauer, AD/CVD Operations, Office II, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-4682 or (202) 482-3860.
On February 2, 2018, Commerce published the
The product covered by this investigation is low melt PSF from Korea. For a full description of the scope of this investigation,
All issues raised in the case and rebuttal briefs by submitted by parties in this investigation are addressed in the Issues and Decision Memorandum accompanying this notice. A list of the issues addressed in the Issues and Decision Memorandum is attached to this notice as Appendix II. The Issues and Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at
As provided in section 782(i) of the Tariff Act of 1930, as amended, (the Act) from February through March 2018, we conducted verification of the sales and cost information submitted by Huvis Corporation (Huvis) and Toray Chemical Korea Inc. (TCK) (collectively, the respondents) for use in our final determination. We used standard verification procedures, including an examination of relevant accounting and production records, and original source documents provided by Huvis and TCK.
Based on our analysis of the comments received and our findings at verification, we made certain changes to the margin calculations for the respondents. For a discussion of these changes,
For the
Section 735(c)(5)(A) of the Act provides that the estimated weighted-average dumping margin for all-other producers and exporters not individually investigated shall be equal to the weighted average of the estimated weighted-average dumping margins established for exporters and producers individually investigated excluding rates that are zero,
The final estimated weighted-average dumping margins are as follows:
We will disclose the calculations performed in this final determination within five days of the date of publication of this notice to parties in this proceeding in accordance with 19 CFR 351.224(b).
In accordance with section 735(c)(1)(B) of the Act, for this final determination, we will direct U.S. Customs and Border Protection (CBP) to continue to suspend liquidation of all entries of low melt PSF, as described in Appendix I of this notice, which are entered, or withdrawn from warehouse, for consumption on or after February 2, 2018, the date of publication in the
For entries made by TCK, in accordance with section 735(c)(4)(B) of the Act, because we continue to find that critical circumstances exist, we will instruct CBP to continue to suspend liquidation of all appropriate entries of low melt PSF from Korea which were entered, or withdrawn from warehouse, for consumption on or after November 4, 2017, which is 90 days prior to the date of publication of the preliminary determination of this investigation in the
With regard to companies covered by the “all-others” rate, we will instruct CBP to suspend liquidation of all entries made by companies subject to the all-others rate of low melt PSF from Korea which were entered, or withdrawn from warehouse, for consumption on or after February 2, 2018, the date of the publication of the
These suspension of liquidation instructions will remain in effect until further notice.
In accordance with section 735(d) of the Act, we will notify the International Trade Commission (ITC) of the final affirmative determination of sales at LTFV. Because Commerce's final determination is affirmative, in accordance with section 735(b)(2) of the Act, the ITC will make its final determination as to whether the domestic industry in the United States is materially injured, or threatened with material injury, by reason of imports, or sales (or the likelihood of sales) for importation of low melt PSF from Korea no later than 45 days after this final determination. If the ITC determines that such injury does not exist, this proceeding will be terminated and all cash deposits will be refunded or canceled. If the ITC determines that such injury does exist, Commerce will issue an antidumping duty order directing CBP to assess, upon further instruction by Commerce, antidumping duties on all imports of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the effective date of the suspension of liquidation, as discussed above in the “Continuation of Suspension of Liquidation” section.
This notice serves as a reminder to parties subject to an 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
This determination and this notice are issued and published pursuant to sections 735(d) and 777(i)(1) of the Act and 19 CFR 351.210(c).
The merchandise subject to this investigation is synthetic staple fibers, not carded or combed, specifically bi-component polyester fibers having a polyester fiber component that melts at a lower temperature than the other polyester fiber component (low melt PSF). The scope includes bi-component polyester staple fibers of any denier or cut length. The subject merchandise may be coated, usually with a finish or dye, or not coated.
Low melt PSF is classifiable under the Harmonized Tariff Schedule of the United States (HTSUS) subheading 5503.20.0015. Although the HTSUS subheading is provided for convenience and customs purposes, the written description of the scope of the merchandise under the investigation is dispositive.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Commerce) preliminarily determines that countervailable subsidies are being provided to producers and exporters of certain plastic decorative ribbon from the People's Republic of China (China). The period of investigation is January 1, 2016, through December 31, 2016.
Applicable June 22, 2018.
Maliha Khan or Nancy Decker, AD/CVD Operations, Office VII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: 202-482-0895 or 202-482-0196, respectively.
This preliminary determination is made in accordance with section 703(b) of the Tariff Act of 1930, as amended (the Act). Commerce published the notice of initiation of this investigation on January 23, 2018.
For a complete description of the events that followed the initiation of this investigation, see the Preliminary Decision Memorandum.
The products covered by this investigation are certain plastic decorative ribbon from China. For a complete description of the scope of this investigation,
In accordance with the preamble to Commerce's regulations,
Commerce is conducting this investigation in accordance with section 701 of the Act. For each of the subsidy programs found countervailable, Commerce preliminarily determines that there is a subsidy,
In making these findings, we relied, in part, on facts available and, because one or more respondents did not act to the best of their ability to respond to our requests for information, we drew an adverse inference where appropriate in selecting from among the facts otherwise available.
In accordance with section 703(d)(1)(A) of the Act, Commerce established rates for Joynice Gifts & Crafts Co., Ltd. (Joynice) and Seng San Enterprises Co., Ltd. (Seng Sen) (the two individually investigated exporters/producers of the subject merchandise that participated in this investigation), and for Santa's Collection Shaoxing Co., Ltd. (which is assigned a rate based on AFA) as well as an all-others rate.
In accordance with sections 703(d)(1)(A) and 705(c)(5)(A) of the Act, for companies not individually investigated, Commerce applies an “all-others” rate. The all-others rate is normally calculated by weight averaging the subsidy rates of the companies selected for individual examination with those companies' export sales of the subject merchandise to the United States, excluding any zero and
In this investigation, Commerce calculated individual countervailable subsidy rates for Joynice and Seng Sen that are not zero,
Commerce preliminarily determines that the following estimated countervailable subsidy rates exist:
In accordance with section 703(d)(1)(B) and (d)(2) of the Act, Commerce will direct U.S. Customs and Border Protection (CBP) to suspend liquidation of entries of subject merchandise as described in the scope of the investigation that were entered, or withdrawn from warehouse, for consumption on or after the date of publication of this notice in the
Commerce intends to disclose its calculations and analysis to interested parties in this preliminary determination within five days of its public announcement, or if there is no public announcement, within five days of the date of this notice in accordance with 19 CFR 351.224(b).
As provided in section 782(i)(1) of the Act, Commerce intends to verify the information relied upon in making its final determination.
Case briefs or other written comments may be submitted to the Assistant Secretary for Enforcement and Compliance no later than seven days after the date on which the last verification report is issued in this investigation. Rebuttal briefs, limited to issues raised in case briefs, may be submitted no later than five days after the deadline date for case briefs.
Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing, limited to issues raised in the case and rebuttal briefs, must submit a written request to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce within 30 days after the date of publication of this notice. Requests should contain the party's name, address, and telephone number, the number of participants, whether any participant is a foreign national, and a list of the issues to be discussed. If a request for a hearing is made, Commerce intends to hold the hearing at the U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230, at a time and date to be determined. Parties should confirm by telephone the date, time, and location of the hearing two days before the scheduled date.
Parties are reminded that briefs and hearing requests are to be filed electronically using ACCESS and that electronically filed documents must be received successfully in their entirety by 5 p.m. Eastern Time on the due date.
In accordance with section 703(f) of the Act, Commerce will notify the International Trade Commission (ITC) of its determination. If Commerce's final determination is affirmative, the ITC will make its final determination before the later of 120 days after the date of this preliminary determination or 45 days after Commerce's final determination.
This determination is issued and published pursuant to sections 703(f) and 777(i) of the Act and 19 CFR 351.205(c).
The merchandise covered by this investigation is certain plastic decorative ribbon having a width (measured at the narrowest span of the ribbon) of less than or equal to four (4) inches in actual measurement, including but not limited to ribbon wound onto itself; a spool, a core or a tube (with or without flanges); attached to a card or strip; wound into a keg- or egg-shaped configuration; made into bows, bow-like items, or other shapes or configurations;
The subject merchandise includes ribbons comprised of one or more layers of substrates made, in whole or in part, of plastics adhered to each other, regardless of the method used to adhere the layers together, including without limitation, ribbons comprised of layers of substrates adhered to each other through a lamination process. Subject merchandise also includes ribbons comprised of (a) one or more layers of substrates made, in whole or in part, of plastics adhered to (b) one or more layers of substrates made, in whole or in part, of non-plastic materials, including, without limitation, substrates made, in whole or in part, of fabric.
The ribbons subject to this investigation may be of any color or combination of colors (including without limitation, ribbons that are transparent, translucent or opaque) and may or may not bear words or images, including without limitation, those of a holiday motif. The subject merchandise includes ribbons with embellishments and/or treatments, including, without limitation, ribbons that are printed, hot-stamped, coated, laminated, flocked, crimped, die-cut, embossed (or that otherwise have impressed designs, images, words or patterns), and ribbons with holographic, metallic, glitter or iridescent finishes.
Subject merchandise includes “pull-bows” an assemblage of ribbons connected to one another, folded flat, and equipped with a means to form such ribbons into the shape of a bow by pulling on a length of material affixed to such assemblage, and “pre-notched” bows, an assemblage of notched ribbon loops arranged one inside the other with the notches in alignment and affixed to each other where notched, and which the end user forms into a bow by separating and spreading the loops circularly around the notches, which form the center of the bow. Subject merchandise includes ribbons that are packaged with non-subject merchandise, including ensembles that include ribbons and other products, such as gift wrap, gift bags, gift tags and/or other gift packaging products. The ribbons are covered by the scope of this investigation; the “other products” (
Excluded from the scope of this investigation are the following: (1) Ribbons formed exclusively by weaving plastic threads together; (2) ribbons that have metal wire in, on, or along the entirety of each of the longitudinal edges of the ribbon; (3) ribbons with an adhesive coating covering the entire span between the longitudinal edges of the ribbon for the entire length of the ribbon; (4) ribbon formed into a bow without a tab or other means for attaching the bow to an object using adhesives, where the bow has: (a) An outer layer that is either flocked or made of fabric, and (b) a flexible metal wire at the base that is suitable for attaching the bow to a Christmas tree or other object by twist-tying; (5) elastic ribbons, meaning ribbons that elongate when stretched and return to their original dimension when the stretching load is removed; (6) ribbons affixed as a decorative detail to non-subject merchandise, such as a gift bag, gift box, gift tin, greeting card or plush toy, or affixed (including by tying) as a decorative detail to packaging containing non-subject merchandise; (7) ribbons that are (a) affixed to non-subject merchandise as a working component of such non-subject merchandise, such as where the ribbon comprises a book marker, bag cinch, or part of an identity card holder, or (b) affixed (including by tying) to non-subject merchandise as a working component that holds or packages such non-subject merchandise or attaches packaging or labeling to such non-subject merchandise, such as a “belly band” around a pair of pajamas, a pair of socks or a blanket; (8) imitation raffia made of plastics having a thickness not more than one (1) mil when measured in an unfolded/untwisted state; and (9) ribbons in the form of bows having a diameter of less than seven-eighths (
Further, excluded from the scope of the antidumping duty investigation are any products covered by the existing antidumping duty order on polyethylene terephthalate film, sheet, and strip (PET Film) from the People's Republic of China (China).
Merchandise covered by this investigation is currently classified in the Harmonized Tariff Schedule of the United States (HTSUS) under subheadings 3920.20.0015 and 3926.40.0010.
Merchandise covered by this investigation also may enter under subheadings 3920.10.0000; 3920.20.0055; 3920.30.0000; 3920.43.5000; 3920.49.0000; 3920.62.0050; 3920.62.0090; 3920.69.0000; 3921.90.1100; 3921.90.1500; 3921.90.1910; 3921.90.1950; 3921.90.4010; 3921.90.4090; 3926.90.9996; 5404.90.0000; 9505.90.4000; 4601.99.9000; 4602.90.0000; 5609.00.3000; 5609.00.4000; and 6307.90.9889. These HTSUS subheadings are provided for convenience and customs purposes; the written description of the scope of this investigation is dispositive.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
Applicable June 22, 2018.
Paul Walker at (202) 482-0413, AD/CVD Operations, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230.
On February 15, 2018, the Department of Commerce (Commerce) initiated less-than-fair-value (LTFV) investigation of imports of cast iron soil pipe from the People's Republic of China (China).
Section 733(b)(1)(A) of the Tariff Act of 1930, as amended (the Act), requires Commerce to issue the preliminary determination in an LTFV investigation
On June 1, 2018, the petitioners submitted a timely request that Commerce postpone the preliminary determination in this LTFV investigation.
For the reasons stated above and because there are no compelling reasons to deny the request, Commerce, in accordance with section 733(c)(1)(A) of the Act, is postponing the deadline for the preliminary determination by 50 days (
This notice is issued and published pursuant to section 733(c)(2) of the Act and 19 CFR 351.205(f)(1).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Commerce) determines that imports of low melt polyester staple fiber (low melt PSF) from Taiwan are being, or are likely to be, sold in the United States at less than fair value (LTFV) during the period of investigation (POI) April 1, 2016, through March 31, 2017. The final dumping margins of sales at LTFV are listed below in the “Final Determination” section of this notice.
Applicable June 22, 2018.
Rebecca Janz or Ajay Menon, AD/CVD Operations, Office II, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-2972 or (202) 482-1993.
On February 2, 2018, Commerce published the
The product covered by this investigation is low melt PSF from Taiwan. For a full description of the scope of this investigation,
All issues raised in the case brief submitted by the petitioner in this investigation are addressed in the Issues and Decision Memorandum accompanying this notice. A list of the issues addressed in the Issues and Decision Memorandum is attached to this notice as Appendix II. The Issues and Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at
As provided in section 782(i) of the Tariff Act of 1930, as amended, (the Act) in January and February 2018, we conducted verification of the sales and cost information submitted by Far Eastern New Century Corporation (FENC) for use in our final determination. We used standard verification procedures, including an examination of relevant accounting and production records, and original source documents provided by FENC.
Based on our analysis of the comments received and our findings at verification, we made certain changes to the margin calculations for FENC. For a discussion of these changes,
Section 735(c)(5)(A) of the Act provides that the estimated weighted-average dumping margin for all other producers and exporters not individually investigated shall be equal to the weighted average of the estimated weighted-average dumping margins established for exporters and producers individually investigated excluding rates that are zero,
The final estimated weighted-average dumping margins are as follows:
We will disclose the calculations performed in this final determination within five days of the date of publication of this notice to parties in this proceeding in accordance with 19 CFR 351.224(b).
In accordance with section 735(c)(1)(B) of the Act, for this final determination, we will direct U.S. Customs and Border Protection (CBP) to continue to suspend liquidation of all entries of low melt polyester staple fiber, as described in Appendix I of this notice, which are entered, or withdrawn from warehouse, for consumption on or after February 2, 2018, the date of publication in the
These suspension of liquidation instructions will remain in effect until further notice.
In accordance with section 735(d) of the Act, we will notify the International Trade Commission (ITC) of the final affirmative determination of sales at LTFV. Because Commerce's final determination is affirmative, in accordance with section 735(b)(2) of the Act, the ITC will make its final determination as to whether the domestic industry in the United States is materially injured, or threatened with material injury, by reason of imports, or sales (or the likelihood of sales) for importation of low melt PSF from Taiwan no later than 45 days after this final determination. If the ITC determines that such injury does not exist, this proceeding will be terminated and all cash deposits will be refunded or canceled. If the ITC determines that such injury does exist, Commerce will issue an antidumping duty order directing CBP to assess, upon further instruction by Commerce, antidumping duties on all imports of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the effective date of the suspension of liquidation, as discussed above in the “Continuation of Suspension of Liquidation” section.
This notice serves as a reminder to parties subject to an 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.
This determination and this notice are issued and published pursuant to sections 735(d) and 777(i)(1) of the Act and 19 CFR 351.210(c).
The merchandise subject to this investigation is synthetic staple fibers, not carded or combed, specifically bi-component polyester fibers having a polyester fiber component that melts at a lower temperature than the other polyester fiber component (low melt PSF). The scope includes bi-component polyester staple fibers of any denier or cut length. The subject merchandise may be coated, usually with a finish or dye, or not coated.
Low melt PSF is classifiable under the Harmonized Tariff Schedule of the United States (HTSUS) subheading 5503.20.0015. Although the HTSUS subheading is provided for convenience and customs purposes, the written description of the scope of the merchandise under the investigation is dispositive.
National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice.
The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.
Written comments must be submitted on or before August 21, 2018.
Direct all written comments to Jennifer Jessup, Departmental Paperwork Clearance Officer, Department of Commerce, Room 6616, 14th and Constitution Avenue NW, Washington, DC 20230 (or via the internet at
Requests for additional information or copies of the information collection instrument and instructions should be directed to Michael Asaro at
This request is for a new information collection.
The Atlantic Large Whale Take Reduction Plan (Plan), developed under the authority of the Marine Mammal Protection Act, seeks to enable the National Marine Fisheries Service (NMFS) to reduce injuries and deaths of large whales, especially right whales, due to incidental entanglement in United States commercial fishing gear. In order to develop fair and effective management measures, the Take Reduction Team (Team) requires comprehensive data on when, where, and how fixed gear vessels fish. While subsets of Plan's vessels report on aspects of their operations, the available data form an incomplete picture. NMFS recognizes that forthcoming changes under select fishery management plans (
This information will initially be collected using a paper form, which respondents will be asked to return by mail. Respondents can also scan and email, or fax their submission. An electronic form will be developed for future iterations.
Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden (including hours and cost) of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.
Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record.
National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice.
The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.
Written comments must be submitted on or before August 21, 2018.
Direct all written comments to Jennifer Jessup, Departmental Paperwork Clearance Officer, Department of Commerce, Room 6616, 14th and Constitution Avenue NW, Washington, DC 20230 (or via the internet at
Requests for additional information or copies of the information collection instrument and instructions should be directed to NOAA National Weather Service Analyze, Forecast, and Support Office, Elliott Jacks, Chief of Forecast Services Division, 301-427-9351,
This request is for a new information collection.
In response to public law H.R. 353, Section 406, NWS conducted several social science engagement activities to assess the current Watch, Warning, and Advisory (WWA) system. There was strong agreement for small adjustments to the current system and some support for an entirely new system. To further explore an alternative system, a public survey was conducted to test knowledge of the current system and a series of “prototypes” as an alternative to WWA. Drawing upon these results, NWS plans to conduct focus groups with its forecasters and partners to explore the opportunities and challenges of implementing a new alerting system.
Focus groups will be conducted in person and/or by webinar.
Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden (including hours and cost) of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.
Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record.
U.S. Consumer Product Safety Commission.
Notice of request for information.
To advance the concepts discussed during the U.S. Consumer Product Safety Commission's (CPSC) Recall Effectiveness Workshop in 2017, the CPSC announces a Request for Information (RFI) from stakeholders to provide information critical to future work on Recall Effectiveness. CPSC asks for responses on a series of questions addressing direct notice and other forms of customer notice. The information provided will help inform CPSC's efforts to continue improving the effectiveness of recalls.
Submit comments by September 5, 2018.
You may submit comments, identified by Docket No. CPSC-2017-0027, by any of the following methods:
Joseph F. Williams, Compliance Officer, the Office of Compliance and Field Operations, U.S. Consumer Product Safety Commission, 4330 East-West Hwy., Bethesda, MD 20814; telephone: 301-504-7585; email:
On July 25, 2017, the CPSC hosted a Recall Effectiveness Workshop. The goal of the workshop was to explore and develop proactive measures that CPSC and stakeholders can undertake to improve recall effectiveness. Seventy-nine external stakeholders attended the workshop, including various retailers, manufacturers, law firms, consumer interest groups, third party recall contractors and consultants, testing laboratories, and other interested parties. CPSC staff facilitated an open discussion among these participants about ways to increase recall effectiveness and also gathered feedback on how CPSC can potentially improve its recall efforts. Additional details may be found here:
Following the workshop, CPSC staff prepared a report, which was released on February 22, 2018. The report stated that the CPSC staff intends to prioritize stakeholders' suggestions to:
• Collaborate on ways to improve direct notice to consumers; and
• collaborate with firms to explore how technology can be used to enhance recall response.
The report explained the reason for this focus:
The full Recall Effectiveness Report may be found here:
The CPSC seeks information on current methods and systems that recalling firms use to assist in providing direct notice to consumers. The CPSC also requests certain information regarding the use of targeted notices to reach consumers who may have purchased a recalled product.
1. What methods are available for directly notifying consumers of recalls (
2. If you use direct notice for recalls, what response rates do you achieve? Do the response rates differ significantly for different recalls? If so, what factors appear to influence the response rates? Do you follow up with additional direct notice if a customer does not respond? How often? For how long?
3. Do other companies or your company use all available direct notice methods during every product recall? If not, why not?
4. Do e-commerce retailers/third party platforms use direct notice capabilities for every recall of products sold through their site/platform? If not, why not?
5. What costs are associated with direct notice? How do costs vary for different forms of notice? What other factors affect cost?
6. What challenges and barriers prevent companies from pursuing or improving direct notice? Please address:
7. What technologies exist or are being developed that would assist a recalling company to acquire direct contact information or capabilities to contact purchasers and/or issue direct notice for recalls?
8. What methods do you use to collect direct contact information at the point of sale?
9. Does your attempt to collect direct contact information depend on the item(s) purchased? Is the cost of the item at all relevant?
10. Have you worked with a third-party entity (
11. For retailers that have information on their customers (
12. What would make direct notice more effective (
13. How can the CPSC help facilitate direct notice to consumers?
14. What can we learn from marketing efforts (
1. What product registration methods are used today to collect consumer information and track purchased/registered products?
2. Why do companies offer product registration? Are product registration programs due to mandatory requirements by CPSC or other agencies, or for other reasons?
3. What are participation rates in product registration? Do you see significant differences in the registration rates for different types of products?
4. What type of information is collected during product registration?
5. Is product registration more or less successful if marketing information is not collected at the same time? Why?
6. What methods are in use or are being developed to increase responses to product registration (
7. When does the personal information collected for product registration get used for marketing purposes?
a. Are opt-in/opt-out choices provided to consumers for marketing? Describe.
8. What technologies exist or are being developed to advance product registration?
9. What would make product registration more effective?
10. How can the CPSC help facilitate or improve product registration rates?
11. Has the ability to register a product online or electronically had an effect on the volume of consumer response to product registration?
A targeted notice is a notice aimed at a particular group of likely affected consumers, but not at a known purchaser or consumer like direct notice (
1. Have you used any of the targeted methods listed above or others to reach consumers? What success have you seen?
2. Do companies use the information previously collected to assist in issuing targeted recall notices when announcing recalls?
3. What costs are generally associated with targeted methods, including targeted search engine ads, paid social media, micro marketing, such as internet radio, and voice assistant technologies?
4. What challenges and barriers prevent companies from pursuing targeted notices for recalls? Please address:
5. What technologies exist or are being developed that can improve the effectiveness of targeted notice?
6. How can the CPSC help facilitate new or improved targeted recall notice campaigns?
7. Are there other forms of recall notice that are worth exploring for more discussion?
1. Would you be interested in working directly with the CPSC to explore best practices for implementing product registration, improving current direct notice capabilities, or developing targeted notices?
2. Are there data showing what forms, types, and frequency of messaging consumers are most likely to respond to in direct and targeted notices?
3. How can companies incentivize consumers to register their products or to provide the information needed for direct notice in the event of a recall?
4. What concerns do consumers have regarding the use of their personal information for recall notification purposes? What can firms do to overcome these concerns?
All data submitted is subject to Section 6 of the Consumer Product Safety Act (15 U.S.C. Section 2055) and may be considered confidential, except to the extent otherwise provided by law. Please identify any portion of your submission that you believe is confidential.
Department of the Air Force, DoD.
Information collection notice.
In compliance with the
Consideration will be given to all comments received by August 21, 2018.
You may submit comments, identified by docket number and title, by any of the following methods:
•
•
To request more information on this proposed information collection or to obtain a copy of the proposal and associated collection instruments, please write to the AFPC/DPFF, Airman & Family Division, 550 C Street West, ATTN: Mr. Patrick Woodworth, JBSA Randolph AFB, TX 78150, or call Mr. Patrick Woodworth at 210-565-3280.
Respondents are A&FRC customers who seek services from A&FRC. A&FRC employees enter customer demographic/service delivery information into AFFIRST per Air Force Instruction 36-3009, Airman and Family Readiness Centers, paragraphs 3.13.1-3.13.3.
Department of the Army, DoD.
Notice of a modified system of records.
The Department of the Army is modifying its system of records notice entitled “Army Career Tracker (ACT), A0350-1b TRADOC”. The Army Career Tracker (ACT) enables Soldiers and Army civilians world-wide with career development and transition resources. ACT provides users with a more efficient and effective way to monitor their career development while allowing leaders to track and advise subordinates on personalized leadership development. As a leader development tool, it integrates data on training, education, and experiential learning from a number of source systems into one personalized and easy to use interface. ACT allows supervisors to track and advise employees on their leadership development and allows career program managers the ability to reach their geographically dispersed careerists. The Total Army Sponsorship Program is also administered through ACT. The sponsorship program provides Soldiers, Army civilians, and their families with resources to facilitate their transition and/or relocation between commands and duty assignments.
Comments will be accepted on or before July 23, 2018. This proposed action will be effective the date following the end of the comment period unless comments are received which result in a contrary determination.
You may submit comments, identified by docket number and title, by any of the following methods:
*
Follow the instructions for submitting comments.
*
Ms. Tracy Rogers, Department of the Army, Privacy Office, U.S. Army Records Management and Declassification Agency, 7701 Telegraph Road, Casey Building, Suite 144, Alexandria, VA 22325-3905 or by calling (703) 428-7499.
The Army Career Tracker, initially implemented in
Additionally, ACT is the Army enterprise application that automates the sponsorship process for personnel relocations. The system ensures a virtual handshake between transitioning Soldiers and civilians and their designated sponsor prior to departure from the unit of current assignment. Army transitioning personnel utilize ACT to make known their sponsorship needs via the Department of the Army (DA) Form 5434, Sponsorship Program Counseling and Information Sheet, as part of the reassignment management process. The completed DA Form 5434 is transmitted to the gaining unit of assignment to ensure personnel receive information and assistance needed during their relocation. The automated and collaborative functions of the system are used to identify sponsors, send notifications, monitor status, provide reporting mechanism, and conduct individual satisfaction surveys.
This system of records notice is being modified to include four routine uses that were omitted in the previous notice. The additional routine uses are for disclosures to: DoD contractors in the performance of the contract; to the National Archives and Records Administration for records inspection purposes; and to another Federal agency for breach mitigation and notification. In addition, the authorities were updated to include 10 U.S.C. 1056, Relocation Assistance, which is the implementing statute for Army Regulation 600-8-8, The Total Army Sponsorship Program. The categories of records was revised to clarify what information is collected on the DA Form 5434, and the description of the safeguards was expanded to address administrative and physical measures that are currently utilized to protect the system of records. All other changes to this notice are administrative in nature. The DoD is publishing the notice in its entirety to comply with current standards and formatting requirements prescribed in OMB Circular A-108, “Federal Agency Responsibilities for Review, Reporting, and Publication under the Privacy Act.”
The Department of the Army's notices for system of records subject to the Privacy Act of 1974, as amended, have been published in the
The proposed systems reports, as required by the Privacy Act, as amended, were submitted on April 27, 2018, to the House Committee on Oversight and Government Reform, the Senate Committee on Homeland Security and Governmental Affairs, and the Office of Management and Budget (OMB) pursuant to OMB Circular No. A-108, “Federal Agency Responsibilities for Review, Reporting, and Publication Under the Privacy Act,” December 23, 2016 (December 23, 2016, 81 FR 94424).
Army Career Tracker (ACT), A0350-1b TRADOC.
Unclassified.
Army commands, installations, and activities. Official mailing addresses are published as an appendix to the Army's compilation of systems of records notices.
Commander, Headquarters, U.S. Army Training and Doctrine Command, Institute of Noncommissioned Officer Professional Development Office (ATCG-NCN), 950 Jefferson Ave., Fort Eustis, VA 23604-5704.
5 U.S.C. 4103, Establishment of training programs; 10 U.S.C. 1056, Relocation assistance programs; 10 U.S.C. 3013, Secretary of the Army; Department of Defense Directive 1322.18, Military Training; Army Regulation (AR) 350-1, Army Training and Leader Development; AR 600-20, Army Command Policy; AR 600-8-8, The Total Army Sponsorship Program; AR 690-950, Career Management; and E.O. 9397 (SSN), as amended.
Army Career Tracker (ACT) is a leadership development tool that integrates training and education into one personalized, easy-to-use website. ACT receives training, education, experiential learning, personnel, and biographical data from several Army information systems and presents a comprehensive and personalized view of Noncommissioned Officer, Officer, and Army civilian career history, course enrollment, course completion, course catalog, and professional development model information. Users can search multiple education and training resources, monitor their career development and receive personalized advice. The system allows civilian and military supervisors, and mentors to monitor the individual's goals and provide them developmental recommendations, notifications and career advice. Supervisors can view records for both their civilian and military employees.
ACT is also used to administer the Total Army Sponsorship Program which helps Soldiers, civilian employees, and families successfully relocate into and out of their commands. Soldiers in the ranks of private through colonel (excluding Soldiers arriving at Initial Military Training and Soldiers making Permanent Change of Station (PCS) moves to student detachments at long-term schools) and civilian employees through grade GS-15, undergoing a PCS move, are offered the opportunity to participate in the advance arrival sponsorship program.
Department of the Army military personnel (active duty, Army National Guard, and Army Reserve), Army Reserve Officers' Training Corps contracted cadets, and Army civilian employees.
Demographic data to include name, grade/rank/series, Social Security Number (SSN); DoD ID Number; Army
Sponsorship data to include gaining unit and arrival date; contact information while on leave (address, phone number, email address); marital status; family members' name, age, gender, relationship, identification of exceptional family member(s); and a questionnaire to determine information needs pertaining to housing preferences, employment information for spouse, pets in the household, child care needs, and local schools.
Course and training data to include credit hours accumulated; examination and course completion status; professional development model; assignment history; student academic status; curricula, course descriptions and schedules; graduation dates; and individual goals.
The individual, DoD personnel (supervisors, mentors, training and human resources staff). Data is also extracted from: Army Knowledge Online (AKO), Integrated Total Army Personnel Database (ITAPDB), Headquarters Army Civilian Personnel System (HQ ACPERS), Defense Civilian Personnel Data System for National Guard (NG-DCPDS), Reserve Component Management System (RCMS), Army Training Requirements & Resources System (ATRRS), Army Learning Management System (ALMS), GoArmyEd, Force Management System website (FMSWEB), Credentialing Opportunities On-Line (COOL), Partnership for Youth Success (PaYS), Soldier Fitness Tracker (SFT), and Comprehensive Soldier Fitness (CSF).
In addition to those disclosures generally permitted under 5 U.S.C. 552a(b) of the Privacy Act if 1974, as amended, the records contained herein may specifically be disclosed outside the DoD as a routine use pursuant to 5 U.S.C. 552a(b)(3) as follows:
a. To contractors, grantees, experts, consultants, students, and others performing or working on a contract, service, grant, cooperative agreement, or other assignment for the federal government when necessary to accomplish an agency function related to this system of records.
b. To the appropriate federal, state, local, territorial, tribal, or foreign, or international law enforcement authority or other appropriate entity where a record, either alone or in conjunction with other information, indicates a violation or potential violation of law, whether criminal, civil, or regulatory in nature.
c. To a Member of Congress or staff acting upon the Member's behalf when the Member or staff requests the information on behalf of, and at the request of, the individual who is the subject of the record.
d. To any component of the Department of Justice for the purpose of representing the DoD, or its components, officers, employees, or members in pending or potential litigation to which the record is pertinent.
e. In an appropriate proceeding before a court, grand jury, or administrative or adjudicative body or official, when the DoD or other Agency representing the DoD determines that the records are relevant and necessary to the proceeding; or in an appropriate proceeding before an administrative or adjudicative body when the adjudicator determines the records to be relevant to the proceeding.
f. To the National Archives and Records Administration for the purpose of records management inspections conducted under the authority of 44 U.S.C. 2904 and 2906.
g. To appropriate agencies, entities, and persons when (1) the DoD suspects or has confirmed that there has been a breach of the system of records; (2) the DoD has determined that as a result of the suspected or confirmed breach there is a risk of harm to individuals, the DoD (including its information systems, programs, and operations), the Federal Government, or national security; and (3) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with the DoD's efforts to respond to the suspected or confirmed breach or to prevent, minimize, or remedy such harm.
h. To another Federal agency or Federal entity, when the DoD determines that information from this system of records is reasonably necessary to assist the 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.
Paper printouts and electronic storage media.
The retrieval of records may be made by use of the individual's name, SSN, DoD ID Number, or Army Knowledge Online User Identification.
Records on local training, individual goals, and sponsorship are maintained until no longer needed for conducting business, but not longer than 6 years, then destroyed. Electronic media is deleted; paper printouts are shredded or burned.
Paper and electronic records are protected in accordance with policies in DoD Manual 5200.01, Volume 4, DoD Information Security Program: Controlled Unclassified Information (CUI). ACT is designed where the PII is viewable only by the affected end user, their selected leader or mentor(s), Army staff, and system administrators. Access to the system is restricted to authorized personnel with Army Knowledge Online (AKO) authorization using sign-on and password, or a Common Access Card (CAC). After an end user is authenticated, they are presented data that is only relevant to them due to role-based security. System administrators are carefully selected and their assignment of their user IDs is managed and audited on a regular basis. ACT's data center uses multiple firewalls and an intrusion detection system (IDS) to protect the data. Furthermore, ACT encrypts both data in transit and data at rest. Records are maintained within secured buildings in areas accessible only to persons having an official need-to-know and who are properly trained and screened.
Individuals seeking access to information about themselves contained in this system should address written inquiries to the Commander, Headquarters, U.S. Army Training and Doctrine Command, Institute of Noncommissioned Officer Professional Development Office (ATCG-NCN), 950 Jefferson Ave., Fort Eustis, VA 23604-5704.
Individual should provide full name, SSN or DoD ID number, military status, or other information verifiable from the record itself.
In addition, the requester must provide either a notarized signature or an unsworn declaration made in accordance with 28 U.S.C. 1746, in the following format:
If executed outside the United States: “I declare (or certify, verify, or state) under penalty of perjury under the laws of the United States of America that the foregoing is true and correct. Executed on (date). (Signature).”
If executed within the United States, its territories, possessions, or commonwealths: “I declare (or certify, verify, or state) under penalty of perjury that the foregoing is true and correct. Executed on (date). (Signature).”
The Army's rules for accessing records, contesting contents, and appealing initial agency determinations are contained in 32 CFR part 505, the Army Privacy Program and AR 25-22, The Army Privacy Program, or may be obtained from the system manager.
Individuals seeking to determine whether information about themselves is contained in this system should address written inquiries to the Commander, Headquarters, U.S. Army Training and Doctrine Command, Institute of Noncommissioned Officer Professional Development Office (ATCG-NCN), 950 Jefferson Ave., Fort Eustis, VA 23604-5704.
Individuals should provide full name, SSN, or DoD ID number, military status, or other information verifiable from the record itself.
In addition, the requester must provide either a notarized signature or an unsworn declaration made in accordance with 28 U.S.C. 1746, in the following format:
If executed outside the United States: “I declare (or certify, verify, or state) under penalty of perjury under the laws of the United States of America that the foregoing is true and correct. Executed on (date). (Signature).”
If executed within the United States, its territories, possessions, or commonwealths: “I declare (or certify, verify, or state) under penalty of perjury that the foregoing is true and correct. Executed on (date). (Signature).”
None.
This system of records notice supersedes all versions previously published in the
Department of Defense.
Renewal of federal advisory committee.
The Department of Defense (DoD) is publishing this notice to announce that it is renewing the charter for the Department of Defense Board of Actuaries (“the Board”).
Jim Freeman, Advisory Committee Management Officer for the Department of Defense, 703-692-5952.
The Board's charter is being renewed pursuant to 10 U.S.C. 183(a) and in accordance with the Federal Advisory Committee Act (FACA) of 1972 (5 U.S.C., Appendix, as amended) and 41 CFR 102-3.50(a). The Board's charter and contact information for the Board's Designated Federal Officer (DFO) can be found at
The Board provides the Secretary of Defense and the Deputy Secretary of Defense, through the Under Secretary for Personnel and Readiness, independent advice and recommendations on matters relating to the Department of Defense (DoD) Military Retirement Fund, the DoD Education Benefits Fund, the DoD Voluntary Separation Incentive Fund, and such other funds as the Secretary of Defense shall specify. The Board shall submit to the Secretary of Defense on an annual basis a report on the actuarial status of each of the following funds and, in doing so, shall: a. Review valuations of the DoD Military Retirement Fund, in accordance with 10 U.S.C. 1465(c), and submit to the President and Congress, not less often than once every four years, a report on the status of that Fund, including such recommendations for modifications to the funding or amortization of that Fund as the Board considers appropriate and necessary to maintain that Fund on a sound actuarial basis; b. Review valuations of the DoD Education Benefits Fund, in accordance with 10 U.S.C. 2006(e), and make recommendations to the President and Congress on such modifications to the funding or amortization of the Fund as the Board considers appropriate to maintain that Fund on a sound actuarial basis; c. Review valuations of the DoD Voluntary Separation Incentive Fund and make recommendations to the President and Congress on such modifications to the funding or amortization of that Fund as the Board considers appropriate to maintain that Fund on a sound actuarial basis; d. Review valuations of such other funds as the Secretary of Defense shall specify for purposes of 10 U.S.C. 183 and make recommendations to the President and Congress on such modifications to the funding or amortization of such funds as the Board considers appropriate to maintain such funds on a sound actuarial basis; and e. Furnish advice and opinions on matters referred to the Board by the Secretary of Defense. The Secretary of Defense shall ensure that the Board has access to such records regarding the DoD Military Retirement Fund, the DoD Education Benefits Fund, the DoD Voluntary Separation Fund, and such funds specified by the Secretary of Defense for purposes of 10 U.S.C. 183 as the Board shall require to determine the actuarial status of such funds.
The Board shall be composed of three members appointed by the Secretary of Defense or the Deputy Secretary of Defense from among qualified professional actuaries who are members of the Society of Actuaries. All members of the Board are appointed to provide advice on behalf of the Government on the basis of their best judgment without representing any particular point of view and in a manner that is free from conflict of interest. Members of the Board who are not employees of the United States are entitled to receive pay of the highest rate of basic pay under the General Schedule of subchapter III of chapter 53 of title 5 U.S.C., for each day the member is engaged in the performance of duties vested in the Board. All members are entitled to reimbursement for official Board-related travel and per diem.
The public or interested organizations may submit written statements to the Board membership about the Board's mission and functions. Written statements may be submitted at any time or in response to the stated agenda of planned meeting of the Board. All written statements shall be submitted to the DFO for the Board, and this individual will ensure that the written statements are provided to the membership for their consideration.
Take notice that the Commission received the following electric corporate filings:
Take notice that the Commission received the following electric rate filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Take notice that the following settlement agreement has been filed with the Commission and is available for public inspection.
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j.
The Commission strongly encourages electronic filing. Please file comments using the Commission's eFiling system at
The Commission's Rules of Practice require all intervenors filing documents with the Commission to serve a copy of that document on each person on the official service list for the project. Further, if an intervenor files comments or documents with the Commission relating to the merits of an issue that may affect the responsibilities of a particular resource agency, they must also serve a copy of the document on that resource agency.
k. Goodyear Lake Hydro filed the Settlement on behalf of itself, the United States Department of the Interior—Fish and Wildlife Service, the New York State Department of Environmental Conservation, and Susquehanna River Basin Commission. Goodyear Lake Hydro states that the goal of the Settlement is to provide for the continued operation of the Colliersville Project with the appropriate long-term environmental and recreation protection, enhancement, and mitigation measures that meet the diverse objectives of maintaining a balance of non-power and power values associated with the project. The Settlement provides for the resolution of operational, fisheries, wildlife, recreational, and water quality issues raised by the signatories to the Settlement. Goodyear Lake Hydro states that the agreements in the Settlement constitute an integrated and indivisible set of measures intended to address non-power and power values relating to the licensing of the Colliersville Project and requests that all terms of the Settlement be incorporated as license conditions, without modification, in any subsequent license issued for the project. The signatories to the Settlement also request a 40-year license term for the project. Lastly, the Settlement incorporates, by reference, a Northern Long-Eared Bat and Bald Eagle Protection Plan (Appendix A) and an Invasive Species Management Plan (Appendix B).
l. A copy of the Settlement is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's website at
All filings must (1) bear in all capital letters the title COMMENTS, REPLY COMMENTS, RECOMMENDATIONS, PRELIMINARY TERMS AND CONDITIONS, or PRELIMINARY FISHWAY PRESCRIPTIONS; (2) set forth in the heading the name of the applicant and the project number of the application to which the filing responds; (3) furnish the name, address, and telephone number of the person submitting the filing; and (4) otherwise comply with the requirements of 18 CFR 385.2001 through 385.2005. All comments, recommendations, terms and conditions or prescriptions must set forth their evidentiary basis and otherwise comply with the requirements of 18 CFR 4.34(b). Agencies may obtain copies of the application directly from the applicant. Each filing must be accompanied by proof of service on all persons listed on the service list prepared by the Commission in this proceeding, in accordance with 18 CFR 4.34(b) and 385.2010.
Register online at
m.
Take notice that the following hydroelectric application has been filed with the Federal Energy Regulatory Commission and is available for public inspection:
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j. Deadline for filing comments, motions to intervene, and protests is 45 days from the issuance of this notice by the Commission. The Commission strongly encourages electronic filing. Please file motions to intervene, protests, and comments using the Commission's eFiling system at
k.
l.
m. Individuals desiring to be included on the Commission's mailing list should so indicate by writing to the Secretary of the Commission.
n.
o.
Take notice that the following hydroelectric application has been filed with the Federal Energy Regulatory Commission and is available for public inspection:
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j. Deadline for filing comments, motions to intervene, and protests is 45 days from the issuance of this notice by the Commission. The Commission strongly encourages electronic filing. Please file motions to intervene, protests, and comments using the Commission's eFiling system at
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m. Individuals desiring to be included on the Commission's mailing list should so indicate by writing to the Secretary of the Commission.
n.
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k. With this notice, we are initiating informal consultation with: (a) The U.S. Fish and Wildlife Service and/or NOAA Fisheries under section 7 of the Endangered Species Act and the joint agency regulations thereunder at 50 CFR part 402 and (b) the Massachusetts and New Hampshire State Historic Preservation Officers, as required by section 106 of the National Historic Preservation Act and the implementing regulations of the Advisory Council on Historic Preservation at 36 CFR 800.2.
l. With this notice, we are designating Boott as the Commission's non-federal representative for carrying out informal consultation, pursuant to section 7 of the Endangered Species Act and section 106 of the National Historic Preservation Act.
m. Boott filed with the Commission a Pre-Application Document (PAD; including a proposed process plan and schedule), pursuant to 18 CFR 5.6 of the Commission's regulations.
n. A copy of the PAD is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's website (
Register online at
o. With this notice, we are soliciting comments on the PAD and Commission staff's Scoping Document 1 (SD1), as well as study requests. All comments on the PAD and SD1, and study requests should be sent to the address above in paragraph h. In addition, all comments on the PAD and SD1, study requests, requests for cooperating agency status, and all communications to and from Commission staff related to the merits of the potential application must be filed with the Commission.
The Commission strongly encourages electronic filing. Please file all documents using the Commission's eFiling system at
All filings with the Commission must bear the appropriate heading: “Comments on Pre-Application Document,” “Study Requests,” “Comments on Scoping Document 1,” “Request for Cooperating Agency Status,” or “Communications to and from Commission Staff.” Any individual or entity interested in submitting study requests, commenting on the PAD or SD1, and any agency requesting cooperating status must do so within 60 days of issuance.
p. Although our current intent is to prepare an environmental assessment (EA), there is the possibility that an Environmental Impact Statement (EIS) will be required. Nevertheless, this meeting will satisfy the NEPA scoping requirements, irrespective of whether an EA or EIS is issued by the Commission.
Commission staff will hold two scoping meetings in the vicinity of the project at the time and place noted below. The daytime meeting will focus on resource agency, Indian tribe, and non-governmental organization concerns, while the evening meeting is primarily for receiving input from the public. We invite all interested individuals, organizations, and agencies to attend one or both of the meetings, and to assist staff in identifying particular study needs, as well as the scope of environmental issues to be addressed in the environmental document. The times and locations of these meetings are as follows:
Scoping Document 1 (SD1), which outlines the subject areas to be addressed in the environmental document, was mailed to the individuals and entities on the Commission's mailing list. Copies of SD1 will be available at the scoping meetings, or may be viewed on the web at
The licensee and Commission staff will conduct an environmental site review of the project on Wednesday, July 18, 2018, starting at 9:00 a.m. All participants should meet at the Eldred L. Field Powerhouse, located at 145 Pawtucket St., Lowell, MA 01854.
If you plan to attend the environmental site review, please email Kevin Webb of Boott at
The Lowell Project's facilities are spread out throughout the City of Lowell. Due to limited parking at many locations, Boott will transport participants between facilities by bus. The tour will last for 5 to 6 hours. For any questions concerning the environmental site visit please contact Kevin Webb at (978) 935-6039 or
At the scoping meetings, staff will: (1) Initiate scoping of the issues; (2) review and discuss existing conditions and resource management objectives; (3)
Meeting participants should come prepared to discuss their issues and/or concerns. Please review the PAD in preparation for the scoping meetings. Directions on how to obtain a copy of the PAD and SD1 are included in item n. of this document.
The meetings will be recorded by a stenographer and will be placed in the public records of the project.
Environmental Protection Agency (EPA).
Notice of proposed stipulated order of partial dismissal; request for public comment.
In accordance with the Environmental Protection Agency (EPA) Administrator's October 16, 2017, Directive Promoting Transparency and Public Participation in Consent Decrees and Settlement Agreements, notice is hereby given of a proposed stipulated order of partial dismissal to address several claims in a lawsuit filed by the Northwest Environmental Advocates (“Plaintiff”) in the United States District Court for the Western District of Washington:
Written comments on the proposed stipulated order of partial dismissal must be received by July 23, 2018.
Submit your comments, identified by Docket ID number EPA-HQ-OGC-2018-0378, online at
Thomas Glazer, Water Law Office (7426N), Office of General Counsel, U.S. Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone: (202) 564-0908; email address:
On February 10, 2014, Plaintiff filed suit in the federal district court for the Western District of Washington. Plaintiff's original Complaint brought five claims alleging violations of ESA section 7, CWA section 303(c), and the Administrative Procedures Act (“APA”). Following EPA's motion to partially dismiss on statute of limitations grounds, NWEA filed an Amended Complaint on September 1, 2015, which alleges four broad sets of claims. Plaintiff's first claim alleges that, on February 11, 2008, EPA approved revised State of Washington Department of Ecology (Washington) water quality standards involving metals conversion factors and ammonia criteria without initiating consultation under ESA section 7(a)(2) in contravention of the ESA. Plaintiffs' second claim alleges that the listing of new species, designation of new critical habit, and Washington's completion of a 2009 study regarding dissolved oxygen all triggered an obligation for EPA to reinitiate consultation on various natural conditions criteria provisions pertaining to temperature and dissolved oxygen that EPA approved on February 11, 2008.
The proposed stipulated order of partial dismissal would resolve these ESA claims. As described in paragraph three of the proposed stipulated order of dismissal, within three years, EPA will complete an ESA effects determination pursuant to 50 CFR 402.14(a) for its February 11, 2008 approval of Washington's revisions to the State's ammonia criteria and, as appropriate, request initiation of any necessary ESA consultation with the Services. If during that time, Washington submits revisions to the ammonia criteria and EPA intends to approve, EPA will complete an effects determination and, if appropriate, request initiation of any necessary ESA consultation with the Services within one year of submission or three years of the Court's approval of the stipulated order of dismissal, whichever is later. Portions of claims three and four would also be dismissed in exchange for commitments by Washington, but EPA is not taking comment on those aspects of the proposed stipulated order of partial dismissal. See the proposed stipulated order of partial dismissal for specific details.
For a period of thirty (30) days following the date of publication of this notice, the Agency will accept written comments relating to the resolution of the ESA claims contained in the proposed stipulated order of partial dismissal from persons who are not named as parties or intervenors to the litigation in question. If so requested, EPA will also consider holding a public
The official public docket for this action (identified by EPA-HQ-OGC-2018-0378) contains a copy of the proposed stipulated order of partial dismissal. The official public docket is available for public viewing at the Office of Environmental Information (OEI) Docket in the EPA Docket Center, EPA West, Room 3334, 1301 Constitution Ave. NW, Washington, DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OEI Docket is (202) 566-1752.
An electronic version of the public docket is available on EPA's website at [Insert URL] and also through
EPA's policy is that copyrighted material, including copyrighted material contained in a public comment, will not be placed in EPA's electronic public docket but will be available only in printed, paper form in the official public docket. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the EPA Docket Center.
You may submit comments as provided in the
If you submit an electronic comment, EPA recommends that you include your name, mailing address, and an email address or other contact information in the body of your comment and with any disk or CD ROM you submit. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. Any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment.
Use of the
Environmental Protection Agency (EPA).
Notice; correction.
The Environmental Protection Agency (EPA) issued a document in the
Patrick Yellin, Monitoring, Assistance, and Media Programs Division, Office of Compliance, Mail Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: (202) 564-2970; fax number: (202) 564-0050; email address:
In the
[37] Docket ID Number: EPA-HQ-OECA-2011-0234; Title: NESHAP for Petroleum Refineries (40 CFR part 63, subpart CC) (Renewal); EPA ICR Number 1692.10; OMB Control Number 2060-0340; Expiration Date: May 31, 2019.
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:
Revision to the
The liquidation of the assets for the receivership has been completed. To the extent permitted by available funds and in accordance with law, the Receiver will be making a final dividend payment to proven creditors.
Based upon the foregoing, the Receiver has determined that the continued existence of the receivership will serve no useful purpose. Consequently, notice is given that the receivership shall be terminated, to be effective no sooner than thirty days after the date of this notice. If any person wishes to comment concerning the termination of the receivership, such comment must be made in writing, identify the receivership to which the comment pertains, and sent within thirty days of the date of this notice to: Federal Deposit Insurance Corporation, Division of Resolutions and Receiverships, Attention: Receivership Oversight Department 34.6, 1601 Bryan Street, Dallas, TX 75201.
No comments concerning the termination of this receivership will be considered which are not sent within this time frame.
The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841
The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The applications will also be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States.
Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than July 13, 2018.
1.
The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and § 225.41 of the Board's Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)).
The notices are available for immediate inspection at the Federal Reserve Bank indicated. The notices also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than July 19, 2018.
1.
Additionally, Beverly Anthony, Trimont, Minnesota, as a member of the Anthony family shareholder control group; to retain shares of FSB, and thereby indirectly retain shares of Trimont Bank.
The companies listed in this notice have applied to the Board for approval, pursuant to the Home Owners' Loan Act (12 U.S.C. 1461
The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The application also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the HOLA (12 U.S.C. 1467a(e)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 10(c)(4)(B) of the HOLA (12 U.S.C. 1467a(c)(4)(B)). Unless otherwise noted, nonbanking activities will be conducted throughout the United States.
Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than July 19, 2018.
1.
Department of Defense (DOD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA).
Notice of request for comments regarding an extension to an existing OMB clearance.
Under the provisions of the Paperwork Reduction Act, the Regulatory Secretariat Division will be submitting to the Office of Management and Budget (OMB) a request to review and approve an existing OMB emergency clearance notice.
Submit comments on or before August 21, 2018.
Submit comments identified by Information Collection 9000-0197; Use of Products and Services of Kaspersky Lab, by any of the following methods:
•
•
The Paperwork Reduction Act of 1995 (44 U.S.C. 3501
DoD, GSA, and NASA requested and OMB authorized emergency processing of an information collection involved in this rule, as OMB Control Number 9000-0197 (FAR case 2018-010, 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities) consistent with 5 CFR 1320.13. DoD, GSA, and NASA have determined the following conditions have been met:
a. The collection of information is needed prior to the expiration of time periods normally associated with a routine submission for review under the provisions of the Paperwork Reduction Act, in view of the deadline for this provision of the NDAA which was signed into law in December 2017 and requires action before the prohibition goes into effect on October 1, 2018.
b. The collection of information is essential to the mission of the agencies to ensure the Federal Government does not purchase prohibited articles, and can respond appropriately if any such articles are not identified until after delivery or use.
c. The use of normal clearance procedures would prevent the collection of information from contractors, for national security purposes.
This requirement supports implementation of Section 1634 of Division A of the National Defense Authorization Act for Fiscal Year 2018 (Pub. L. 115-91). This section prohibits Government use of any hardware, software, or services developed or provided, in whole or in part, by Kaspersky Lab or its related entities. This requirement is implemented in the Federal Acquisition Regulation (FAR) through the clause at FAR 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities.
This clearance covers the following requirement:
FAR 52.204-23 requires contractors to report covered products identified during performance of a contract.
DoD, GSA, and NASA request approval of this information collection in order to implement the law. The information will be used by agency personnel to identify and remove prohibited hardware, software, or services from Government use. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor.
A notice was published in the
The public reporting burden for this collection of information consists of reports of identified covered articles during contract performance as required by 52.204-23. Reports are estimated to average 1.5 hour per response, including the time for reviewing definitions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the report.
Public comments are particularly invited on: Whether this collection of information is necessary for the proper performance of functions of the FAR, and will have practical utility; whether the estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the collection of information on those entities who will respond, through the use of appropriate technological collection techniques or other forms of information technology (IT).
With respect to the evaluation of burdens, in particular, DoD, GSA, and NASA especially welcome public comments on:
(1) The types of personnel that would be involved in developing and maintaining compliance with prohibition and required reports (
(2) The types of system changes specifically required within an entity to comply with this rule, as well as associated costs; and
(3) Steps that an entity will take in order to achieve compliance, as well as associated hours and costs;
(4) Any data that can help to inform the average number of subcontracts that may be affected by this rule.
Please cite OMB Control No. 9000-0197, Use of Products and Services of Kaspersky Lab, in all correspondence.
Department of Defense (DOD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA).
Notice of request for public comments regarding an extension to an existing OMB clearance.
Under the provisions of the Paperwork Reduction Act, the Regulatory Secretariat Division will be submitting to the Office of Management and Budget (OMB) a request to review and approve an existing OMB emergency clearance notice.
Submit comments on or before August 21, 2018.
Submit comments identified by Information Collection 9000-0198; Violations of Arms Control Treaties or Agreements with the United States, by any of the following methods:
•
•
The Paperwork Reduction Act of 1995 (44 U.S.C. 3501
DoD, GSA, and NASA requested and OMB authorized emergency processing of an information collection involved in this rule, as OMB Control Number 9000-0198 (FAR case 2017-018, 52.209-13, Violation of Arms Control Treaties or Agreements—Certifications) consistent with 5 CFR 1320.13. DoD, GSA, and NASA have determined the following conditions have been met:
a. The collection of information is needed prior to the expiration of time periods normally associated with a routine submission for review under the provisions of the Paperwork Reduction Act.
b. The collection of information is essential to the mission of the agencies to ensure the Federal Government does not award contracts to offerors, and any entity owned or controlled by the offeror that has engaged in any activity that violates arms control treaties or agreements with the United States.
c. The use of normal clearance procedures would prevent the collection of information from contractors, for national security purposes.
Section 1290 of Public Law 114-328 (codified at 22 U.S.C. 2593e) went into effect on December 23, 2016. The implementation of this FAR case will protect against doing business with entities that engage in any activity that contributed to or is a significant factor in a country's failure to comply with arms control treaties or agreements with the United States. This action is necessary because of statutory requirements relating to a national security function of the United States.
A notice was published in the
Centers for Medicare & Medicaid Services (CMS), HHS.
Final notice.
This final notice announces our decision to approve The Compliance Team (TCT) for continued recognition as a national accrediting organization for Rural Health Clinics (RHCs) that wish to participate in the Medicare or Medicaid programs.
Christina Mister-Ward, (410) 786-2441.
Monda Shaver, (410) 786-3410.
Marie Vasbinder, 410-786-8665.
Under the Medicare program, eligible beneficiaries may receive covered services in a rural health clinic (RHC) provided certain requirements are met by the RHC. Section 1861(aa) and 1905(l)(1) of the Social Security Act (the Act), establish distinct criteria for facilities seeking designation as a RHC. Regulations concerning provider agreements are at 42 CFR part 489 and those pertaining to activities relating to the survey and certification of facilities are at 42 CFR part 488, subpart A. The regulations at 42 CFR part 491, subpart A specify the conditions that a RHC must meet to participate in the Medicare program. The scope of covered services and the conditions for Medicare payment for RHCs are set forth at 42 CFR part 405, subpart X.
Generally, to enter into a provider agreement with the Medicare program, a RHC must first be certified by a state survey agency as complying with the
There is an alternative, however, to surveys by state agencies. Section 1865(a)(1) of the Act provides that, if a provider entity demonstrates through accreditation by an approved national accrediting organization that all applicable Medicare conditions are met or exceeded, we will deem those provider entities as having met the requirements. Accreditation by an accrediting organization is voluntary and is not required for Medicare participation.
If an accrediting organization is recognized by the Secretary as having standards for accreditation that meet or exceed Medicare requirements, any provider entity accredited by the national accrediting body's approved program would be deemed to meet the Medicare conditions. A national accrediting organization applying for CMS approval of its accreditation program under 42 CFR part 488, subpart A, must provide us with reasonable assurance that the accrediting organization requires the accredited provider entities to meet requirements that are at least as stringent as the Medicare conditions. Our regulations concerning the approval of accrediting organizations are set forth at § 488.5. Section 488.5(e)(2)(i) requires an accrediting organization to reapply for continued approval of its accreditation program every 6 years or as determined by CMS. The Compliance Team's (TCT's) current term of approval for its RHC accreditation program expires July 18, 2018.
Section 1865(a)(3)(A) of the Act provides a statutory timetable to ensure that our review of applications for CMS-approval of an accreditation program is conducted in a timely manner. The Act provides us 210 days after the date of receipt of a complete application, with any documentation necessary to make the determination, to complete our survey activities and application process. Within 60 days after receiving a complete application, we must publish a notice in the
In the January 23, 2018
• The equivalency of TCT's standards for RHCs as compared with CMS's RHC conditions for certification.
• TCT's survey process to determine the following:
++ The composition of the survey team, surveyor qualifications, and the ability of the organization to provide continuing surveyor training.
++ The comparability of TCT's processes to those of state agencies, including survey frequency, and the ability to investigate and respond appropriately to complaints against accredited facilities.
++ TCT's processes and procedures for monitoring a RHC determined to be out of compliance with TCT's program requirements. These monitoring procedures are used only when TCT identifies noncompliance. If noncompliance is identified through validation reviews or complaint surveys, the state survey agency monitors corrections as specified at § 488.9(c).
++ TCT's capacity to report deficiencies to the surveyed facilities and respond to the facility's plan of correction in a timely manner.
++ TCT's capacity to provide CMS with electronic data and reports necessary for effective validation and assessment of the organization's survey process.
++ The adequacy of TCT's staff and other resources, and its financial viability.
++ TCT's capacity to adequately fund required surveys.
++ TCT's policies with respect to whether surveys are announced or unannounced, to assure that surveys are unannounced.
++ TCT's agreement to provide CMS with a copy of the most current accreditation survey together with any other information related to the survey as CMS may require (including corrective action plans).
In accordance with section 1865(a)(3)(A) of the Act, the January 23, 2018 proposed notice also solicited public comments regarding whether TCT's requirements met or exceeded the Medicare Condition for Certification (CfC) for RHCs. We received one comment in response to our proposed notice. The comment received expressed support for TCT's RHC accreditation program.
We compared TCT's RCH accreditation requirements and survey process with the Medicare CfCs at 42 CFR part 491, the survey and certification process requirements of parts 488 and 489 and survey process as outlined in the State Operations Manual (SOM). TCT's standards crosswalk was also examined to ensure that the appropriate CMS regulations would be included in citations as appropriate. Our review and evaluation of TCT's RHC application, which was conducted as described in section III. of this final notice, yielded the following areas where, as of the date of this notice, TCT has revised its standards and certification processes so that its processes are comparable to CMS requirements:
• Section 491.2(1), to update its standard for nurse practitioner and accompanying crosswalk to remove the duplicative language “by the currently certified”.
• Section 491.4, to address staff licensure compliance in its surveyor guidance.
• Sections 491.7(a)(2) through (b)(3), to correct its crosswalk to reflect the correct standard reference ADM 4.0.1.
• Section 491.8(a)(3), to update its standard to address the regulatory requirement that at least one physician assistant or nurse practitioner be employed by the clinic.
• Sections 491.8(c)(1)(i) and 491.9(b)(2), to correct the standard language to clarify the required membership of the group of professional personnel responsible for policy development and implementation.
• Section 491.8(c)(2)(i), to correct erroneously cited CMS regulatory references.
• Section 491.9(b)(4), to update its standard language to clarify the required membership of the group of professional personnel responsible for policy review annually.
• Section 491.10(a)(1), to update its standards and crosswalk to explicitly require the RHC to maintain a clinical record system in addition to maintaining the record system in accordance with written policies and procedures.
• Section 491.12(c)(3)(i), to update its standard to include reference to RHC “staff” and to delete reference to “FQHC.”
• Section 491.12(d)(1)(iv), to update surveyor guidance to include specific examples of acceptable methods for documenting the evaluation of the effectiveness of RHC staff training, and the demonstration of RHC staff knowledge and competency.
• To clearly include frequency of monitoring on-going compliance as a required element for acceptable plan of corrections.
• To clarify its Administrative Policy regarding removal and denial of accreditation.
• To ensure each deficiency is cited at the appropriate level according to the scope and severity of the finding.
• To ensure all provider-submitted plans of correction address all non-compliant practices identified on survey.
• To address the inaccurate reporting of facility and survey data to CMS.
• To provide evidence ensuring staff were educated on its policy related required personal file documents to be located on site at the RHC.
• To provide evidence ensuring staff are educated on its policy related to deficiencies that are corrected onsite.
• To identify patient medical records while protecting the patient's identity during the survey event.
Based on our review and observations described in section III of this final notice, we have determined that TCT's rural health clinic requirements meet or exceed our requirements, and its survey processes are comparable to ours. Therefore, we approve TCT as a national accreditation organization for hospitals that request participation in the Medicare program, effective July 18, 2018 through July 18, 2024.
This document does not impose information collection requirements, that is, reporting, recordkeeping or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Centers for Medicare and Medicaid Services, HHS.
Notice with request for comment.
This proposed notice acknowledges the receipt of an application from the American Association for Accreditation of Ambulatory Surgery Facilities, Inc. for continued recognition as a national accrediting organization for Ambulatory Surgical Centers that wish to participate in the Medicare or Medicaid programs.
To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on July 23, 2018.
In commenting, refer to file code CMS-3358-PN. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.
Comments, including mass comment submissions, must be submitted in one of the following three ways (please choose only one of the ways listed):
1.
2.
Please allow sufficient time for mailed comments to be received before the close of the comment period.
3.
For information on viewing public comments, see the beginning of the
Erin McCoy, (410) 786-2337.
Monda Shaver, (410) 786-3410.
Marie Vasbinder, (410) 786-8665.
Under the Medicare program, eligible beneficiaries may receive covered services from an Ambulatory Surgical Center (ASC) provided certain requirements are met. Section 1832(a)(2)(F)(i) of the Social Security Act (the Act) establishes distinct criteria for facilities seeking designation as an ASC. Regulations concerning provider agreements are at 42 CFR part 489 and those pertaining to activities relating to the survey and certification of facilities are at 42 CFR part 488. The regulations at 42 CFR part 416 specify the conditions that an ASC must meet in order to participate in the Medicare program, the scope of covered services, and the conditions for Medicare payment for ASCs.
Generally, to enter into an agreement, an ASC must first be certified by a State survey agency as complying with the conditions or requirements set forth in part 416 of our Medicare regulations. Thereafter, the ASC is subject to regular surveys by a State survey agency to determine whether it continues to meet these requirements.
Section 1865(a)(1) of the Act provides that, if a provider entity demonstrates through accreditation by a Centers for Medicare & Medicaid Services (CMS) approved national accrediting organization (AO) that all applicable Medicare conditions are met or exceeded, we may deem those provider entities as having met the requirements. Accreditation by an AO is voluntary and is not required for Medicare participation.
If an AO is recognized by the Secretary of the Department of Health and Human Services as having standards for accreditation that meet or exceed Medicare requirements, any provider entity accredited by the national accrediting body's approved program may be deemed to meet the Medicare conditions. An AO applying
The American Association for Accreditation of Ambulatory Surgery Facilities, Inc.'s (AAAASF's) current term of approval for its ASC program expires November 27, 2018.
Section 1865(a)(2) of the Act and our regulations at § 488.5 require that our findings concerning review and approval of an AO's requirements consider, among other factors, the applying AO's requirements for accreditation; survey procedures; resources for conducting required surveys; capacity to furnish information for use in enforcement activities; monitoring procedures for provider entities found not in compliance with the conditions or requirements; and ability to provide CMS with the necessary data for validation.
Section 1865(a)(3)(A) of the Act further requires that we publish, within 60 days of receipt of an organization's complete application, a notice identifying the national accrediting body making the request, describing the nature of the request, and providing at least a 30-day public comment period. We have 210 days from the receipt of a complete application to publish notice of approval or denial of the application.
The purpose of this proposed notice is to inform the public of AAAASF's request for continued CMS-approval of its ASC accreditation program. This notice also solicits public comment on whether AAAASF's requirements meet or exceed the Medicare conditions for coverage (CfCs) for ASCs.
AAAASF submitted all the necessary materials to enable us to make a determination concerning its request for continued CMS-approval of its ASC accreditation program. This application was determined to be complete on May 1, 2018. Under Section 1865(a)(2) of the Act and our regulations at § 488.5, our review and evaluation of AAAASF will be conducted in accordance with, but not necessarily limited to, the following factors:
• The equivalency of AAAASF's standards for ASCs as compared with Medicare's CfCs for ASCs.
• AAAASF's survey process to determine the following:
++ The composition of the survey team, surveyor qualifications, and the ability of the organization to provide continuing surveyor training.
++ The comparability of AAAASF's processes to those of State agencies, including survey frequency, and the ability to investigate and respond appropriately to complaints against accredited facilities.
++ AAAASF's processes and procedures for monitoring an ASC found out of compliance with AAAASF's program requirements. These monitoring procedures are used only when AAAASF identifies noncompliance. If noncompliance is identified through validation reviews or complaint surveys, the State survey agency monitors corrections as specified at § 488.9(c)(1).
++ AAAASF's capacity to report deficiencies to the surveyed facilities and respond to the facility's plan of correction in a timely manner.
++ AAAASF's capacity to provide CMS with electronic data and reports necessary for effective validation and assessment of the organization's survey process.
++ The adequacy of AAAASF's staff and other resources, and its financial viability.
++ AAAASF's capacity to adequately fund required surveys.
++ AAAASF's policies with respect to whether surveys are announced or unannounced, to assure that surveys are unannounced.
++ AAAASF's agreement to provide CMS with a copy of the most current accreditation survey together with any other information related to the survey as CMS may require (including corrective action plans).
Upon completion of our evaluation, including evaluation of public comments received as a result of this notice, we will publish a final notice in the
This document does not impose information collection requirements, that is, reporting, recordkeeping or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35).
Because of the large number of public comments we normally receive on
Upon completion of our evaluation, including evaluation of comments received as a result of this notice, we will publish a final notice in the
Centers for Medicare & Medicaid Services (CMS), HHS.
Cancellation of meeting.
On June 1, 2018, we published a
Lynne Johnson, Acting Designated Federal Official, Office of Communications, CMS, 7500 Security Boulevard, Mail Stop S1-05-06, Baltimore, MD 21244, 410-786-0897, email
Administration for Children and Families, HHS.
Request for public comment.
The Administration for Children and Families, HHS, solicits comments by July 22, 2018 on initial criteria and potential candidate programs and services for review in a Clearinghouse of evidence-based practices in accordance with the Family First Prevention Services Act of 2018. The Clearinghouse will identify promising, supported, and well-supported practices for mental health and substance abuse prevention and treatment programs, in-home parent skill-based programs, and kinship navigator programs appropriate for children who are candidates for foster care pregnant or parenting foster youth, and the parents or kin caregivers of those children and youth.
Invitation to Comment: HHS invites comments regarding this Notice. To ensure that your comments have maximum effect, please identify clearly the section of this Notice that your comment addresses.
The Family First Prevention Services Act (FFPSA) was signed into law as part of the Bipartisan Budget Act (H.R. 1892) on February 9, 2018. FFPSA enables States to use Federal funds available under parts B and E of title IV of the Social Security Act to provide enhanced support to children and families and prevent foster care placements through the provision of evidence-based mental health and substance abuse prevention and treatment services, in-home parent skill-based programs, and kinship navigator services. As described in the statutory language, these services and programs are intended “for children who are candidates for foster care or who are pregnant or parenting foster youth and the parents or kin caregivers of the children”.
FFPSA requires an independent systematic review of evidence to designate programs and services as “promising,” “supported,” and “well-supported” practices, defined as follows in section 471(e)(4)(C):
• Promising Practice: “A practice shall be considered to be a `promising practice' if the practice is superior to an appropriate comparison practice using conventional standards of statistical significance (in terms of demonstrated meaningful improvements in validated measures of important child and parent outcomes, such as mental health, substance abuse, and child safety and well-being), as established by the results or outcomes of at least one study that—(1) was rated by an independent systematic review for the quality of the study design and execution and determined to be well-designed and well-executed; and (2) utilized some form of control (such as an untreated group, a placebo group, or a wait list study).”
• Supported Practice: “A practice shall be considered to be a `supported practice' if (I) the practice is superior to an appropriate comparison practice using conventional standards of statistical significance (in terms of demonstrated meaningful improvements in validated measures of important child and parent outcomes, such as mental health, substance abuse, and child safety and well-being), as established by the results or outcomes of at least one study that—(aa) was rated by an independent systematic review for the quality of the study design and execution and determined to be well-designed and well-executed; and (bb) was a rigorous random-controlled trial (or, if not available, a study using a rigorous quasi-experimental research design); and (cc) was carried out in a usual care or practice setting and (II) the study described in sub-clause (I) established that the practice has a sustained effect (when compared to a control group) for at least 6 months beyond the end of treatment.”
• Well-supported Practice: “A practice shall be considered to be a `well-supported practice' if (I) the practice is superior to an appropriate comparison practice using conventional standards of statistical significance (in terms of demonstrated meaningful improvements in validated measures of important child and parent outcomes, such as mental health, substance abuse, and child safety and well-being), as established by the results or outcomes of at least two studies that—(aa) were rated by an independent systematic review for the quality of the study design and execution and determined to be well-designed and well-executed; and (bb) were rigorous random-controlled trials (or, if not available, studies using a rigorous quasi-experimental research design); and (cc) were carried out in a usual care or practice setting and (II) at least one of the studies described in sub-clause (I) established that the practice has a sustained effect (when compared to a control group) for at least 1 year beyond the end of treatment.”
In accordance with FFPSA, practices must also meet the following requirements:
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•
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In order to meet these requirements, the Administration for Children and Families (ACF) in the Department of Health and Human Services (HHS) intends to establish and maintain a public Clearinghouse of practices, including culturally specific, or location- or population-based adaptations of practices, identified via a systematic review of evidence on relevant programs and services. In accordance with FFPSA and building from other federal evidence reviews, HHS is developing initial criteria that will be used to designate programs and services as promising, supported, and well-supported practices. HHS will also identify a preliminary list of candidate services and programs that will be considered for systematic review.
This Notice (1) identifies and requests comment on potential initial criteria for (a) identifying eligible programs and services for review by the Clearinghouse, (b) prioritizing eligible programs and services for review, (c) identifying eligible studies aligned with prioritized programs and services, (d) prioritizing eligible studies for rating, (e) rating studies, and (f) rating programs and services as promising, supported, and well-supported practices. This Notice (2) requests comment on potential programs and services that may meet the aforementioned criteria and that should be considered as candidates for systematic review. After comments are received, HHS will revise and publish the initial criteria and a preliminary list of candidate programs and services to be considered for review; and begin to conduct reviews. This Notice is one step in ensuring that activities associated with the development of a Clearinghouse are
2.1
2.1.1 Types of Programs and Services. HHS intends to limit eligibility to mental health and substance abuse prevention and treatment services, in-home parent skill-based programs (including parenting skills training, parent education, and individual and family counseling), and kinship navigator programs.
2.1.2 Book/Manual/Writings Available. HHS intends to limit eligibility to programs or services that have a book, manual, or other available documentation that specifies the components of the practice protocol and describes how to administer the practice.
2.2
2.2.1 Types of Programs and Services. As noted in 2.1.1.
2.2.2 Target Population of Interest. HHS intends to prioritize programs or services for review that have been developed or used to target children and families involved in the child welfare system or populations similar to those involved in the child welfare system. This Notice requests comment on populations that may be considered “similar” to those involved in the child welfare system.
2.2.3 Target Outcomes. HHS intends to prioritize programs or services for review that aim to impact target outcomes. Target outcomes should be defined in accordance with FFPSA statutory language [section 471(e)(4)(C)] and include those outcomes that “. . . prevent child abuse and neglect, and reduce the likelihood of foster care placement by supporting birth families and kinship families and improving targeted supports for pregnant and parenting youth and their children.” These may include, but are not limited to, “. . . important child and parent outcomes, such as mental health, substance abuse, and child safety and well-being.” This Notice requests comment on which types of mental health, substance abuse, and child and family outcomes should be considered as `target outcomes' and requests research evidence to support recommendations of `target outcomes'. HHS does not intend to include access to service, satisfaction with programs and services, and referral to programs and services as `target outcomes'.
2.2.4 Number of Impact Studies. HHS intends to prioritize programs or services with at least two studies with non-overlapping analytic samples and distinct implementations examining effectiveness/impact.
2.2.5 In Use/Active. HHS intends to prioritize programs or services currently in use in the U.S. Programs or services that are no longer in operation or have no information available about active implementation will not be prioritized.
2.2.6 Implementation and Fidelity Support. HHS intends to prioritize programs or services that have implementation training and staff support and/or fidelity monitoring tools and resources available to implementers in the United States.
2.2.7 Trauma-Informed. HHS may also prioritize services and programs that have been implemented using a trauma-informed approach. FFPSA statutory language [section 471(e)(4)(B)] states, “The services or programs to be provided to or on behalf of a child are provided under an organizational structure and treatment framework that involves understanding, recognizing, and responding to the effects of all types of trauma and in accordance with recognized principles of a trauma-informed approach and trauma-specific interventions to address trauma's consequences and facilitate healing.” This Notice requests comment on the feasibility of prioritizing programs and services based on past implementation in accordance with trauma-informed principles.
2.2.8 Delivery Setting for In-Home Parent Skill-Based Programs and Services. HHS intends to prioritize in-home parent skill-based programs and services where the primary service delivery strategy takes place in the caregivers' place of residence.
2.3
2.3.1 Impact Study. HHS intends to limit eligibility to studies included in government reports and peer-reviewed journal articles that assess effectiveness (
2.3.2 Target Outcomes. HHS intends to limit eligibility to studies that examine the impact of the service or program on at least one `target outcome', as described in section
2.3.3 Conducted in the U.S., U.K., Canada, New Zealand, or Australia. HHS intends to limit eligibility to studies conducted with samples in the U.S., U.K., Canada, New Zealand, or Australia to ensure that the evidence base reflects the populations where programs and services will be implemented.
2.3.4 Study Published in English. HHS intends to limit eligibility to studies published in English.
2.3.5 Published or Prepared in or after 1990. HHS intends to limit eligibility to studies published or prepared in or after 1990.
2.3.6 Usual Care or Practice Setting. HHS intends to limit eligibility to studies carried out in a usual care or practice setting in accordance with FFPSA [section 471(e)(4)(C)]. This Notice requests comment on the definition of usual care or practice settings.
2.4
2.4.1 Implementation Period: FFPSA [section 471(e)(1)(A) and (B)] states that the Secretary may make a payment to a State for providing services or programs “for not more than a 12-month period”. This Notice requests comment on whether studies with program or service implementation periods of longer than 12 months should be considered for review and if so, whether any other implementation period cutoff should be included as a study prioritization criterion.
2.4.2 Sample of Interest. HHS intends to prioritize studies that include samples of children and families involved in the child welfare system or populations similar to those involved in the child welfare system. This Notice requests comment on populations that may be considered “similar” to those involved in the child welfare system.
2.5
2.5.1 Favorable Effects. HHS intends to rate studies based on whether they demonstrate at least one meaningful favorable effect (
2.5.2 Unfavorable Effects. HHS intends to rate studies based on the number of unfavorable effects (
2.5.3 Sustained Favorable Effect. HHS intends for studies with at least one favorable effect on a `target outcome', as determined by the criteria in
2.5.4 Rigorous Study Design. HHS intends to rate studies as either high, moderate, or low on the rigor and appropriateness of their study design. Study designs that receive the highest rating will be either Randomized Controlled Trials (RCTs) or rigorous quasi-experimental designs. HHS defines randomized controlled trials as a study design in which sample members are assigned to the program or service and comparison groups by chance. Randomized control designs are often considered the “gold standard” of research design because personal characteristics (before the program or service begins) do not affect whether someone is assigned to the program or service or control group. HHS defines a quasi-experimental design as a study design in which sample members are selected for the program or service and comparison groups in a nonrandom way. Similar to criteria considered in other federal evidence clearinghouses, rigorous study designs will be those that are appropriately powered, include an appropriate control group, maintain original assignment to study arms, and are appropriate to combat threats to internal validity. This Notice requests comment on threats to internal validity that should be considered. This Notice requests comment on appropriate thresholds for evaluating and assigning a rating to a study design.
2.5.5 Rigorous Study Analysis. HHS intends to rate studies as either high, moderate, or low on the rigor and appropriateness of their analysis. Study analyses that receive the highest rating may be those that tested and established baseline equivalence, appropriately accounted for overall and differential sample attrition, appropriately accounted for multiple comparisons, and when necessary accounted for clustering. This Notice requests comment on appropriate thresholds for evaluating and assigning a rating to a study analysis.
2.5.6 Reliability, Validity, and Systematic Administration of Outcome Measures. HHS intends to rate studies as either high, moderate, or low on the extent to which `target outcome' measures are reliable (
2.6
2.6.1
2.6.2
2.6.3
HHS does not intend to rate a program or service as a `promising', `supported', or `well-supported practice' if there is an empirical basis, as evidenced by multiple unfavorable effects on target or non-target outcomes across reviewed studies, as described in
This Notice requests comment on potential candidate programs and services to consider for the systematic evidence review. Comments should identify how recommended programs and services meet the criteria described in section
Comments may be submitted until July 22, 2018 by email to
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) announces a
The meeting will be held on September 13, 2018, from 8:30 a.m. to 5 p.m. and on September 14, 2018, from 8 a.m. to 3 p.m.
FDA White Oak Conference Center, 10903 New Hampshire Ave., Bldg. 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:
Caryn Cohen, Office of Science, Center for Tobacco Products, Food and Drug Administration, Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993-0002, 1-877-287-1373, 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 the Agency is not responsible for providing access to electrical outlets.
FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Caryn Cohen at least 7 days in advance of the meeting (see,
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).
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.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.
The meeting 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 contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the contract proposals, 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 urgent need to meet timing limitations imposed by the intramural research review cycle.
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.
Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the Office of AIDS Research Advisory Council.
The meeting will be open to the public, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting.
Any interested participants are encouraged to join this meeting at the weblink provided, at least 30 minutes prior to the scheduled start time. Information is also available on the Institute's/Center's home page:
National Institutes of Health, HHS.
Notice.
The National Institute of Dental and Craniofacial Research, 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 Patent Applications listed in the Supplementary Information section of this notice to ERYTHRYx Therapeutics, located in Los Angeles, California.
Only written comments and/or applications for a license which are received by the Office of Technology Transfer and Innovation Access, National Institute of Dental and Craniofacial Research on or before July 9, 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: Yun Mei, Technology Transfer and Patent Specialist, Office of Technology Transfer and Innovation Access, National Institute of Dental and Craniofacial Research, National Institutes of Health, BLDG 1 DEM, RM667, 6701 Democracy Blvd., Bethesda, MD 20817; Telephone: (301) 827-4639; Facsimile: (301) 496-1005; Email:
1. U.S. Provisional Patent Application No. 61/885,258, filed October 1, 2013 and entitled “Methods of Modulating Erythropoiesis with Arginine Vasopressin Receptor 1B Molecules” (HHS Reference No. E-619-2013-0-US-01);
2. PCT Application No. PCT/US2014/058613, filed October 1, 2014 and entitled “Methods of Modulating Erythropoiesis with Arginine Vasopressin Receptor 1B Molecules” (HHS Reference No. E-619-2013-0-PCT-02);
3. U.S. Patent Application No. 15/022,531, filed March 16, 2016 and entitled “Methods of Modulating Erythropoiesis with Arginine Vasopressin Receptor 1B Molecules” (HHS Reference No. E-619-2013-0-US-03);
The patent rights in these inventions have been assigned and/or exclusively licensed to the government of the United States of America.
The prospective exclusive license territory may be the United States and the field of use may be limited to “Use of arginine vasopressin receptor 1B agonists to treat anemia caused by (i) chronic renal failure on dialysis, (ii) receiving myelosuppressive chemotherapy, or (iii) lacking antidiuretic hormone.”
The subject technology is a method of using arginine vasopressin receptor 1B (AVPR1B) agonists to increase the number of red blood cells to treat anemia. The inventors discovered that hematopoietic stem cells express AVPR1B receptor, and these receptors play a key role in promoting hematopoietic stem and progenitor cell proliferation. The number of red blood cells and their precursors significantly increased on day 2 following vasopressin administration, an onset time much faster than erythropoietin (EPO), which is commonly used to stimulate red blood cell production for anemia treatment. EPO takes about a week to manifest its clinical effects. The AVPR1B agonists can be used to jumpstart the hematopoietic system and erythropoietin can be used to sustain the effect.
The subject technology is a repurposing of an existing drug, vasopressin, an AVPR1B agonist, also called antidiuretic hormone. It is a nine-amino acid peptide secreted from the posterior pituitary and used to treat patients with central diabetes insipidus, an uncommon disorder that causes an imbalance of water in the body. This imbalance leads to excretion of large amount of urine (polyuria) and intense thirst even after drinking fluids (polydipsia).
This notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive license will be royalty bearing, and the prospective exclusive license may be granted unless within fifteen (15) days from the date of this published notice, the National Institute of Dental and Craniofacial Research 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 license application, will not be treated confidentially, and may be made publicly available.
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.
National Institutes of Health, HHS.
Notice.
The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Dr. Barry Buchbinder, 240-627-3678;
Technology description follows.
In pursuit of an effective vaccine to end the global HIV-1/AIDS pandemic, researchers at the Vaccine Research Center (“VRC”) continue to study the structure of HIV-1. Recently, these researchers have determined the three-dimensional structure of the HIV-1 Envelope trimeric ectodomain (“Env”), comprised of three gp120 and three gp41 subunits, in its prefusion, mature, closed conformation.
The researchers hypothesize that immunization with the prefusion, closed HIV-1 Env protein will elicit a neutralizing immune response. The VRC researchers engineered a portion of the HIV-1 Env trimer to stabilize it in this closed conformation for use as an immunogen.
This technology is available for licensing for commercial development in accordance with 35 U.S.C. 209 and 37 CFR part 404, as well as for further development and evaluation under a research collaboration.
• Vaccine for prevention of HIV-1 infection.
• Therapeutic vaccine for treatment of HIV-1 infection.
• Currently, no licensed HIV-1 vaccine exists.
• In vitro studies characterizing the immunogen and its interaction with HIV antibodies.
• In vivo results including immunogenicity in rabbits and guinea pigs, neutralizing activity of resulting serum.
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.
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 contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.
The meeting 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.
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.
Coast Guard, DHS.
Sixty-day notice requesting comments.
In compliance with the Paperwork Reduction Act of 1995, the U.S. Coast Guard intends to submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs (OIRA), requesting an extension of its approval for the following collection of information: 1625-0010, Defect/Noncompliance Report and Campaign Update Report; without change. Our ICR describes the information we seek to collect from the public. Before submitting this ICR to OIRA, the Coast Guard is inviting comments as described below.
Comments must reach the Coast Guard on or before August 21, 2018.
You may submit comments identified by Coast Guard docket number [USCG-2018-0490] to the Coast Guard using the Federal eRulemaking Portal at
A copy of the ICR is available through the docket on the internet at
Mr. Anthony Smith, Office of Information Management, telephone 202-475-3532, or fax 202-372-8405, for questions on these documents.
This Notice relies on the authority of the Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to OIRA seeking the approval, extension, or renewal of a Coast Guard collection of information (Collection). The ICR contains information describing the Collection's purpose, the Collection's likely burden on the affected public, an explanation of the necessity of the Collection, and other important information describing the Collection. There is one ICR for each Collection.
The Coast Guard invites comments on whether this ICR should be granted based on the Collection being necessary for the proper performance of Departmental functions. In particular, the Coast Guard would appreciate comments addressing: (1) The practical utility of the Collection; (2) the accuracy of the estimated burden of the Collection; (3) ways to enhance the quality, utility, and clarity of information subject to the Collection; and (4) ways to minimize the burden of the Collection on respondents, including the use of automated collection techniques or other forms of information technology. In response to your comments, we may revise this ICR or decide not to seek an extension of approval for the Collection.
We encourage you to respond to this request by submitting comments and related materials. Comments must contain the OMB Control Number of the ICR and the docket number of this request, [USCG-2018-0490], and must be received by August 21, 2018.
We encourage you to submit comments through the Federal eRulemaking Portal at
We accept anonymous comments. All comments received will be posted without change to
The Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended.
Coast Guard, DHS.
Notice of policy; request for comments.
The Coast Guard is announcing the availability of CG-MMC Policy Letter No. 02-18 titled “Guidelines for Qualifications of Personnel for Issuing STCW Endorsements for Basic and Advanced Polar Code Operations.” This policy provides guidance for the issuance of Merchant Mariner Credential endorsements in accordance with the International Convention on Standards of Training, Certification and Watchkeeping for Seafarers, 1978, as amended, for Basic and Advanced Polar Code Operations. This policy is effective today, but the Coast Guard requests public comments on it.
This policy is effective on June 22, 2018.
Comments and related material must be received by the Coast Guard on or before September 20, 2018.
Policy Letter No. 02-18 is available in docket number USCG-2018-0278 on
For information about this policy, contact Cathleen Mauro CG-MMC-1 by phone at (202) 372-1449 or by email at
The International Maritime Organization (IMO) adopted the International Code for Ships Operating in Polar Waters, commonly referred to as the Polar Code, to address safety and environmental requirements for ships and the level of training required for deck officers serving on them. The Polar Code came into force on January 1, 2017.
The International Convention on Standards of Training, Certification and Watchkeeping for Seafarers, 1978, as amended, (STCW) Convention and Code is the instrument that provides the international standards for seafarer training. Through the work of the IMO's Sub-committee on Human Element, Training and Watchkeeping, amendments to the STCW Convention and Code were developed to define the training requirements supporting the implementation of the Polar Code. These amendments provide minimum standards of competence, sea service and training requirements for certification at the basic and advanced levels. They also contain transitional provisions for mariners with experience operating in polar waters to meet the new requirements. These amendments enter into force on July 1, 2018. After this date, deck officers on ships operating in polar waters will be required to have a Merchant Mariner Credential (MMC) endorsement in Basic or Advanced Polar Code operations.
To address the gap between the time the Polar Code entered into force (January 2017) and the time the supporting STCW amendments enter into force (July 2018), the Coast Guard provided CG-OES Policy Letter No. 01-16, “Guidelines for Training of Personnel on Ships Subject to the Polar Code” (81 FR 7552, Feb. 12, 2016).
CG-OES Policy Letter No. 01-16 was an interim measure to ensure there would be sufficiently trained U.S. mariners by the time the Polar Code entered into force. The Coast Guard did not issue endorsements to mariners who completed training in accordance with that policy.
Cognizant of the approaching date that the STCW amendments enter into force, the Coast Guard will issue STCW endorsements in Basic and Advanced Polar Code Operations to mariners who have voluntarily fulfilled the STCW requirements and who request the endorsement. CG-MMC policy letter No. 02-18 provides information on how to request the endorsement. These endorsements are not currently mandated by Coast Guard regulation; however, since the United States is signatory to the STCW Convention, vessel owners and operators should be aware that their vessels are subject to foreign port state control actions including detention if mariners are not compliant with the STCW Convention and Code.
The policy letter is effective today, and the National Maritime Center is now accepting applications for Polar Code Operations endorsements. We request public comments on the policy letter, including the instructions for requesting endorsements, so that we may improve the letter if needed.
We view public participation as essential to effective policy development, and will consider all comments and material received during the comment period. If you submit a comment, please include the docket number for this action, and indicate the specific section of CG-MMC Policy Letter No. 02-18 to which your comment applies. Please make your comments as specific as possible, and include any applicable supporting data or other information, such as cost information, you may have.
We encourage you to submit comments through the Federal eRulemaking Portal at
We accept anonymous comments. All comments received will be posted without change to
We issue this notice of policy availability under the authority of 5 U.S.C. 552(a) and 46 U.S.C. 7101.
Bureau of Land Management, Interior.
Notice of auction and sale.
The Secretary of the Interior (Secretary), through the Bureau of Land Management (BLM) New Mexico State Office, is issuing this Notice to conduct an auction and sale from the Federal Helium Program, administered by the
The schedule for the auction and sale process is:
The July 18, 2018, helium auction will be held in the main conference room of the Amarillo Field Office, 801 South Fillmore, Suite 500, Amarillo, TX 79101. Supplementary documents referenced in this Notice are available at the BLM helium operations website at:
Samuel R.M. Burton, Amarillo Field Manager, telephone: 806-356-1000, email:
In October 2013, Congress passed the HSA. The HSA requires the Department of the Interior, through the BLM Director, to offer for auction and sale annually a portion of the helium reserves owned by the United States and stored underground at the Cliffside Gas Field near Amarillo, Texas.
On July 23, 2014, the BLM published a “Final Notice for Implementation of Helium Stewardship Act Sales and Auctions” in the
On August 24, 2015, the BLM published a “Notice of Final Action: Crude Helium Sale and Auction for Fiscal Year 2016 Delivery” in the
All previous Final Notices are available from the Helium Stewardship, HSA Implementation page of the BLM helium website at
Table 1 identifies the volumes to be offered for auction and sale in FY 2018 for FY 2019 delivery.
6 lots of 25 MMcf each; and
5 lots of 15 MMcf each; and
3 lots of 5 MMcf each.
Supplementary documents referenced in this Notice are available at the BLM helium operations website at:
a. This
b. The HSA (50 U.S.C. 167);
c. FY 2019 Helium Auction Notice and Guide;
d. 2016 Storage Contract (template for information only);
e. Determination of Fair Market Value Pricing of Crude Helium;
f. Storage Fees;
g. Required Forms for Helium Reporting; and
h. FY 2014 through FY 2018
The HSA of 2013 (Pub. L. 113-40) codified to various sections in 50 U.S.C. 167-167q.
Bureau of Land Management, Interior.
Notice of intent.
In compliance with the National Environmental Policy Act of 1969 (NEPA), as amended, and the Federal Land Policy and Management Act of 1976 (FLPMA), as amended, the Bureau of Land Management (BLM), Arizona Strip Field Office, St. George, Utah, intends to amend a portion of the Arizona Strip Field Office (ASFO) Resource Management Plan (RMP) related to the Kanab Creek Area of Critical Environmental Concern (ACEC). The BLM will incorporate the analysis for the RMP amendment into a Federal Energy Regulatory Commission (FERC) Environmental Impact Statement (EIS) for the Lake Powell Pipeline Project. FERC is the lead agency and the BLM is a cooperating agency. FERC's EIS will analyze the proposed Lake Powell Pipeline Project and the proposed RMP amendment to consider allowing development of the Lake Powell Pipeline within the Kanab Creek ACEC. By this notice the BLM is announcing the beginning of the scoping process to solicit public comments and identify issues pursuant to BLM's land use planning regulations.
This notice initiates the public scoping process for the RMP amendment with an associated EIS. Comments on issues may be submitted in writing until July 23, 2018. The date(s) and location(s) of any scoping meetings will be announced at least 15 days in advance through local media, newspapers, and the BLM website at:
You may submit comments on issues and planning criteria related to the Kanab Creek ACEC RMP amendment by any of the following methods:
•
•
•
•
Documents pertinent to this proposal may be examined at the Arizona Strip Field Office at the address above.
Lorraine Christian, BLM Arizona Strip Field Manager, telephone: 435-688-3200; email:
The planning area is located in Coconino and Mohave Counties, Arizona. Only a small portion (900 acres) of the Kanab Creek ACEC would be affected by the proposed Lake Powell Pipeline route, but an RMP amendment is required in order to address inconsistencies between the management direction in the current RMP, the proposed route for the pipeline, and an existing utility corridor designated under the Energy Policy Act of 2005.
Approximately 1 mile of the proposed pipeline would run within an existing utility corridor, designated by the BLM pursuant to Section 368 of the Energy Policy Act of 2005, which overlaps a portion of the ACEC. Approximately 0.5 mile of the proposed pipeline would run inside the ACEC, but outside the existing utility corridor; this pipeline route is proposed due to steep rugged terrain which could be avoided by routing the pipeline outside of the utility corridor. The ASFO RMP encourages new utility rights-of-way (ROW) to be located within the utility corridor to the greatest extent possible. However, the ASFO RMP also established ACECs as “avoidance areas” for new ROWs. The BLM proposes to amend the ASFO RMP to: (1) Resolve the conflict between the designated Section 368 utility corridor and the ACEC decisions; and (2) Determine whether to allow the proposed Lake Powell Pipeline outside of the utility corridor, and if so, change the visual resource management class for that portion of the ACEC from Class II (where changes to the landscape should be low) to either Class III or Class IV in order to be compatible with utility development.
The purpose of the public scoping process is to determine relevant issues that will influence the scope of the environmental analysis, including alternatives, and guide the planning process. Preliminary issues for the RMP amendment area have been identified by BLM personnel; Federal, State, and local agencies; and other stakeholders. These issues include: Cultural resources, specifically tribal resources and values; special status species; riparian habitat; visual resources; special designations (
Preliminary planning criteria include: (1) The BLM will continue to manage the Kanab Creek ACEC in accordance with FLPMA and other applicable laws and regulations; (2) The BLM will continue to manage Utility Corridor No. 113-116 in accordance with FLPMA and other applicable laws and regulations; and (3) The amendment process will follow the FLPMA planning process.
You may submit comments on issues and planning criteria in writing to the BLM at any ASFO RMP amendment public-scoping meeting, or you may submit them to the BLM using one of the methods listed in the
The BLM will coordinate the processes of fulfilling requirements of NEPA and Section 106 of the National Historic Preservation Act (54 U.S.C. 306108), as provided in 36 CFR 800.2(d)(3).
The BLM will consult with Indian tribes on a government-to-government basis in accordance with Executive Order 13175 and other policies. Tribal concerns, including impacts on Indian trust assets and potential impacts to cultural resources, will be given due consideration. Federal, State, and local
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 personally identifying information—may be made publicly available at any time. While you can ask the BLM in your comment to withhold your personally-identifying information from public review, we cannot guarantee that we will be able to do so.
The minutes and list of attendees for each scoping meeting will be available to the public and open for 30 days after the meeting to any participant who wishes to clarify the views he or she expressed. The BLM will evaluate all identified issues, and will place them into one of three categories:
1. Issues to be resolved in the RMP amendment;
2. Issues to be resolved through policy or administrative action; or
3. Issues beyond the scope of this RMP amendment.
An explanation will be provided in FERC's Draft EIS as to why an issue was placed in category two or three. The public is also encouraged to help identify any issues that should be addressed in the RMP. The BLM will work collaboratively with interested parties to identify the management decisions that are best suited to local, regional, and national needs and concerns.
The BLM will use an interdisciplinary approach to develop the RMP amendment in order to consider the variety of resource issues and concerns identified, as well as to develop alternatives to the proposed RMP amendment. Specialists with expertise in the following disciplines will be involved in the planning process: Archaeology and cultural resources, tribal issues, wildlife, visual resources, lands, realty, and special area designations.
40 CFR 1501.7 and 43 CFR 1610.2.
Bureau of Land Management, Interior.
Notice of availability.
In accordance with the National Environmental Policy Act of 1969, as amended, and the Federal Land Policy and Management Act of 1976, as amended, the Bureau of Land Management (BLM) has prepared the NPL Final Environmental Impact Statement (Final EIS) for the NPL project in the BLM Pinedale and Rock Springs Field Offices.
The BLM will not issue a final decision on the proposal for a minimum of 30 days after the date that the Environmental Protection Agency publishes its Notice of Availability (NOA) in the
The NPL Final EIS is available for public review at the BLM Pinedale Field Office, 1625 West Pine Street, Pinedale, Wyoming; the BLM High Desert District Office, 280 Highway 191 North, Rock Springs, Wyoming; and the BLM Wyoming State Office, 5353 Yellowstone Road, Cheyenne, Wyoming. The document may also be reviewed online at
Kellie Roadifer, NPL EIS Project Manager, BLM Pinedale Field Office, PO Box 768, Pinedale, WY 82941, (307) 367-5309,
The NPL project is located immediately south and west of the existing Jonah Gas Field in Sublette County, Wyoming. The project area lies within the BLM Wyoming High Desert District (HDD) and spans the Pinedale Field Office (PFO) in the north and Rock Springs Field Office (RSFO) to the south.
The project encompasses approximately 141,000 acres of public, State, and private lands. Approximately 96% of the project area is on BLM-administered public lands. Within the NPL project area, there are both unitized and non-unitized development areas.
Jonah Energy LLC, the current operator after purchasing Encana Oil and Gas Inc.'s leasehold interest in the project, is proposing up to 3,500 directionally drilled wells (depth range from 6,500 to 13,500 feet) over a 10-year period. Under Jonah Energy's proposal, most wells would be co-located on multi-well pads, with no more than four well pads per 640 acres in areas outside of Greater Sage-grouse Priority Habitat Management Areas (PHMA). There would be only one disturbance per 640 acres inside PHMA. On average, each well pad would be 18 acres in size. Regional gathering facilities would be utilized instead of placing compressors at each well pad. Associated access roads, pipelines, and other ancillary facilities would be co-located where possible to further minimize surface disturbance.
There are approximately 48,036 acres of PHMA, 27,292 acres of Greater Sage-grouse Winter Concentration Area (WCA), and 1,259 acres of Sagebrush Focal Areas (SFAs) within the NPL project area. All of the SFA is within the Rock Springs Field Office.
Cooperating agencies for this EIS include the State of Wyoming, with active participation from many state agencies including the Wyoming Game and Fish Department, State Historic Preservation Office, the Wyoming Department of Environmental Quality and the Wyoming Department of Agriculture. Local cooperating agencies include Sweetwater, Lincoln and Sublette Counties, and the Sublette County Conservation District.
The Notice of Intent to prepare the EIS was published on April 12, 2011 (70 FR 20370), initiating a 30-day formal public scoping period. Public scoping meetings were held in Pinedale, Rock Springs, and Marbleton, WY. Public scoping comments were used to identify issues that informed the formulation of alternatives and framed the scope of analysis for the NPL EIS.
A total of 1,238 scoping comments were received, with 29 resource issues identified. Key issues identified during scoping informed the formulation of alternatives and framed the scope of analysis for the NPL Final EIS. The issues include:
In response to the scoping comments received, the BLM developed three alternatives to the Proposed Action: The No Action Alternative, utilizing existing standard stipulations and examining the project area under the historical rate of development of around three wells per year; Alternative A, utilizing a phased approach moving through existing leased oil and gas units and responding to identified wildlife issues; and Alternative B, which addressed a broad range of resource concerns in response to issues identified during scoping.
Alternatives A and B each analyzed the same rate of development as the Proposed Action, as well as the use of regional gathering facilities. However, in addition to varying resource protection measures, each alternative analyzed differing densities of development between one to four well pads per 640 acres, depending on the resource considerations of the project area. Additionally, Alternative A analyzed the merits of developing the project area in three geographically defined phases, occurring sequentially, and taking into consideration existing oil and gas units.
Interim and final reclamation activities would be implemented under all alternatives to return the landscape to its previous condition in conformance with the NPL Reclamation Plan and the relevant Resource Management Plans (RMP).
All alternatives conform to the Pinedale Field Office Resource Management Plan Record of Decision (2008) and the Rock Springs Field Office Green River Resource Management Plan Record of Decision (1997), as amended by the Record of Decision and Approved Resource Management Plan Amendments for the Rocky Mountain Region, Including the Greater Sage-Grouse Sub-Region of Wyoming (2015).
The Draft EIS Notice of Availability was published on July 7, 2017 (129 FR 31628), opening a 45-day public comment period. Public meetings were held on July 25, 2017 in Pinedale, and July 26, 2017 in Rock Springs. Over 1,000 individual comment letters were received. Comments included identified issues associated with each alternative, including feasibility and sufficiency of the analysis and impacts to specific resources as a result of each alternative. Comments were considered and incorporated as appropriate into the Final EIS; however, the analysis of the alternatives and the identified impacts did not significantly change.
The Final EIS is consistent with the BLM's obligations under the Federal Land Policy and Management Act.
40 CFR 1506.6 and 40 CFR 1506.10.
United States International Trade Commission.
June 28, 2018 at 11:00 a.m.
Room 101, 500 E Street SW, Washington, DC 20436, Telephone: (202) 205-2000.
Open to the public.
1.
2. Minutes.
3. Ratification List.
4. Vote on Inv. Nos. 731-TA-1369-1372 (Final) (Fine Denier Polyester Staple Fiber from China, India, Korea, and Taiwan). The Commission is currently scheduled to complete and file its determinations and views of the Commission by July 13, 2018.
5.
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.
Notice of application.
Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before July 23, 2018. Such persons may also file a written request for a hearing on the application on or before July 23, 2018.
Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152.
The Attorney General has delegated his authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Assistant Administrator of the DEA Diversion Control Division (“Assistant Administrator”) pursuant to section 7 of 28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR 1301.34(a), this is notice that on April 24, 2018, Unither Manufacturing LLC, 331 Clay Road, Rochester, New York 14623 applied to be registered as an importer of methylphenidate (1724), a basic class of controlled substance listed in schedule II.
The company plans to import the listed substance solely for updated
Office of Justice Programs, Bureau of Justice Assistance (BJA), Justice.
Notice of meeting.
This is an announcement of a meeting (via WebEx/conference call-in) of the Public Safety Officer Medal of Valor Review Board to consider a range of issues of importance to the Board, to include but not limited to: The MOV Charter renewal; Bylaws; membership/terms; nomination eligibility; the conflict of interest policy and procedures; the pending 2016-2017 MOV ceremony; the 2017-2018 nominations, program outreach and marketing efforts; potential updates to the administrative system; and other issues of interest to the Board. The meeting date and time is listed below.
Tuesday, August 7, 2018, 1:00 p.m. to 2:00 p.m. EST.
This meeting will take place via WebEx/conference call-in.
Gregory Joy, Policy Advisor, Bureau of Justice Assistance, Office of Justice Programs, 810 7th Street NW, Washington, DC 20531, by telephone at (202) 514-1369, toll free (866) 859-2687, or by email at
The Public Safety Officer Medal of Valor Review Board carries out those advisory functions specified in 42 U.S.C. 15202. Pursuant to 42 U.S.C. 15201, the President of the United States is authorized to award the Public Safety Officer Medal of Valor, the highest national award for valor by a public safety officer.
This meeting/conference call is open to the public at the offices of BJA. For security purposes, members of the public who wish to participate must register at least seven (7) days in advance of the meeting/conference call by contacting Mr. Joy. All interested participants will be required to meet at the Bureau of Justice Assistance, Office of Justice Programs, 810 7th Street NW, Washington, DC, 20531, and will be required to sign in at the front desk.
Access to the meeting/conference call will not be allowed without prior registration. Anyone requiring special accommodations should contact Mr. Joy at least seven (7) days in advance of the meeting. Please submit any comments or written statements for consideration by the Review Board in writing at least seven (7) days in advance of the meeting date.
Department of Labor (DOL).
Notice.
The U.S. Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995. This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. Currently, the Office of Disability Employment Policy (ODEP) of the Department of Labor (DOL) is soliciting comments concerning the proposed collection of information for the
A copy of the proposed information collection request (ICR) can be obtained by contacting the office listed below in the
Submit comments on or before August 21, 2018.
Submit written comments to the Office of Disability Employment Policy, Room S-1303, 200 Constitution Avenue NW, Washington, DC 20210, Attention: Juston Locks, Workforce Research Analyst, Division of Policy Planning and Research.
Juston Locks, Workforce Research Analyst, Division of Policy Planning & Research, Office of Disability Employment Policy, U.S. Department of Labor, Room S-1303, 200 Constitution Avenue NW, Washington, DC 20210; telephone (202) 693-7880 (this is not a toll free number). Copies of this notice may be obtained in alternative formats (Large print, Braille, Audio Tape, or Disc), upon request by calling (202) 693-7880 (this is not a toll-free number). TTY/TTD callers may dial (202) 693-7881 to obtain information or to request materials in alternative formats.
In FY 2018, the Department of Labor and the Social Security Administration are collaborating to develop and test promising stay-at-work/return-to-work (SAW/RTW) early intervention strategies and evaluate outcomes for individuals who are at risk of experiencing work disability.
SAW/RTW programs succeed by returning injured workers to productive work as soon as medically possible by providing interim part-time or light duty work and accommodations, as necessary. The RETAIN Demonstration Projects are modeled after promising programs currently operating in Washington State, including the Centers of Occupational Health and Education (COHE),
The primary goals of the RETAIN Demonstration Projects are:
1. To increase employment retention and labor force participation of individuals who acquire, and/or are at risk of developing, work disabilities; and
2. To reduce long-term work disability among project participants, including the need for federal disability benefits (
The ultimate purpose of the demonstration is to validate and bring to scale evidence-based strategies to accomplish these goals.
By September 2018, up to eight states will receive funding through a cooperative agreement to create systems changes by developing and implementing partnerships and strategies to test the effects of the provision of comprehensive, coordinated health and employment-related services and supports to injured or ill workers who have acquired, or are at risk of developing, a work disability. Awards will be made in two phases. In Phase 1, up to eight states will receive awards to complete start-up activities and launch a small pilot. In Phase 2, up to four of those states will receive awards to scale up their pilot to full implementation. Only Phase 1 awardees will be eligible to compete for Phase 2 awards.
The purpose of the RETAIN employee participant information collection is to understand and assess RETAIN program start-up, pilot projects, and full implementation.
DOL is interested in comments that:
• Evaluate whether the proposed collection of information is necessary, and whether the information will have practical utility;
• evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• enhance the quality, utility, and clarity of the information to be collected; and
• minimize the burden of the collection of information on those who are to respond.
This information collection is subject to the PRA. A federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless it is approved by the OMB under the PRA and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid Control Number. See 5 CFR 1320.5(a) and 1320.6.
Comments submitted in response to this Notice will be summarized and/or included in the request for Office of Management and Budget approval of the ICR; they will also become a matter of public record.
Notice of availability; request for comments.
The Department of Labor (DOL) is submitting the Wage and Hour Division (WHD) sponsored information collection request (ICR) revision titled, “Fair Labor Standards Act Special Employment Provisions,” to the Office of Management and Budget (OMB) for review and approval for use in accordance with the Paperwork Reduction Act (PRA) of 1995. Public comments on the ICR are invited.
The OMB will consider all written comments that agency receives on or before July 23, 2018.
A copy of this ICR with applicable supporting documentation; including a description of the likely respondents, proposed frequency of response, and estimated total burden may be obtained free of charge from the
Submit comments about this request by mail to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL-WHD, Office of Management and Budget, Room 10235, 725 17th Street NW, Washington, DC 20503; by Fax: 202-395-5806 (this is not a toll-free number); or by email:
Michel Smyth by telephone at 202-693-4129, TTY 202-693-8064, (these are not toll-free numbers) or sending an email to
This ICR seeks approval under the PRA for revisions to the Fair Labor Standards Act (FLSA) Special Employment Provisions information collection. FLSA special employment provisions relate to restrictions on industrial homework and to the use of special certificates that allow for the employment of categories of workers who may be paid less than the statutory minimum wage to the extent necessary to prevent curtailment of their employment opportunities. This information collection has been classified as a revision, because the Department proposes to revise forms WH-226 (Application for Authority to Employ Workers with Disabilities at Special Minimum Wages) and WH-226A (Supplemental Data Sheet for Application for Authority to Employ Workers with Disabilities at Special Minimum Wages). The proposed changes would provide an electronic platform the public may use to submit Forms WH-226 and WH-226A. The substance of the proposed electronic forms is substantially the same with minor word changes to accommodate the type of submission (electronic versus paper). FLSA sections 11(d) and 14(a) and 14(b) authorize this information collection.
This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless it is approved by the OMB under the PRA and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid Control Number.
Interested parties are encouraged to send comments to the OMB, Office of Information and Regulatory Affairs at the address shown in the
The OMB is particularly interested in comments that:
• 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;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
44 U.S.C. 3507(a)(1)(D).
Notice of availability; request for comments.
The Department of Labor (DOL) is submitting the Employment and Training Administration (ETA) sponsored information collection request (ICR) titled, “Attestation for Employers Seeking to Employ H-2B Nonimmigrant Workers Under Section 543 of the Consolidated Appropriations Act, 2017,” to the Office of Management and Budget (OMB) for review and approval for use in accordance with the Paperwork Reduction Act (PRA) of 1995. Public comments on the ICR are invited.
The OMB will consider all written comments that agency receives on or before July 23, 2018.
A copy of this ICR with applicable supporting documentation; including a description of the likely respondents, proposed frequency of response, and estimated total burden may be obtained free of charge from the
Submit comments about this request by mail or courier to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL-ETA, Office of Management and Budget, Room 10235, 725 17th Street NW, Washington, DC 20503; by Fax: 202-395-5806 (this is not a toll-free number); or by email:
Michel Smyth by telephone at 202-693-4129, TTY 202-693-8064, (these are not toll-free numbers) or sending an email to
This ICR seeks approval under the PRA for revisions to the Attestation for Employers Seeking to Employ H-2B Nonimmigrant Workers Under Section 543 of the Consolidated Appropriations Act, 2017 information collection. As set forth in the Temporary Rule,
This proposed information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless it is approved by the OMB under the PRA and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information if the collection of information does not display a valid Control Number.
Interested parties are encouraged to send comments to the OMB, Office of Information and Regulatory Affairs at the address shown in the
• 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;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
44 U.S.C. 3507(a)(1)(D).
Mine Safety and Health Administration, Labor.
Notice.
This notice is a summary of petitions for modification submitted to the Mine Safety and Health Administration (MSHA) by the parties listed below.
All comments on the petitions must be received by MSHA's Office of Standards, Regulations, and Variances on or before July 23, 2018.
You may submit your comments, identified by “docket
1.
2.
3.
MSHA will consider only comments postmarked by the U.S. Postal Service or proof of delivery from another delivery service such as UPS or Federal Express on or before the deadline for comments.
Barbara Barron, Office of Standards, Regulations, and Variances at 202-693-9447 (phone),
Section 101(c) of the Federal Mine Safety and Health Act of 1977 and Title 30 of the Code of Federal Regulations Part 44 govern the application, processing, and disposition of petitions for modification.
Section 101(c) of the Federal Mine Safety and Health Act of 1977 (Mine Act) allows the mine operator or representative of miners to file a petition to modify the application of any mandatory safety standard to a coal or other mine if the Secretary of Labor (Secretary) determines that:
1. An alternative method of achieving the result of such standard exists which will at all times guarantee no less than the same measure of protection afforded the miners of such mine by such standard; or
2. That the application of such standard to such mine will result in a diminution of safety to the miners in such mine.
In addition, the regulations at 30 CFR 44.10 and 44.11 establish the requirements and procedures for filing petitions for modification.
(1) The Road Fork #52 mine extracts coal from the Pocahontas No. 3 coal seam. The Road Fork #52 mine will operate two continuous miner sections producing coal 5 to 6 days per week.
(2) In addition to the horizontal coalbed methane wells, there are many vertical oil and gas wells which exist in the reserve area of the Road Fork #52 mine.
(3) Road Fork #52 mine will employ the continuous mining room and pillar method of mining. It is anticipated that each vertical wellbore will be mined through only once in any seam.
(4) With respect to vertical mines, the petitioner proposes to modify 30 CFR 75.1700 as provided for below. The modifications requested would allow petitioner to mine through vertical wellbores as encountered and whenever the safety barrier diameter is reduced to a distance less than the District Manager would approve pursuant to § 75.1700 for plugged oil or gas wells penetrating the Pocahontas No. 3 Coal Seam and other mineable coal seams.
(a) The petitioner proposes to use the following procedures when cleaning out and preparing oil and gas wells prior to plugging and replugging;
(1) A diligent effort will be made to clean the borehole to the original total depth. If this depth cannot be reached, the borehole will be cleaned out to a depth which would permit the placement of at least 200 feet of expanding cement below the base of the lowest mineable coalbed.
(2) When cleaning the borehole, a diligent effort will be made to remove all the casing in the borehole. If it is not possible to remove all casing, the casing which remains will be perforated, or ripped, at intervals spaced close enough to permit expanding cement slurry to infiltrate the annulus between the casing and the borehole wall for a distance of at least 200 feet below the base of the lowest mineable coalbed.
(3) If the cleaned-out borehole produces gas, a mechanical bridge plug will be placed in the borehole in a competent stratum at least 200 feet below the base of the lowest mineable coalbed, but above the top of the uppermost hydrocarbon-producing stratum. If it is not possible to set a mechanical bridge plug, a substantial brush plug may be used in place of the mechanical bridge plug.
(4) Logs will be made consisting of a caliper survey directional deviation survey and logs suitable for determining the top and bottom of the lowest mineable coalbed and potential hydrocarbon producing strata and the location for the bridge plug.
(5) If the uppermost hydrocarbon-producing stratum is within 200 feet of the base of the lowest mineable coalbed, properly placed mechanical bridge plugs or a suitable brush plug, described in subparagraph (a)(3) above, will be used to isolate the hydrocarbon-producing stratum from the expanding cement plug. Nevertheless, a minimum of 200 feet of expanding cement will be placed below the lowest mineable coalbed.
(6) The wellbore will be completely filled and circulated with a gel that inhibits any flow of gas, supports the walls of the borehole, and increases the density of the expanding cement. This gel will be pumped through open-end tubing that extends to approximately 20 feet above the bottom of the cleaned out area of the borehole or bridge plug.
(b) The petitioner proposes to use the following procedures when plugging oil and gas wells to the surface:
(1) A cement plug will be set in the wellbore by pumping an expanding cement slurry down the tubing to displace the gel and fill the borehole to the surface. As an alternative, the cement slurry may be pumped down the tubing so that the borehole is filled with Portland cement or a Portland cement-fly ash mixture from approximately 100 feet above the top of the lowest mineable coalbed to the surface with an expanding cement plug extending from at least 200 feet below the lowest mineable coalbed to the bottom of the Portland cement. There will be at least 200 feet of expanding cement below the base of the lowest mineable coalbed.
(2) A small quantity of steel turnings, or other small magnetic particles, will be embedded in the top of the cement near the surface to serve as a permanent magnetic monument of the borehole.
(c) The petitioner proposes the following procedures when using the vent pipe method for plugging oil and gas wells:
(1) A 4
(2) A cement plug will be set in the wellbore by pumping an expanding
(3) All fluid will be evacuated from the vent pipe to facilitate testing for gases. During the evacuation of fluid, the expanding cement will not be disturbed.
(4) The top of the vent pipe will be protected to prevent liquids or solids from entering the wellbore, but permit ready access to the full internal diameter of the vent pipe when necessary.
(d) The petitioner proposes to use the following procedures when plugging oil or gas wells for subsequent use as degasification boreholes:
(1) A cement plug will be set in the wellbore by pumping an expanding cement slurry down the tubing to displace the gel and provide at least 200 feet of expanding cement below the lowest mineable coalbed. The top of the expanding cement will extend upward to about the top of the coalbed being mined. This distance will be based on the average height of the roof strata breakage for the mine.
(2) To facilitate methane drainage, degasification casing of suitable diameter, slotted or perforated throughout its lower 150 to 200 feet, will be set in the borehole to a point 10 to 30 feet above the top of the expanding cement.
(3) The annulus between the degasification casing and the borehole wall will be cemented from a point immediately above the slots or perforations to the surface.
(4) The degasification casing will be cleaned out for its total length.
(5) The top of the degasification casing will be fitted with a wellhead equipped as required by the DM. Such equipment may include check valves, shut-in valves, sampling ports, flame arrestor equipment, and security fencing.
(e) The petitioner proposes to use the well plugging procedures described above and the cut-through procedures described below whenever the petitioner reduces the safety barrier diameter to a distance less than the DM would approve pursuant to § 75.1700, or proceeds with an intent to cut-through a plugged well.
(1) The petitioner will notify the DM or his designee prior to reducing the safety barrier to a distance less than the DM would approve pursuant to § 75.1700 or proceeding with an intent to cut through a plugged well.
(2) Mining through a plugged well will be done on a shift approved by the DM or designee.
(3) Prior to mining through a plugged well, the petitioner will notify the DM or designee, representative of the miners, and the appropriate State agency in sufficient time for them to have a representative present.
(4) Drivage sites will be installed at the last open crosscut near the place to be mined to ensure intersection of the well. The drivage sites will not be more than 50 feet from the well.
(5) Firefighting equipment, including fire extinguishers, rock dust, and sufficient fire hose to reach the working face area of the mining-through will be available when either the conventional or continuous mining method is used. The fire hose will be located in the last open crosscut of the entry or room. All fire hoses will be ready for operation during the mining-through.
(6) Sufficient supplies of roof support and ventilation materials will be available and located at the last open crosscut. In addition, an emergency plug and/or plugs will be available in the immediate area of the mine-through.
(7) At least the quantity of air required by the approved mine ventilation plan, but not less than 6,000 cubic feet per minute for scrubber equipped continuous miners or not less than 9,000 cubic feet per minute for continuous miner sections using auxiliary fans or line brattice only, will be used to ventilate the working face during the mining- through operation.
(8) Equipment will be checked for permissibility and serviced on the shift prior to mining-through the well and the water line maintained to the tail piece with a sufficient amount of fire hose to reach the farthest point of penetration on the section.
(9) The methane monitor on the continuous mining machine will be calibrated on the shift prior to mining-through the well.
(10) When mining is in progress, tests for methane will be made with a hand-held methane detector at least every 10 minutes from the time that mining with the continuous mining machine is within 30 feet of the well until the well is intersected and immediately prior to mining through. During the actual cutting through process, no individual will be allowed on the return side until mining-through has been completed and the area has been examined and declared safe.
(11) The working place will be free from accumulations of coal dust and coal spillages, and rock dust will be placed on the roof, rib and floor within 20 feet of the face when mining through or near the well on the shift or shifts during which the cut-through will occur.
(12) When the wellbore is intersected, all equipment will be deenergized and the place thoroughly examined and determined safe before mining is resumed. Any well casing will be removed and no open flames will be permitted in the area until adequate ventilation has been established around the wellbore.
(13) After a well has been intersected and the working place determined safe, mining will continue inby the well a sufficient distance to permit adequate ventilation around the area of the wellbore.
(14) No person will be permitted in the area of the mining-through operation except those actually engaged in the operation, company personnel, representatives of the miners, personnel from MSHA, and personnel from the appropriate State agency.
(15) The mining-through operation will be under the direct supervision of a certified official. Instructions concerning the mining-through operation will be issued only by the certified official in charge.
(16) MSHA personnel may interrupt or halt the mining-through operation when it is necessary for the safety of the miners.
(17) A copy of the petition will be maintained at the mine and be available to the miners.
(18) The petitioner will file a plugging affidavit setting forth the persons who participated in the work, a description of the plugging work, and certification by the petitioner that the well has been plugged as described.
(19) Within 60 days after the proposed decision and order (PDO) becomes final, the petitioner will submit proposed revisions for its approved 30 CFR part 48 training plan to the DM. These proposed revisions will include initial and refresher training regarding compliance with the terms and conditions in the PDO.
(f) Prior to mining through a vertical wellbore of a well, in addition to complying with the modifications described above, the petitioner will verify that the following procedures have been performed on the well:
(1) If water is present, it will be bailed from the vertical section of the wellbore, as close to the coal seam elevation as practical using normal bailing equipment.
(2) The surface wellhead will be maintained open to bring the vertical section of the wellbore to outside atmospheric pressure.
(g) In addition, the petitioner proposes to do the following:
(1) Install drivage sites within 80 feet of the mine-through point.
(2) Provide firefighting equipment near the working face, including two 10—pound fire extinguishers, 240 pounds of rock dust, and fire hose of sufficient length to reach the working face and capable of delivering at least 50 gallons per minute of water at minimum pressure of 50 pounds per square inch.
(3) Supply a quantity of at least 9,000 CFM of intake air at the face, but no less than the approved ventilation plan amount, of intake air at the face.
(4) Calibrate the continuous miner methane monitor on one of the five production shifts prior to the shift during which the mine-through is anticipated.
(5) Test for methane with a hand-held methane detector at least every 10 minutes during the time mining is conducted within 30 feet of the wellbore.
(6) Deenergize all equipment and thoroughly examine the area when the wellbore is intersected.
(7) Continue hand-held methane detector tests at least every 10 minutes during production shifts until mining has progressed 20 feet past the initial mine-through point once the area has been determined to be safe and mining has resumed.
(h) Only company personnel, personnel from MSHA, and personnel from the appropriate West Virginia agency will be permitted in the area of the mine-through operation.
(i) The mine-through operation will be under the direct supervision of the certified official. Instructions concerning the mine-through operation will be issued only by a certified official.
The petitioner asserts that the proposed alternative method will at all times guarantee no less than the same measure of protection from the potential hazards against which the existing standard was intended to guard.
Notice.
The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a preclearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995. This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. Currently, the Office of Workers' Compensation Programs is soliciting comments concerning the proposed collection: Rehabilitation Maintenance Certificate (OWCP-17). A copy of the proposed information collection request can be obtained by contacting the office listed below in the addresses section of this Notice.
Written comments must be submitted to the office listed in the addresses section below on or before August 21, 2018.
You may submit comments by mail, delivery service, or by hand to Ms. Yoon Ferguson, U.S. Department of Labor, 200 Constitution Ave. NW, Room S-3323, Washington, DC 20210; by fax to (202) 354-9647; or by Email to
* 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;
* evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
* enhance the quality, utility and clarity of the information to be collected; and
* minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
Comments submitted in response to this notice will be summarized and/or included in the request for Office of Management and Budget approval of the information collection request; they will also become a matter of public record.
Pursuant to 10 CFR 2.313(c) and 2.321(b), the Atomic Safety and Licensing Board in the above-captioned
All correspondence, documents, and other materials shall continue to be filed in accordance with the NRC E-Filing rule.
In Notice document 2018-12506 beginning on page 28456 in the issue of Tuesday, June 19, 2018, make the following correction:
On page 28464, in the second column, the seventh and eighth paragraphs should read as follows:
“Date of amendment request: April 13, 2018. A publicly-available version is in ADAMS under Accession No. ML18103A252.
Description of amendment request: The amendment request proposes to change Technical Specifications (TSs) Limiting Condition for Operation 3.5.5 to not require the Passive Residual Heat Removal Heat Exchanger to be operable in Mode 5 during vacuum fill operations. Additionally, the requested amendment proposes to change Surveillance Requirement (SR) 3.5.7.1 regarding operability requirements for the In-containment Refueling Water Storage Tank and associated flow paths and proposes to add an additional SR 3.5.7.2 to address operability requirements that are not required during vacuum fill operations. Finally, the requested amendment proposes conforming changes to the Updated Final Safety Analysis Report, Appendix 19E, Subsection 2.3.2.4.”
Nuclear Regulatory Commission.
Exemption and combined license amendment; issuance.
The U.S. Nuclear Regulatory Commission (NRC) is granting an exemption to allow a departure from the certification information of Tier 1 of the generic AP1000 design control document (DCD) and is issuing License Amendment Nos. 123 and 122 to Combined Licenses (COL), NPF-91 and NPF-92, respectively. The COLs were issued to Southern Nuclear Operating Company, Inc., and Georgia Power Company, Oglethorpe Power Corporation, MEAG Power SPVM, LLC, MEAG Power SPVJ, LLC, MEAG Power SPVP, LLC, and the City of Dalton, Georgia (the licensee); for construction and operation of the Vogtle Electric Generating Plant (VEGP) Units 3 and 4, located in Burke County, Georgia.
The granting of the exemption allows the changes to Tier 1 information that is requested in the amendment. Because the acceptability of the exemption was determined in part by the acceptability of the amendment, the exemption and amendment are being issued concurrently.
The exemption and amendment were issued on April 20, 2018.
Please refer to Docket ID NRC-2008-0252 when contacting the NRC about the availability of information regarding this document. You may access information related to this document, which the NRC possesses and is publicly available, using any of the following methods:
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Paul Kallan, Office of New Reactors, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-2809; email:
The NRC is granting exemptions from paragraph B of section III, “Scope and Contents,” of appendix D, “Design Certification Rule for the AP1000,” to part 52 of title 10 of the
Part of the justification for granting the exemptions was provided by the review of the amendments. Because the exemption is necessary in order to issue the requested license amendment, the NRC granted the exemptions and issued the amendments concurrently, rather than in sequence. This included issuing a combined safety evaluation containing the NRC staff's review of both the exemption request and the license amendment. The exemptions met all applicable regulatory criteria set forth in 10 CFR 50.12, 10 CFR 52.7, and Section VIII.A.4 of appendix D to 10 CFR part 52. The license amendments were found to be acceptable as well. The combined safety evaluation is available in ADAMS under Accession No. ML18085A628.
Identical exemption documents (except for referenced unit numbers and license numbers) were issued to the licensee for VEGP Units 3 and 4 (COLs NPF-91 and NPF-92). The exemption documents for VEGP Units 3 and 4 can be found in ADAMS under Accession Nos. ML18085A622 and ML18085A623, respectively. The exemption is reproduced (with the exception of abbreviated titles and additional citations) in Section II of this document. The amendment documents for COLs NPF-91 and NPF-92 are available in ADAMS under Accession Nos. ML18085A624 and ML18085A626, respectively. A summary of the amendment documents is provided in Section III of this document.
Reproduced below is the exemption document issued to VEGP, Units 3 and Unit 4. It makes reference to the combined safety evaluation that provides the reasoning for the findings made by the NRC (and listed under Item 1) in order to grant the exemption:
1. In a letter dated August 31, 2017, and supplemented by letters dated February 9, 2018, and March 8, 2018, the licensee requested from the Commission an exemption from the provisions of 10 CFR part 52, appendix D, section III.B, as part of license amendment request (LAR) 17-023, “Improvements to Main Control Room Post-Accident Radiological Consequences.”
For the reasons set forth in Section 3.1, “Evaluation of Exemption,” of the NRC staff's safety evaluation, which can be found in ADAMS under Accession No. ML18085A628, the Commission finds that:
A. The exemption is authorized by law;
B. The exemption presents no undue risk to public health and safety;
C. The exemption is consistent with the common defense and security;
D. Special circumstances are present in that the application of the rule in this circumstance is not necessary to serve the underlying purpose of the rule;
E. The special circumstances outweigh any decrease in safety that may result from the reduction in standardization caused by the exemption; and
F. The exemption will not result in a significant decrease in the level of safety otherwise provided by the design.
2. Accordingly, the licensee is granted an exemption from the certified DCD Tier 1 information, with corresponding changes to Appendix C of the Facility Combined Licenses as described in the licensee's request dated August 31, 2017, as supplemented by letters dated February 9, 2018, and March 8, 2018. This exemption is related to, and necessary for, the granting of License Amendment Nos. 123 and 122, which is being issued concurrently with this exemption.
3. As explained in Section 5.0, “Environmental Consideration,” of the NRC staff's safety evaluation (ADAMS Accession No. ML18085A628), this exemption meets the eligibility criteria for categorical exclusion set forth in 10 CFR 51.22(c)(9). Therefore, pursuant to 10 CFR 51.22(b), no environmental impact statement or environmental assessment needs to be prepared in connection with the issuance of the exemption.
4. These exemptions are effective as of the date of its issuance.
By letter dated August 31, 2017, and supplemented by letters dated February 9, 2018, and March 8, 2018, the licensee requested that the NRC amend the COLs for VEGP, Units 3 and 4, COLs NPF-91 and NPF-92. The proposed amendment is described in Section I of this
The Commission has determined for these amendments that the application complies with the standards and requirements of the Atomic Energy Act of 1954, as amended (the Act), and the Commission's rules and regulations. The Commission has made appropriate findings as required by the Act and the Commission's rules and regulations in 10 CFR chapter I, which are set forth in the license amendment.
A notice of consideration of issuance of amendment to facility operating license or combined license, as applicable, proposed no significant hazards consideration determination, and opportunity for a hearing in connection with these actions, was published in the
The Commission has determined that these amendments satisfy the criteria for categorical exclusion in accordance with 10 CFR 51.22. Therefore, pursuant to 10 CFR 51.22(b), no environmental impact statement or environmental assessment need be prepared for these amendments.
Using the reasons set forth in the combined safety evaluation, the staff granted the exemption and issued the amendment that the licensee requested on August 31, 2017, and supplemented on February 9, 2018 and March 8, 2018.
The exemptions and amendments were issued on April 20, 2018, as part of a combined package to the licensee (ADAMS Accession No. ML18085A620).
For the Nuclear Regulatory Commission.
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing for the Commission's consideration concerning negotiated service agreements. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202-789-6820.
The Commission gives notice that the Postal Service has filed request(s) for the Commission to consider matters related to negotiated service agreement(s). The requests(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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2.
This notice will be published in the
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
LCH SA is proposing to amend its Risk Management Procedures (the “Procedures”) to adopt a Liquidity Risk Modelling Framework (the “Framework”), which describes the Liquidity Stress Testing framework by which the Collateral and Liquidity Risk Management department (“CaLRM”) of LCH Group Holdings Limited (“LCH Group”) assures that LCH SA has enough cash available to meet any financial obligations, both expected and unexpected, that may arise over the liquidation period for each of the clearing services that LCH SA offers.
In addition to its CDSClear service, LCH SA provides clearing services in connection with cash equities and derivatives listed for trading on Euronext (EquityClear), commodity derivatives listed for trading on Euronext (CommodityClear), and tri-party Repo transactions (RepoClear).
In its filing with the Commission, LCH SA 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. LCH SA has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
LCH SA currently maintains a number of well-developed policies and procedures designed to manage its
In brief, the Framework: (i) Identifies LCH SA's sources of liquidity and corresponding liquidity risks; (ii) identifies LCH SA's liquidity requirements with respect to its members and its interoperable central counterparty (“CCP”);
The proposed Framework first identifies the main sources of liquidity available to LCH SA, cash and non-cash collateral, and assigns non-cash collateral to one of three tiers.
The proposed Framework then highlights the three principal events under which LCH SA would require liquidity: (i) The default of one or more clearing members; (ii) the default of CC&G; and (iii) operational liquidity needs (each defined below).
The proposed Framework also examines liquidity needs arising from members' defaults, liquidity needs arising from an interoperating central counterparty's default (currently CC&G), and the manner in which operational liquidity requirements are determined. Liquidity needs arising from members' defaults are those needs arising from fulfilment of the settlement of the securities of the defaulted clearing member; posting of variation margin to non-defaulting members on the positions held by the defaulted clearing member(s); the value of bonds pledged at the Banque de France; haircuts by the European Central Bank on securities posted by the defaulting Clearing Member; and investment losses. Liquidity needs arising from interoperating CCPs' defaults are those needs arising from the service closure of the Italian Clearing activity (
The proposed Framework next describes the metrics used to determine LCH SA's liquidity needs that are calculated each day over a five-day period. Such metrics include: (i) The liquidity coverage ratio; (ii) a monthly rolling average liquidity buffer; (iii) a daily minimum liquidity buffer; and (iv) required cash collateral.
With respect to the liquidity coverage ratio, the proposed Framework explains how the liquidity coverage ratio is determined for each of the clearing services that LCH SA offers in a Cover 2 scenario,
Finally, the Framework describes the reverse stress test that LCH SA runs at least quarterly. The reverse stress test is designed to help determine the limits of the models and of the liquidity risk management framework by modelling extreme market conditions that go beyond what are considered plausible market conditions over a 5-day time horizon. LCH SA stresses seven risk factors independently, and also considers these risk factors together in two combined reverse stress test scenarios, the Behavioural and Macro-economic.
LCH SA has determined that the Proposed Rule Change is consistent with the requirements of Section 17A of the Act
In particular, EMIR Article 44 provides, in part:
“A CCP shall at all times have access to adequate liquidity to perform its services and activities. . . . A CCP shall measure, on a daily basis, its potential liquidity needs [taking] into account the liquidity risk generated by the default of at least the two clearing members to which it has the largest exposures.”
LCH SA does not believe the Proposed Rule Change would have any impact, or impose any burden, on competition. The Proposed Rule Change does not address any competitive issue or have any impact on the competition among central counterparties. LCH SA operates an open access model, and the Proposed Rule Change will have no effect on this model.
Written comments relating to the Proposed Rule Change have not been solicited or received. LCH SA will notify the Commission of any written comments received by LCH SA.
Within 45 days of the date of publication of this notice in the
(A) By order approve or disapprove such proposed rule change, or
(B) institute proceedings to determine whether the proposed rule change should be disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
All comments received will be posted without change. Persons submitting comments are cautioned that we do not redact or edit personal identifying information from comment submissions. You should submit only information that you wish to make available publicly. All submissions should refer to File Number SR-LCH SA-2018-003 and should be submitted on or before July 12, 2018.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Exchange proposes to amend Exchange Rule 1101A, Terms of Option Contracts.
The text of the proposed rule change is available on the Exchange's website at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The purpose of the proposed rule change is to adopt new Commentary .06 to Exchange Rules 1101A, to codify that the Exchange will defer to The Options Clearing Corporation (“OCC”) in determining settlement prices for index options when OCC elects to do so in accordance with its own rules and bylaws. Such OCC-determined settlement prices may be determined in a manner that differs from the settlement price procedures under the Exchange's own rules.
Exchange Rule 1101A(d) currently states that the Rules of the Options Clearing Corporation specify that, unless the Rules of the Exchange provide otherwise, the current index
The Exchange proposes to add new Commentary .06 to Rule 1101A to make clear that the Exchange's settlement price procedures shall not be used if the current index value at expiration is fixed in accordance with OCC rules and by-laws. This language recognizes that OCC is authorized under its rules and by-laws to take certain actions relating to settlement in the event of the unavailability or inaccuracy of the current underlying interest value.
Proposed Rule 1101A Commentary .06 is based in part upon Chapter XIV, Section 10(g) of the Nasdaq rulebook, Chapter XIV, Section 10(g) of the BX rulebook, and ISE Rule 2008(g).
The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
OCC may elect to use various procedures in the event it exercises its authority to set settlement prices.
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. On the contrary, the Exchange believes that the proposed amendment will benefit investors, market participants, and the marketplace in general by stating that the Exchange will defer to OCC in the determination of settlement prices when and if OCC exercises its authority under its own settlement price procedures in accordance with its rules and by-laws.
No written comments were either solicited or received.
The Exchange has filed the proposed rule change pursuant to Section 19(b)(3)(A) of the Act
A proposed rule change filed under Rule 19b-4(f)(6)
At any time within 60 days of the filing of such 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 under Section 19(b)(2)(B) 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 May 8, 2018, Fixed Income Clearing Corporation (“FICC”) filed with the Securities and Exchange Commission (“Commission”) proposed rule change SR-FICC-2018-004, pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The proposed rule change would update FICC's Government Securities Division (“GSD”) Rulebook (“GSD Rules”) and FICC's Mortgage-Backed Securities Division (“MBSD”) Clearing Rules (“MBSD Rules”)
In a securities transaction, a settlement fail occurs when the seller does not deliver the securities to the buyer on the agreed upon settlement date. FICC states that although settlement fails are generally not treated as contractual default events, provided that the failing seller delivers the securities soon after the settlement date, persistent elevated levels of settlement fails create market inefficiencies and increase credit risk for market participants.
To help mitigate settlement fails, FICC maintains a fails charge in both the GSD Rules and the MBSD Rules.
FICC's proposal comes in response to a recent announcement by the Treasury Market Practices Group (“TMPG”),
FICC states that as one of the largest participants in U.S. Government securities market, it is imperative that FICC implement the TMPG's recommendation to help maintain consistency and symmetry within the market.
Pursuant to TMPG guidelines, if the Federal Open Market Committee (“FOMC”) specifies a target range in lieu of a target level, the lower limit of the target range announced by the FOMC would be used in the calculation of the fails charge.
While FICC states that it would follow the TMPG guidelines in this regard,
FICC proposes to make a technical change regarding references to the federal funds rate in the fails charge calculation in both the GSD Rules and the MBSD Rules. Specifically, FICC would replace current term “Target Fed funds target rate” in Section 14 of GSD Rule 11 and the current term “fed funds target rate” in MBSD Rule 12 with the new term “target level for the federal funds rate,” which is the term used by the TMPG in its guidance.
FICC also proposes to amend certain terms in the fails charge provisions of both the GSD Rules and MBSD Rules in order to use defined terms and to enhance clarity and consistency within the rules. Specifically, in GSD Rule 11, Section 14, and in MBSD Rule 12, FICC would replace the term “Fedwire” with the defined term “FedWire.”
While the GSD Rules expressly set forth the fails charge cap (
FICC proposes to implement the proposed changes on July 2, 2018.
Section 19(b)(2)(C) of the Act directs the Commission to approve a proposed rule change of a self-regulatory organization if it finds that such proposed rule change is consistent with the requirements of the Act and rules and regulations thereunder applicable to such organization.
Section 17A(b)(3)(F) of the Act requires, in part, that the rules of a clearing agency, such as FICC, be designed to promote the prompt and accurate clearance and settlement of securities transactions.
As discussed above, the proposed rule change would update both the GSD Rules and the MBSD Rules of FICC to add a one percent floor to the respective GSD and MBSD fails charge calculations. In the absence of such a floor, during periods of elevated target levels for the federal funds rate, the current GSD and MBSD fails charge calculations could result in a zero charge to a seller that fails to deliver securities to a buyer promptly.
As discussed above, persistent elevated levels of settlement fails can create market inefficiencies and increase credit risk for market participants, which could negatively affect the prompt and accurate clearance and settlement of securities transactions. Fails charges are designed to address such negative effects by encouraging market participants to complete their securities settlement obligations promptly.
FICC's proposal to implement a one percent floor to the fails charge calculations would advance FICC's efforts to discourage settlement fails by ensuring that the fails charge calculation would not produce a zero charge, particularly during periods of elevated target levels for the federal funds rate. In turn, ensuring that the respective
Rule 17Ad-22(e)(23)(ii) under the Act requires each covered clearing agency
As discussed above, the proposed rule change would update both the GSD Rules and the MBSD Rules to clarify the target rate that may be used in the fails charge calculations under certain circumstances and make certain technical changes to the fails charge provisions to ensure consistent use of defined terms. The proposed rule change also would update the MBSD Rules to clarify that a cap applies to the MBSD fails charge.
These clarifications are designed help ensure that the GSD and MBSD fails charges are transparent and clear to market participants. Increasing transparency and clarity around these charges would help market participants better understand the operation of the fails charges, and thereby provide market participants with increased predictability and certainty regarding their obligations to FICC. Accordingly, the Commission finds that the proposed rule change would help establish, implement, and maintain FICC's rules in a manner reasonably designed to provide sufficient information to enable participants to identify and evaluate the risks, fees, and other material costs they incur by participating in FICC, consistent with Rule 17Ad-22(e)(23)(ii) under the Act.
On the basis of the foregoing, the Commission finds that the proposal is consistent with the requirements of the Act, in particular the requirements of Section 17A of the Act
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT.
Notice.
This notice announces a public meeting of the Voluntary Information-sharing System (VIS) Working Group. The VIS Working Group will convene to discuss and identify recommendations to establish a voluntary information-sharing system.
The public meeting will be held on August 23, 2018, from 8:30 a.m. to 5:00 p.m. ET. Members of the public who wish to attend in person should register no later than August 16, 2018. Individuals requiring accommodations, such as sign language interpretation or other ancillary aids, may notify PHMSA by August 16, 2018. For additional information, see the
The meeting will be held at the U.S. Department of Transportation, 1200 New Jersey Ave. SE, Washington, DC 20590. The meeting agenda and additional information will be published on the following VIS Working Group registration page at:
The meetings will not be webcast; however, presentations will be available on the meeting website and posted on the E-Gov website,
Anyone can search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). Therefore, consider reviewing DOT's complete Privacy Act Statement in the
If you wish to receive confirmation of receipt of your written comments, please include a self-addressed, stamped postcard with the following
DOT may solicit comments from the public regarding certain general notices. DOT posts these comments, without edit, including any personal information the commenter provides, to
For information about the meeting, contact Dr. Christie Murray by phone at 202-366-4996 or by email at
The VIS Working Group is an advisory committee established in accordance with Section 10 of the Protecting our Infrastructure of Pipelines and Enhancing Safety Act of 2016 (Pub. L. 114-183), the Federal Advisory Committee Act of 1972 (5 U.S.C., App. 2, as amended), and 41 CFR 102-3.50(a).
The VIS Working Group agenda will include briefings on topics such as mandate requirements, integrity management, data types and tools, in-line inspection and other direct assessment methods, geographic information system implementation, subcommittee considerations, lessons learned, examples of existing information-sharing systems, safety management systems, and more. As part of its work, the committee will ultimately provide recommendations to the Secretary, as required and specifically outlined in Section 10 of Public Law 114-183, addressing:
(a) The need for, and the identification of, a system to ensure that dig verification data are shared with in-line inspection operators to the extent consistent with the need to maintain proprietary and security-sensitive data in a confidential manner to improve pipeline safety and inspection technology;
(b) Ways to encourage the exchange of pipeline inspection information and the development of advanced pipeline inspection technologies and enhanced risk analysis;
(c) Opportunities to share data, including dig verification data between operators of pipeline facilities and in-line inspector vendors to expand knowledge of the advantages and disadvantages of the different types of in-line inspection technology and methodologies;
(d) Options to create a secure system that protects proprietary data while encouraging the exchange of pipeline inspection information and the development of advanced pipeline inspection technologies and enhanced risk analysis;
(e) Means and best practices for the protection of safety and security-sensitive information and proprietary information; and
(f) Regulatory, funding, and legal barriers to sharing the information described in paragraphs (a) through (d).
The Secretary will publish the VIS Working Group's recommendations on a publicly available DOT website and in the docket. The VIS Working Group will fulfill its purpose once its recommendations are published online.
PHMSA will publish the agenda on the PHMSA meeting page at:
Office of the Comptroller of the Currency, Treasury.
Notice and request for comment.
The OCC, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other federal agencies to take this opportunity to comment on a continuing information collection as required by the Paperwork Reduction Act of 1995.
An agency may not conduct or sponsor, and a respondent is not required to respond to, an information collection unless it displays a currently valid OMB control number.
The OCC is soliciting comment concerning the renewal of its information collection titled, “Procedures to Enhance the Accuracy and Integrity of Information Furnished to Consumer Reporting Agencies under Section 312 of the Fair and Accurate Credit Transactions Act.” The OCC also is giving notice that it has sent the collection to OMB for review.
Comments must be received by July 23, 2018.
Commenters are encouraged to submit comments by email, if possible. You may submit comments by any of the following methods:
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Additionally, please send a copy of your comments by mail to: OCC Desk Officer, 1557-0238, U.S. Office of Management and Budget, 725 17th Street NW, #10235, Washington, DC 20503 or by email to
You may review comments and other related materials that pertain to this information collection
• Viewing Comments Electronically: Go to
• For assistance in navigating
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Mary H. Gottlieb, OCC Clearance Officer, (202) 649-5490 or, for persons who are deaf or hearing impaired, TTY, (202) 649-5597, Legislative and Regulatory Activities Division, Office of the Comptroller of the Currency, 400 7th Street SW, suite 3E-218, Washington, DC 20219.
Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from OMB for each collection of information that they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) to include agency requests and requirements that members of the public submit reports, keep records, or provide information to a third party. The OCC is asking OMB to extend its approval for this collection.
Twelve CFR 1022.42(a) requires furnishers to establish and implement reasonable written policies and procedures regarding the accuracy and integrity of consumer information that they provide to a consumer reporting agency (CRA).
Section 1022.43(a) requires a furnisher to conduct a reasonable investigation of a dispute initiated directly by a consumer in certain circumstances. Furnishers are required to have procedures to ensure that disputes received directly from consumers are handled in a substantially similar manner to those complaints received through CRAs.
Section 1022.43(f)(2) incorporates the statutory requirement that a furnisher must notify a consumer by mail or other means (if authorized by the consumer) not later than five business days after making a determination that a dispute is frivolous or irrelevant. Section 1022.43(f)(3) incorporates the statute's content requirements for the notices.
The OCC issued a notice for 60 days of comment on April 2, 2018, 83 FR 14104. No comments were received. Comments continue to be invited on:
(a) Whether the collection of information is necessary for the proper performance of the functions of the OCC, including whether the information has practical utility;
(b) The accuracy of the OCC's estimate of the burden of the collection of information;
(c) Ways to enhance the quality, utility, and clarity of the information to be collected;
(d) Ways to minimize the burden of the collection on respondents, including through the use of automated collection techniques or other forms of information technology; and
(e) Estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information.
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
In compliance with the Paperwork Reduction Act (PRA) of 1995, this notice announces that the Veterans Benefits Administration, Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden and it includes the actual data collection instrument.
Comments must be submitted on or before July 23, 2018.
Submit written comments on the collection of information through
Cynthia Harvey-Pryor, Office of Quality, Privacy and Risk (OQPR), Department of Veterans Affairs, 810 Vermont Avenue NW, Washington, DC 20420, (202) 461-5870 or email
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
By direction of the Secretary.
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
In compliance with the Paperwork Reduction Act (PRA) of 1995, this notice announces that the Veterans Benefits Administration, Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden and it includes the actual data collection instrument.
Comments must be submitted on or before July 23, 2018.
Submit written comments on the collection of information through
Cynthia Harvey-Pryor, Enterprise Records Service (005R1B), Department of Veterans Affairs, 810 Vermont Avenue NW, Washington, DC 20420, (202) 461-5870 or email
Public Law 104-13; 44 U.S.C. 3501-3521.
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
By direction of the Secretary.
Securities and Exchange Commission.
Final rule.
The Securities and Exchange Commission is adopting new rule 30e-3 under the Investment Company Act of 1940. Subject to conditions, new rule 30e-3 will provide certain registered investment companies with an optional method to satisfy their obligations to transmit shareholder reports by making such reports and other materials accessible at a website address specified in a notice to investors. We are also adopting amendments to rule 498 under the Securities Act of 1933 and our fund registration forms to require that during a certain transition period funds that choose to implement the new delivery method for shareholder reports provide prominent disclosures in prospectuses and certain other shareholder documents that will notify investors of the upcoming change in transmission format for a period of two years. New rule 30e-3 and the amendments to rule 498 and our registration forms address the fact that some investors may wish to receive shareholder reports in paper. As such, the new rule incorporates a set of protections so that investors who prefer to receive reports in paper will continue to receive them in that format. These protections include, among others, a minimum length phase-in period that ends no earlier than December 31, 2020 and notice requirements that must be implemented and followed beginning January 1, 2019, or the date shares are first publicly offered, if a registered investment company would want to use new rule 30e-3 as of January 1, 2021. The rule requires that a paper notice be sent to an investor each time a current shareholder report is accessible online. The notice must include instructions for how an investor can elect—at any time—to receive all future reports in paper, or request to receive particular reports in paper on an
This rule is effective January 1, 2019, except:
• Amendatory Instructions 5 and 25 to 17 CFR 230.498 and Form N-CSR (referenced in 17 CFR 249.331 and 274.128), which are effective January 1, 2021; and
• Amendatory Instructions 6, 13, 16, 18, 20, 22, and 24 to 17 CFR 230.498, 17 CFR 270.30e-3, Form N-1A (referenced in 17 CFR 239.15A and 274.11A), Form N-2 (referenced in 17 CFR 239.14 and 274.11a-1), Form N-3 (referenced in 17 CFR 239.17a and 274.11b), Form N-4 (referenced in 17 CFR 239.17b and 274.11c), and Form N-6 (referenced in 17 CFR 239.17c and 274.11d), which are effective January 1, 2022.
J. Matthew DeLesDernier and John Lee, Senior Counsels; or Michael C. Pawluk, Senior Special Counsel, at (202) 551-6792, Investment Company Regulation Office, Division of Investment Management, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-8549.
The Securities and Exchange Commission (the “Commission”) is adopting: New rule 30e-3
Today we are adopting rule 30e-3 under the Investment Company Act,
This new option is intended to modernize the manner in which funds deliver periodic information to investors. We believe it will improve investors' ability to access and use this information (for example, by providing investors with access to at least a full year of complete portfolio holdings information in one location), while reducing expenses associated with printing and mailing that are borne by funds, and ultimately, by their investors. The rule draws on the Commission's experience of more than twenty years with use of the internet as a medium to provide documents and other information to investors.
In addition, in 2007, the Commission engaged a consultant to conduct focus group interviews and a telephone survey concerning investors' views and opinions about various disclosure documents filed by companies, including mutual funds. The consultant's report concerning the focus group testing and related transcripts are in the comment file for this rule (
We continue to search for better ways of providing investors with the disclosure that they need to evaluate funds in which they are considering investing or currently hold shares. As part of these general efforts, we are also issuing a Request for Comment directed at investors regarding ways in which fund disclosure, including shareholder reports, may be improved.
We received over 1,000 comments on the Proposing Release, the vast majority of which specifically commented on
Commenters opposed to the proposed rule focused on concerns such as the impact on certain demographic groups that may have limited access to the internet, the proposed rule's use of implied consent, the extent to which cost savings under the proposed rule would not be as great as anticipated by the Commission, and the adverse impact on certain third parties such as the paper industry and mail carriers.
After consideration of the comments we received, we are adopting rule 30e-3 with several modifications designed to respond to investor protection concerns, provide additional flexibility and clarity in the operation of this transmission regime, and further increase cost savings for investors. Some key elements of the new transmission framework under rule 30e-3 include:
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We are committed to continuously improving the content and delivery of information to investors, including through efforts that encourage the use of technology to provide investors with the tools they need to evaluate their investments, and reducing costs and other regulatory burdens where appropriate. To that end, today we are taking two related actions intended to further these goals.
First, we approved amendments to rules of the New York Stock Exchange (“NYSE”) regarding processing fees paid to financial intermediaries for the delivery of shareholder reports and Notices under “notice and access” rules such as rule 30e-3 to investors holding shares through certain financial intermediaries.
Second, today we also are issuing two releases requesting comment on issues related to shareholder reports. In the first release, we are requesting comment on enhancing fund disclosures to improve the investor experience and to help investors make more informed investment decisions.
In the second release, we are requesting comment on the processing fees charged by intermediaries for distributing fund shareholder reports and other materials to investors.
Most commenters on the proposal focused on whether we should adopt rule 30e-3 and particularly its optional method of satisfying requirements to transmit shareholder reports by making them available on websites. We discuss below general comments received on the proposal, as well as why we have determined to adopt the rule. Specific comments on the particular provisions of the rule as proposed are discussed in more detail in Sections II.B.2-II.E below.
Commenters supporting the rule cited the benefits of allowing transmission of shareholder reports by making them accessible on websites, including improving the overall accessibility of the information
A number of commenters stated that website disclosure is consistent with many investors' preferences.
A number of commenters in opposition to the proposed rule, however, suggested that the rule could have adverse effects on investors.
A number of commenters addressed the use of “implied consent” to allow for website transmission of shareholder reports. One commenter pointed to behavioral research that suggested implied consent is a “weak” reflection of actual willingness and that the introduction of new processes (
We also received a number of comments stating that website transmission of shareholder reports should not be the default transmission option.
On the other hand, we received several comments stating that the proposed rule better aligns with investor preferences for access to financial information,
Many commenters supporting the proposed rule stated that the rule would result in reduced printing and mailing costs for funds (and ultimately fund investors).
One commenter claimed that the cost savings realized from proposed rule 30e-3 would likely not be passed on to investors and would not have a noticeable impact on investor costs even if it were passed on to investors.
Finally, several commenters highlighted that the potential cost savings for funds and investors resulting from the proposed rule may depend in part on the application of the NYSE processing fees that funds pay to financial intermediaries.
Some commenters also supported the proposed rule as consistent with other regulatory frameworks adopted by the Commission and other regulatory bodies that encourage website availability as a means to satisfy disclosure obligations.
In December 2015, Congress amended the Gramm-Leach-Bliley Act (“GLBA”) as part of the Fixing America's Surface Transportation Act. These amendments to the GLBA provide an exception under which financial institutions that meet certain conditions are not required to provide annual privacy notices to customers. Because the Bureau determined that the alternative delivery method was no longer necessary in light of this new statutory exception, the Bureau proposed in June 2016 to remove the alternative delivery method from its regulations implementing the GLBA.
Some commenters highlighted the environmental benefits associated with the reduction of paper reports under the rule, including fewer trees needed to make paper and a reduction in landfill waste.
A number of commenters also expressed a preference for transmission of paper shareholder reports because of the reliability and security of information delivered by the U.S. Postal Service.
We also received a number of comments expressing cybersecurity concerns related to the proposed rule. The vast majority of these comments, however, did not appear to fully appreciate the method of transmission proposed under the rule (
We are sensitive to these issues and acknowledge the importance of protecting the security of personal information. However, we do not believe that this new method of transmission would meaningfully increase the cybersecurity risks, such as identity thefts or “phishing” attacks, noted by these commenters. Rule 30e-3, as proposed and adopted, does not present email “phishing” attack concerns because investors will not receive email communications as a result of the rule. Rather, shareholder reports would be posted on a public website, and investors would be provided with a paper notice regarding their availability. The final rule does not require that a Notice contain any personally identifiable information. If a fund were to choose to include this information in a Notice, the fund should take measures to protect this information just as funds do today regarding other mailings, like account statements, that may contain sensitive information.
In December 2017, the Investor Advisory Committee
After consideration of the comments discussed above, we are adopting rule 30e-3 with several modifications designed to address preservation of investor preferences, cost, and administrability of the rule. Rule 30e-3 is intended to modernize the manner in which shareholder reports and other information are made available to investors and reduce expenses associated with printing and mailing that are currently borne by funds, and ultimately, fund investors.
Reliance on the rule is optional. Funds are permitted to satisfy their delivery obligations by mailing shareholder reports in paper, delivering reports pursuant to the Commission's electronic delivery guidance, providing notice and website accessibility pursuant to rule 30e-3, or any combination of the foregoing, so long as the conditions of the applicable transmission methods are met. We believe that a fund is in the best position to choose whether or not to implement the rule after considering the costs and benefits of the rule, including consideration of the needs and preferences of the fund's particular investors.
The rule is consistent with our prior initiatives to harness the benefits of the internet and other new technologies for investors,
According to the most recent U.S. census data, approximately 77.2% of U.S. households had some form of internet access in their home in 2015 and 86.8% have a computer (
Understanding that an investor's experience when accessing a shareholder report may differ between a mobile device and a laptop, we request comment about investor experiences and preferences for fund disclosures on mobile devices in the Disclosure Request for Comment.
These trends have also extended to use of the internet for financial purposes. For example, a recent survey by the Investment Company Institute found that in 2017, 95% of U.S. households owning mutual funds had internet access (up from about two-thirds in 2000), with widespread use of the internet among various age groups, education levels and income levels, including access by 86% of mutual fund owning households headed by someone age 65 or older.
We recognize that it is critical for investors to continue to receive disclosure through means that are convenient and accessible for them.
• First, the final rule provides that investors who prefer to receive reports in paper may continue to do so, either by making a one-time request to receive all future reports in paper, or by requesting individual reports in paper whenever they desire.
• Second, as outlined below in Sections II.B.2.f and II.E, we are adopting an extended transition period with staged effective dates. During the extended transition period, the earliest that Notices may be transmitted to investors in lieu of paper reports is January 1, 2021. In general, funds will be required to provide two years of notice to shareholders before relying on the rule. Therefore, funds that begin providing notice at the start of 2019 will complete the two-year notice period, and may begin relying on the rule, on January 1, 2021. In addition, funds that are newly offered during the period of January 1, 2019 through December 31, 2020 may rely on the rule starting January 1, 2021, if they provide notice to shareholders starting with their first public offering. Funds that are newly offered on January 1, 2021 and thereafter would not be subject to the condition and could therefore rely on the rule immediately without providing any advance notice through required statements. All other funds may not rely on the rule until they have completed a full two year notice period or until January 1, 2022, whichever comes first.
Although we are eliminating the Initial Statement requirement, we nonetheless believe that it is important that investors receive sufficient notice of the change in transmission method and sufficient opportunity to express their delivery preference. Therefore, the extended transition period is designed to ensure that investors receive disclosures during the extended transition period and to provide funds electing to make use of this optional method and financial intermediaries time to educate investors of the coming change through disclosures on prospectuses and certain other fund documents and through other means. It will also provide funds and financial intermediaries with time to implement any necessary operations and systems changes. Finally, the Commission staff will also use this extended transition period to engage in educational and investor outreach efforts.
We believe these protections will mitigate the various concerns raised by commenters regarding this new optional method for funds to satisfy requirements to transmit shareholder reports.
New rule 30e-3 provides that a registered management company (and any separate series thereof) or UIT may satisfy its obligation to transmit a report required by rule 30e-1 or rule 30e-2, respectively, if certain conditions set forth in the rule are satisfied.
These conditions are generally consistent with similar conditions in other rules adopted by the Commission, including its rules regarding the use of a summary prospectus and internet availability of proxy materials.
Rule 30e-3 provides funds an optional means of satisfying shareholder report transmission obligations under rule 30e-1 and rule 30e-2.
We are adopting generally as proposed, except as indicated below, certain requirements relating to the availability of the shareholder report and other materials for funds relying on rule 30e-3. Specifically, in order to satisfy transmission obligations under rule 30e-1 or rule 30e-2, the current report to shareholders must be publicly accessible, free of charge, at a specified website address.
Funds are not currently required to send first- and third-quarter portfolio holdings information to investors or make that information accessible on their websites. To provide investors with convenient access to the most recent four quarters of portfolio holdings, the rule requires that, in addition to posting the most current shareholder report, the following fund documents must also be posted at the specified website: (1) Any report with respect to the fund for the prior reporting period that was transmitted to shareholders of record pursuant to rule 30e-1 or rule 30e-2, if any;
The fund's prior shareholder report and portfolio holdings information for its first and third fiscal quarters are required to be publicly accessible in the same manner and for the same time period as the current shareholder report.
To conform the format and content of the portfolio holdings schedules for the first and third quarters to those schedules presented in the fund's shareholder reports for the second and fourth quarters, the rule requires the schedules for the first and third quarters to be presented in accordance with the schedules set forth in §§ 210.12-12 through 12-14 of Regulation S-X, which need not be audited.
In a change from the proposal, the final rule requires that if a report required to be posted includes a summary schedule of investments,
One commenter recommended that funds retain the ability to use the summary schedule of investments if they rely on the proposed rule.
We continue to be concerned that use of a summary schedule of investments with rule 30e-3 would be potentially confusing or cumbersome for investors seeking access to the complete portfolio schedule. At the same time, we acknowledge that a fund may choose to use a summary schedule for cost considerations or otherwise, and we continue to believe that the summary schedule can help investors focus on a fund's principal holdings and thereby better evaluate the fund's risk profile and investment strategy. The restriction contained in proposed rule 30e-3 effectively would have required a fund using the summary schedule to create and distribute two separate reports to shareholders (
To avoid the related administrative cost and other burdens associated with such a scenario, and at the same time help to provide investors with easy access to the complete portfolio schedule, the final rule requires, in a change from the proposal, that if a report required to be posted at the specified website (
Like the schedule of investments required to be included with shareholder reports (and filed as part of reports on Form N-CSR), quarterly schedules of portfolio holdings currently required to be reported on Form N-Q, and monthly schedules of portfolio holdings that will be required to be reported on Form N-PORT,
As proposed, the final rule also requires compliance with certain conditions designed to ensure the accessibility of shareholder reports and other required materials.
The rule includes a safe harbor provision that would allow a fund to continue relying on the rule even if it did not satisfy the posting condition of the rule for a temporary period of time.
One commenter recommended that the final rule clarify that the materials required to be posted could be posted on a third-party website or landing page, similar to what is allowed under the current process for notice and access for proxy materials.
Rule 30e-3 requires funds relying on the rule with respect to an investor to send a paper Notice notifying the investor of the availability of the report.
While most commenters focused on technical aspects of the Notice, one commenter encouraged the Commission to consider eliminating the Notice requirement altogether, which the commenter believed would lead to additional cost savings and environmental benefits.
We continue to believe that it is important for all investors to receive the Notice, as it will contemporaneously alert them to the availability of a shareholder report online and will provide them with information on how to obtain a paper copy of the report. Therefore, we are adopting as proposed the Notice requirements as to format (
In a change from the proposal, the final rule extends from 60 days to 70 days the period of time in which the Notice must be sent to investors after the close of the period covered by the related report.
First, in a change from the proposal and as discussed below, we are permitting the Notice to accompany other materials, including a shareholder's account statement. Because shareholder reports are generally prepared at or shortly before the end of the 60 days following the close of the reporting period, and account statements (whether monthly, quarterly, or annual) are typically prepared and mailed within a few days after the close of the applicable month end, a Notice would generally not be able to accompany an account statement mailing if the Notice is sent out within 60 days following the close of the reporting period.
Second, as also discussed below, we are permitting the Notice to include content from the shareholder report, and also requiring any such Notices to be filed with the Commission as part of a fund's report on Form N-CSR. Extending the time period to 70 days permits funds additional time to prepare Notices after finalizing their related shareholder reports, and matches up with the 70-day filing period for reports on Form N-CSR.
As under the proposal, the Notice must be in plain English so that investors can easily understand it.
• As was proposed, the Notice must contain a prominent legend in bold-face type stating that an important report to shareholders is available online and in paper by request, and in a change from the proposal, the Notice may include information identifying the fund, its sponsor (including any investment adviser or sub-adviser to the fund), a variable annuity or variable life insurance contract or insurance company issuer thereof, or a financial intermediary through which shares of the fund are held;
• as was generally proposed (but with certain modifications), the Notice must state that the report contains important information about the fund, including as proposed its portfolio holdings and, in a change from the proposal, its financial statements;
• in a change from the proposal, the Notice may include a brief listing of other types of information contained in the report;
• as was proposed, the Notice must state that the report is available on the internet or, upon request, by mail, and encourage shareholders to access and review the report;
• as was proposed, the Notice must include the website address where the shareholder report and other required portfolio information is posted (
• as was generally proposed (with certain modifications), the Notice must include a toll-free (or collect) telephone number to contact the fund or the shareholder's financial intermediary
• in a change from the proposal, the Notice may include other methods by which a shareholder can contact the fund or the shareholder's financial intermediary (
• in a change from the proposal, the Notice is not required to be accompanied by a reply card.
We requested comment on whether the proposed disclosures in the Notice, including the required statement that the report contains important information about the fund, were appropriate. One commenter suggested that the content of the Notice be enhanced to require disclosures relating to “important information, such as [f]und performance and portfolio manager insights,” noting that enhanced disclosures could encourage investors to access their shareholder reports.
Some commenters recommended modifications to the proposed website address requirements. One commenter suggested that the rule not require the Notice to include a specific website address, which would allow the industry more flexibility in implementing the rule.
After consideration of these comments, we have determined to eliminate from the final rule the proposed requirement that the Notice include the website address for individual reports. We agree with those commenters suggesting that such a requirement could result in unnecessary administrative burdens, and believe that limiting the website link to the landing page, where the shareholder report and other required materials are available, meets our objective of directing investors to the shareholder report in an easily accessible manner. The address used must be specific enough to lead investors directly to the documents that are required to be accessible under the rule's conditions, but may be a central site with prominent links to each document. The website may not be the home page or section of the website other than on which the documents are posted.
To access their reports, investors will be required to key in the website address provided in the Notice. Some
In a change from the proposal, the final rule also provides that the Notice may include, in addition to a website address, other equivalent methods or means to facilitate shareholder access to the shareholder report and other required materials.
We proposed that the Notice not only be required to include a toll-free telephone number that an investor can use to notify the fund that he or she wishes to receive paper reports in the future, but also a reply form that is pre-addressed with postage-paid as an alternative means by which the investor can notify the fund of his or her preference.
Another commenter indicated that including a reply form that is pre-addressed with postage paid would cost approximately $1,325,000 in the aggregate per year.
Another commenter estimated cost savings from the elimination of reply cards to be approximately $10 million.
After considering the comments we received, we have determined not to require funds to include a reply card.
However, the final rule permits the Notice to include additional means by which an investor can contact the fund or the investor's financial intermediary.
In providing the required toll-free (or collect) telephone number and other means, we encourage the use of methods that allow shareholders to express their preference as conveniently as possible, such as by limiting the need for investors to speak with multiple representatives or navigate through multiple telephone menus or web pages, or otherwise minimizing the steps necessary to express a preference. To record investor preferences, a fund might, for example, provide an automated system, live representatives, a toll-free (or collect) telephone number that is dedicated solely for this purpose, or a prompt for investors when they access their shareholder account information online, such as through the use of a pop-up.
In light of the principle that effective rulemaking should not end with rule adoption, the staff will review, and report to the Commission on, the implementation of rule 30e-3 to evaluate whether funds are employing processes that effectively facilitate investor election of delivery preferences, including the ease through which investors may elect delivery preferences, taking into account, among other things, the continued development of delivery mechanisms and the evolving array of retail investor preferences. For example, the staff's review would include an evaluation of the number of investors who have elected paper delivery, whether such election is on an ad hoc basis or permanent basis, the means through which the election was made (telephone, online or otherwise), and the overall investor experience relating to the election of delivery preferences. The purpose of such review would be to better inform the Commission and the staff on whether funds are implementing processes that effectively facilitate investors making elections consistent with investors' preferences and on whether any further action should be taken to facilitate investor election of delivery preferences.
Some commenters recommended that the final rule permit the Notice to include disclosures informing investors how they can affirmatively consent to electronic delivery of shareholder reports and other documents.
Finally, in a change from the proposal, the final rule permits a Notice to include pictures, logos, or similar design elements so long as the design is not misleading and the information is clear.
The Notice is designed to alert investors to the availability of a shareholder report online and to provide investors with information on how to obtain paper reports if that is their preference. As we noted in the Proposing Release, we believe it is important to limit the total information included in the Notice, in order to ensure that information regarding the availability of a shareholder report does not become obscured. Therefore, we proposed that the rule limit the information contained in the Notice to the information required by the rule, but requested comment on whether we should require that the Notice not contain any additional information other than that specified by the rule.
In addition to the comments described above regarding types of additional information that should be permitted in the Notice (
After consideration of these comments, we believe that permitting—but not requiring as a condition to use this optional method—the inclusion of certain additional information in the Notice is appropriate so long as it is limited to content from the shareholder report for which Notice is being given.
We are persuaded that permitting additional flexibility regarding the content of the Notice is appropriate, and may result in funds crafting Notices that convey to investors certain key content from the shareholder report, while also encouraging investors to access the shareholder report for more detailed information.
Additionally, the Investor Advisory Committee recommended that “the Commission engage in investor testing of the proposed [summary document and layered] disclosure, or encourage testing by industry members, to ensure that the proposed approach delivers the expected benefits of reducing costs for funds and distributors without sacrificing disclosure quality.”
Consistent with the Investor Advisory Committee Recommendation, we note that the Fund Retail Investor Experience and Disclosure Request for Comment, as well as investor testing of disclosure alternatives, are two key initiatives the Commission is using to assess our current disclosure framework for funds and to consider possible changes to that framework.
Providing funds the flexibility to include in the Notice certain information from the shareholder report is intended to allow them to identify and provide content they believe is particularly informative to their investors. Funds that decide to include additional information from the report in their Notices generally should consider the appropriateness of such information, the benefits to investors, and the cost impacts associated with adding information to the Notice. When including content from the report in a Notice, funds have obligations with respect to the antifraud provisions of the
While the final rule does not prescribe a specific page limit, funds generally should limit optional content to a relatively brief amount to avoid detracting from the primary purpose of the Notice and to encourage investors to access the shareholder report itself. As discussed further below, we are requiring funds that choose to transmit Notices with additional information from the shareholder report to file such Notices as part of their reports on Form N-CSR.
To further ensure that the information contained in the Notice would not be obscured, the rule as proposed would have prohibited the Notice from being incorporated into or combined with another document,
Some commenters recommended that the final rule permit the use of a single, consolidated Notice for funds within the same fund complex or for funds held in the same intermediary contract or account.
Some commenters recommended that the final rule permit the Notice to be incorporated into the summary prospectus and account statements, stating it would provide additional visibility due to investor interest in those documents.
After consideration of the comments, we have modified the final rule to permit the use of consolidated Notices.
We have also modified the final rule to permit the Notice to accompany additional materials beyond a current summary prospectus, statutory prospectus, statement of additional information, or Notice of internet Availability of Proxy Materials. As with consolidated Notices, we believe that permitting Notices to accompany other documents not only could result in additional cost savings (
Similar to the Commission's rules on householding prospectuses, shareholder reports, and proxy statements and information statements,
We proposed to require that a form of the Notice be filed with the Commission not later than 10 days after the Notice is sent to shareholders.
Commenters generally opposed filing the Notice semi-annually as part of a separate filing. Some commenters recommended that the Notice be filed instead as an exhibit to Form N-CEN or Form N-CSR.
After further consideration of these comments, we have modified the final rule as follows. Notices that do not contain content from the report (as permitted by paragraph (c)(3)) would not be required to be filed with the Commission because we do not expect those Notices to change significantly from period to period.
On the other hand, Notices that contain content from the report as permitted by paragraph (c)(3) would be required to be filed with the Commission as part of the fund's report on Form N-CSR.
As a condition to reliance on the rule, we proposed to require that the fund or UIT (or a financial intermediary through which shares of the fund or UIT may be purchased or sold) must send, at no cost to the requestor and by U.S. first class mail or other reasonably prompt means, a paper copy of the most recent annual and semi-annual reports of the fund (or underlying fund in the case of a UIT), and portfolio holdings of the fund (or underlying fund in the case of a UIT) as of its most recent first and third fiscal quarters, to any person ad hoc requesting copies of any such documents within three business days after receiving a request for a paper copy.
While we believe that many investors would prefer internet availability of shareholder reports based on investor
Under the proposal, rule 30e-3 would have permitted use of the rule as to a particular investor only if the investor either previously affirmatively consented to this method of transmission, or was determined to have provided implied consent (if affirmative consent was not received) by sending an Initial Statement to investors.
While the householding rules require that consent (other than implied consent) be “in writing,” we did not propose a similar “in writing” requirement because, consistent with the Commission's guidance on electronic delivery, consent may be provided in a number of ways, including in writing, electronically, or telephonically.
Comments were mixed regarding the Initial Statement and the proposal's use of both affirmative and implied consent. Some commenters recommended removing provisions of the proposed rule that allow affirmative consent and provide solely for implied consent.
One commenter suggested that the final rule eliminate the Initial Statement requirement altogether.
After considering comments, we have eliminated the proposed Initial Statement from the final rule. Instead, we are adopting an extended transition period. During the extended transition period, an investor in a mutual fund, for example, that seeks to begin relying on the rule before January 1, 2022 would receive approximately six notices of the upcoming change over a two-year period (each year, investors will receive notice on the summary prospectus or prospectus, as well as the semi-annual and annual report to shareholders.). The extended transition period is an appropriate, effective, and cost-efficient method of funds informing shareholders of the change in transmission format in lieu of the proposed Initial Statement provisions.
In addition, the extended transition period will provide time for funds, financial intermediaries, and Commission staff to undertake efforts to raise investor awareness of the change in transmission method before funds are permitted to begin relying on the rule. These efforts, combined with the requirement that Notices be transmitted in lieu of paper reports informing investors of their ability to receive paper reports, will help ensure that all investors—including those who hold only funds that first choose to rely on the rule on or after January 1, 2022—nonetheless are made aware of the change in transmission method and the option to receive reports in the manner they prefer. We believe that upon the completion of this extended transition period it is appropriate to begin allowing all funds to rely on the rule.
Although the final rule replaces the proposed provisions relating to the Initial Statement with the extended transition period, the final rule also includes provisions enabling an investor to elect to receive future shareholder reports in paper after making a one-time election. Specifically, the rule provides that a fund may not rely on rule 30e-3 to satisfy its obligations to transmit a report if at any time after the fund has notified the investor of its intent to rely on the rule or provided a Notice to the investor, the investor has notified the fund (or the investor's financial intermediary) that the investor wishes to receive paper copies of shareholder reports.
One commenter suggested that the current system of notice and access for the delivery of proxy materials relies entirely on an implied consent approach.
Beginning as early as January 1, 2019, funds will track investor preferences for paper copies of reports. We have adopted this date for two reasons. First, this date provides funds, financial intermediaries, and other service providers with a period of time to update systems to begin tracking investor paper preferences for shareholder reports.
Under the proposed rule, each fund, including each series of a registrant offering multiple series, would have needed to obtain separate consent as to an investor, regardless of whether consent was obtained from that investor by other series offered by that registrant. An investor preferring paper copies also would have needed to deny or revoke consent for each fund, including each series, for which the shareholder preferred to receive paper copies of reports. In the Proposing Release we requested comment on whether consent should be obtained separately as to each fund, or whether consent that is applied to one fund could be inferred as to other funds held by the investor. We also requested comment on whether there were any special considerations relating to investors who invest through intermediaries.
Commenters who addressed this issue uniformly recommended that consent should be permitted to be inferred with respect to all funds held by an investor within a fund complex
After consideration of the issues raised by commenters, we agree that applying the investor's election for paper reports at the investor account level,
Rule 30e-1(d) permits an open-end management investment company to transmit a copy of its prospectus or statement of additional information in place of its shareholder report, if it includes all of the information that would otherwise be required to be contained in the shareholder report.
Rather than making the rule effective immediately and requiring an Initial Statement, as proposed, we are adopting an extended transition period with staged effective dates.
The extended transition period is designed so that investors will receive disclosures to alert them to the change in the transmission method and allow them to express their delivery preference while also providing funds and financial intermediaries a period of time to educate investors of the coming change through disclosures on prospectuses and certain other fund documents and through other means. It will also provide funds and financial intermediaries with time to implement any necessary operations and systems changes. Finally, the Commission staff will also use this extended transition period to engage in educational and investor outreach efforts. As discussed above, after consideration of comments received on the proposal, we believe that the enhanced disclosure requirements during this extended transition period are a more appropriate and effective method of providing investors with advance notice of a fund's intent to rely on rule 30e-3 than the proposed Initial Statement requirement.
Except as specified below, a fund generally may rely on rule 30e-3 to transmit a report to an investor before January 1, 2022, only after providing required statements over a two-year period as follows:
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A fund may otherwise begin to rely on rule 30e-3 before January 1, 2022 if the fund includes the required statement on the applicable disclosure documents for a period of two years prior to beginning to rely on the rule.
In connection with our adoption of rule 30e-3, we are also adopting related amendments to certain of our rules and forms. First, we are adopting, as proposed, amendments to rule 498 under the Securities Act, which concerns the use of a summary prospectus,
Second, in a change from the proposal, the final rule permits a summary prospectus to include instructions describing how a shareholder can elect to receive prospectuses or other documents and communications by electronic delivery.
Third, we are amending rule 498 under the Securities Act, as proposed, to include a Notice required by rule 30e-3 among the materials that are permitted to have equal or greater prominence when accompanying a summary prospectus prepared in reliance on rule 498.
Fourth, to notify investors of the upcoming change in transmission format, and in a change from the proposal, we are also amending rule 498 and certain fund registration forms to require that funds intending to rely on rule 30e-3 prior to January 1, 2022 include prominent disclosures on the cover page or beginning of their summary prospectuses; on the front cover page of their statutory prospectuses; and on the front cover page or beginning of their annual and semi-annual reports, for two years during the three-year period between January 1, 2019 and December 31, 2021.
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In addition, we understand that a small number of issuers of variable life insurance policies continue to register their securities on Form S-6 [17 CFR 239.16]. Such issuers may rely on rule 30e-3 prior to January 1, 2022 if comparable notice is provided on prospectuses (or supplements thereto) delivered to policyholders during the extended transition period.
In addition to providing advance notice to investors of their fund's expected use of the rule, these disclosures are intended to provide important information to both current and prospective investors that gives them an overview of the change in delivery format options, including the fact that reports will be made available on a website and that they will be able to retain delivery of their reports in paper if they should so desire. We believe that these disclosure requirements help to mitigate commenters' concerns regarding the use of the Initial Statements as a condition to reliance on the rule. We encourage the use of graphical indicators such as flags or other design elements to further draw investor attention to these disclosures. Beginning January 1, 2022, these cover page disclosures will no longer be required.
As acknowledged in our proposal and stated by commenters, most fund investors are not direct shareholders of record, but instead engage an investment professional and hold their fund investments as beneficial owners
Certain commenters expressed concerns regarding potential complexities and costs for broker-dealers to administer proposed rule 30e-3.
Multiple commenters requested that the Commission clarify intermediaries' role with respect to delivering Initial Statements and Notices under proposed rule 30e-3, as well as their role in delivering paper copies of shareholder reports to fund beneficial owners upon request.
After consideration of the comments we received, including concerns raised regarding the role of financial intermediaries, we have made several modifications to the rule designed to respond to investor protection concerns, streamline and clarify the operation of the transmission regime, provide additional flexibility, and further increase cost savings for investors. For example, we have eliminated the requirement to send an Initial Statement and reply cards under the final rule. In addition, the final rule permits flexibility with respect to the preparation and mailing of Notices, and requires that elections to receive paper reports apply on an account-level basis, instead of a fund by fund basis.
In response to commenters' concerns regarding broker-dealer activities under the new rule 30e-3 framework, below we provide guidance addressing the processes that could be followed by broker-dealers and other intermediaries that deliver shareholder reports to beneficial owners. To remind funds and others of the guidance provided in this release, we have added a note to final rule 30e-3 indicating that this release contains a discussion of how the conditions and requirements of the rule may apply in the context of investors holding fund shares through financial intermediaries.
Financial intermediaries already perform many functions similar to those outlined in rule 30e-3. For example, intermediaries currently forward to beneficial owners a variety of materials from funds and other issuers of securities, including shareholder reports. Many intermediaries operate websites that host shareholder reports and other materials relating to a beneficial owner's investments. Intermediaries today also collect and maintain investor preferences as to delivery format (
SRO rules require broker-dealers to distribute shareholder reports to beneficial owners.
The rule permits flexibility in the preparation and delivery of Notices. For example, a Notice could relate solely to an individual fund, or multiple Notices can be combined together to create a consolidated Notice.
A fund may determine that for cost or other reasons, it would be preferable for the broker-dealer to prepare and distribute a consolidated Notice for beneficial owners who may be invested in multiple funds offered by one or more fund complexes.
Notices prepared by broker-dealers generally should be consistent with paragraph (c) of rule 30e-3. For example, as discussed in the section below,
The final rule prohibits reliance on the rule if a shareholder has expressed a preference that the shareholder wishes to receive paper copies of shareholder reports.
In response to concerns raised by commenters regarding the burdens and costs of tracking elections to receive paper reports on a fund by fund basis,
Today, paper copies of statutory prospectuses or statements of additional information may be requested by beneficial owners on an ad hoc basis in cases where a fund uses a summary prospectus.
We note that the rule's approach of delivering Notices, together with the option of permitting shareholders to request paper copies on either an ad hoc or ongoing basis, is generally similar to the operational approach currently used by many broker-dealers (and funds) for the delivery of fund materials, including proxy materials. We believe that existing systems for default electronic delivery could be leveraged by broker-dealers in implementing the final rules in order to establish new processes and procedures for delivery of shareholder reports at a lower cost than would be the case if such systems did not already exist.
To facilitate beneficial owners' elections to receive future reports in paper, a broker-dealer firm generally should provide information on how to contact the firm (or if applicable, the fund) in conjunction with the delivery of Notices. For Notices prepared by the broker-dealer firm, the Notice could contain the toll-free telephone number of the firm and other methods by which beneficial owners could contact the firm. If the broker-dealer firm is delivering Notices prepared by a fund, the firm could include with the Notice information containing the toll-free telephone number of the firm and other methods by which beneficial owners could contact the firm.
A commenter also requested a transition period of at least 24 months following the effective date of the rule to allow time to address new systems, processes and procedures required to comply with the rule.
The final rule does not require that the website where the required materials are available be maintained by any particular party. Instead, the rule provides that the required materials must be posted at the website specified in the Notice.
Commenters observed that it could be more efficient for a broker-dealer to establish its own website (or utilize a central third-party website) on which shareholder materials would be hosted, and identify this website (as opposed to each fund or fund family's website) in any Notices prepared by the broker-dealer.
While rule 30e-3 as proposed would apply only to shareholder reports, we also requested comment in the Proposing Release on whether we should permit a similar framework to satisfy delivery obligations for summary or statutory prospectuses.
While we appreciate these recommendations, we believe that the appropriate incremental step is rule 30e-3, as adopted. As discussed above, we are seeking comment on the content, delivery, and design of fund disclosure as well as the processing fees for delivering fund shareholder reports and other materials to investors, and may consider in the future an electronic or notice and access delivery framework for documents other than shareholder reports.
In the Proposing Release, we stated that because the use of proposed rule 30e-3 would be optional, we believed that a compliance period was unnecessary and expected that funds would be able to rely on the rule immediately after the effective date provided they first transmit an Initial Statement.
After further consideration, we are adopting an extended transition period with staged effective dates for rule 30e-3 and the related amendments we are adopting today. While rule 30e-3 will become effective on January 1, 2019, the rule provides that a fund may only begin transmitting Notices pursuant to the rule beginning January 1, 2021.
We are adopting a delayed effective date of January 1, 2019 to provide funds, broker-dealers and other financial intermediaries, and service providers with an adequate period of time to modify systems and operations to accommodate the new transmission framework. Beginning as early as January 1, 2019, however, funds and intermediaries will begin to track investor elections for paper copies of the shareholder report.
As discussed above, we are also requiring funds to provide prominent disclosures on the cover page or beginning of their summary prospectuses, and cover pages of their statutory prospectuses, and annual and semi-annual reports, informing investors of the change in delivery format options if the funds intend to rely on the rule prior to January 1, 2022.
As also discussed above, we are permitting funds to include content from the shareholder report in the Notice under rule 30e-3(c)(3), provided that funds that choose to transmit Notices with additional information from the shareholder report file those Notices as part of their reports on Form N-CSR.
We are also amending rule 14a-16 under the Exchange Act to include a Notice required by rule 30e-3 among the materials that are permitted to accompany a Notice of internet Availability of Proxy Materials.
We are amending Section 800 of 17 CFR part 200 to display control numbers assigned to information collection requirements for rule 30e-3 by the Office of Management and Budget pursuant to the Paperwork Reduction Act. This amendment is effective January 1, 2019.
As noted earlier, we are persuaded by commenters that the proposed provisions of the rule regarding affirmative and implied consent through use of an Initial Statement would add unnecessary complexity to the implementation of the rule without a corresponding benefit.
Although we are requiring most funds, as a condition to relying on rule 30e-3 before January 1, 2022, to include the required disclosures regarding the upcoming change on prospectuses and shareholder reports, we also encourage funds and financial intermediaries (
We believe that this engagement with investors could build upon funds' and intermediaries' existing efforts to ask investors to elect electronic delivery. It is our understanding that funds and intermediaries periodically solicit investors to opt-into electronic delivery of account and fund related documents, including shareholder reports, in lieu of receiving documents in paper. We are aware that some of these efforts have included:
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We believe that the levels of internet access and electronic availability and delivery of financial information will continue to increase
We are mindful of the importance of assessing the costs and benefits of our rules. Section 2(b) of the Securities Act, Section 3(f) of the Exchange Act, and Section 2(c) of the Investment Company Act require us, when engaging in rulemaking that requires us to consider or determine whether an action is necessary or appropriate in (or, with respect to the Investment Company Act, consistent with) the public interest, to consider, in addition to the protection of investors, whether the action will promote efficiency, competition, and capital formation.
At the outset, the Commission notes that, where possible, it has sought to quantify the costs, benefits, and effects on efficiency, competition, and capital formation expected to result from new rule 30e-3, the amendments to various rules and registration forms, and their reasonable alternatives. The economic effects of new rule 30e-3 are dependent on a number of factors, including the number of funds that rely on the rule; for those funds that rely on the rule, the number of investors that ultimately select paper transmission; the extent to which funds currently rely on Commission guidance to transmit shareholder reports electronically; the extent to which investors currently have opted into electronic delivery;
New rule 30e-3 allows funds to satisfy shareholder report transmission requirements by making such reports publicly accessible on a website if they meet certain conditions. This new option is designed to modernize the manner in which periodic information is made available to investors. We believe it will improve the information's overall accessibility while reducing expenses associated with printing and mailing that are borne by funds, and ultimately, by their investors. The rule also draws on the Commission's investor testing efforts and other empirical research concerning investors' preferences about methods of delivery for required disclosure documents and use of the internet for financial and other purposes generally.
Further, printing and mailing expenses associated with shareholder reports are typically passed on to fund investors through fund expense ratios. Currently, if investors with a preference for electronic delivery do not take the necessary step of affirmatively electing electronic delivery pursuant to the Commission's current guidance on electronic delivery, the shared costs associated with printing and mailing reports incurred by investors will be higher than if shareholder reports were delivered in paper form only to those investors that have a preference for paper delivery. The new rule, however, creates an optional regulatory structure that eliminates the need for investors to take the step to affirmatively elect electronic delivery and enables funds to make website availability of shareholder reports the default, which will reduce the printing and mailing costs shared by investors while still accommodating the interests of those investors who prefer paper copies.
Under the final rule, which makes website availability the default, some investors with a preference for paper reports may fail to request paper because of the “status quo” bias discussed above.
As we discuss in greater detail below, we estimate that aggregate cost savings, net of compliance costs, after the first year of reliance on rule 30e-3 would be approximately $141.4 million per year, or approximately 55% of the annual printing and mailing costs under the existing requirements.
For purposes of the estimates below, we aggregate printing and mailing costs for positions held directly and positions held in street name. We assume that the printing and mailing costs are incurred, and cost savings realized, by funds. As discussed above, intermediaries and other third parties incur printing and mailing costs on behalf of funds in instances of positions held in street name, and such intermediaries and other third parties are expected to incur a portion of the aggregate costs and cost savings from rule 30e-3.
Due to the optional nature of the rule, we expect that, in general, each fund will only rely on the rule if the benefits to that fund exceed the costs. We have provided estimates of the aggregate costs associated with printing and mailing shareholder reports. However, as discussed in further detail below, in certain cases the Commission is unable to quantify other economic effects, such as how the availability of shareholder reports online will affect investors' use
The baseline from which we analyze the economic effects of rule 30e-3, as well as the related rule and registration form amendments, is the current set of regulatory requirements under which funds transmit shareholder reports to investors. The baseline also includes the current practice of many funds to make some or all of these reports—or other materials listing portfolio investment information—accessible on their websites. The baseline reflects the fact that some funds transmit these materials electronically today, pursuant to Commission guidance that permits such a transmission method on a shareholder-by-shareholder “opt-in” basis, provided that certain other conditions are met.
The parties that could be affected by new rule 30e-3 are funds that currently are or would be required to transmit shareholder reports under rule 30e-1 or 30e-2; shareholders of funds; financial intermediaries and other third parties involved in the distribution of shareholder reports to beneficial owners of funds on behalf of funds; and current and future users of fund portfolio investment information, including investors and third-party information providers. Some commenters have also suggested that the rule may have effects on the environment, the paper industry, and mail carriers.
The assets of all registered investment companies exceeded $19 trillion at year-end 2016, having grown from about $5.8 trillion at the end of 1998.
Rules 30e-1 and 30e-2 generally require funds to transmit reports to shareholders at least semi-annually, with holdings as of the end of the second and fourth fiscal quarters disclosed in the fund's semi-annual and annual reports, respectively.
In addition to providing paper copies of shareholder reports to investors, some funds may voluntarily, or because of other requirements, make some or all of these reports—or other materials listing portfolio holdings at particular times—accessible on websites. For example, rule 498 under the Securities Act, which concerns the use of a summary prospectus, requires that shareholder reports be made publicly available on a website if a summary prospectus is used.
Under existing Commission guidance, funds can transmit shareholder reports or other documents electronically in lieu of paper delivery if they satisfy certain conditions relating to investor notice, access, and evidence of delivery. The Commission's guidance indicates that one way evidence of delivery can be demonstrated as to an investor is if an investor has agreed to electronic transmission on an affirmative “opt-in” basis.
Some shareholder reports are currently transmitted electronically under this guidance. One commenter estimated that 43% of reports to street name holders are delivered electronically and projected that 59% of reports to street name holders will be delivered electronically in 2018.
Another commenter stated that for accounts held directly, “an informal sampling of some of our members with direct-at-fund business showed an average e-delivery rate of about 40 percent.”
While these figures demonstrate that electronic delivery is used for a significant proportion of shareholder reports (which affects the baseline printing and mailing costs across funds under the existing requirements), because a fund is not required to report to the Commission the extent to which it relies on Commission guidance, we lack information to estimate the percentage of funds that solely or predominantly rely on electronic delivery under existing Commission guidance. We recognize, consistent with the comments we have received, that electronic delivery of reports to some investors under existing Commission guidance may continue to reduce printing and mailing costs in the future, regardless of whether rule 30e-3 is adopted.
In the Proposing Release, we estimated aggregate annual printing and mailing costs under the existing requirements to be approximately $116.4 million.
Using 2017 industry figures, we estimate that there are 11,906 funds and 724 UITs.
We are unable to determine how likely it is that the costs would be close to the lower or upper bound of the range, thus, we present the midpoint of the range for reference.
Rule 30e-3, to the extent that it is relied upon by funds, will likely provide benefits to both current and prospective investors. First, the rule is expected to benefit funds and their investors by reducing aggregate expenses related to the delivery of paper shareholder reports. Second, we believe that the rule may facilitate investor review of periodic information by increasing its overall accessibility. We discuss these benefits in greater detail below.
The expected benefits described below will not necessarily be distributed uniformly across all funds that choose to rely on rule 30e-3. First, funds that currently have low printing and mailing costs—for example, because they have shorter shareholder reports or lower per-page printing costs—will realize smaller net cost savings from rule 30e-3. Similarly, funds that deliver many of their shareholder reports electronically in reliance on existing Commission guidance will realize smaller net cost savings from rule 30e-3, although they may still realize net cost savings associated with those investors who do not opt into electronic delivery. Further, even if the net cost savings from rule 30e-3 are small, investors and funds may still realize some benefits from website accessibility of first- and third-quarter portfolio holdings information that currently may be found only on EDGAR.
Second, when funds presently rely on rule 498, which among its requirements includes website posting of shareholder reports when using a summary prospectus, the potential benefits to investors of having the shareholder report available in an electronic format alongside other fund information will likely be smaller. However, funds that presently rely on rule 498 may still realize net cost savings from no longer printing and mailing as many shareholder reports. The use of rule 30e-3 by funds that presently rely on rule 498 will also result in the benefits to investors of website accessibility of fund portfolio holdings information for the first and third fiscal quarters.
Funds that choose to rely on rule 30e-3 could be at a competitive advantage if investors choose funds based on their preference for website availability, either because investors prefer to view shareholder reports electronically or because funds that rely on rule 30e-3 could have lower expense ratios due to savings of printing and mailing costs. Additionally, as discussed above, some commenters discussed potential benefits of rule 30e-3 for the environment.
As discussed in Section II.E above, in a change from the proposal, we are adopting an extended transition period with staggered effective dates for new rule 30e-3 and the other amendments adopted today. This extended transition period would defer the realization of the benefits discussed above. However, it would provide the separate benefit of enabling investors more time to become informed of the potential forthcoming change in the delivery manner of their shareholder reports and also provide funds, financial intermediaries, and service providers with a period of time to modify systems and operations to accommodate the new shareholder report delivery framework.
As discussed in Section II.B.3 above, in a change from the proposal, we are also amending rule 498 to permit a summary prospectus to include a description of how a shareholder can elect to receive prospectuses or other documents and communications by electronic delivery.
We anticipate that funds relying on rule 30e-3, and their investors, will benefit from gains in the efficiency and a reduction in the expenses related to the distribution of paper shareholder reports. Although the rule will have minimal effect, if any, on the expenses associated with the preparation of reports, we expect that the expenses associated with printing and mailing of shareholder reports will be substantially reduced. By reducing fund expenses, printing and mailing cost savings are expected to increase the portion of investor money that is retained in the fund rather than used to cover expenses, resulting, over time, in a net positive effect on the level of capital invested in funds. Furthermore, to the extent that reductions in fund expenses due to printing and mailing cost savings have a positive effect on fund performance and attract new investors or additional capital from existing investors, the rule may result in further capital formation benefits. We are unable to precisely estimate the magnitude of capital formation effects that may result from our projected cost savings under the rule because the magnitude of such effects may be affected by the extent of pass-through of cost savings and by other factors that affect the flow of investor capital into mutual funds, including other components of fund returns, overall market returns, and returns on investments other than funds.
Specifically, because the new rule provides a structure for making website accessibility of shareholder reports and other materials the default delivery method, funds relying on rule 30e-3 will only incur printing and mailing costs as necessary to accommodate those investors opting for paper, and printing and mailing costs associated with Notices delivered to investors who have not made such an election.
As we have recognized in the past, affirmative shareholder consent can be difficult to obtain even for practices that many shareholders may prefer,
In the Proposing Release, we estimated approximately $105 million in annual (gross) cost savings if the proposed rule were adopted.
Several commenters provided alternative estimates of potential cost savings associated with the printing and mailing of shareholder reports under the proposed rule.
Another commenter estimated that the proposed rule would result in savings of up to 50%.
After considering the estimates and information provided by commenters about the potential factors that may affect net cost savings on an ongoing basis, and after considering the changes made in the final rule from the proposal, we have revised the estimates of annual gross cost savings and annual costs of relying on rule 30e-3.
First, we have revised our estimate of gross annual cost savings for the funds that rely on rule 30e-3, estimated to be $105 million in the proposal.
Second, after considering comments regarding printing and mailing costs for funds that rely on rule 30e-3, and after considering modifications to the final rule from the proposal, we have revised the estimated costs of relying on rule 30e-3. As we discuss in greater detail in Section III.D.1 below, we now estimate that, after the first year of reliance on rule 30e-3, aggregate annual costs of relying on the rule will be approximately $89.2 million, yielding aggregate annual net cost savings of approximately $141.4 million, or approximately 55% of the annual printing and mailing costs under the existing requirements.
After the first year of reliance on rule 30e-3, the aggregate annual compliance cost of rule 30e-3 is estimated to be $89,202,128.
Annual savings from rule 30e-3, net of compliance costs, as a share of annual printing and mailing costs under the existing requirements are estimated to be: $230,575,360 − $89,202,128 = $141,373,232. $141,373,232 ÷ $256,194,844 = 55%.
The revised estimates also reflect revised estimates of the number of funds updated to reflect industry figures and revised requirements of the final rule.
If a smaller
There likely is variation across individual funds both in existing printing and mailing costs and in cost savings and compliance costs that are expected on an initial or ongoing basis from rule 30e-3, depending on the extent of reliance on electronic delivery under Commission guidance. Although we cannot comprehensively quantify such differences, for instance, because of uncertainty about the future rate of growth in the use of electronic delivery under Commission guidance by funds that choose to rely on rule 30e-3, we recognize that funds that rely on rule 30e-3 may realize smaller net cost savings if they rely to a greater extent on electronic delivery of shareholder reports under existing Commission guidance.
To the extent that funds elect to rely on rule 30e-3, the rule will also increase the electronic accessibility to investors of portfolio investment information from the first and third fiscal quarters (or from the second and fourth fiscal quarters if a shareholder report contained a summary schedule of portfolio holdings) that might otherwise be only available on EDGAR, which in turn may result in greater investor review of that information. In addition, because the portfolio information must be publicly available on a website in the same location as the shareholder reports required to be posted on the website, the rule could further increase the likelihood that both existing investors and potential future fund investors review the portfolio information for the first and third quarters when they review the shareholder reports. To the extent that investors seeking information about an individual fund are likely to visit the specified website, having many of a fund's important shareholder documents in a single location on the fund's website could increase the visibility of, and facilitate access to, that information for current and future investors.
Importantly, the rule will increase website accessibility of shareholder
Greater use of shareholder reports and portfolio information by current and potential future investors could result in more informed investment decisions and an increase in competition among funds for investor capital. A better understanding of fund investment strategies, portfolio composition, and investment risks could also result in a more efficient allocation of capital across funds and other investments. An increase in the ability of investors to access and review information about different funds also could increase the competition among funds for investor capital.
Furthermore, during the extended transition period, funds intending to rely on rule 30e-3 will be required to include prominent disclosures on the cover page or beginning of their summary, and cover pages of their statutory prospectuses, and annual and semi-annual shareholder reports for up to two years before beginning to deliver Notices under the rule.
Further, as discussed in Section II.B.3 above, in a change from the proposal, we are permitting funds that elect to rely on rule 30e-3 to incorporate in the Notice, in addition to a website address, other equivalent methods or means to facilitate shareholder access to the website address. Such methods or means could include, for example, a Quick Response Code (QR code) or similar information that leads to the required website address. This change is expected to provide additional optional methods by which investors can access shareholder reports on the website, which, depending on the method, could result in a reduction in the effort and time required for investors to access the shareholder report.
Finally, as discussed in Section II.B.3 above, in a change from the proposal, the final rule permits a Notice to include pictures, logos, or similar design elements so long as the design is not misleading and the information is clear, as well as additional information about the fund, so long as it is limited to information contained in the shareholder report for which Notice is being given.
Funds that rely on rule 30e-3 will incur costs to comply with the rule's conditions. These and other costs are discussed below. Because reliance on rule 30e-3 will be optional, a particular fund is not expected to rely on the rule if the costs to the fund to rely on the rule exceed its benefits. Funds that deem the costs of meeting the conditions of rule 30e-3 to exceed the benefits of this optional rule are expected to elect not to rely on the rule and therefore not incur any compliance costs associated with rule 30e-3. Among investors in funds that elect to rely on the rule, investors with a preference for paper delivery that fail to express it may be less likely to review the information in the reports because it is not presented in their preferred format.
As we discussed in Section II.E above, we are adopting an extended transition period with staged effective dates. This will defer the time when the costs of compliance with rule 30e-3 discussed in Sections III.D.1.a through III.D.1.c below will be incurred.
Relative to the baseline, funds relying on the new rule will incur compliance costs associated with satisfying the conditions of the rule, as discussed below. To the extent possible, we have attempted to quantify these costs.
We have made various modifications to the requirements of the final rule from the proposal, as described in Section II above, in part to address issues raised by commenters. To increase investor awareness of a fund's intention to rely on rule 30e-3 and to inform investors of the upcoming changes in the transmission method, in a change from the proposal, we are adopting an extended transition period with staged effective dates and a temporary condition requiring funds to include during the extended transition period certain disclosures on summary prospectuses, statutory prospectuses and shareholder reports for up to two years prior to the date a fund would begin sending Notices in reliance on the rule. As a result of this provision, the compliance costs for funds that rely on rule 30e-3 will be higher than the compliance costs that would have been incurred under the proposal, as discussed in Sections III.D.1.c and III.D.1.d below.
However, we have also made modifications from the proposal as a result of which the compliance costs will be lower than the compliance costs
In the Proposing Release, preparing one Initial Statement was estimated to require 1.5 burden hours in the first year and 0.5 burden hours in each subsequent year, with 25% of that burden carried by outside counsel.
In the Proposing Release, we estimated printing and mailing costs for one Notice or Initial Statement to be $1,000.
Based on updated industry figures, we now estimate that 11,367 funds will elect to rely on rule 30e-3.
One commenter estimated cost savings from the elimination of the Initial Statement to be approximately $60 million.
As we discuss in Section II.B.3 above, in a modification from the proposal, we are permitting funds to incorporate content from the shareholder report in Notices relating to shareholder reports required to be transmitted under rule 30e-1. However, funds may incur additional costs for incorporating content from the shareholder report into the Notice and filing such Notices with reports on Form N-CSR, as well as potentially increase their printing and mailing costs, depending on the length of the Notice. We expect that funds will only elect to include content from shareholder reports in Notices if they believe the benefits to funds and investors outweigh the increase in their costs of preparing and distributing Notices with additional content. Likewise, funds may choose to deploy certain additional optional methods to facilitate access of shareholder reports (
As discussed in Section IV.C below, we have reflected these modifications, as well as commenter input, in the revised burden estimates for the Notice for purposes of the Paperwork Reduction Act of 1995, which we incorporate in the cost analysis below.
We have also specified that the schedule of portfolio investment information as of the end of the first and third fiscal quarters must be presented in a manner consistent with the reporting requirements of Regulation S-X. As most funds have established procedures in place to prepare and review such disclosures and familiarity with the disclosure requirements, this provision should not result in significant compliance costs.
As we discuss below, we have also revised certain assumptions underlying our estimates. First, we have revised our estimate of the number of funds that will rely on rule 30e-3 upward to 11,367 to reflect updates to the industry data figures that were utilized in the Proposing Release.
Second, where applicable, we have attempted to address comments related to our estimates. Two commenters stated that the proposal underestimated the costs under rule 30e-3 (for instance, processing fees for broker-held accounts) and thus overestimated the net cost savings expected under rule 30e-3.
In the Proposing Release, we estimated that compliance costs of rule 30e-3 would be, in the aggregate, approximately $32 million each year, with approximately $16 million in additional one-time costs being incurred in the first year following the effective date (resulting in aggregate compliance costs of approximately $48 million in the first year).
Funds that rely on rule 30e-3 in the aggregate are expected to incur costs of approximately $3.2 million in the first year of relying on rule 30e-3 and $2.7 million in each subsequent year to make the shareholder reports and portfolio information publicly accessible at a specified website.
We estimate that funds that elect to rely on rule 30e-3 will incur, in the aggregate, approximately 9,386 burden hours during the first year of relying on rule 30e-3 and 8,476 burden hours each following year to comply with the website posting requirements of the rule.
In the aggregate, we estimate that the total external cost for funds to comply with the website posting requirements of the rule will be approximately $228,000 during the first year, with the external cost in subsequent years likely to be negligible.
We estimate that funds will incur, in the aggregate, approximately $14.3 million in the first year of relying on rule 30e-3 and approximately $10.2 million in each subsequent year in costs to prepare and review Notices and to file Notices with additional content with reports on Form N-CSR.
We estimate that funds that elect to rely on rule 30e-3 will incur, in the aggregate, an internal hour burden of approximately 25,576 hours in the first year and 17,051 hours each following year in connection with the Notice conditions of the rule.
We did not receive any comments on our proposed estimate of the proportion of the time required to prepare Initial Statements and Notices that would be carried out by outside counsel, and we are maintaining that estimate today. We are, however, updating our estimate of the hourly rate for the work carried out by compliance attorneys based on updated salary estimates to $353 per hour.
The incremental annual costs of filing Notices with additional content with reports on Form N-CSR are estimated to be approximately $1.9 million, using burden estimates for purposes of the PRA.
Finally, we estimate that external costs related to the Notice requirements of rule 30e-3 will be, in the aggregate, approximately $3.4 million in the first year and $2.3 million each following year.
We estimate that funds that rely on rule 30e-3 will incur, in the aggregate, approximately $76.3 million per year in printing and mailing costs for Notices and costs of delivery of shareholder reports in paper form upon shareholder request.
In a change from the proposal, funds will not be required to prepare and mail the Initial Statement. Therefore, the cost estimates are revised from the proposal to reflect the elimination of the Initial Statement printing, mailing and processing costs. The cost estimates are further revised to reflect changes we are making to the Notice requirements relative to the proposal, including eliminating the reply card requirement, permitting Notices to be incorporated into or combined with other Notices, as well as expanding the ability to combine Notices with other mailings. The estimates further incorporate certain revisions to the assumptions, relative to the proposal, based on the input we have received from commenters. In particular, we have revised the baseline assumption about the magnitude of printing and mailing costs as a share of the total external cost of compliance with rules 30e-1 and 30e-2, from one-third in the proposal, to two-thirds, as explained below.
Further, in light of the above comments on the estimates in the Proposing Release and the modifications we are making today (including eliminating the reply card requirement for Notices, permitting Notices to accompany other Notices and other types of documents, and permitting funds to include optional content from the shareholder report in the Notice),
We now estimate that each fund that relies upon rule 30e-3 will incur an external cost of approximately $6,212 per year for printing and mailing Notices.
In addition, under rule 30e-3, investors will have the option to request shareholder reports and other materials to be delivered in paper form and also to request paper copies for individual documents even if they do not request paper delivery for all documents. Funds that rely on rule 30e-3 will therefore incur expenses related to printing and mailing shareholder reports and other materials for those shareholders. We estimate that funds that elect to rely on rule 30e-3 will incur, in the aggregate, annual external costs of approximately $5.7 million to comply with the rule's requirements to print and mail shareholder reports upon request.
In connection with tracking shareholder requests for paper under rule 30e-3, funds and intermediaries may incur costs to implement and maintain systems to record shareholder preferences for paper delivery and requests for paper copies of shareholder reports under rule 30e-3.
The modifications made from the proposal, including the elimination of the Initial Statement, the tracking of delivery preferences at the account rather than position level, and the permanent nature of the opt-in to paper delivery, are expected to reduce operational complexities and make it easier for existing systems to be leveraged for purposes of tracking investor preferences for paper delivery under rule 30e-3. Further, the extended transition period, added in a change from the proposal, is expected to provide funds and intermediaries additional time to implement the necessary system changes.
We recognize that certain changes from the proposal, such as eliminating the requirement to mail the Initial Statement, eliminating the reply card, and adding required prominent disclosures on summary and statutory prospectuses and shareholder reports, may affect the number of investors who elect paper delivery due to changes to investor awareness regarding the option to request paper delivery under rule 30e-3, resulting in different printing and mailing costs under rule 30e-3 than estimated above. However, we are not able to quantify these effects due to uncertainty about the number of investors who may elect paper delivery as a result of these changes.
In a modification from the proposal, we are amending rule 498 and certain fund registration forms setting forth a temporary condition requiring funds to include during the extended transition period certain disclosures on summary prospectuses, statutory prospectuses, and shareholder reports for up to two years prior to the date a fund would begin sending Notices in reliance on the rule. During the extended transition period, funds intending to rely on rule 30e-3 as early as permitted will include prominent disclosures on the cover page or beginning of their summary prospectuses, and cover pages of their statutory prospectuses and shareholder reports for a period of up to two years.
As described above, the condition will take effect on January, 1, 2019 and expire on January 1, 2022.
However, for existing funds, the application of these provisions during the extended transition period and the associated costs and benefits will be determined by the timing of the fund's own decision to rely on rule 30e-3 and to begin informing investors of the fund's intent to rely on rule 30e-3 by including prominent disclosures on fund documents during the extended transition period (
The final rule provides funds the flexibility to make the election to rely on rule 30e-3 at the time that is most appropriate for the fund's specific circumstances while including prominent disclosure requirements during the extended transition period to enhance investor awareness of the upcoming changes in the shareholder report delivery framework. Such flexibility is expected to enable funds to select the most efficient manner of shareholder report delivery and for funds that elect to rely on the rule, the most efficient approach to transition to rule 30e-3.
The final rule allows new funds that enter the industry in January 2021 or later to begin relying on rule 30e-3 immediately from the date the fund first publicly offers its shares without having to provide prominent disclosures, which is different from the application of the rule to funds in existence during 2019-2020 that will have had to provide up to two years of prominent disclosures, and incur the associated cost, as a condition of relying on rule 30e-3 beginning on January 1, 2021. In this respect, existing funds wishing to rely on the rule beginning on January 1, 2021 will incur a cost that funds newly formed on or after that date will not. Moreover, those existing funds that delay their decision to rely on the rule (that is, those that decide after January 1, 2019) may incur the opportunity cost due to not being able to begin relying on the rule starting January 1, 2021. Although in that respect, existing and new funds are treated differently, we note that all funds that decide to rely on the rule as early as possible—either before January 1, 2019 or at their inception—will be treated similarly.
We estimate that there are 11,181 funds that file Form N-1A,
We estimate that funds will incur, in the aggregate, 9,057 hours in the first year and 4,529 hours in the second year to satisfy the disclosure requirements associated with the amendments to rule 498.
Based on an estimated wage rate of about $284 per hour,
We estimate that there are 711 closed-end funds that file Form N-2,
We estimate that there are 14 funds that file Form N-3,
As we discuss below, we estimate funds that will rely on rule 30e-3 will make 1,488 filings of Form N-4, with the total annual hour burden associated with the amendments to Form N-4 of 1,488 hours in the first year and 744 hours in the second year.
As we discuss below, we estimate funds that will rely on rule 30e-3 will make 425 filings of Form N-6, with the total annual hour burden associated with the amendments to Form N-6 of 425 hours in the first year and 213 hours in the second year.
Although we believe that the provisions of the final rule enable investors to receive shareholders reports in the format they prefer, that website availability of shareholder reports and portfolio information is consistent with many investors' preferences,
However, another commenter suggested that surveys about readership may be unreliable because respondents may misstate their readership, because surveys did not ask respondents specifically about whether they read the reports, and because surveys often have methodological problems that lead to a likely overstatement of the baseline readership. The commenter also expressed skepticism that “large number[s] of individual investors are avid readers of their paper shareholder reports” due to the length and technical nature of the reports, especially when published on a consolidated basis, and argued that it is thus not possible to conclude that fewer investors would read reports online.
To the extent that a reduction in the review of shareholder reports by such investors decreases how informed they are about funds, it could potentially decrease their ability to efficiently allocate capital across funds and other investments. A decrease in the ability of investors to access and review information about different funds could also decrease the competition among funds for investor capital. However, these potential effects will be attenuated to the extent that investors rely on other sources of information and disclosures, in addition to shareholder reports, to obtain information about funds.
In a change from the proposal, after considering the input from commenters, we are not requiring pre-paid reply cards to be sent together with Notices,
However, we have sought to mitigate such potential adverse effects in the final rule.
In a change from the proposal, the final rule permits a Notice to include additional information about the fund, so long as it is limited to information contained in the shareholder report for which Notice is being given.
In addition, although we expect investors to benefit from a reduction in printing and mailing costs borne by their funds, we recognize that some investors may incur printing costs due to manually printing specific documents of their choosing.
It is possible that funds that choose to rely on rule 30e-3 could be at a competitive disadvantage if investors choose funds based on their preference for the default of paper delivery. Funds for which such competitive effects outweigh the cost savings from reliance on rule 30e-3 can choose not to rely on rule 30e-3.
Rule 30e-3 and related rule and form amendments could also potentially have costs extending beyond the asset management industry. Some commenters expressed concern about the long-term effects of rule 30e-3 on other industries, including the paper industry.
Commission staff has also examined different ways in which the information that funds provide to investors could be made more accessible while still promoting the ability of investors to receive these important documents via their preferred method. Some of these alternatives are discussed throughout the release to explain why the Commission ultimately chose to adopt the rule in its current state. We discuss below several additional alternatives that the Commission considered.
As an alternative, we considered whether we should eliminate the Notice requirement, as suggested by one commenter.
As another alternative, we could have required or permitted the Notice, which meets the content requirements in the final rule, or alternatively, additional content requirements as described below, to be sent via email, as suggested by some commenters.
Nevertheless, as discussed above, we continue to believe that it is important for investors to receive the Notice, as it will contemporaneously alert them to the availability of a shareholder report online. A Notice will also provide investors with information on how to obtain a paper copy of the report, which makes it easier for investors with a preference for paper to request shareholder reports in paper. The benefits from requiring the Notice to be in paper form include, for example, that there may be instances where an investor provided his or her email for certain limited purposes without necessarily intending to receive shareholder reports or notices of reports through email.
In a modification from the proposal, we are permitting funds to incorporate content from their shareholder reports into Notices relating to shareholder reports required to be transmitted under rule 30e-1, as discussed in greater detail in Section II.B.2.b.ii above. As alternatives, we considered, as a condition of reliance on rule 30e-3, either (1) limiting the types of content from the shareholder report that is
However, both alternatives would limit the flexibility of funds to tailor Notice content to include the types of information from shareholder reports that may be more relevant and valuable for investors in the specific fund, potentially affecting how useful the Notice content is to those investors.
Further, if the additional information required to be included in Notices under the second alternative is more extensive than the information that funds would otherwise elect to include in Notices under the final rule, the second alternative could increase Notice preparation, printing, and mailing costs, which would be passed on to fund investors, relative to the final rule.
We also recognize that the number of funds that rely on rule 30e-3 may decrease under this alternative in the event that funds find rule 30e-3 to be less advantageous as a result of increased Notice preparation, printing, and mailing costs. Overall, we believe that the Notice provisions of the final rule permit sufficient flexibility for funds to present additional information from the shareholder report in Notices sent to investors without imposing additional burdens and costs on those funds that would not expect their investors to find such information to be of added value.
We are adopting a temporary condition of reliance on rule 30e-3 that requires funds intending to rely on rule 30e-3 to provide prominent disclosures on certain fund documents for up to two years during the extended transition period. As an alternative, we could require all funds, including funds that elect to rely on rule 30e-3 after the temporary condition expires, to provide two years of prominent disclosures on certain fund documents prior to being able to rely on rule 30e-3. This alternative may benefit some investors in funds that elect to rely on rule 30e-3 in the future by increasing their awareness of the fund's intent to rely on rule 30e-3. However, this benefit is likely to decrease as time elapses since the rule's effective date and an increasing number of investors becomes aware of the industry-wide changes in the shareholder report delivery framework under rule 30e-3, including as a result of receiving prominent disclosures on fund documents and Notices under rule 30e-3 sent by other funds in which investors hold positions. This alternative likely would reduce the benefits to funds, and in turn, to fund investors, relative to the final rule, by retaining on an indefinite basis a two-year delay in the ability of funds to realize printing and mailing cost savings from rule 30e-3. This alternative also would result in higher costs of prominent disclosures being incurred by funds, and in turn, fund investors, beyond the end of the extended transition period.
New rule 30e-3 contains a “collection of information” within the meaning of the Paperwork Reduction Act of 1995 (the “PRA”).
The titles for the existing collections of information are: “Rule 30e-1 under the Investment Company Act of 1940, Reports to Stockholders of Management Companies” (OMB Control No. 3235-0025); “Rule 30e-2 (17 CFR 270.30e-2) pursuant to Section 30(e) of the Investment Company Act of 1940 (15 U.S.C. 80a-29(e)), Reports to Shareholders of Unit Investment Trusts” (OMB Control No. 3235-0494); “Rule 498 under the Securities Act of 1933, Summary Prospectuses for Open-End Management Investment Companies” (OMB Control No. 3235-0648); “Form N-1A under the Securities Act of 1933 and under the Investment Company Act of 1940, Registration Statement of Open-End Management Investment Companies” (OMB Control No. 3235-0307); “Form N-2 under the Investment Company Act of 1940 and Securities Act of 1933, Registration Statement of Closed-End Management Investment Companies” (OMB Control No. 3235-0026); “Form N-3 under the Securities Act of 1933 and under the Investment Company Act of 1940, Registration Statement of Separate Accounts Organized as Management Investment Companies” (OMB Control No. 3235-0316); “Form N-4 under the Securities Act of 1933 and under the Investment Company Act of 1940, Registration Statement of Separate Accounts Organized as Unit Investment Trust” (OMB Control No. 3235-0318); “Form N-6 under the Securities Act of 1933 and under the Investment Company Act of 1940, Registration Statement of Separate Accounts Organized as Unit Investment Trust” (OMB Control No. 3235-0503); and “Form N-CSR under the Securities Exchange Act of 1934 and under the Investment Company Act of 1940, Certified Shareholder Report of Registered Management Investment Companies” (OMB Control No. 3235-0570). The title for the new collection of information is: “Rule 30e-3 under the Investment Company Act of 1940, internet Availability of Reports to Shareholders” (OMB Control No. 3235-0758).
We published notice soliciting comments on the collection of information requirements in the Proposing Release and submitted the proposed collection of information to the Office of Management and Budget (“OMB”) for review in accordance with 44 U.S.C. 3507(d) and 5 CFR 1320.11. 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 control number.
The Commission is adopting new rule 30e-3 under the Investment Company Act and certain related amendments. This reform is designed to modernize the manner in which periodic information is transmitted to investors, which we believe will improve investors' experience while reducing expenses associated with printing and mailing shareholder reports that are borne by investment companies and ultimately their investors. We discuss below the collection of information burdens associated with this reform.
New rule 30e-3 will provide certain funds with an optional method to satisfy requirements to transmit shareholder reports by making such reports and certain other materials publicly accessible on a website, provided that certain other conditions are satisfied.
Rule 30e-3 provides that a fund may satisfy its obligations to transmit a report to shareholders if certain conditions set forth in the rule are satisfied. Among these conditions are the requirements that the fund's shareholder report, any report with respect to the fund for the prior reporting period that was transmitted to shareholders of record pursuant to rule 30e-1 or rule 30e-2, and in the case of a report relating to a fund other than a money market fund or an SBIC, the fund's complete portfolio holdings as of the close of its most recent first and third fiscal quarters, be publicly accessible, free of charge, at a specified website address.
In the Proposing Release, we estimated that 11,957 funds could rely on proposed new rule 30e-3.
We have revised our estimate of the number of funds that may rely on rule 30e-3 upward from 11,957 to 12,630 to reflect updates to the industry data figures that were utilized in the Proposing Release.
In the Proposing Release, of the remaining funds estimated to rely on proposed rule 30e-3, we further estimated that approximately 90% of those funds (or 1,014 funds) already had a website.
We did not receive any comments on our estimates in the Proposing Release of the proportion of those funds that would rely on the proposed rule and already have a website but that do not rely on the summary prospectus rule today, the burden of the website posting requirements for funds not relying on the summary prospectus rule that have a website, and the burden of the website posting requirements for funds that do not have a website, and we are maintaining those estimates today, with adjustments to reflect the updated industry figures since the Proposing Release. Thus, we estimate that, of the 1,137 funds estimated to rely on the new rule but that do not rely on the summary prospectus rule,
Accordingly, we estimate that the posting requirements will result in an average annual hour burden of about 0.83 hours per fund in the first year of compliance
In the Proposing Release, we estimated that certain funds would bear an external cost burden in complying with the rule. The external cost burden is the cost of goods and services purchased in connection with complying with the rule, which, with respect to the posting requirements, will include costs associated with development of a website. With respect to those funds that would rely on proposed rule 30e-3 but that do not currently have a website, we estimated that the posting requirements of the proposed rule would result in an external cost burden of $2,000 per fund in the first year to develop a website but no cost burden in subsequent years.
As proposed, rule 30e-3 would have permitted an optional method to satisfy requirements to transmit shareholder reports by posting reports online with respect to a particular investor only if either the investor previously consented to this optional method of website availability or the investor's consent could be inferred under certain conditions specified in the rule.
Proposed rule 30e-3 would have required a Notice be sent to investors within 60 days of the close of the reporting period covered by the related report. Under the final rule, a Notice is required to be sent to investors within 70 days of the close of the reporting period to which the report relates.
As discussed in Section IV.A above and as we estimated in the proposal, we estimate that 90% of all eligible funds (or 11,367 funds) will choose to rely on new rule 30e-3.
For those funds relying on the rule, in the Proposing Release we estimated that each fund will require two hours to prepare and file the first Notice in the first year and an hour for each subsequent notice.
We did not receive any comments on our proposed estimates of the time required to prepare Notices, or on the estimated proportion of the preparation time required to prepare Notices that would be carried out internally or by outside counsel. As discussed above, the requirements regarding the Notice in the final rule, including removing the direct URL to the shareholder report and the reply card requirement, permitting Notices to be incorporated into or combined with other Notices, expanding the ability to combine Notices with other mailings, as well as removing the filing requirement (other than for Notices that include content from the report to which it relates as discussed in Section IV.F below), will collectively affect the estimated burden associated with the preparation of Notices. We are maintaining our estimate of the 75% preparation time that would be incurred by the fund internally, the first Notice in the first year required hours of two hours, and our estimate of subsequent Notice required hours of one hour to account for an increase in some funds that may include content from the shareholder report in the Notice.
Accordingly, we estimate that the Notice will result in an average annual hour burden of about 2.25 hours per fund in the first year
In addition, we estimate that funds will incur external costs if they rely on rule 30e-3. The external cost burden is the cost of goods and services purchased in connection with complying with the rule, which, with respect to the Notice, we have estimated would include the costs associated with outside counsel and printing and mailing costs.
In the Proposing Release, we estimated that 25% of the time required to comply with the requirements concerning preparation of the Notice would be carried out by outside counsel retained by the fund at a rate of $380 per hour.
We estimated in the Proposing Release that the external costs associated with rules 30e-1 and 30e-2 (the rules relating to shareholder reports) would be $31,061 and $20,000, respectively.
We estimated in the Proposing Release that the Notice would require lower printing and mailing costs given the significantly smaller size of the documents. Specifically, we estimated that each Notice would require 10% of the annual printing and mailing costs associated with paper shareholder reports.
We note that some commenters specifically discussed the processing fees for broker-held accounts separately from other printing and mailing costs, while, in the Proposing Release, our estimates for printing and mailing were meant to encompass all of those costs more broadly.
Some commenters also suggested that the costs associated with the proposed reply card requirements may have been understated.
In light of the above comments on the estimates in the Proposing Release and the modifications we are making today, we have determined to increase our estimate of the percentage of annual printing and mailing costs (including processing fees) associated with shareholder reports that will be associated with the printing and mailing of each Notice from the 10% that we had originally proposed to 15%.
We also estimate, as we did in the Proposing Release, that there would be no other external costs attributable to the Notice.
We did not receive any comments on this proposed estimate, and we are maintaining it today, except that we are revising the share of expenses upward from one-third to two-thirds. Thus, we estimate that the external cost burden associated with each Notice will be about $3,106.
Because each fund relying on rule 30e-3 will be required, in the final rule, to send two Notices in the first year, we estimate that the external costs for the first year on a per fund will be $6,212.
We estimated in the Proposing Release that funds may incur external costs in connection with the requirement to provide a shareholder report upon request of an investor. We estimated that the annual costs associated with printing and mailing these reports would be $500 per fund.
In total, rule 30e-3 will impose an average total annual hour burden of 28,610 hours on applicable funds
We estimate, as we did in the Proposing Release, that rule 30e-3 will have the effect of reducing the external cost burden associated with rules 30e-1 and 30e-2. Rule 30e-1 requires a fund to transmit shareholder reports to its investors.
In the Proposing Release, we estimated, with respect to rule 30e-1, that each fund currently incurs an annual hourly burden of 84 hours and an annual external cost burden of $31,061 per fund.
In connection with recent amendments to Regulation S-X, which prescribes the form and content of fund financial statements, we estimated that each fund would incur 2.5 additional burden hours per year after the first year to comply with rule 30e-1.
As discussed above, we continue to estimate that 90% of all funds will rely on rule 30e-3.
Although commenters did not opine on the proposed estimate of the proportion of total external costs associated with rules 30e-1 and 30e-2 associated with printing and mailing expenses, some did provide estimates of the current total costs of print and mail delivery that suggest that our estimated proportion of those costs may have been understated, and we have determined to revise our estimate upwards to two-thirds, which yields overall printing and mailing expenses that are more similar to those estimated by commenters compared to the estimates in the Proposing Release.
We have also made adjustments to these estimates to reflect updated industry data since the Proposing Release regarding the number of funds. Accordingly, we estimate that for the 90% of funds estimated to rely on rule 30e-3 the total annual external cost burden for rule 30e-1 will be $110,943,110,
In a change from the proposal, as discussed above, we are amending rule 498 under the Securities Act and certain fund registration forms to require that funds intending to rely on rule 30e-3 prior to January 1, 2022 include prominent disclosures on the cover page or beginning of their summary prospectuses, and cover pages of their statutory prospectuses, and annual and semi-annual reports, for two years during the three-year period between January 1, 2019 and December 31, 2021.
Currently, we estimate that funds have the following total annual burdens for compliance with: Rule 498 (15,798 hours), Form N-1A (1,596,749 hours), Form N-2 (73,250 hours), Form N-3 (2,500 hours), Form N-4 (343,117 hours), and Form N-6 (85,269 hours). Based on updated industry data figures and the amendments to rule 498 and the registration statements being adopted today, we have revised these estimates as follows.
As discussed above, we estimate that there are 12,630 funds that could rely on rule 30e-3.
We estimate that there are 11,181 funds that could file registration statements or amendments to registration statements on Form N-1A.
We estimate that there are 711 funds that could file registration statements or amendments to registration statements on Form N-2.
We estimate that there are 14 funds that could file registration statements or amendments to registration statements on Form N-3.
We estimate that there are 1,653 responses on Form N-4 each year. Of this group, we estimate that 1,488 of the responses will be made by funds that will rely on rule 30e-3.
We estimate that there are 472 responses on Form N-6 each year. Of this group, we estimate that 425 of the responses will be made by funds that will rely on rule 30e-3.
In a modification from the proposal, as discussed above, we are amending Form N-CSR to require that for fund Notices that include content from the report to which it relates, a copy of the Notice must be filed as part of the fund's report on Form N-CSR.
We estimate that there are 10,715 funds that will rely on rule 30e-3 and could prepare Notices that include content from the report to which it relates.
We estimate that of the 10,715 funds to rely on rule 30e-3 that could add content to the Notice from the report to which it relates, that 5,358 funds would add content from the shareholder Report to the Notice and would therefore be required to file such Notices with reports on Form N-CSR.
This Final Regulatory Flexibility Analysis (“FRFA”) has been prepared in accordance with Section 4(a) of the Regulatory Flexibility Act (“RFA”).
Rule 30e-3 is designed to modernize the manner in which periodic information is transmitted to investors. Rule 30e-3 will provide certain funds with an optional method to satisfy shareholder transmission requirements by making the reports and other materials publicly accessible on a website, provided that certain other conditions are satisfied. We believe the rule will improve investors' experience while reducing expenses associated with printing and mailing shareholder reports that are borne by investment companies and ultimately their investors.
In connection with our adoption of rule 30e-3, we are also adopting related amendments to certain of our rules and forms. We are amending rule 498 and certain fund registration forms to require that funds intending to rely on rule 30e-3 include during the extended
In the Proposing Release, we requested comment on each aspect of the IRFA, including the number of small entities that would be affected by the proposed amendments, the existence or nature of the potential impact of the proposals on small entities discussed in the analysis and how to quantify the impact of the proposed rules. As discussed above, we received extensive comments regarding the potential costs and benefits of the proposals.
An investment company is a small entity if, together with other investment companies in the same group of related investment companies, it has net assets of $50 million or less as of the end of its most recent fiscal year.
The amendments will create, amend, and eliminate current reporting, recordkeeping and other compliance requirements for small entities.
Rule 30e-3 is designed to provide funds with an optional method to satisfy requirements to transmit shareholder reports by posting reports online if they meet certain conditions.
We estimate that approximately 88 registered investment companies are small entities that will rely on the rule.
As discussed above, we estimate that reliance on rule 30e-3 will result in certain costs and benefits related to the website availability of shareholder reports for each fund, including small entities, with savings of approximately $20,285 per year for each fund with respect to their regulatory obligation to deliver shareholder reports to investors in savings related to printing and mailing costs for shareholder reports, and costs of $7,847 per year for each fund to implement new rule 30e-3 in costs related to website accessibility requirements, Notice preparation, and printing, mailing, and processing fees for the Notices.
We received no direct comments on the IRFA analysis of rule 30e-3 but as discussed above, we received comments on the rule and projected expense savings from the rule. We have discussed these comments in our discussion of the final rule and our cost/benefit and PRA estimates above.
We are amending rule 498 under the Securities Act and certain fund registration forms to require that funds intending to rely on rule 30e-3 include prominent disclosures on the cover page (or beginning) of their summary prospectuses, statutory prospectuses, and shareholder reports in advance of the date on which funds could begin to rely upon the rule.
We estimate that the costs of these related disclosures will be $284-$721 in the first year and $142-$437 in each of the second and third years for each fund that relies upon rule 30e-3 and that could file registration statements or amendments to registration statements on Form N-1A (including funds that rely upon rule 498), Form N-2, Form
We are amending Form N-CSR to require that for fund Notices that include content from the shareholder report to which it relates, a copy of the Notice must be filed as part of the fund's report on Form N-CSR.
The RFA directs the Commission to consider significant alternatives that would accomplish our stated objective, while minimizing any significant economic impact on small entities. The Commission considered the following alternatives for small entities in relation to our forms and form amendments and rules and rule amendments: (i) Establishing different reporting requirements or timetables that take into account resources available to small entities; (ii) the clarification, consolidation, or simplification of compliance and reporting requirements under the rule for such small entities; (iii) using performance rather than design standards; and (iv) exempting small entities from all or part of the proposal.
Regarding the first alternative, we note that small entities currently follow the same requirements that larger entities do when delivering reports to shareholders. The Commission believes that establishing different reporting requirements or timetables for small entities to deliver reports to shareholders would not be consistent with the Commission's overarching goal of industry oversight and investor protection. We note that, because reliance on rule 30e-3 will be optional, similar to the proposal, a particular fund is not expected to rely on the rule if the costs to the fund to rely on the rule to that fund exceeds its benefits. Funds that do not rely on the rule will therefore not incur compliance costs.
Regarding the second and third alternatives, we do not believe that clarification, consolidation, or simplification of compliance and reporting requirements, or performance rather than design standards, are appropriate in this context. In order to promote comparability and transparency, we believe that shareholder reports should be delivered to shareholders in a manner that will allow investors to better review and compare their investments across funds, including small entities. Therefore, we believe that it is appropriate in this context for shareholder reports to be delivered pursuant to uniform design, compliance, and reporting standards and requirements designed by the Commission. Further regarding clarification of compliance and reporting requirements for small entities, we note that we will publish a small entity compliance guide that will be posted on our website following adoption of rule 30e-3.
Regarding the fourth alternative, we note that in addition to providing funds with an optional method to satisfy their obligations to deliver shareholder reports by posting reports online if they meet certain conditions, rule 30e-3 is designed with certain safeguards to respond to investor protection concerns. For example, the rule requires that the shareholder reports and other required materials are publicly accessible free of charge at a website address specified in the Notice, and includes provisions designed to preserve the ability of investors to elect to receive paper reports free of charge. Therefore, we believe that exempting small entities from all or part of the proposal would not be consistent with the Commission's overarching goal of industry oversight and investor protection.
We are adopting the rule and rule and form amendments contained in this document under the authority set forth in the Securities Act, particularly Sections 5, 6, 7, 10, and 19 thereof [15 U.S.C. 77a
Administrative practice and procedure, Organization and functions (Government agencies).
Investment companies, Reporting and recordkeeping requirements, Securities.
For reasons set forth in the preamble, title 17, chapter II of the
44 U.S.C. 3506; 44 U.S.C. 3507.
(b) * * *
15 U.S.C. 77b, 77b note, 77c, 77d, 77f, 77g, 77h, 77j, 77r, 77s, 77z-3, 77sss, 78c, 78d, 78j, 78
(b) * * *
(1) * * *
(v) The following legend:
Before you invest, you may want to review the Fund's prospectus, which contains more information about the Fund and its risks. You can find the Fund's prospectus, reports to shareholders, and other information about the Fund online at [___]. You can also get this information at no cost by calling [___] or by sending an email request to [___].
(A) The legend must provide a website address, other than the address of the Commission's electronic filing system; toll free (or collect) telephone number; and email address that investors can use to obtain the Statutory Prospectus and other information. The website address must be specific enough to lead investors directly to the Statutory Prospectus and other materials that are required to be accessible under paragraph (e)(1) of this section, rather than to the home page or other section of the website on which the materials are posted. The website could be a central site with prominent links to each document. The legend may indicate, if applicable, that the Statutory Prospectus and other information are available from a financial intermediary (such as a broker-dealer or bank) through which shares of the Fund may be purchased or sold.
(B) If a Fund incorporates any information by reference into the Summary Prospectus, the legend must identify the type of document (
(vi) The Summary Prospectus may provide instructions describing how a shareholder can elect to receive prospectuses or other documents and communications by electronic delivery.
(vii) A statement to the following effect, if applicable:
Beginning on [date], as permitted by regulations adopted by the Securities and Exchange Commission, paper copies of the Fund's shareholder reports will no longer be sent by mail, unless you specifically request paper copies of the reports from the Fund [or from your financial intermediary, such as a broker-dealer or bank]. Instead, the reports will be made available on a website, and you will be notified by mail each time a report is posted and provided with a website link to access the report.
If you already elected to receive shareholder reports electronically, you will not be affected by this change and you need not take any action. You may elect to receive shareholder reports and other communications from the Fund [or your financial intermediary] electronically by [insert instructions].
You may elect to receive all future reports in paper free of charge. You can inform the Fund [or your financial intermediary] that you wish to continue receiving paper copies of your shareholder reports by [insert instructions]. Your election to receive reports in paper will apply to all funds held with [the fund complex/your financial intermediary].
The addition reads as follows:
(b) * * *
(1) * * *
(v) * * *
(A) * * * If a Fund relies on § 270.30e-3 of this chapter to transmit a report, the legend must also include the website address required by § 270.30e-3(c)(1)(iii) of this chapter if different from the website address required by this paragraph (b)(1)(v)(A).
15 U.S.C. 77c, 77f, 77g, 77h, 77j, 77s, 77z-2, 77z-3, 77sss, 78c, 78l, 78m, 78n, 78o(d), 78o-7 note, 78u-5, 78w(a), 78ll, 78mm, 80a-2(a), 80a-3, 80a-8, 80a-9, 80a-10, 80a-13, 80a-24, 80a-26, 80a-29, 80a-30, and 80a-37; and sec. 107, Pub. L. 112-106, 126 Stat. 312, unless otherwise noted.
15 U.S.C. 77c, 77d, 77g, 77j, 77s, 77z-2, 77z-3, 77eee, 77ggg, 77nnn, 77sss, 77ttt, 78c, 78c-3, 78c-5, 78d, 78e, 78f, 78g, 78i, 78j, 78j-1, 78k, 78k-1, 78
15 U.S.C. 78a
15 U.S.C. 80a-1
(a)
(b)
(i)
(ii)
(iii)
(iv)
(2) The website address relied upon for compliance with this section may not be the address of the Commission's electronic filing system.
(3) The materials that are accessible in accordance with paragraph (b)(1) of this section must be presented on the website in a format, or formats, that are convenient for both reading online and printing on paper.
(4) Persons accessing the materials specified in paragraph (b)(1) of this section must be able to permanently retain, free of charge, an electronic version of such materials in a format, or formats, that meet the conditions of paragraph (b)(3) of this section.
(5) The conditions set forth in paragraphs (b)(1) through (b)(4) of this section shall be deemed to be met, notwithstanding the fact that the materials specified in paragraph (b)(1) of this section are not available for a time in the manner required by paragraphs (b)(1) through (b)(4) of this section, provided that:
(i) The Company has reasonable procedures in place to ensure that the specified materials are available in the manner required by paragraphs (b)(1) through (b)(4) of this section; and
(ii) The Company takes prompt action to ensure that the specified documents become available in the manner required by paragraphs (b)(1) through (b)(4) of this section, as soon as practicable following the earlier of the time at which it knows or reasonably should have known that the documents are not available in the manner required by paragraphs (b)(1) through (b)(4) of this section.
(c)
(1) The Notice must be written using plain English principles pursuant to paragraph (d) of this section and:
(i) Contain a prominent legend in bold-face type that states “[An] Important Report[s] to [Shareholders] of [Fund] [is/are] Now Available Online and In Print by Request.” The Notice may also include information identifying the Fund, the Fund's sponsor (including any investment adviser or sub-adviser to the Fund), a variable annuity or variable life insurance contract or insurance company issuer thereof, or a financial intermediary through which shares of the Fund are held.
(ii) State that the Report contains important information about the Fund, including its portfolio holdings and financial statements. The statement may also include a brief listing of other types of information contained in the Report.
(iii) State that the Report is available at the website address specified in the Notice or, upon request, by mail, and encourage the shareholder to access and review the Report.
(iv) Include a website address where the Report and other materials specified in paragraph (b)(1) of this section are available. The website address must be specific enough to lead investors directly to the documents that are required to be accessible under paragraph (b)(1) of this section, rather than to the home page or section of the website other than on which the documents are posted. The website may be a central site with prominent links to each document. In addition to the website address, the Notice may contain any other equivalent method or means to access the Report or other materials specified in paragraph (b)(1) of this section.
(v) Provide a toll-free (or collect) telephone number to contact the Company or the shareholder's financial intermediary, and:
(A) Provide instructions describing how a shareholder may request a paper or email copy of the Report and other materials specified in paragraph (b)(1) of this section at no charge, and an indication that he/she will not otherwise receive a paper or email copy;
(B) Explain that the shareholder can at any time elect to receive print reports in the future and provide instructions describing how a shareholder may make that election (
(C) If applicable, provide instructions describing how a shareholder can elect
(2) The Notice may include additional methods by which a shareholder can contact the Company or the shareholder's financial intermediary (
(3) A Notice relating to a Report required by § 270.30e-1 may include content from the Report if such content is set forth after the information required by paragraph (c)(1) of this section.
(4) The Notice may not be incorporated into, or combined with, another document, except that the Notice may incorporate or combine one or more other Notices.
(5) The Notice must be sent separately from other types of shareholder communications and may not accompany any other document or materials;
(i) One or more other Notices;
(ii) A current Summary Prospectus, Statutory Prospectus, Statement of Additional Information, or Notice of Internet Availability of Proxy Materials under § 240.14a-16 of this chapter;
(iii) In the case of a Fund held in a separate account funding a variable annuity or variable life insurance contract, such contract or the Statutory Prospectus and Statement of Additional Information for such contract; or
(iv) The shareholder's account statement.
(6) A Notice required by this paragraph (c) will be considered transmitted to a shareholder of record if the conditions set forth in § 270.30e-1(f), § 270.30e-2(b), § 240.14a-3(e), or § 240.14c-3(c) of this chapter are satisfied with respect to that shareholder.
(d)
(2) The Notice must be drafted so that, at a minimum, it substantially complies with each of the following plain English writing principles:
(i) Short sentences;
(ii) Definite, concrete, everyday words;
(iii) Active voice;
(iv) Tabular presentation or bullet lists for complex material, whenever possible;
(v) No legal jargon or highly technical business terms; and
(vi) No multiple negatives.
(e)
(f)
(2) A shareholder who has notified the Company (or the shareholder's financial intermediary) that the shareholder wishes to receive paper copies of shareholder reports with respect to a Fund will be deemed to have requested paper copies of shareholder reports with respect to:
(i) Any and all current and future Funds held through an account or accounts with:
(A) The Fund's transfer agent or principal underwriter or agent thereof for the same “group of related investment companies” as such term is defined in § 270.0-10; or
(B) A financial intermediary; and
(ii) Any and all Funds held currently and in the future in a separate account funding a variable annuity or variable life insurance contract.
(g)
(h)
(1)
(2)
(3)
(4)
(5)
(i)
(i) Beginning on January 1, 2021, if:
(A) The Company has included the required statement on each prospectus, summary prospectus, annual report to shareholders, and semi-annual report to shareholders, as applicable, required to be delivered or transmitted to shareholders for the period beginning on the date the Company first publicly offers its shares, and ending on December 31, 2020; or
(B) The Company first publicly offers its shares on or after January 1, 2021; or
(ii) In all other cases, after the Company has included the required statement on each prospectus, summary prospectus, annual report to shareholders, and semi-annual report to shareholders, as applicable, required to be delivered or transmitted to shareholders for a period of two years or January 1, 2022, whichever comes first.
(2) For purposes of this paragraph (i), a “required statement” means the statement regarding the Company's intent to rely on this section specified by:
(i) Its applicable registration form, and
(ii) In the case of a Fund that uses a summary prospectus, § 230.498 of this chapter.
For a discussion of how the conditions and requirements of this rule may apply in the context of investors holding Fund shares through financial intermediaries, see Investment Company Release No. 33115 (June 5, 2018).
15 U.S.C. 77f, 77g, 77h, 77j, 77s, 78c(b), 78
The additions read as follows:
The text of Form N-1A does not, and this amendment will not, appear in the Code of Federal Regulations.
(a) * * *
(5) If applicable, the statement required by rule 498(b)(1)(vii) under the Securities Act.
(d) * * *
(8)
Beginning on [date], as permitted by regulations adopted by the Securities and Exchange Commission, paper copies of the Fund's shareholder reports like this one will no longer be sent by mail, unless you specifically request paper copies of the reports from the Fund [or from the your financial intermediary, such as a broker-dealer or bank]. Instead, the reports will be made available on a website, and you will be notified by mail each time a report is posted and provided with a website link to access the report.
If you already elected to receive shareholder reports electronically, you will not be affected by this change and you need not take any action. You may elect to receive shareholder reports and other communications from the Fund [or your financial intermediary] electronically by [insert instructions].
You may elect to receive all future reports in paper free of charge. You can inform the Fund [or your financial intermediary] that you wish to continue receiving paper copies of your shareholder reports by [insert instructions]. Your election to receive reports in paper will apply to all funds held with [the fund complex/your financial intermediary].
The additions read as follows:
The text of Form N-2 does not, and this amendment will not, appear in the Code of Federal Regulations.
1. * * *
Beginning on [date], as permitted by regulations adopted by the Securities and Exchange Commission, paper copies of the Registrant's shareholder reports will no longer be sent by mail, unless you specifically request paper copies of the reports from the Registrant [or from your financial intermediary, such as a broker-dealer or bank]. Instead, the reports will be made available on a website, and you will be notified by mail each time a report is posted and provided with a website link to access the report.
If you already elected to receive shareholder reports electronically, you will not be affected by this change and you need not take any action. You may elect to receive shareholder reports and other communications from the Registrant [or your financial intermediary] electronically by [insert instructions].
You may elect to receive all future reports in paper free of charge. You can inform the Registrant [or your financial intermediary] that you wish to continue receiving paper copies of your shareholder reports by [insert instructions]. Your election to receive reports in paper will apply to all funds held with [the fund complex/your financial intermediary].
6. * * *
g. Include on the front cover page or at the beginning of the annual or semi-annual report a statement to the following effect, if applicable:
Beginning on [date], as permitted by regulations adopted by the Securities and Exchange Commission, paper copies of the Registrant's shareholder reports like this one will no longer be sent by mail, unless you specifically request paper copies of the reports from the Registrant [or from your financial intermediary, such as a broker-dealer or bank]. Instead, the reports will be made available on a website, and you will be notified by mail each time a report is posted and provided with a website link to access the report.
If you already elected to receive shareholder reports electronically, you will not be affected by this change and you need not take any action. You may elect to receive shareholder reports and other communications from the Registrant [or your financial intermediary] electronically by [insert instructions].
You may elect to receive all future reports in paper free of charge. You can inform the Registrant [or your financial intermediary] that you wish to continue receiving paper copies of your shareholder reports by [insert instructions]. Your election to receive reports in paper will apply to all funds held with [the fund complex/your financial intermediary].
The additions read as follows:
The text of Form N-3 does not, and these amendments will not, appear in the Code of Federal Regulations.
(a) * * *
(xi) A statement to the following effect, if applicable:
Beginning on [date], as permitted by regulations adopted by the Securities and Exchange Commission, paper copies of the Registrant's shareholder reports will no longer be sent by mail, unless you specifically request paper copies of the reports from the Registrant [or from your financial intermediary, such as a broker-dealer or bank]. Instead, the reports will be made available on a website, and you will be notified by mail each time a report is posted and provided with a website link to access the report.
If you already elected to receive shareholder reports electronically, you will not be affected by this change and
You may elect to receive all future reports in paper free of charge. You can inform the Registrant [or your financial intermediary] that you wish to continue receiving paper copies of your shareholder reports by [insert instructions]. Your election to receive reports in paper will apply to all funds held with [the fund complex/your financial intermediary].
(a) * * *
6. * * *
(vii) Include on the front cover page or at the beginning of the annual or semi-annual report a statement to the following effect, if applicable:
Beginning on [date], as permitted by regulations adopted by the Securities and Exchange Commission, paper copies of the Registrant's shareholder reports like this one will no longer be sent by mail, unless you specifically request paper copies of the reports from the Registrant [or from your financial intermediary, such as a broker-dealer or bank]. Instead, the reports will be made available on a website, and you will be notified by mail each time a report is posted and provided with a website link to access the report.
If you already elected to receive shareholder reports electronically, you will not be affected by this change and you need not take any action. You may elect to receive shareholder reports and other communications from the Registrant [or your financial intermediary] electronically by [insert instructions].
You may elect to receive all future reports in paper free of charge. You can inform the Registrant [or your financial intermediary] that you wish to continue receiving paper copies of your shareholder reports by [insert instructions]. Your election to receive reports in paper will apply to all funds held with [the fund complex/your financial intermediary].
The additions read as follows:
The text of Form N-4 does not, and these amendments will not, appear in the Code of Federal Regulations.
(a) * * *
(x) A statement to the following effect, if applicable:
Beginning on [date], as permitted by regulations adopted by the Securities and Exchange Commission, paper copies of the shareholder reports for portfolio companies [available under your contract] will no longer be sent by mail, unless you specifically request paper copies of the reports from the Registrant [or from your financial intermediary]. Instead, the reports will be made available on a website, and you will be notified by mail each time a report is posted and provided with a website link to access the report.
If you already elected to receive shareholder reports electronically, you will not be affected by this change and you need not take any action. You may elect to receive shareholder reports and other communications from the Registrant [or your financial intermediary] electronically by [insert instructions].
You may elect to receive all future reports in paper free of charge. You can inform the Registrant [or your financial intermediary] that you wish to continue receiving paper copies of your shareholder reports by [insert instructions]. Your election to receive reports in paper will apply to all portfolio companies [available under your contract].
The additions read as follows:
The text of Form N-6 does not, and these amendments will not, appear in the Code of Federal Regulations.
(a) * * *
(6) A statement to the following effect, if applicable:
Beginning on [date], as permitted by regulations adopted by the Securities and Exchange Commission, paper copies of the shareholder reports for portfolio companies [available under your contract] will no longer be sent by mail, unless you specifically request paper copies of the reports from the Registrant [or from your financial intermediary]. Instead, the reports will be made available on a website, and you will be notified by mail each time a report is posted and provided with a website link to access the report.
If you already elected to receive shareholder reports electronically, you will not be affected by this change and you need not take any action. You may elect to receive shareholder reports and other communications from the Registrant [or your financial intermediary] electronically by [insert instructions].
You may elect to receive all future reports in paper free of charge. You can inform the Registrant [or your financial intermediary] that you wish to continue receiving paper copies of your shareholder reports by [insert instructions]. Your election to receive reports in paper will apply to all portfolio companies [available under your contract].
The designation and addition read as follows:
The text of Form N-CSR does not, and these amendments will not, appear in the Code of Federal Regulations.
(a) Include a copy of the report transmitted to stockholders pursuant to Rule 30e-1 under the Act (17 CFR 270.30e-1).
(b) Include a copy of each notice transmitted to stockholders in reliance on Rule 30e-3 under the Act (17 CFR 270.30e-3) that contains disclosures
By the Commission.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Proposed rule; request for comments.
NMFS has received a petition for an incidental take regulation (ITR) from the Bureau of Ocean Energy Management (BOEM). The requested ITR would govern the authorization of take of small numbers of marine mammals over the course of five years incidental to geophysical survey activities conducted by industry operators in Federal waters of the U.S. Gulf of Mexico (GOM). BOEM submitted the petition in support of oil and gas industry operators, who would conduct the activities. A final ITR would allow for the issuance of Letters of Authorization (LOA) to the aforementioned industry operators over a five-year period. As required by the Marine Mammal Protection Act (MMPA), NMFS requests comments on its proposed rule, including the following; the proposed regulations, several alternatives to the proposed regulations described in the “Proposed Mitigation” and “Alternatives for Consideration” sections of the preamble, two baselines against which to evaluate the incremental economic impacts of the proposed regulations (addressed in the “Economic Baseline” section), and, two sections with broader implications: A clarification of NMFS's interpretation and application of the “small numbers” standard (see the “Small Numbers” section of the preamble); and an alternative method for assessing Level B harassment from exposure to anthropogenic noise (see the “Estimated Take” section of the preamble).
Comments and information must be received no later than August 21, 2018.
You may submit comments on this document, identified by NOAA-NMFS-2018-0043, by any of the following methods:
•
•
Comments regarding any aspect of the collection of information requirement contained in this proposed rule should be sent to NMFS via one of the means provided here and to the Office of Information and Regulatory Affairs, NEOB-10202, Office of Management and Budget, Attn: Desk Officer, Washington, DC 20503,
Ben Laws, 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:
This proposed rule would establish a framework under the authority of the MMPA (16 U.S.C. 1361
Section 101(a)(5)(A) of the MMPA (16 U.S.C. 1371(a)(5)(A)) directs the Secretary of Commerce to allow, upon request, the incidental, but not intentional taking of small numbers of marine mammals by U.S. citizens who engage in a specified activity (other than commercial fishing) within a specified geographical region for up to five years if, after notice and public comment, the agency makes certain findings and issues regulations that set forth permissible methods of taking pursuant to that activity and other means of effecting the “least practicable adverse impact” on the affected species or stocks and their habitat (see the discussion below in the “Proposed Mitigation” section), as well as monitoring and reporting requirements. Section 101(a)(5)(A) of the MMPA and the implementing regulations at 50 CFR part 216, subpart I provide the legal basis for issuing this proposed rule containing five-year regulations, and for any subsequent LOAs. As directed by this legal authority, this proposed rule contains mitigation, monitoring, and reporting requirements.
Following is a summary of the major provisions of this proposed rule regarding geophysical survey activities. These measures include:
• Standard detection-based mitigation measures, including use of visual and acoustic observation to detect marine mammals and shut down acoustic sources in certain circumstances;
• Time-area restrictions designed to avoid effects to certain species of marine mammals in times and/or places believed to be of greatest importance;
• Vessel strike avoidance measures; and
• Monitoring and reporting requirements.
Section 101(a)(5)(A) 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, or 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
In August 2017, BOEM produced a final Programmatic Environmental Impact Statement (PEIS) to evaluate potential significant environmental effects of geological and geophysical (G&G) activities on the Outer Continental Shelf (OCS) of the GOM, pursuant to requirements of NEPA. These activities include geophysical surveys in support of hydrocarbon exploration and development, as are described in the petition for ITR before NMFS. The PEIS is available online at:
BOEM was formerly known as the Minerals Management Service (MMS) and, later, the Bureau of Ocean Energy Management, Regulation, and Enforcement (BOEMRE). On December 20, 2002, MMS petitioned NMFS for rulemaking under Section 101(a)(5)(A) of the MMPA to authorize take of sperm whales (
On December 8, 2016 (81 FR 88664), we published a notice of receipt of the petition in the
Geophysical surveys are conducted in support of hydrocarbon exploration and development in the GOM, typically by companies that provide such services to the oil and gas industry. Broadly, these surveys include (1) deep penetration surveys using large airgun arrays as the acoustic source, (2) shallow penetration surveys using a small airgun array, single airgun, or subbottom profiler as the acoustic source, and (3) high-resolution surveys, which may use a variety of acoustic sources. Generally speaking, these surveys may occur within Federal territorial waters and waters of the U.S. Exclusive Economic Zone (EEZ) (
This proposed rule would establish a framework under the authority of the MMPA (16 U.S.C. 1361
The specified activity consists of geophysical surveys conducted by industry operators for a variety of reasons related to hydrocarbon exploration, development, and production. These operators are typically companies that provide geophysical services, such as data acquisition and processing, to the oil and gas industry, including exploration and production companies. The petition describes a five-year period of geophysical survey activity and provides estimates of the amount of effort by survey type and location. BOEM's PEIS (BOEM, 2017) describes a range of potential survey effort. The levels of effort in the petition (which form the basis for the modeling effort described later in the “Estimated Take” section) are the high-end estimates. Actual total amounts of effort by survey type and location would not be known in advance of receiving LOA requests from industry operators.
Geophysical surveys are conducted to obtain information on marine seabed
Deep penetration seismic surveys using airgun arrays as an acoustic source (sound sources are described in the “Detailed Description of Activities” section) are a primary method of obtaining geophysical data used to characterize subsurface structure. These surveys are designed to illuminate deeper subsurface structures and formations that may be of economic interest as a reservoir for oil and gas exploitation. A deep penetration survey uses an acoustic source suited to provide data on geological formations that may be thousands of meters (m) beneath the seafloor, as compared with a shallow penetration or high resolution geophysical (HRG) survey that may be intended to evaluate shallow subsurface formations or the seafloor itself (
Deep penetration surveys may be two-dimensional (2D) or three-dimensional (3D) (see Figure 1-2 of the petition), and there are a variety of survey methodologies designed to provide the specific data of interest. 2D surveys are designed to acquire data over large areas (thousands of square miles) in order to screen for potential hydrocarbon prospectivity, and provide a cross-sectional image of the structure. In contrast, 3D surveys may use similar acoustic sources but are designed to cover smaller areas with greater resolution (
Shallow penetration and high-resolution surveys are designed to highlight seabed and near-surface potential obstructions, archaeology, and geohazards that may have safety implications during rig installation or well and development facility siting. Shallow penetration surveys may use a small airgun array, single airgun, or subbottom profiler, while high-resolution surveys (which are limited to imaging the seafloor itself) may use single or multibeam echosounders or side-scan sonars.
The specified activities may occur at any time during the five-year period of validity of the proposed regulations. Actual dates and duration of individual surveys are not known. Survey activities are generally 24-hour operations. However, BOEM estimates that a typical seismic survey experiences approximately 20 to 30 percent of non-operational downtime due to a variety of factors, including technical or mechanical problems, standby for weather or other interferences, and implementation of mitigation measures.
The proposed survey activities would occur off the Gulf of Mexico coast of the United States, within BOEM's Western, Central, and Eastern GOM OCS planning areas (approximately within the U.S. EEZ; Figure 1). U.S. waters of the GOM include only the northern GOM. BOEM manages development of U.S. Federal OCS energy and mineral resources within OCS regions, which are divided into planning areas. Within planning areas are lease blocks, on which specific production activities may occur. Geophysical survey activities may occur on scales ranging from entire planning areas to multiple or specific lease blocks, or could occur at specific potential or existing facilities within a lease block.
In addition to general knowledge and other citations contained herein, this section relies upon the descriptions found in Sherman and Hempel (2009), Wilkinson
The GOM is a deep marginal sea—the largest semi-enclosed coastal sea of the western Atlantic—bordered by Cuba, Mexico, and the United States and encompassing more than 1.5 million square kilometers (km
The distribution of plankton in the deeper waters of the GOM, especially the northern and eastern parts of the Gulf, is controlled by the Loop Current (Mullin and Fulling, 2004). The temporal movement of all organisms, including marine mammals and their prey, may be affected by upwelling of nutrient rich cold water eddies (Davis
The northern GOM is characterized as semi-tropical, with a seasonal temperature regime influenced mainly by tropical currents in the summer and continental influences during the winter. The GOM is topographically diverse, with an extensive continental shelf (comprising about 30 percent of the total area), a steep continental slope, and distinctive bathymetric and morphologic processes and features. These include the Flower Garden Banks, which are surface expressions of salt domes that host the northernmost coral reefs in the U.S. The northern GOM also has a small section of the larger abyssal plain of the greater GOM. The GOM has about 60 percent of U.S. tidal marshes, hosting significant nursery habitat for fish and other marine species. A major climatological feature is tropical storm activity, including hurricanes. Sea surface temperature ranges from 14-24 °C in the winter and 28-30 °C in the summer. The area is considered to be of moderately high productivity (referring to fixated carbon (
Muddy clay-silts and muddy sands dominate bottom substrates of the region offshore Texas and Louisiana, transitioning to sand, gravel, and shell from Alabama to Florida. The shelf off Florida is a carbonate limestone substrate overlain with sand and silt, supporting extensive seagrass beds, and interspersed with gravel-rock and coral reefs. The continental shelf in the western GOM is broadest (up to 135 miles) off Houston, Texas, and east to offshore the Atchafalaya Delta, Louisiana. It reaches its narrowest point (approximately 12 miles) near the mouth of the Mississippi River southeast of New Orleans, Louisiana. The continental shelf is narrow offshore Mobile Bay, Alabama, but broadens significantly offshore Florida to almost 200 miles wide.
Topography of the continental slope off the Florida panhandle is relatively smooth and featureless aside from the De Soto Canyon, whereas the slope off western Florida is distinguished by steep gradients and irregular topography. In the central and western GOM, the continental slope is characterized by canyons, troughs, mini-basins, and salt structures (
The GOM is strongly influenced by freshwater input from several rivers, most importantly the Mississippi River and its tributary, the Atchafalaya River. The Mississippi River and its tributaries drain a large portion of the continental United States and carry large amounts of freshwater into the GOM along with sediment and a variety of nutrients and pollutants. The highest volume of
Wetlands in the GOM have experienced severe loss and degradation, due in part to interference with normal erosional/depositional processes, sea level rise, and coastal subsidence. Wetlands are converted to open water when accretion is insufficient to compensate for natural subsidence, while large areas of wetlands have been drained for industrial, urban, and agricultural development. Increasing salinity due to saltwater intrusion accompanies these changes, which further exacerbates the loss of coastal flora. This loss of wetlands ultimately increases erosion due to waves and tides, with the whole issue exacerbated by sea level rise.
The northern GOM hosts a vigorous complex of offshore hydrocarbon exploration, extraction, shipping, service, construction, and refining industries, resulting in additional impacts to coastal wetlands as well as large- and small-scale petroleum discharges and oil spills. Of particular note, in 2010 the
The GOM is also known for having many natural hydrocarbon seeps that contribute to a background level of chemicals in the environment. Chemosynthetic communities with aerobic bacterial components typically are associated with natural oil seeps. These naturally occurring seeps are common in deep slope waters, and there are hundreds of known, constant seeps that produce perennial slicks of oil at consistent locations (Kvenvolden and Cooper, 2003). DWH NRDA Trustees (2016) provided an estimate of the total amount of natural oil seepage in the GOM of between 9 and 23 million gallons per year. Although there is much uncertainty in attempting to estimate seepage rates (Kvenvolden and Cooper, 2003), it is clear that natural seepage is not comparable to the DWH oil spill release; about six to 15 times more oil was released from a single location in 87 days as is typically slowly released in a year from thousands of seeps across the entire GOM.
In addition to being a major area for activities associated with the oil and gas industry, the GOM hosts significant amounts of commercial fishing and tourism activities and has two of the world's busiest shipping fairways and top-ranking ports for container and passenger vessel traffic, all of which are noise-producing activities. The underwater environment is typically loud due to ambient sound, which is defined as environmental background sound levels lacking a single source or point (Richardson
The sum of the various natural and anthropogenic sound sources that comprise ambient sound at any given location and time depends not only on the source levels (as determined by current weather conditions and levels of biological and human activity) but also on the ability of sound to propagate through the environment. In turn, sound propagation is dependent on the spatially and temporally varying properties of the water column and sea floor, and is frequency-dependent. As a result of the dependence on a large number of varying factors, ambient sound levels can be expected to vary widely over both coarse and fine spatial and temporal scales. Sound levels at a given frequency and location can vary by 10-20 decibels (dB) from day to day (Richardson
Estabrook
Wiggins
An airgun is a device used to emit acoustic energy pulses into the seafloor, and generally consists of a steel cylinder that is charged with high-pressure air. There are different types of airguns; differences between types of airguns are generally in the mechanical parts that release the pressurized air, and the bubble and acoustic energy released are effectively the same. Airguns are typically operated at a firing pressure of 2,000 pounds per square inch (psi). Release of the compressed air into the water column generates a signal that reflects (or refracts) off the seafloor and/or subsurface layers having acoustic impedance contrast. Individual airguns are available in different volumetric sizes and, for deep penetration seismic surveys, are towed in arrays (
Airgun arrays are typically configured in subarrays of 6-12 airguns each. Towed hydrophone streamers (described below) may follow the array by 100-200 m and can be 5-12 kilometer (km) long. The airgun array and streamers are typically towed at a speed of approximately 4.5 to 5 knots (kn). BOEM notes that arrays used for deep penetration surveys typically have between 20-80 individual elements, with a total volume of 1,500-8,460 in
Airguns are considered to be low-frequency acoustic sources, producing sound with energy in a frequency range from less than 10 Hz to 2 kHz (though there may be energy in the signal at frequencies up to 5 kHz), with most energy radiated at frequencies below 500 Hz. Frequencies of interest to industry are below approximately 100 Hz. The amplitude of the acoustic wave emitted from the source is equal in all directions (
When fired, a brief (~0.1 second) pulse of sound is emitted by all airguns in an array nearly simultaneously, in order to increase the amplitude of the overall source pressure signal. The combined signal amplitude and directivity is dependent on the number and sizes of individual airguns and their geometric positions within the array. The airguns are silent during the intervening periods, with the array typically fired on a fixed distance (or shot point) interval. The intervals are optimized for water depth and the distance of important geological features below seafloor, but a typical interval in relatively deep water might be approximately every 10-20 s (or 25-50 m, depending on vessel speed). The return signal is recorded by a listening device, and later analyzed with computer interpretation and mapping systems used to depict the subsurface. There must be enough time between shots for the sound signals to propagate down to and reflect from the feature of interest, and then to propagate upward to be received on hydrophones or geophones. Reverberation of sound from previous shots must also be given time to dissipate. The receiving hydrophones can be towed behind or in front of the airgun array (may be towed from the source vessel or from a separate receiver vessel), or geophone receivers can be deployed on the seabed. Receivers may be displaced several kilometers horizontally away from the source, so horizontal propagation time is also considered in setting the interval between shots.
Sound levels for airgun arrays are typically modeled or measured at some distance from the source and a nominal source level then back-calculated. Because these arrays constitute a distributed acoustic source rather than a single point source (
Survey protocols generally involve a predetermined set of survey, or track, lines. The seismic acquisition vessel(s) (source vessel) will travel down a linear track for some distance until a line of data is acquired, then turn and acquire data on a different track. In some cases, data is acquired as the source vessel(s) turns continuously rather than moving on a linear track (
The general activities described here could occur pre- or post-leasing and/or on- or off-lease. Pre-lease surveys are more likely to involve larger-scale activity designed to explore or evaluate geologic formations. Post-lease activities may also include deep penetration surveys, but would be expected to be smaller in spatial and temporal scale as they are associated with specific leased blocks. Shallow penetration and HRG surveys are more likely to be associated with specific leased blocks and/or facilities, with HRG surveys used along pipeline routes and to search for archaeological resources and/or benthic communities. Specific types of surveys are described below (summarized from the petition); for full detail please refer to sections 1.2 and 1.3 of the petition.
While these descriptions reflect existing technologies and current practice, new technologies and/or uses of existing technologies may come into practice during the period of validity of these proposed regulations. NMFS will evaluate any such developments on a case-specific basis to determine whether expected impacts on marine mammals are consistent with those described or referenced in this document and, therefore, whether any anticipated take incidental to use of those new technologies or practices is appropriately authorized under what would be the existing regulatory framework. We also note here that activities that may result in incidental take of marine mammals, and which would therefore appropriately require authorization under the MMPA, are not limited to those activities requiring permits from BOEM. Operators should be aware that there may be some activities previously unpermitted by BOEM, such as certain ancillary activities, that would appropriately be subject to the requirements of this proposed rule and they should consult NMFS regarding the need to obtain a LOA under this rule prior to conducting such activities. Unauthorized taking of marine mammals is a violation of the MMPA.
We described previously the basic differences between 2D and 3D surveys. A typical 2D survey deploys a single array covering an area approximately 12.5-18 m long and 16-36 m wide behind the source vessel, whereas a 3D vessel may deploy multiple source arrays and/or streamers, with a potentially much larger width behind the vessel. A 3D vessel usually will tow 8-14 streamers (but as many as 24), each 3-8 km long. For example, an array containing ten streamers could have a total swath width behind the vessel of 675-1,350 m. Among 3D surveys in particular, there are a variety of survey designs employed to acquire the specific data of interest. These survey types may differ in the number of vessels used (for source or receiver), sound sources deployed, and the location or type of hydrophones. Conventional, single-vessel 3D surveys are referred to as narrow azimuth (NAZ) surveys. Other 3D survey techniques include wide-azimuth (WAZ), multi-azimuth (MAZ), rich-azimuth (RAZ), and full-azimuth (FAZ) surveys. Please see Figures 1-10 and 1-11 in the petition for depictions of these survey geometries.
In conventional 3D seismic surveys involving a single source vessel, only a subset of the reflected wave field can be obtained because of the narrow range of source-receiver azimuths (thus called NAZ surveys). Newer survey techniques, as well as improvements in data processing, provide better data quality than that achievable using traditional NAZ surveys, including better illumination, higher signal-to-noise ratios, and higher resolution. This is useful in imaging subsurface areas containing complex geologic structures, particularly those beneath salt bodies with irregular geometries.
Offset refers to the distance between a source and a particular receiver, while azimuth refers to the angles covered by the various directions between a source and individual receiving sensors. With NAZ surveys, the width (crossline dimension) of the nominal area imaged when the source is fired one time will be less than half the length (inline dimension). The aspect ratio (crossline divided by inline) of this nominal area is much less than 0.5 (see Figure 1-10 of the petition).
To achieve wider azimuthal coverage, multiple source vessels are deployed in order to achieve greater crossline dimension of the nominal area imaged. Different WAZ methods using multiple source vessels and, in some cases, multiple receiver vessels, are depicted in Figure 1-11 of the petition. A basic method used to acquire MAZ data involves a single source and streamer vessel, using conventional 3D survey methodology, covering transects on the same area multiple times along different azimuthal directions (Figure 1-11D of
In summary, 3D survey design involves a vessel with one or more acoustic sources covering an area of interest with relatively tight spatial configuration. In order to provide richer, more useful data, particularly in areas with more difficult geology, survey designs become more complicated with additional source and/or receiver vessels operating in potentially increasingly complicated choreographies. The time required to complete one pass of a trackline for a single NAZ vessel and the time required for one pass by a multi-vessel entourage conducting a WAZ survey will be essentially the same. Turn times will be somewhat longer during multi-vessel surveys to ensure that all vessels are properly aligned prior to beginning the next trackline. Turn times depend mostly on the vessels and the equipment they are towing (as in conventional 3D surveys); however, the number of vessels towing streamers in the entire entourage is the main determinant of the turn time. The MAZ technique, where multiple passes are made, increases the time needed for a survey in proportion to the number of passes that will be made within an area. The reduction in the number of passes is one of the most significant driving factors in continued efforts to design more efficient surveys. Coil surveys, described previously, reduce the total survey time due to elimination of the trackline-turn methodology.
Types of 2D VSPs are defined by source location, as follows: (1) Zero-offset VSPs involve a single source position that is close to the well (often deployed from a platform) compared to the depths where the sensors are placed (thereby causing the sensors to receive mostly vertically propagating energy); (2) offset VSPs involve a stationary vessel-based source position (or multiple positions) that is far enough away from the well that the recorded waveforms have a significant amount of horizontally-propagating energy; (3) walkaway VSPs involve a moving vessel and multiple source positions along a line away from the well; and (4) deviated-well VSPs involve source positions placed vertically above a well path. See Figure 1-12 of the petition for depictions.
3D VSPs involve use of multi-level sensor strings, allowing 1,500 to 3,000 m to be instrumented within a well. As with 2D VSPs, individual airguns and arrays used are generally similar to those used in towed-streamer surveys. The data acquisition design could involve typical 3D rectangular survey vessel track patterns, or spiral track patterns with the source vessel moving away from the well. For 3D VSPs, the distance from the well covered by the source vessel will approximately equal the depth of the well (see Figure 1-13 in the petition).
Checkshot surveys are similar to zero-offset VSPs but are less complex. The purpose of a checkshot survey is to estimate the velocity of sound in rocks penetrated by the well, and these surveys are typically conducted quickly. These surveys involve a single source typically hung from a platform and a sensor placed at a few depths in the well, where only the first energy arrival is recorded.
SWD refers to the acquisition of borehole data, using an airgun array as an acoustic source, while there is downtime from the actual drilling operation. SWD surveys are run intermittently for weeks up until the well completion depth.
HRG surveys may be conducted using airguns as the acoustic source. These typically use one or two airguns that are the same as those described for use in arrays during deep penetration surveys. However, the total volume is typically only approximately 40-400 in
Electromechanical sources are generally considered to be relatively
Subbottom profiling surveys are typically used for high-resolution imaging of the shallow subsurface. These surveys may use a variety of acoustic sources, commonly referred to as “boomers,” “sparkers,” or “chirps.” A sparker uses electricity to vaporize water, creating collapsing bubbles that produce a broadband (50 Hz to 4 kHz), omnidirectional pulse of sound that can penetrate a few hundred meters into the subsurface. Short hydrophone arrays towed near the sparker receive the return signal; typically, the sparker is towed on one side of the vessel and the hydrophone array is towed on the other side. A boomer consists of a circular piston moved by electromagnetic force, generating a broadband acoustic pulse (300 Hz to 3 kHz, though adjustments to the applied electrical impulse may increase the frequency). Boomer systems can penetrate as deep as 200 m in soft sediments, though a more typical penetration may be 25-50 m. Boomer sources show some directionality, which increases with the acoustic frequency; at frequencies below 1 kHz they can usually be considered omnidirectional. Boomers are typically sled-mounted and towed behind the vessel, with short hydrophone arrays used to receive the return signal. The characteristics of the acoustic wave emitted by the boomer source are comparable to those emitted by the sparker source.
Chirp (Compressed High-Intensity Radiated Pulse) sources operate differently, sending a continuous sweep of frequencies (
Side-scan sonars and echosounders do not penetrate the surface of the seabed, using reflections of sound pulses to locate, image, and aid in the identification of objects in the water column and on the seafloor, and to determine water depth. Echosounders typically emit short, single-frequency signals, with frequency decreasing as water depth increases. A deep-water system might operate at approximately 3-12 kHz, while a shallow-water system might operate at 200 kHz or greater. Multibeam echosounder systems use an array of transducers that project a fan-shaped beam under the hull of a vessel and perpendicular to the direction of motion, producing a swath of depth measurements to ensure full coverage of an area. Echosounders are typically hull-mounted or deployed on AUVs. Side-scan sonar systems produce shaded relief images of the ocean bottom by recording the intensity and timing of signals reflected off the seafloor, and consist of two transducers on the sides of the towed sonar body that are oriented perpendicularly to the towing direction. The signals are typically single-frequency, with a highly directional beam that is wide across-track and narrow in the direction of travel. Due to the transducer placement, side-scan sonars may not effectively image the area directly beneath the vessel and are often used in conjunction with echosounders. Side-scan sonars are typically high-frequency sources and therefore have a limited range (50-200 m). In deeper water, the source may be towed at greater depth or deployed on an AUV.
Because the specifics of acoustic sources to be used would not be known in advance of receiving LOA requests from industry operators, it is necessary to define representative acoustic source parameters, as well as representative survey patterns. BOEM determined realistic representative proxy sound sources and survey patterns, which are used in the modeling and more broadly to support the analysis, after discussions with individual geophysical companies.
Representative sources include a single airgun, an airgun array, and multiple electromechanical sources: Boomer, chirp, multibeam echosounder, and side-scan sonar. Two major survey types were considered: Large-area seismic and small-area, high-resolution geotechnical. Large-area seismic surveys are assumed to cover more than 1,000 mi
The nominal airgun sources used for analysis of the proposed action include a small single airgun (90 in
Source vessels are assumed to travel at an average speed of 4.5-5 kn (
2D surveys were simulated by assuming use of a single 8,000 in
3D NAZ surveys were simulated by assuming use of two source vessels towing identical arrays. Sources at each vessel produce seismic pulses simultaneously. Both vessels follow the same track, but were separated along the track by 6 km. The production lines were laterally spaced by 1 km (see Figure 106 of the modeling report). The production lines were filled via a racetrack fill-in method with eight loops in each racetrack (7-8 km wide turn). Forty-nine lines were required to fully cover the survey area. The vessel speed was 4.9 kn and the shot interval was 15 s (approximately every 37.5 m) for each vessel.
3D WAZ surveys were simulated by assuming use of four source vessels towing identical arrays. Sources at each vessel produce seismic pulses sequentially. The tracks of each vessel had the same geometry and had 1.2 km lateral offset. The vessels also had 500 m offset along the track (see Figure 107 of the modeling report). The production lines were filled in with a racetrack fill-in method with two loops in each racetrack (9.6 km wide turn). Forty lines were required to fully cover the survey area. The vessel speed was 4.5 kn, with individual vessel shot interval of 86.4 s (approximately every 200 m)—equivalent to 21.6 s for the group.
Coil surveys are performed by multiple vessels that sail a series of circular tracks with some angular separation while towing acoustic sources. These surveys were simulated by assuming use of four source vessels towing identical arrays. Sources at each vessel produce seismic pulses simultaneously. Tracks consist of a series of circles with 12.5 km diameter (see Figure 108 of the modeling report). Once each vessel completes a full circle, it advances to the next one along a tangential connection segment. The offset between the center of one circle and the next, either along-swath or between swaths, was 5 km. The full survey geometry consisted of two tracks with identical configuration with 1.2 km and 600 m offsets along X and Y directions, respectively. Two of the four vessels followed the first track with 180° separation; the other two vessels followed the second track with 180 ° separation relative to each other and 90 ° separation relative to the first pair. One hundred circles per vessel pair were required to fully cover the survey area. The vessel speed was 4.9 kn and the shot interval was 20 s (approximately every 50 m) for each vessel.
For small-area, high-resolution geotechnical surveys, we described the proxy single airgun source above. The representative boomer system was the Applied Acoustics AA301, based on a single plate with approximately 40 cm baffle diameter. The input energy for the AA301 boomer plate was up to 350 joules (J) per pulse or 1,000 J per second. The width of the pulse was 0.15-0.4 milliseconds (ms). A source verification study performed on a similar system by Martin
As noted above, certain high-resolution acoustic sources may be deployed together and used concurrently. Here, the modeling assumes that a multibeam echosounder, side-scan sonar, and chirp subbottom profiler are operated concurrently and deployed on an AUV. Towing depth of the AUV was assumed to be 4 m below the sea surface when the water depth was less than 100 m and 40 m above the seafloor where water depth was more than 100 m. The representative multibeam echosounder (MBES) system was the Simrad EM2000 (manufactured by Kongsberg Maritime AS). According to manufacturer specifications, this device operates at 200 kHz and is equipped with a transducer head that produces a single beam 17 ° x 88 ° wide. The nominal source level was 203 dB rms SPL, with per-pulse SEL dependent on the pulse length (160-175 dB). Pulse width is 0.04-1.3 ms. The representative side-scan sonar is the EdgeTech 2200 IM, which works at two frequencies simultaneously (120 and 410 kHz). The beam angle produced by two side-mounted transducers was 70 ° x 0.8 ° at 120 kHz and 70 ° x 0.5 ° at 410 kHz. At 120 kHz, the estimated peak source level is 210 dB with pulse length of 8.3 ms; at 410 kHz these values are 216 dB and 2.4 ms. The chirp subbottom profiler uses the same side-scan sonar system, which is designed as a modular system for installation on an AUV, and adds the DW-424, a full spectrum chirp subbottom profiler that produces a sweep signal in the frequency range from 4 to 24 kHz. The projected beamwidth varies from 15 ° to 25 ° depending on the emitted frequency, with estimated source level of 200 dB and pulse length of 10 ms.
For these HRG surveys, the same survey pattern was assumed regardless of the source. Total survey area was assumed to be an area of 1 x 3 lease blocks, equivalent to 5 x 14.5 km or approximately 72.5 km
As noted previously, actual total amounts of effort by survey type and location would not be known in advance of receiving LOA requests from industry operators. Therefore, BOEM provided projections of survey level of effort for the different survey types for a 10-year period (note that this proposed rule covers only a 5-year period). In order to construct a realistic scenario for future geophysical survey effort, BOEM evaluated recent trends in permit applications as well as industry estimates of future survey activity. BOEM also accounted for restrictions under the Gulf of Mexico Energy Security Act (GOMESA; Pub. L. 109-432), which precludes leasing, pre-leasing, or any related activity (though not geophysical surveys that have been permitted) in the GOM east of 86°41′ W, in BOEM's Eastern Planning Area (EPA) and within 125 mi (201 km) of Florida, or in BOEM's Central Planning Area (CPA) and within 100 mi of Florida (and according to certain other detailed stipulations). These leasing restrictions, which will to some degree influence geophysical survey effort, are in place until June 30, 2022.
In order to provide some spatial resolution to the projections of survey effort and to provide reasonably similar areas within which acoustic modeling might be conducted, the geographic region was divided into seven zones, largely on the basis of water depth, seabed slope, and defined BOEM planning area boundaries. Shelf regions typically extend from shore to approximately 100-200 m water depths where bathymetric relief is gradual (off Florida's west coast, the shelf extends
Available information regarding cetacean density in the GOM (
Table 2 provides a summary of the projected levels of effort. Very little effort is predicted in the EPA, with no deep penetration surveys expected in Zone 1 and an annual average of 63 survey days predicted in Zone 4. Similarly, very little overall effort is expected in western shelf waters. The vast majority of effort is expected to occur in the CPA, in all water depths. For deep penetration surveys, 3D NAZ is expected to be the most common survey type (in terms of total survey says) with approximately 65 percent of the total. 3D WAZ surveys represent approximately 22 percent of total survey days. Shallow penetration surveys overall represent an insignificant addition to the projected deep penetration effort, reflecting the smaller amount of effort associated with these survey types.
Year 1 provides an example of what might be a high-effort year in the GOM, while Year 9 is representative of a low-effort year. A moderate level of effort in the GOM, according to these projections, would be similar to the level of effort projected for Year 4. However, per-zone ranges can provide a different outlook than does an assessment of total year projected effort across zones. For example, in the “high” effort annual scenario (Year 1; considering total projected survey days across zones), there are 263 projected survey days in Zone 2, while the “moderate” effort annual scenario (Year 4) projects 446 survey days in Zone 2. Projected levels of effort presented here represent expected maxima, and it is possible that actual levels of effort will be lower, whether due to effects of the economy on industry activities or other reasons. Please see Figure 3.2-1 of BOEM's PEIS (BOEM, 2017) for projected potential ranges of survey activity. The ranges of projected activity level include an upper bound based on industry capacity in the GOM and a lower bound that accounts for a number of things that could affect these activities (
Proposed mitigation, monitoring, and reporting measures are described in detail later in this document (please see “Proposed Mitigation” and “Proposed Monitoring and Reporting”).
Sections 3 and 4 of the petition summarize available information regarding status and trends, distribution and habitat preferences, and behavior and life history of the potentially affected species. We refer the reader to these descriptions, to descriptions of the affected environment in Appendix E of BOEM's PEIS, as well as to NMFS's Stock Assessment Reports (SAR;
Table 3 lists all species with expected potential for occurrence in the Gulf of Mexico and summarizes information related to the population or stock. For taxonomy, we follow Committee on Taxonomy (2017). While no mortality or serious injury is anticipated or proposed for authorization, potential biological removal (PBR; defined in the MMPA as the maximum number of animals, not including natural mortalities, that may be removed from a marine mammal stock while allowing that stock to reach or maintain its optimum sustainable population) and annual serious injury and mortality from anthropogenic sources are included here as gross indicators of the status of the species and other threats (as described in NMFS's SARs).
Species that could potentially occur in the proposed survey areas, but are not reasonably expected to have potential to
Marine mammal abundance estimates presented in this document represent the total number of individuals that make up a given stock or the total number estimated within a particular study area. NMFS's stock abundance estimates for most species represent the total estimate of individuals within the geographic area, if known, that comprises that stock. All managed stocks in this region are assessed in NMFS's U.S. Atlantic SARs (
In some cases, species are treated as guilds. In general ecological terms, a guild is a group of species that have similar requirements and play a similar role within a community. However, for purposes of stock assessment or abundance prediction, certain species may be treated together as a guild because they are difficult to distinguish visually and many observations are ambiguous. For example, NMFS's GOM SARs assess stocks of
Twenty-one species (with 25 managed stocks) have the potential to co-occur with the proposed survey activities. Extralimital species or stocks unlikely to co-occur with survey activity include 31 estuarine bottlenose dolphin stocks (discussed below), the blue whale (
Roberts
Estuarine stocks of bottlenose dolphin primarily inhabit inshore waters of bays, sounds, and estuaries (BSE), and stocks are defined throughout waters adjacent to the specified geographical region. However, estuarine stock ranges are generally described as including coastal waters (
In addition, the West Indian manatee (
For the majority of species potentially present in the specified geographical region, NMFS has designated only a single generic stock (
During aerial and ship-based cetacean surveys, the most commonly sighted species in the GOM are bottlenose dolphins, pantropical spotted dolphins, Atlantic spotted dolphins, Risso's dolphins, sperm whales, and
For the bottlenose dolphin, NMFS defines an oceanic stock, a continental shelf stock, and three coastal stocks. As in the northwestern Atlantic Ocean, there are two general bottlenose dolphin ecotypes: “coastal” and “offshore.” These ecotypes are genetically and morphologically distinct (Hoelzel
In Table 3 above, we report two sets of abundance estimates: those from NMFS's SARs and those predicted by Roberts
The Roberts
As a further illustration of the distinction between the SARs and model-predicted abundance estimates, the current NMFS stock abundance estimates for most GOM species are based on direct observations from shipboard surveys conducted in 2009 (from the 200-m isobath to the edge of the U.S. EEZ) and not corrected for detection bias, whereas the exposure estimates presented herein for those species are based on the abundance predicted by a density surface model informed by observations from surveys conducted over approximately 20 years and covariates associated at the observation level. To directly compare the estimated exposures predicted by the outputs of the Roberts
Although there is no designated critical habitat for marine mammal species in the specified geographical region, BIAs for marine mammals are recognized. For example, the GOM Bryde's whale is a very small population that is genetically distinct from other Bryde's whales and not genetically diverse within the GOM (Rosel and Wilcox, 2014). Further, the species is typically observed only within a narrowly circumscribed area within the eastern GOM. Therefore, this area is described as a year-round BIA by LaBrecque
LaBrecque
The northern GOM UME was determined to have begun in March 2010 and extended through July 2014. The event included all cetaceans stranded during this time in Alabama, Mississippi, and Louisiana and all cetaceans other than bottlenose dolphins stranded in the Florida Panhandle (Franklin County through Escambia County), with a total of 1,141 cetaceans stranded or reported dead offshore. For reference, the same area experienced a normal average of 75 strandings per year from 2002-09 (Litz
The UME investigation and the
However, increased dolphin strandings occurred in Louisiana and Mississippi before the DWH oil spill, and identified stranding clusters within the UME suggest that the event may involve different additional contributing factors varying by location, time, and population (Venn-Watson
Subsequent health assessments of live dolphins from Barataria Bay and comparison to a reference population found significantly increased adrenal disease, lung disease, and poor health, while histological evaluations of samples from dead stranded animals from within and outside the UME area found that UME animals were more likely to have lung and adrenal lesions and to have primary bacterial pneumonia, which caused or contributed significantly to death (Schwacke
The prevalence of brucellosis and morbillivirus infections was low and biotoxin levels were low or below the detection limit, meaning that these were not likely primary causes of the UME (Venn-Watson
While the number of dolphin mortalities in the area decreased after the peak from March 2010-July 2014, it does not indicate that the effects of the oil spill on these populations have ended. Researchers still saw evidence of chronic lung disease and adrenal impairment four years after the spill (in July 2014) and saw evidence of failed pregnancies in 2015 (Smith
Prior UMEs averaged six months in duration and involved significantly fewer mortalities. In most of these relatively localized events, dolphin morbillivirus or brevetoxicosis was confirmed or suspected as a causal factor (Litz
We introduced the DWH oil spill—which includes the impacts of the spill as well as the response efforts—previously in our description of the “Specified Geographical Region.” Here we provide additional description of the potential effects of the spill on the marine mammals that may be affected by the activities that are the subject of this proposed rule. The summary provided below is an incorporation by reference of relevant information from DWH NRDA Trustees (2016) and DWH MMIQT (2015); more detail on the DWH oil spill and its effects on marine mammals is available in these documents. Additional technical reports relating to the assessment of marine mammal injury due to the DWH oil spill are available online at:
On April 20, 2010, the
An estimated 7.7 billion standard cubic feet of natural gas was released in association with the oil; bacteria proliferated, consumed the gas, and died. Mucus produced by bacteria, as well as some of the bacterial mass itself, agglomerated with brown-colored oil droplets and settled through the water column—this phenomenon is referred to as “marine oil snow.” Oil, released from the well-head approximately 1,500 m deep, moved with currents, creating a plume of oil within the deep sea; oil and associated “marine oil snow” also settled on the sea floor. More buoyant oil traveled up through the water column and formed large surface slicks; at its maximum extent, oil covered over 40,000 km
Dispersants are chemicals that reduce the tension between oil and water, leading to the formation of oil droplets that more readily disperse within the water column. A main purpose of using dispersants is to enhance the rate at
The DWH oil spill was subject to the provisions of the Oil Pollution Act (OPA) of 1990 (33 U.S.C. 2701
The injury assessment first requires a determination of whether an incident injured natural resources. Trustees must establish that a pathway existed from the oil discharge to the resource, confirm that resources were exposed to the discharge, and evaluate the adverse effects that occurred as a result of the exposure (or response activities). Subsequently, the assessment requires injury quantification (including degree and spatiotemporal extent), essentially by comparing the post-event conditions with the pre-event baseline. For a fuller overview of the injury assessment process in this case, please see Takeshita
The marine mammal injury assessment synthesized data from NRDA field studies, stranded carcasses collected by the Southeast Marine Mammal Stranding Network, historical data on marine mammal populations, NRDA toxicity testing studies, and the published literature. DWH oil was found to cause problems with the regulation of stress hormone secretion from adrenal cells and kidney cells, which will affect an animal's ability to regulate body functions and respond appropriately to stressful situations, thus leading to reduced fitness. Bottlenose dolphins living in habitats contaminated with DWH oil showed signs of adrenal dysfunction, and dead, stranded dolphins from areas contaminated with DWH oil had smaller adrenal glands (Schwacke
Findings related to bottlenose dolphins living in heavily oiled nearshore habitats were described previously in the UME discussion. Due to the difficulty of investigating marine mammals in pelagic environments and across the entire region impacted by the event, the injury assessment focused on health assessments conducted on bottlenose dolphins in nearshore habitats (
Investigators then used a population modeling approach to capture the overlapping and synergistic relationships among the three metrics for injury, and to quantify the entire scope of DWH marine mammal injury to populations into the future, expressed as “lost cetacean years” due to the DWH oil spill (which represents years lost due to premature mortality as well as the resultant loss of reproductive output). This approach allowed for consideration of long-term impacts resulting from immediate losses and reproductive failures in the few years following the spill, as well as expected persistent impacts on survival and reproduction for exposed animals well into the future (Takeshita
To calculate the increase in percent mortality for the shelf and oceanic marine mammal stocks, the Barataria Bay percent mortality was applied to the percentage of animals in each stock that was exposed to oil. This percentage was calculated assuming that animals experiencing a level of cumulative surface oiling similar to or greater than that in Barataria Bay would have been likely to suffer a similar or greater degree and magnitude of injury. This is likely a conservative estimate of impacts, because: (1) Shelf and oceanic species experienced long exposures (up to 90 days) to very high concentrations of fresh oil and a diverse suite of response activities, while estuarine dolphins were not exposed until later in the spill period and to weathered oil products at lower water concentrations; (2) oceanic cetaceans dive longer and to deeper depths, and it is possible that the types of lung injuries observed in estuarine dolphins may be more severe for oceanic cetaceans; and (3) cetaceans in deeper waters were exposed to very high concentrations of volatile gas compounds at the water's surface near the wellhead.
As an example of the calculation, 47 percent of the spinner dolphin stock range in the northern GOM experienced oiling equal to or greater than Barataria Bay, and, therefore, was assumed to have experienced a rate of mortality increase equal to that calculated for Barataria Bay (35 percent). Thus, the entire northern GOM spinner dolphin stock is assumed to have experienced a 16 percent mortality increase (0.35 × 0.47 = 0.16). Similarly, the percentage of females with reproductive failure in Barataria Bay and Mississippi Sound (46 percent; stocks pooled for sample size considerations) is considered to be the best estimate of excess failed pregnancies for other marine mammals in the oil spill footprint, and the percentage of the population with a guarded or worse health prognosis—compared with dolphins sampled in a healthy reference population—from Barataria Bay (37 percent) was applied to other stocks.
The population modeling approach used in the injury quantification allows consideration of long-term impacts resulting from individual losses, adverse reproductive effects, and persistent impacts on survival for exposed animals. The model was run using baseline mortality and reproductive parameters to determine what the population trajectory of each stock would have been if the DWH spill had not happened. The same model was then run a second time, with estimates for excess mortality, reproductive
The results of these calculations for each affected shelf and oceanic stock, and for northern and western coastal stocks of bottlenose dolphin, are presented in Table 4. The eastern coastal stock of bottlenose dolphin was considered to be not affected by the DWH oil spill, as the cumulative footprint of oil did not overlap the stock's range. Results for BSE dolphin stocks are not presented here. No analysis was performed for Fraser's dolphins or killer whales; although they are present in the GOM, sightings are rare and there were no historical sightings in the oil spill footprint during the surveys used in the quantification process. These stocks were likely injured, but no information is available on which to base a quantification effort.
Coastal and oceanic marine mammals were injured by exposure to oil from the DWH spill; nearly all of the stocks that overlap with the oil spill footprint have demonstrable, quantifiable injuries, and the remaining stocks (for which there is no quantifiable injury) were also likely injured, though there is not currently enough information to make a determination. Injuries included elevated mortality rates, reduced reproduction, and disease. Due to these effects, affected populations may require decades to recover absent successful efforts at restoration (
Due to the scope of the spill, the magnitude of potentially injured populations, and the difficulties and limitations of working with marine mammals, it is impossible to quantify injury without uncertainty. Wherever possible, the quantification results represent ranges of values that encapsulate the uncertainty inherent in the underlying datasets. The population model outputs shown in Table 4 best represent the temporal magnitude of the injury and the potential recovery time from the injury.
Aside from the heavily impacted stocks of bottlenose dolphin, two species of particular concern are the sperm whale and Bryde's whale. For the Bryde's whale, it was estimated that 48 percent of the population was impacted by DWH oil, resulting in an estimated 22 percent maximum decline in population size that will require 69 years to recovery. However, small populations are highly susceptible to
In the absence of active (and effective) restoration, marine mammal stocks across the northern GOM will take many years to recover (Table 4). Marine mammals are slow to reach reproductive maturity, only give birth to a single offspring every 3 to 5 years, and are generally long lived (with lifespans up to 80 years). Two populations of killer whales suffered losses of 33 and 41 percent in the year following the
In addition to injuries from direct exposure to DWH oil, marine mammal habitat was degraded. Exposure to oil at or near the surface occurred in an area of high biological abundance and high productivity during a time of year (spring and summer) that corresponds with peaks in seasonal productivity in the northern GOM. Developing fish larvae exposed to the surface slick suffered almost 100 percent mortality, and oil concentrations at different levels in the water column exceeded levels known to cause mortality and sub-lethal effects to fish—this is expected to have caused the loss of millions to billions of fish that would have reached one year of age. However, though damage to fish and invertebrate populations was likely significant during the time oil was present, populations of directly affected fish and invertebrate species appear not to have suffered a lasting impact. Although marine mammals were harmed through the effects of DWH oil on plankton, fish, and invertebrate populations, it is difficult to interpret any long-term impacts on marine mammal populations resulting from significant short-term impacts on prey populations. Prey reductions, when they occur, can have cascading effects on larger species. Animals in the wild live in a dynamic relationship with their environment and available resources, balancing energy expenditures and nutritional uptake in order to survive, remain healthy, and reproduce. Any impact that shifts that balance by diminishing food resources or requiring unusual expenditures of energy—whether to acquire prey, avoid predators, fight disease and infection, or successfully reproduce—is inherently harmful to the species. Additionally, as noted previously, injury due to the DWH oil spill is considered an ecosystem-level event, which will impact marine mammals in particular due to their long lives and position as apex predators reliant upon a healthy ecosystem (
Hearing is the most important sensory modality for marine mammals underwater, and exposure to anthropogenic sound can have deleterious effects. To appropriately assess the potential effects of exposure to sound, it is necessary to understand the frequency ranges marine mammals are able to hear. Current data indicate that not all marine mammal species have equal hearing capabilities (
• Low-frequency cetaceans (mysticetes): Generalized hearing is estimated to occur between approximately 7 Hz and 35 kHz, with best hearing estimated to be from 100 Hz to 8 kHz;
• Mid-frequency cetaceans (larger toothed whales, beaked whales, and most delphinids): Generalized hearing is estimated to occur between approximately 150 Hz and 160 kHz, with best hearing from 10 to less than 100 kHz;
• High-frequency cetaceans (porpoises, river dolphins, and members of the genera
For more detail concerning these groups and associated frequency ranges, please see NMFS (2016) for a review of available information. Twenty-one species of cetacean have the reasonable potential to co-occur with the proposed survey activities. Please refer to Table 3. Of the cetacean species that may be present, one is classified as a low-frequency cetacean (
This section includes a summary and discussion of the ways that components of the specified activity may impact marine mammals and their habitat. The “Estimated Take” section later in this document includes a quantitative analysis of the number of individuals that are expected to be taken by this activity. The “Negligible Impact Analysis and Determination” section considers the content of this section and
This section contains a brief technical background on sound, on the characteristics of certain sound types, and on metrics used in this proposal inasmuch as the information is relevant to other sections of this document. For general information on sound and its interaction with the marine environment, please see,
Sound travels in waves, the basic components of which are frequency, wavelength, velocity, and amplitude. Frequency is the number of pressure waves that pass by a reference point per unit of time and is measured in Hz or cycles per second. Wavelength is the distance between two peaks or corresponding points of a sound wave (length of one cycle). Higher frequency sounds have shorter wavelengths than lower frequency sounds, and typically attenuate (decrease) more rapidly, except in certain cases in shallower water. Amplitude is the height of the sound pressure wave or the “loudness” of a sound and is typically described using the relative unit of the dB. A sound pressure level (SPL) in dB is described as the ratio between a measured pressure and a reference pressure (for underwater sound, this is 1 microPascal (μPa)), and is a logarithmic unit that accounts for large variations in amplitude; therefore, a relatively small change in dB corresponds to large changes in sound pressure. The source level (SL) represents the SPL referenced at a distance of 1 m from the source (referenced to 1 μPa), while the received level is the SPL at the listener's position (referenced to 1 μPa).
When underwater objects vibrate or activity occurs, sound-pressure waves are created. These waves alternately compress and decompress the water as the sound wave travels. Underwater sound waves radiate in a manner similar to ripples on the surface of a pond and may be either directed in a beam or beams or may radiate in all directions (omnidirectional sources), as is nominally the case for sound produced by airguns (though when grouped in arrays there is some directionality). The compressions and decompressions associated with sound waves are detected as changes in pressure by aquatic life and man-made sound receptors such as hydrophones.
Sounds are often considered to fall into one of two general types: Pulsed and non-pulsed (defined in the following). The distinction between these two sound types is important because they have differing potential to cause physical effects, particularly with regard to hearing (
Pulsed sound sources (
Non-pulsed sounds can be tonal, narrowband, or broadband, brief or prolonged, and may be either continuous or intermittent (ANSI, 1995; NIOSH, 1998). Some of these non-pulsed sounds can be transient signals of short duration but without the essential properties of pulses (
Root mean square (rms) is the quadratic mean sound pressure over the duration of an impulse. Root mean square is calculated by squaring all of the sound amplitudes, averaging the squares, and then taking the square root of the average (Urick, 1983). Root mean square accounts for both positive and negative values; squaring the pressures makes all values positive so that they may be accounted for in the summation of pressure levels (Hastings and Popper, 2005). The length of the time window used for the purpose of the rms SPL calculation can be selected using different approaches. This value is commonly defined as the 90 percent energy pulse duration, containing the central 90 percent (from 5 to 95 percent of the total) of the cumulative square pressure (or sound exposure level) of the pulse. However, as was the case in the modeling performed for this effort, a fixed time window may be used. Here, a sliding window was used to calculate rms SPL values for a series of fixed window lengths within the pulse. The maximum value of rms SPL over all time window positions is taken to represent the rms SPL of the pulse. This measurement is often used in the context of discussing behavioral effects, in part because behavioral effects, which often result from auditory cues, may be better expressed through averaged units than by peak pressures. Energy equivalent SPL (denoted
Sound exposure level (SEL; represented as dB re 1 μPa
Peak sound pressure (also referred to as zero-to-peak sound pressure or 0-pk) is the maximum instantaneous sound
Airguns produce pulsed signals, with energy in a frequency range from about 10-2,000 Hz, and most energy radiated at frequencies below 200 Hz. Larger airguns, with larger internal air volume, produce higher broadband sound levels with sound energy spectrum shifted toward the lower frequencies. The amplitude of the acoustic wave emitted from the source is equal in all directions (
Acoustic sources used for HRG surveys generally produce higher frequency signals with highly directional beam patterns. These sources are generally considered to be intermittent, with typically brief signal durations, and temporal characteristics that more closely resemble those of impulsive sounds than non-impulsive sounds. Boomers generate a high-amplitude broadband (100 Hz-10 kHz) acoustic pulse with high downward directivity, though may be considered omnidirectional at frequencies below 1 kHz. Subbottom profiler systems generally project a chirp pulse spanning an operator-selectable frequency band, usually between 1 to 20 kHz, with a single beam directed vertically down. Multibeam echosounders use an array of transducers that project a high-frequency, fan-shaped beam under the hull of a survey ship and perpendicular to the direction of motion. Side-scan sonars use two transducers to project high-frequency beams that are usually wide in the vertical plane (50°-70°) and very narrow in the horizontal plane (less than a few degrees).
Vessel noise, produced largely by cavitation of propellers and by machinery inside the hull, is considered a non-pulsed sound. Sounds emitted by survey vessels are low frequency and continuous, but would be widely dispersed in both space and time. Survey vessel traffic is of low density compared to traffic associated with commercial shipping, industry support vessels, or commercial fishing vessels, and would therefore be expected to represent an insignificant incremental increase in the total amount of anthropogenic sound input to the marine environment. For these reasons, we do not consider vessel traffic noise further in this analysis.
Note that, in the following discussion, we refer in many cases to a review article concerning studies of noise-induced hearing loss conducted from 1996-2015 (
Richardson
We describe more severe effects (
When a live or dead marine mammal swims or floats onto shore and is incapable of returning to sea, the event is termed a “stranding” (16 U.S.C. 1421h(3)). Marine mammals are known to strand for a variety of reasons, such as infectious agents, biotoxicosis, starvation, fishery interaction, ship strike, unusual oceanographic or weather events, sound exposure, or combinations of these stressors sustained concurrently or in series (
Use of military tactical sonar has been implicated in multiple investigated stranding events, although one stranding event was contemporaneous with and reasonably associated spatially
When PTS occurs, there is physical damage to the sound receptors in the ear (
Relationships between TTS and PTS thresholds have not been studied in marine mammals, and there is no PTS data for cetaceans, but such relationships are assumed to be similar to those in humans and other terrestrial mammals. PTS typically occurs at exposure levels at least several decibels above (a 40-dB threshold shift approximates PTS onset;
For mid-frequency cetaceans in particular, potential protective mechanisms may help limit onset of TTS or prevent onset of PTS. Such mechanisms include dampening of hearing, auditory adaptation, or behavioral amelioration (
TTS is the mildest form of hearing impairment that can occur during exposure to sound (Kryter, 1985). While experiencing TTS, the hearing threshold rises, and a sound must be at a higher level in order to be heard. In terrestrial and marine mammals, TTS can last from minutes or hours to days (in cases of strong TTS). In many cases, hearing sensitivity recovers rapidly after exposure to the sound ends. Few data on sound levels and durations necessary to elicit mild TTS have been obtained for marine mammals.
Marine mammal hearing plays a critical role in communication with conspecifics, and interpretation of environmental cues for purposes such as predator avoidance and prey capture. Depending on the degree (elevation of threshold in dB), duration (
Finneran
Currently, TTS data only exist for four species of cetaceans (bottlenose dolphin, beluga whale (
Critical questions remain regarding the rate of TTS growth and recovery after exposure to intermittent noise and the effects of single and multiple pulses. Data at present are also insufficient to construct generalized models for recovery and determine the time necessary to treat subsequent exposures as independent events. More information is needed on the relationship between auditory evoked potential and behavioral measures of TTS for various stimuli. For summaries of data on TTS in marine mammals or for further discussion of TTS onset thresholds, please see Southall
Habituation can occur when an animal's response to a stimulus wanes with repeated exposure, usually in the absence of unpleasant associated events (Wartzok
Available studies show wide variation in response to underwater sound; therefore, it is difficult to predict specifically how any given sound in a particular instance might affect marine mammals perceiving the signal. If a marine mammal does react briefly to an underwater sound by changing its behavior or moving a small distance, the impacts of the change are unlikely to be significant to the individual, let alone the stock or population. However, if a sound source displaces marine mammals from an important feeding or breeding area for a prolonged period, impacts on individuals and populations could be significant (
Changes in dive behavior can vary widely, and may consist of increased or decreased dive times and surface intervals as well as changes in the rates of ascent and descent during a dive (
Disruption of feeding behavior can be difficult to correlate with anthropogenic sound exposure (but see discussion of impacts to sperm whale foraging behavior below and in “Proposed Mitigation”), so it is usually inferred by observed displacement from known foraging areas, the appearance of secondary indicators (
Visual tracking, passive acoustic monitoring, and movement recording tags were used to quantify sperm whale behavior prior to, during, and following exposure to airgun arrays at received levels in the range 140-160 dB at distances of 7-13 km, following a phase-in of sound intensity and full array exposures at 1-13 km (Madsen
Variations in respiration naturally vary with different behaviors and alterations to breathing rate as a function of acoustic exposure can be expected to co-occur with other behavioral reactions, such as a flight response or an alteration in diving. However, respiration rates in and of themselves may be representative of annoyance or an acute stress response. Various studies have shown that respiration rates may either be unaffected or could increase, depending on the species and signal characteristics, again highlighting the importance in understanding species differences in the tolerance of underwater noise when determining the potential for impacts resulting from anthropogenic sound exposure (
Marine mammals vocalize for different purposes and across multiple modes, such as whistling, echolocation click production, calling, and singing. Changes in vocalization behavior in response to anthropogenic noise can
Cerchio
Castellote
Seismic pulses at average received levels of 131 dB re 1 μPa
Avoidance is the displacement of an individual from an area or migration path as a result of the presence of a sound or other stressors, and is one of the most obvious manifestations of disturbance in marine mammals (Richardson
Forney
A flight response is a dramatic change in normal movement to a directed and rapid movement away from the perceived location of a sound source. The flight response differs from other avoidance responses in the intensity of the response (
Behavioral disturbance can also impact marine mammals in more subtle ways. Increased vigilance may result in costs related to diversion of focus and attention (
Many animals perform vital functions, such as feeding, resting, traveling, and socializing, on a diel cycle (24-hour cycle). Disruption of such functions resulting from reactions to stressors such as sound exposure are more likely to be significant if they last more than one diel cycle or recur on subsequent days (Southall
Stone (2015a) reported data from at-sea observations during 1,196 airgun surveys from 1994 to 2010. When large arrays of airguns (considered to be 500 in
Neuroendocrine stress responses often involve the hypothalamus-pituitary-adrenal system. Virtually all neuroendocrine functions that are affected by stress—including immune competence, reproduction, metabolism, and behavior—are regulated by pituitary hormones. Stress-induced changes in the secretion of pituitary hormones have been implicated in failed reproduction, altered metabolism, reduced immune competence, and behavioral disturbance (
The primary distinction between stress (which is adaptive and does not normally place an animal at risk) and “distress” is the cost of the response. During a stress response, an animal uses glycogen stores that can be quickly replenished once the stress is alleviated. In such circumstances, the cost of the stress response would not pose serious fitness consequences. However, when an animal does not have sufficient energy reserves to satisfy the energetic costs of a stress response, energy resources must be diverted from other functions. This state of distress will last until the animal replenishes its energetic reserves sufficiently to restore normal function.
Relationships between these physiological mechanisms, animal behavior, and the costs of stress responses are well-studied through controlled experiments and for both laboratory and free-ranging animals (
Under certain circumstances, marine mammals experiencing significant masking could also be impaired from maximizing their performance fitness in survival and reproduction. Therefore, when the coincident (masking) sound is man-made, it may be considered harassment when disrupting or altering critical behaviors. It is important to
The frequency range of the potentially masking sound is important in determining any potential behavioral impacts. For example, low-frequency signals may have less effect on high-frequency echolocation sounds produced by odontocetes but are more likely to affect detection of mysticete communication calls and other potentially important natural sounds such as those produced by surf and some prey species. The masking of communication signals by anthropogenic noise may be considered as a reduction in the communication space of animals (
Masking affects both senders and receivers of acoustic signals and can potentially have long-term chronic effects on marine mammals at the population level as well as at the individual level. Low-frequency ambient sound levels have increased by as much as 20 dB (more than three times in terms of SPL) in the world's ocean from pre-industrial periods, with most of the increase from distant commercial shipping (Hildebrand, 2009). All anthropogenic sound sources, but especially chronic and lower-frequency signals (
Vessel collisions with marine mammals, or ship strikes, can result in death or serious injury of the animal. Wounds resulting from ship strike may include massive trauma, hemorrhaging, broken bones, or propeller lacerations (Knowlton and Kraus, 2001). An animal at the surface may be struck directly by a vessel, a surfacing animal may hit the bottom of a vessel, or an animal just below the surface may be cut by a vessel's propeller. Superficial strikes may not kill or result in the death of the animal. These interactions are typically associated with large whales, which are occasionally found draped across the bulbous bow of large commercial ships upon arrival in port. Although smaller cetaceans are more maneuverable in relation to large vessels than are large whales, they may also be susceptible to strike. The severity of injuries typically depends on the size and speed of the vessel, with the probability of death or serious injury increasing as vessel speed increases (Knowlton and Kraus, 2001; Laist
Pace and Silber (2005) also found that the probability of death or serious injury increased rapidly with increasing vessel speed. Specifically, the predicted probability of serious injury or death increased from 45 to 75 percent as vessel speed increased from 10 to 14 kn, and exceeded 90 percent at 17 kn. Higher speeds during collisions result in greater force of impact, but higher speeds also appear to increase the chance of severe injuries or death through increased likelihood of collision by pulling whales toward the vessel (Clyne, 1999; Knowlton
In an effort to reduce the number and severity of strikes of the endangered North Atlantic right whale, NMFS implemented speed restrictions in 2008 (73 FR 60173; October 10, 2008). These restrictions require that vessels greater than or equal to 65 ft (19.8 m) in length travel at less than or equal to 10 kn near key port entrances and in certain areas of right whale aggregation along the U.S. eastern seaboard. Conn and Silber (2013) estimated that these restrictions reduced total ship strike mortality risk levels by 80 to 90 percent.
For vessels used in geophysical survey activities, vessel speed while towing gear is typically only 4-5 kn. At these speeds, both the possibility of striking a marine mammal and the possibility of a strike resulting in serious injury or mortality are discountable. At average transit speed, the probability of serious injury or mortality resulting from a strike is less than 50 percent. However, the likelihood of a strike actually happening is again unlikely. Ship strikes, as analyzed in the studies cited above, generally involve commercial shipping, which is much more common in both space and time than is geophysical survey activity. Jensen and Silber (2004) summarized ship strikes of large whales worldwide from 1975-2003 and found that most collisions occurred in the open ocean and involved large vessels (
It is possible for ship strikes to occur while traveling at slow speeds. For example, a hydrographic survey vessel traveling at low speed (5.5 kn) while conducting mapping surveys off the central California coast struck and killed a blue whale in 2009. The State of California determined that the whale had suddenly and unexpectedly surfaced beneath the hull, with the result that the propeller severed the whale's vertebrae, and that this was an unavoidable event. The strike represented the only such incident in approximately 540,000 hours of similar coastal mapping activity (
Although the likelihood of vessels associated with geophysical surveys striking a marine mammal are low, we require a robust ship strike avoidance protocol (see “Proposed Mitigation”), which we believe eliminates any
Here, we briefly address the potential risks due to entanglement and contaminant spills. We are not aware of any records of marine mammal entanglement in towed arrays such as those considered here, and we address measures designed to eliminate the potential for entanglement in gear used by OBS surveys in “proposed Mitigation.” The discharge of trash and debris is prohibited (33 CFR 151.51-77) unless it is passed through a machine that breaks up solids such that they can pass through a 25-mm mesh screen. All other trash and debris must be returned to shore for proper disposal with municipal and solid waste. Some personal items may be accidentally lost overboard. However, U.S. Coast Guard and Environmental Protection Act regulations require operators to become proactive in avoiding accidental loss of solid waste items by developing waste management plans, posting informational placards, manifesting trash sent to shore, and using special precautions such as covering outside trash bins to prevent accidental loss of solid waste. Any permits issued by BOEM would include guidance for the handling and disposal of marine trash and debris, similar to BSEE's Notice to Lessees 2015-G03 (“Marine Trash and Debris Awareness and Elimination”) (BSEE, 2015; BOEM, 2017). We believe entanglement risks are essentially eliminated by the proposed requirements, and entanglement risks are not discussed further in this document.
Marine mammals could be affected by accidentally spilled diesel fuel from a vessel associated with proposed survey activities. Quantities of diesel fuel on the sea surface may affect marine mammals through various pathways: Surface contact of the fuel with skin and other mucous membranes, inhalation of concentrated petroleum vapors, or ingestion of the fuel (direct ingestion or by the ingestion of contaminated prey) (
Placement of equipment, such as nodes, on the seafloor could damage areas of hard bottom where direct contact with the seafloor occurs and could crush epifauna (organisms that live on the seafloor or surface of other organisms). Damage to unknown or unseen hard bottom could occur, but because of the small area covered by most bottom-founded equipment, the patchy distribution of hard bottom habitat, BOEM's review process, and BOEM's application of avoidance conditions of approval, contact with unknown hard bottom is expected to be rare and impacts minor. Seafloor disturbance in areas of soft bottom can cause loss of small patches of epifauna and infauna due to burial or crushing, and bottom-feeding fishes could be temporarily displaced from feeding areas. Overall, any effects of physical damage to habitat are expected to be minor and temporary.
Fish utilize the soundscape and components of sound in their environment to perform important functions such as foraging, predator avoidance, mating, and spawning (
Fish react to sounds which are especially strong and/or intermittent low-frequency sounds, and behavioral responses such as flight or avoidance are the most likely effects. Short duration, sharp sounds can cause overt or subtle changes in fish behavior and local distribution. The reaction of fish to airguns depends on the physiological state of the fish, past exposures, motivation (
SPLs of sufficient strength have been known to cause injury to fish and fish mortality and, in some studies, fish auditory systems have been damaged by airgun noise (McCauley
Injury caused by barotrauma can range from slight to severe and can cause death, and is most likely for fish with swim bladders. Barotrauma injuries have been documented during controlled exposure to impact pile driving (an impulsive noise source, as are airguns) (Halvorsen
Invertebrates appear to be able to detect sounds (Pumphrey, 1950; Frings and Frings, 1967) and are most sensitive to low-frequency sounds (Packard
Impacts to benthic communities from impulsive sound generated by active acoustic sound sources are not well documented. There are no published data that indicate whether threshold shift injuries or effects of auditory masking occur in benthic invertebrates, and there are little data to suggest whether sounds from seismic surveys would have any substantial impact on invertebrate behavior (Hawkins
There is little information concerning potential impacts of noise on zooplankton populations. However, one recent study (McCauley
Prey species exposed to sound might move away from the sound source, experience TTS, experience masking of biologically relevant sounds, or show no obvious direct effects. Mortality from decompression injuries is possible in close proximity to a sound, but only limited data on mortality in response to airgun noise exposure are available (Hawkins
Soundscapes are also defined by, and acoustic habitat influenced by, the total contribution of anthropogenic sound. This may include incidental emissions from sources such as vessel traffic, or may be intentionally introduced to the marine environment for data acquisition purposes (as in the use of airgun arrays). Anthropogenic noise varies widely in its frequency content, duration, and loudness and these characteristics greatly influence the potential habitat-mediated effects to marine mammals (please also see the previous discussion on masking in the “Acoustic Effects” subsection), which may range from local effects for brief periods of time to chronic effects over large areas and for long durations. Depending on the extent of effects to habitat, animals may alter their communications signals (thereby potentially expending additional energy) or miss acoustic cues (either conspecific or adventitious). Problems arising from a failure to detect cues are more likely to occur when noise stimuli are chronic and overlap with biologically relevant cues used for communication, orientation, and predator/prey detection (Francis and Barber, 2013). For more detail on these concepts see,
The term “listening area” refers to the region of ocean over which sources of sound can be detected by an animal at the center of the space. Loss of communication space concerns the area over which a specific animal signal, used to communicate with conspecifics in biologically-important contexts (
Specific to the GOM and the activities considered here, Matthews
As discussed previously in this section, direct exposure to the pulses produced by airguns can result in acute impacts at close ranges. However, low-frequency dominant airgun noise undergoes multiple reflections at the ocean bottom and surface and refraction through the water column, both of which cause prolonged decay time of the original acoustic signals (Urick, 1984). Extended decay time can lead to high sound levels lasting from one impulse to the onset of the next, elevating ambient noise levels (Guan
Acoustic modeling was conducted for ten locations (“receiver sites”) within the study area to examine aggregate noise produced over a full year. The locations of the receiver sites are given in Table 5 and shown in the map of Figure 4. These sites were chosen to reflect areas of biological importance to cetaceans, (
Note that “closure areas” depicted in Figure 4 represent those described in Chapter 2.8 of BOEM (2017), which are in some cases different from those described in this document (see the “Proposed Mitigation” section). Matthews
Several simplifying assumptions were necessary. Changes in the distribution of survey activities would result in differences in the relative amount of noise accumulating at different receiver sites, and that variance was not examined. Instead, results associated with zone-varying densities of activity types but homogenous distributions of activities of each type within zones were presented. The approach applied accounts for spatial variance in resulting cumulative noise due to factors affecting sound propagation (
The average of the projected annual amounts of survey activities for ten
The acoustic fields at the receiver sites were modeled at frequencies from 10 Hz to 5 kHz, for sources up to 500 km away. Results are provided for three depths as available at each receiver location: 5, 30, and 500 m. Annual cumulative SELs and time-averaged equivalent SPLs (
A baseline ambient noise level must be assumed to estimate lost listening area and changes in communication space for various levels of activity. Here, ambient noise levels were defined as some contribution of commercial shipping noise in the 50-800 Hz band and noise from natural sounds (produced mainly by wind and waves). The commercial shipping noise levels were obtained from products available at
The lost listening area assessment method has been applied to in-air noise (Barber
The communication space assessment was performed for Bryde's whales and sperm whales using methods previously implemented for examining anthropogenic noise effects on whales (Clark
For sperm whales, calculations were performed in the third-octave frequency band centered at 3,150 Hz, with a specified sound level of 181 dB at 1 m (Madsen
In the 3,150 Hz band, noise contribution from airgun survey activities in the GOM was estimated between 82.0 and 82.1 dB for all sites and all alternatives, levels similar to the estimated baseline levels of 82.0 dB at all sites. Therefore, the analysis shows that the survey activities do not significantly contribute to the soundscape in the 3,150 Hz band, and that there will be no significant change in communication space for sperm whales under the modeled alternatives. Because other sperm whale calls are higher-frequency, they would not be expected to be affected. However, we must be clear that this analysis is in reference to potential chronic effects resulting from changes to effective communication space, and that acute expects, as discussed elsewhere in this preamble, remain of concern for sperm whales. The remaining discussion that follows is in reference to the findings for Bryde's whales and to general findings for other hearing groups.
The lost listening area and communication space metrics do not reflect variance in an individual animal's experience of the noise produced by the modeled activities from one moment to the next. With both sources of noise and animals moving, the time-series of an individual's noise exposure will show considerable variation. The methods used by Matthews
At most sites, lost listening area was greater for deeper waters than for shallower waters, which is attributed to the downward-refracting sound speed profile near the surface, caused by the thermocline, which steers sound to deeper depths. The winter sound speed profile applied in the CCE modeling (February) was considered to be conservative relative to summer, as it includes a surface sound channel at certain sites that are conducive to sound propagation from shallow sound sources. Shallow water noise levels were reduced due to surface interactions that increase transmission loss, particularly for low frequencies. Listening area reductions were also generally most severe when weighted for low-frequency hearing cetaceans. Filters that more heavily weighted the mid-frequencies modeled in this study (150 Hz-5 kHz) often reduced estimates of lost listening area. Canyon areas in the central and eastern GOM saw significant loss of listening area. Both low- and mid-frequency weighted losses were high in the Mississippi Canyon, while only low-frequency weighted values were high for the De Soto Canyon. Both of these sites are considered important to sperm whales as well as other deep diving odontocetes. Other areas relevant to sperm whales, including site 4 off the Dry Tortugas, also saw heavy reductions in listening area. Additional heavily affected sites were those chosen to represent locations with predicted high densities of cryptic deep divers (
Comparison between results provided for the two metrics applied in the CCE report highlights important interpretive differences for evaluating the biological implications of background noise. The strength of the communication space approach is that it evaluates potential contractions in the availability of a signal of documented importance to a population of animals of key management interest in the region. In this case, losses of communication space for Bryde's whales were estimated to be higher in eastern and central GOM canyons and shelf break areas. The maintenance of listening area and communication space at site 7 is of particular interest because the location is within the area of designated biological importance to the Bryde's whale. The apparent protection of listening area and communication space within the calling frequencies utilized by the Bryde's whale appears to take advantage of both local propagation conditions and the predicted lower levels of survey activity in the shallower portions of the Eastern Planning Area, which more strongly affect noise levels at this site. However, the significant loss of low-frequency listening area and communication space for their calls estimated for in additional locations, including just off the shelf in the eastern GOM, is of concern for this population.
The effectiveness of time-area restrictions for maintaining communication space or listening area were highly variable among locations. This assessment evaluated the implications of displacing a portion (25 percent) of the activity that would have taken place within a restriction area to within the remaining area outside the restriction. Thus, sites that were within large restriction areas (sites 6 and 8) experienced reduced cumulative noise levels and improved listening and communication conditions when those restrictions were in effect. Conditions at sites within restrictions designed around biologically important areas (sites 7 and 10) were not improved solely because they were not degraded under non-restriction conditions. In contrast, some sites outside restrictions, particularly those located in deeper water zones that correspond with denser projected levels of survey activity (sites 1, 3, and 5) experienced higher noise levels with time-area restrictions, due to activity that was displaced to within their propagation vicinity. Finally, the methods used in this assessment to remove 10 percent of shots from survey activity closest to the receiver locations are likely to have reduced the relative difference between accumulated energy resulting from smaller restrictions (which further eliminated shots that would have taken place within the 160 dB buffered restriction areas). This loss of resolution between restriction and non-restriction results does not adequately capture the reduction in acute noise exposure that could be experienced by animals through implementation of a restriction.
The CCE report is described here in order to present information regarding potential longer-term and wider-range noise effects from sources such as airguns. The metrics applied in this study do not, in and of themselves, document the consequences of lost listening area or communication space for the survivorship or reproductive success of individual animals. However, they do translate a growing body of scientific evidence for concern regarding the degradation of the quality of high-value acoustic habitats into quantifiable attributes that can related to baseline conditions, including those to which animals have evolved.
In general, losses of broadband listening area far exceeded losses of communication space when evaluated at the same locations and under the same activity levels. This is appropriate to the interpretive role of the lost listening space calculation, which is to provide a more conservative estimate of the areas over which animals have access to a variety of acoustic cues of importance to their survival and reproductive success. Acoustic cues provide particularly important information in areas where other sensory cues are diminished (
This section provides an estimate of the number and type of incidental takes that may be expected to occur under the proposed activity, which will inform NMFS's negligible impact determination. Realized incidental takes would be determined by the actual levels of activity at specific times and places that occur under any issued LOAs.
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).
Incidental takes would primarily be expected to be by Level B harassment, as use of the described acoustic sources has the potential to result in disruption of behavioral patterns for individual marine mammals. There is also some potential for auditory injury (Level A harassment) to result for mysticetes and high frequency species due to the size of the predicted auditory injury zones for those species. Auditory injury is less likely to occur for mid-frequency species, due to their relative lack of sensitivity to the frequencies at which the primary energy of an airgun signal is found, as well as such species' general lower sensitivity to auditory injury as compared to high-frequency cetaceans. As discussed in further detail below, we do not expect auditory injury for mid-frequency cetaceans. The proposed mitigation and monitoring measures are expected to minimize the severity of such taking to the extent practicable. No mortality is anticipated as a result of these activities.
Using the best available science, NMFS has developed acoustic thresholds that identify the received level of underwater sound above which exposed marine mammals would be reasonably expected to exhibit behavioral disruptions (equated to Level B harassment) or to incur PTS of some degree (equated to Level A harassment).
Based on the practical need to use a relatively simple threshold based on available information that is both predictable and measurable for most activities, NMFS has historically used a generalized acoustic threshold based on received level to estimate the onset of Level B harassment. This approach was developed based on the 1997 High-Energy Seismic Survey Workshop (HESS, 1999) and a 1998 NMFS workshop on acoustic criteria, and assumed a step-function threshold. A step-function threshold assumes that animals receiving SPLs that exceed the threshold will always respond in a way that constitutes behavioral harassment, while those receiving SPLs below the threshold will not. This approach assumes that the responses of marine mammals would not be affected by differences in acoustic conditions; differences between species and populations; differences in gender, age, reproductive status, or social behavior; or the prior experience of the individuals (or any other contextual factor). For impulsive sources, such as airguns, a threshold of 160 dB rms SPL was selected on the basis of measured avoidance responses observed in whales. Specifically, the threshold was initially derived from data for mother-calf pairs of migrating gray whales (Malme
However, most marine mammals exposed to impulse noise demonstrate responses of varying magnitude in the 140‐180 dB rms exposure range (Southall
Southall
In assessing the potential for behavioral response as a result of sonar exposure, the U.S. Navy has developed, with NMFS, acoustic risk functions (or “dose-response” functions) that relate an exposure to the probability of response. These assume that the probability of a response depends first on the “dose” (in this case, the received level of sound) and that the probability of a response increases as the “dose” increases (
NMFS acknowledges that the 160-dB rms step-function approach is simplistic, and that an approach reflecting a more complex probabilistic function is better reflective of available scientific information. Such an approach takes the fundamental step of acknowledging the potential for Level B harassment at exposures to received levels below 160 dB rms (as well as the potential that animals exposed to received levels above 160 dB rms will not respond in ways constituting behavioral harassment). Zeddies
The approach described by Wood
NMFS is currently evaluating available information towards development of guidance for assessing the effects of anthropogenic sound on marine mammal behavior. For this specified activity we have determined it appropriate to use the Zeddies
While we believe that the general approach of Wood
Both the Wood
Regarding mysticetes, changes in vocalization associated with exposure to airgun surveys within migratory and non-migratory contexts have been observed (
We also acknowledge concern regarding the differences between sperm whales and other cetaceans in the mid-frequency group,
Additionally, the application of the Nowacek
Finally, other than providing the 50 percent midpoint, Nowacek
• Dividing sound sources into two groups (
• Choosing metrics that best address the impacts of noise on hearing sensitivity,
• Dividing marine mammals into hearing groups and developing auditory weighting functions based on the
The premise of the dual criteria approach is that, while there is no definitive answer to the question of which acoustic metric is most appropriate for assessing the potential for injury, both the received level and duration of received signals are important to an understanding of the potential for auditory injury. Therefore, peak SPL is used to define a pressure criterion above which auditory injury is predicted to occur, regardless of exposure duration (
NMFS (2016) recommends 24 hours as a maximum accumulation period relative to cSEL thresholds. These thresholds were developed by compiling and synthesizing the best available science, and are provided in Table 7 below. The references, analysis, and methodology used in the development of the thresholds are described in NMFS (2016), which is available online at:
The technical guidance was classified as a Highly Influential Scientific Assessment and, as such, underwent three independent peer reviews, at three different stages in its development, including a follow-up to one of the peer reviews, prior to its dissemination by NMFS. Details of each peer review are included within the technical guidance, and specific peer reviewer comments and NMFS's responses are available online at:
Zeddies
A modeling workshop was held in 2014 as a collaborative effort between the American Petroleum Institute (API) and the International Association of Geophysical Contractors (IAGC), NMFS, and BOEM. The objectives of the workshop were to identify: (1) Gaps in modeling sound fields from airgun arrays and other active acoustic sources, including data requirements and performance in various contexts, (2) gaps in approaches to integration of modeled sound fields with biological data to estimate marine mammal exposures, and (3) assumptions and uncertainties in approaches and resultant effects on exposure estimates. This workshop aided BOEM and NMFS's development of a Request for Proposals, Statement of Work, and, ultimately, the methodologies undertaken in the modeling project.
The project was divided into two phases. Each phase produced exposure estimates computed from modeled sound levels as received by simulated animals (animats) in a specific modeling area. In Phase I (described below under “Test Scenarios;” all other discussion here refers to Phase II), a typical 3D WAZ survey was simulated at two locations in order to establish the basic methodological approach and to provide results used to evaluate test scenarios that could influence exposure estimates. Results from the test scenarios were then used to guide the main modeling effort of Phase II. In Phase II, the GOM was divided into seven modeling zones with six survey types simulated within each zone to estimate the potential effects of each survey.
The zones were designed as described previously (“Description of the Specified Activity;” Figure 2)—shelf and slope waters were divided into eastern, central and, western zones, plus a single deep-water zone—to account for both the geospatial dependence of acoustic fields and the geographic variations of animal distributions. The selected boundaries considered sound propagation conditions and species distribution to create regions of optimized uniformity in both acoustic environment and animal density. Survey types included deep penetration surveys using a large airgun array (2D, 3D NAZ, 3D WAZ, and coil), shallow penetration surveys using a single airgun, and high resolution surveys concurrently using side-scan sonar, subbottom profiler, and multibeam echosounder. The results from each zone were summed to provide GOM-wide estimates of take for each marine mammal species for each survey type
Acoustic source emission levels and directivity of a single airgun and an airgun array were modeled using JASCO Applied Sciences' Airgun Array Source Model (AASM). Source levels for high-resolution sources were obtained from manufacturer's specifications for representative sources. The AASM accounts for the physics of oscillation and radiation of airgun bubbles (Ziolkowski, 1970) and nonlinear pressure interactions between airguns, port throttling, bubble damping, and generator-injector gun behavior (Dragoset, 1984; Laws
It should be noted that source modeling for the boomer source was compared to that for the single airgun. Results of the comparison indicate that the acoustic field modeling results for the airgun adequately approximate the ones for the boomer. Considering the negligible fraction of total surveys conducted using boomers and that the estimated impact from the single airgun is always greater than for the boomer, the single airgun results were used as a conservative substitute for the boomer.
Underwater sound propagation (
At frequencies less than 2 kHz, MONM computes acoustic propagation via a wide-angle parabolic equation (PE) solution to the acoustic wave equation (Collins, 1993) based on a version of the U.S. Naval Research Laboratory's Range-dependent Acoustic Model (RAM) modified to account for an elastic seabed (Zhang and Tindle, 1995). MONM-RAM incorporates bathymetry, underwater sound speed as a function of depth, and a geoacoustic profile based on seafloor composition, and accounts for source horizontal directivity. The PE method has been extensively benchmarked and is widely employed in the underwater acoustics community (Collins
These propagation models effectively assume a continuous wave source, which is an acceptable assumption for a pulse in the case of the SEL metric because the energy in the various multi-path arrivals is summed. When significant multi-path arrivals cause broadening of the pulse, the continuous wave assumption breaks down for pressure metrics such as rms SPL. Multipath arrivals can have very different temporal and spectral properties when received by marine mammals (Madsen
Models are more efficient at estimating SEL than rms SPL. Therefore, conversions may be necessary to derive the corresponding rms SPL. Propagation was modeled for a subset of sites using a full-wave RAM PE model (FWRAM), from which broadband SEL to SPL conversion factors were calculated using a sliding 100 ms integration window. This window was selected to represent the shortest expected temporal integration time for the mammalian ear (Plomp and Bouman, 1959; MacGillivray
For electromechanical source and single airgun propagation modeling, a fixed conversion difference of +10 dB from SEL to rms SPL was applied at all receiver positions, because there was little variability over the range of propagation for these sources. This approach is accurate at distances where the pulse duration is less than 100 ms, and conservative for longer distances. Most of the effects of these sources occur at relatively short distances where the pulse durations are short so this approach is not expected to be overly conservative even for lower-level effects. This is a conservative but reasonable approximation to simplify the variability across all HRG sources, effectively assuming that an HRG transmission is on for only 1/10 of a second for any given second.
As described below, in order to accurately estimate exposure a simulation must adequately cover the various location- and season-specific environments. The surveys may be conducted at any location within the planning area and occur at any time of
A set of 30 sites was selected to calculate acoustic propagation loss grids as functions of source, range from the source, azimuth from the source, and receiver depth. These were then used as inputs to the acoustic exposure model. Geographic coordinates and water column depth of each acoustic modeling site are listed in Table 48 of the modeling report. The environmental parameters and acoustic propagation conditions represented by these 30 modeling sites were chosen to be representative of the prevalent acoustic propagation conditions within the survey extents. Inputs are as follows:
• Water depths throughout the modeled area were obtained from the National Geophysical Data Center's U.S. Coastal Relief Model l. Bathymetry data have a horizontal resolution of approximately 80 x 90 m.
• The top sections of the sediment cover in the GOM are represented by layers of unconsolidated sediments at least several hundred meters thick, with grain size of the surficial sediments following the general trend for sedimentary basins (decreasing with the distance from the shore). For the shelf zone, the general surficial bottom type was assumed to be sand, for the slope zone silt, and for the deep zone clay. In constructing a geoacoustic model for input to MONM, a median grain size value was generally selected. Assumed geoacoustic properties for each zone as a function of depth are presented in Tables 52-55 of the modeling report.
• The sound speed profiles for the modeled sites were derived from temperature and salinity profiles from the U.S. Naval Oceanographic Office's
Variation in the sound speed profile throughout the year was investigated and a set of 12 sound speed profiles produced, each representing one month in the shelf, slope, and deep zones. The set was divided into four seasons and, for each zone, one month was selected to represent the propagation conditions in the water column in each season. Acoustic fields were modeled using sound speed profiles for winter (January-March) and summer (July-September). Profiles for Season 1 (February) provided the most conservative propagation environment because a surface duct, caused by upward refraction in the top 50-75 m (of sound above 500 and 250 Hz, respectively), was present. Ducting of the sound above the relevant frequency cutoffs is important as most marine mammals are sensitive to these sounds and the horizontal far-field acoustic projection from the airgun array sources do have significant energy in this part of the spectrum. Profiles for Season 3 (August or September) provided the least conservative results because they have weak to no sound channels at the surface and are strongly downward refracting in the top 200 m. Only the top 100 m of the water column are affected by the seasonal variation in the sound speed.
Many assumptions are necessary in modeling complex scenarios. When possible, the most representative data or methods were used. When necessary, the choices were made to be conservative so as not to ultimately underestimate potential marine mammal exposures to noise. Assumptions related to acoustic modeling include:
• The environmental input parameters used for transmission loss modeling were from databases that provide averaged values with limited spatial and temporal resolution. Sound speed profiles are averaged seasonal values taken from many sample locations. Geoacoustic parameters (including sediment type, thickness, and reflectivity coefficients) and bathymetric grids are smoothed and averaged to characterize large regions of the seafloor. Local variability, which can be affected by weather, daily temperature cycles, and small-scale surface and sediment details, generally increases signal transmission loss, but was removed by these averaging processes. As a result, the transmission loss could in some cases be underestimated and, therefore, the received levels would be overestimated.
• The acoustic propagation model, MONM, used the horizontal-direction source level for all vertical angles. This may slightly underestimate the true sound levels in the vertical directional beam of the array that ensonifies a zone directly under the array. This is expected to be a minor effect given the small volume over which the reduction occurs. Additionally, there is a steep angle limitation in the PE model used in MONM that also leads to slightly reduced levels directly under the array. The wide-angle PE that is used in MONM is accurate to at least 70 degrees. The reduced-level zone is a cone within a few degrees of vertical, which represents a relatively small water volume that should not significantly affect results.
• Seasons modeled: To account for seasonal variation in propagation, winter (most conservative) and summer (least conservative) were both used to calculate exposure estimates. Propagation during spring and fall was found to be almost identical to the results for summer, so those seasons were represented with the summer results. The primary seasonal influence on transmission loss is the presence of a sound channel, or duct, near the surface in winter.
The best available scientific information was considered in conducting marine mammal exposure estimates (the basis for estimating take). Historically, distance sampling methodology (Buckland
Roberts
In the GOM, there are clear differences in marine mammal distribution by water depth,
The sound received by an animal when near a sound source is a function of the animal's position relative to the source, and both source and animals may be moving. To a reasonable approximation, we know, predict, or specify the location of the sound source, a 3D sound field around the source, and the expected occurrence of animals within 100 km
Several models for marine mammal movement have been developed (
Parameter values to control animat movement are typically determined using available species-specific behavioral studies, but the amount and quality of available data varies by species. While available data often provides a detailed description of the proximate behavior expected for real individual animals, species with more available information must be used as surrogates for those without sufficient available information. In this study, pantropical spotted dolphins are used as a surrogate for Clymene, spinner, and
Species-specific animats were created with programmed behavioral parameters describing dive depth, surfacing and dive durations, swimming speed, course change, and behavioral aversions (
During all simulations in this modeling effort, any animat that left the simulation area as it crossed the simulation boundary was replaced by a new animat traveling in the same direction and entering at the opposite boundary. For example, an animat heading north and crossing the northern boundary of the simulation was replaced by a new animat heading north and entering at the southern boundary. By replacing animats in this manner, the animat modeling density remained constant. Animats were only allowed to be `taken' once during a 24-hr evaluation period. That is, an animat whose received level exceeds the peak SPL threshold more than once during an evaluation period was only counted once. Energy accumulation for SEL occurred throughout the 24-hr integration period and was reset at the beginning of each period. Similarly, the maximum received rms SPL was determined for the entirety of the evaluation period and reset at the beginning of each period.
In Figure 2, the large transparent boxes represent the seven defined modeling areas (animal simulation extents) within the seven zones. During the survey simulations, the source was moved within the smaller survey area extents, but the sound output would ensonify a larger area (represented by the animal simulation extents). These animat simulation boxes set the geographic limits of the 3MB simulation.
For the large-area surveys, injury simulation boxes extend outward (north, south, east, and west) by 10 km from the survey limits, a distance over which the unweighted received levels drop below 160 dB SEL for a single shot. The behavior simulation boxes, on the other hand, extend outward by 50 km from the survey limits, a distance necessary to ensure that the animat movement modeling extends out to where the weighted received levels drop to 120 dB rms SPL or lower, and below 160 dB SEL for unweighted received levels. Geographic extent of the boxes is shown in Tables 59-60 of the modeling report.
The received levels for the single airgun and electromechanical sources drop off much more quickly with range than for the airgun array sources discussed above. Consequently, the 3MB simulation boxes for the small-area surveys were extended to 10 km from the center of the survey in each cardinal direction, a much larger distance than that required for the received level conditions, but one that supports more realistic animal movements. Geographic extent of the boxes is shown in Table 61 of the modeling report.
The JASCO Exposure Modeling System (JEMS) combines animal movement data (
All survey simulations were for 7 days and a sliding 4-hr window approach was used to get the average 24-hr exposure. In this sliding-windows approach, 42 exposure estimate samples are obtained for each seven-day simulation, with the mean value then used as the 24-hr exposure estimate for that survey. The 24-hr exposure levels were then scaled by the projected level of effort for each survey type (
As described above for acoustic modeling, assumptions and choices must be made when modeling complex scenarios:
•
• Mitigation procedures, such as shutting down an airgun array when animals are detected within an established exclusion zone, can reduce the injury exposure estimates. Mitigation effectiveness was found to be influenced by several factors, most importantly the ability to detect the animals within the exclusion zone. Some species are more easily detected than others, and detection probability varies with weather and observational set-up. Weather during any seismic survey is unknown beforehand and detection probabilities are difficult to predict, so the effects of mitigation were not included in the exposure estimates (see Test Scenario 3, below).
• Aversion is a context-dependent behavioral response affected by biological factors, including energetic and reproductive state, sociality, and health status of individual animals. Animals may avoid loud or annoying sounds, which could reduce exposure levels. The effect of aversion itself
Potential for disruption of behavioral patterns was also evaluated using NMFS's standard 160 dB rms criterion. To evaluate this likelihood, the exposure simulation was set to use unweighted rms SPL acoustic fields. The number of animats that received an exposure greater than 160 dB was counted as the number of behavioral responses. However, note that the modeling report also separately evaluated exposures at received levels exceeding 180 dB rms; therefore, the true number of exposures greater than 160 dB rms would be the sum of separately calculated exposures between 160 and 180 dB and greater than 180 dB. As with the other criteria, the animat received level was reset at the beginning of each 24-hr integration window. Please see Zeddies
As described above, Phase I of the modeling effort involved preliminary modeling of a typical 3D WAZ survey (all survey parameters were described under “Detailed Description of Activities”), which was simulated at two locations in order to establish the basic methodological approach and to provide results used to evaluate test scenarios that could influence exposure estimates. We provide a summary of each of the six evaluated test scenarios below. For all test scenarios, please see the modeling report for full details.
Locations considered were both near the Mississippi Canyon, including a site centered on the slope of the continental shelf break and a site centered on the deep ocean plain (please see Figure 10 in Zeddies
To evaluate potential behavioral response, 30-day simulations of the hypothetical 3D WAZ survey were run at both sites for each of the species evaluated. The boundaries of the simulation were determined from transmission loss calculations, and were set at 50 km from the source.
Exposure estimates from 30-day and 5-day simulations, using different animat seeding values (0.1 and 2.0 animats/km
To investigate potential systematic, and possibly unknown, biases in the modeling procedure, behavioral exposure estimates were determined for subsets of the simulations. Behavioral exposure estimates were determined as a function of time by finding the number of exposures occurring in 24-hr subsets using a sliding window that advanced in 4-hr increments. Trends
The number of animats exposed to levels exceeding threshold for 24-hr time periods multiplied by the number of days in the simulations was compared to the number of animats exposed to levels exceeding threshold for the entire duration of the simulations. Given that an animat represents an individual marine mammal, scaling up the 24-hr average SPL exposure estimates to 30 days greatly overestimates the number of individual marine mammals exposed to levels exceeding threshold when determined over the entire simulation (although the estimated instances of exposure are reasonably accurate). This occurs because animats were commonly exposed to levels exceeding these thresholds and the relatively short reset period of 24-hr means that individual animats were, in effect, counted several times during the scale-up (
The systematic trends evident in the modeling procedure indicated that survey design can affect exposure estimates when scaling is used. Therefore, the minimum duration of a simulation should include all of the acoustic environments likely to be encountered during the operation. The test scenario produced the following recommendations, which were employed during the Phase II modeling effort: (1) Identify the shortest large-scale animal movement time-period (
This test scenario also illustrated that knowing the amount of time that animals are exposed to levels exceeding the threshold criteria can provide additional information about the potential impacts of the activity. For example, the amounts of time that animats were exposed to levels exceeding 160 dB rms SPL over the 30-day duration were approximately twice as long as the average times in a 24-hr window, as it was common for the threshold to be exceeded on multiple separate occasions. Two factors contributed to the total time thresholds were exceeded—the amount of time per occasion (
Zeddies
With regard to uncertainty relating to animal movement parameters, comparisons between animals generally resulted in similar exposure estimates when the same filtering and thresholds were applied. The exposure estimates for bottlenose dolphins, short-finned pilot whales and, to some extent, sperm whales were similar. For sperm whales, however, the behavioral depth restriction for this species (animats do not enter water depths less than 1,000 m) resulted in differences. Sperm whales also showed greater potential of behavioral response to noise exposure than other species with the same auditory thresholds. Sperm whales are deep divers; in this downward refracting environment they appear to receive consistently greater exposures relative to shallow diving species.
In order to address overall uncertainty in the exposure estimates resulting from combined uncertainty due to both acoustic and animal modeling, a “bootstrap” resampling process was used in which relevant uncertainty could be added to animats' received levels. For example, for potential auditory injury, the primary acoustic uncertainty was the source level variance. Airguns are designed to have low inter-shot variability and predicted source levels within 3 dB. A conservative estimate of ±3 dB standard deviation was used to investigate the effects of source level variance on SEL injury exposure estimates. While the mean number of animats above SEL threshold increased relative to the expected value, the exposure estimate distributions did not change much. For potential behavioral disturbance, propagation uncertainty (due to the greater ranges involved) also contributes to the uncertainty in the acoustic modeling predictions; therefore, 6 dB was chosen as a test to include both the source variance plus uncertainty due to propagation. The mean behavioral disruption estimates and the distribution ranges stayed approximately the same when ± 6dB of acoustic variability was included. During resampling, acoustic uncertainty can be combined with real-world density (mean ± standard deviation) and social group size (mean ± standard deviation). In general, the uncertainty associated with the animals (density and group size) does not change the mean exposure estimate, but can affect the exposure estimate distribution.
Level A harassment exposure estimates associated with the 5-day survey simulation were calculated with and without a mitigation procedure. Exposure estimates were computed relative to SEL and peak SPL exposure criteria. Airgun shutdown was modeled by zeroing all animat received levels when an animat was detected within an exclusion zone, with detection registered when the horizontal range of an animat from the source was less than 500 m, its depth was less than 50 m, and a random draw from a uniform distribution between 0 and 1 indicated detection. If the random value was less than the assumed
The inclusion of mitigation procedures in the simulations reduced the numbers of exposures based on peak SPL criteria for five out of six species and detection probabilities considered, even though an extension in the survey period due to line re-shoot was taken into account. The exception was Bryde's whales, due to low real-world density values. Mitigation effectiveness, expressed as the reduction in the number of individual animals exposed, was generally related to animal densities; species with higher densities were more often exposed and the reduction in the number of exposures from mitigation was greater. As expected, the percentage reduction in exposures for species with relatively high detection probability was higher than the percentage reduction for species with relatively low detection probability.
The usefulness of mitigation depends on species characteristics and environmental conditions, meaning that there is a high degree of inherent variability (and potential error) involved in attempting to predict some reduction in potential exposures resulting from mitigation effectiveness. Reductions due to mitigation for easily-detected species with large populations may be large in terms of percentage decrease (assuming shutdown is a required measure) while, for low-density species that are difficult to detect in rough seas, there may be little realistic mitigation effect. Further, for deep-diving species with unreliable
As for mitigation effectiveness, a test scenario was investigated using a modeling approach to quantify the potential reduction in injury exposure estimates due to aversion. Aversion is simulated as a reduction in received levels and, because little is known about the received levels at which animals begin to avert, the sound levels and probabilities used to evaluate potential behavioral disturbance are used to approximate aversion. However, it is possible that aversion could occur at greater or lesser received sound levels, depending on the context and/or motivation of the animal. It is important to note that, as considered here, aversion itself can represent a behavioral disruption; therefore, aversion is only meaningful in reducing the potential for injury,
Injury exposure estimates associated with the 5-day 3D WAZ simulation were determined with and without aversion. The difference in the mean value of the exposure estimate distributions with and without aversion indicates the effect of aversion on the injury exposure estimates. Each animat sampled during the bootstrap resampling process has an associated exposure history,
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•
•
•
Adjusted exposure histories were computed separately for each source, animat, and episode of aversion; each occurrence of aversive behavior was thus independent. Although the probability of aversion was defined in terms of the rms SPL, exposure histories were recorded in terms of the per-pulse SEL. A nominal conversion offset of +10 dB from SEL to rms SPL was used so the two metrics could be compared. Cumulative SELs over the 5-day simulation, were weighted using Type I filters for Bryde's whales and Type II filters for mid- and high-frequency cetaceans, but behavioral effects were estimated using Type I filters for all species, with appropriate adjustments made to the 5-day SEL exposure histories. The mean time spent in an averted state for four of six species were approximately 18 and 4 min for the slope and deep sites, respectively. For beaked whales, the means were 41 and 19 min. Too few Bryde's whale animats exceeded threshold to obtain a reliable statistical measure.
Aversion in the simulations reduced the numbers of exposures based on peak SPL criteria for most species. Aversion effectiveness, as measured by the percentage reduction in the exposure estimates, could be high: Approximately 85 percent for bottlenose dolphins, Cuvier's beaked whales, short-finned pilot whales, and sperm whales, and 40 percent for dwarf sperm whales. Bryde's whales, whose real-world densities were so low that no exposures were modeled even in the absence of aversion, were the exception. The numbers of exposures based on SEL criteria were near zero for most species even without aversion. The reduction in exposures was influenced by the criteria used to estimate exposures and by the assumptions made with respect to aversion probability. For example, although the real-world densities of dwarf sperm whales (a high-frequency cetacean) are similar to those for Cuvier's beaked whales (a mid-frequency cetacean), exposure estimates and the decrease in number of exposure estimates arising from aversion were different. The differences in aversion effectiveness reflect differences in injury threshold criteria and aversion probability. Ultimately, the effects of aversion were not quantified in the Phase II modeling due to lack of information regarding species-specific degree of aversion and level of onset.
The investigations found that while SEL increases for overlapping surveys, injury due to accumulated energy is a rare event, and threshold exceedance resulted from a few high-level exposures near a source rather than an accumulation of many lower-level exposures. The range to injury assessed by peak SPL is up to a few hundred meters and does not accumulate. Injury in typical airgun surveys, therefore, occurs mainly because of a close encounter with a single airgun array. There are practical limits to how close two acquisition lines can be without one survey source interfering with the other survey's recordings. Depending on the survey type and the propagation environment of the area, the stand-off distance between fully concurrent surveys operating independently may be several tens of kilometers. If two surveys are conducted in closer proximity, then the operators will generally agree to
For potential behavioral disturbance, overlapping surveys may affect exposure estimates, but the effect is either small or potentially negative (reducing the overall number of estimated exposures). Because coincident reception in which the sound level increases appreciably occurs only in small portions of the ensonified volume, overlapping survey sound fields do not generally result in higher maximum received sound pressure levels. And, because animals may only be “taken” once within a 24-hr window, animals exposed in more than one survey are only counted once in the aggregate of the surveys. This does not preclude possible behavioral effects of animals spending more time above threshold, but such effects are not addressed by existing criteria.
From an energetic perspective, the relative firing pattern of different arrays does not matter. The same SEL will be registered when two arrays are alternated or fired simultaneously. For the pressure-based metrics, peak SPL and rms SPL, simultaneous firing can increase the received levels, but in only a small portion of the ensonified volume. Because the maximum received levels are rarely increased, the exposure estimates based on SPL are rarely increased. The most likely place for meaningful summation to occur is very near the source, and in that case the firing pattern would be included in the simulation and therefore in the exposure estimates.
In summary, neither separation distance nor simultaneous firing is of significant concern when estimating exposures using the current criteria.
NMFS is aware of criticism that the modeling results are unrealistic or overly conservative (
We call attention to our own public comments submitted to BOEM following review of the draft PEIS: “[NMFS] disagrees that the PEIS analysis is based on the `upper limit' of potential marine mammal exposures to sound produced by [survey] activities. The PEIS provides no reasonable justification as to why the exposure estimates [. . .] should be considered as `conservative upper limits', represent an `overestimate,' or are `unrealistically high.' [NMFS] believes that the exposure estimates represent a conservative but reasonable best estimate [. . . .] [NMFS] disagrees that `each of the inputs into the models is purposely developed to be conservative.' Although it may be correct that conservativeness accumulates throughout the analysis, BOEM has not adequately described the nature of conservativeness associated with model inputs or to what degree (either quantitatively or qualitatively) such conservativeness `accumulates.' While exposure modeling is inherently complex, complexity does not inherently result in overestimation of exposures [. . . .] [NMFS] strongly disagrees that the exposure estimates are `overly conservative,' are `upper limits,' or that these estimates are in some way differentiated from what might actually be expected to occur.” Finally, we note that BOEM's final PEIS removed erroneous statements and provided additional clarification regarding descriptions of the modeling results to more accurately describe the nature of the results as a conservative but reasonable best estimate, consistent with NMFS's comments on the draft PEIS.
IAGC and API contracted with JASCO Applied Sciences, who performed the modeling effort, to conduct additional analysis regarding the effect that various acoustic model parameters or inputs have on the outputs used to estimate numbers of animals exposed to threshold levels of sound from geophysical sources used in the GOM (“
Here, we address some specific issues regarding the modeling assumptions and briefly address the results provided by Zeddies
• Representative large array. The Associations state that the selected array (8,000 in
The particular array was selected as a realistic representative proxy after BOEM's discussions with individual geophysical companies. An 8,000-in
The exact configuration of the 4,130 in
• Sound propagation modeling. Acoustic propagation in the GOM is complex and routinely changing due to variations in the Loop Current (and its eddies) and weather (including hurricanes). Additionally, propagation modeling needs to address a wide range of water depths (
• Mitigation and aversion. As discussed in further detail above, the effects of mitigation and aversion on exposure estimates were investigated via Test Scenarios. We acknowledge that both of these factors would lead to a reduction in likely injurious exposure to some degree. However, these factors were ultimately not quantified in the modeling because, in summary, there is too much inherent uncertainty regarding the effectiveness of detection-based mitigation to support any reasonable quantification of its effect in reducing injurious exposure and there is too little information regarding the likely level of onset and degree of aversion to justify its use in the modeling. Zeddies
In conclusion, and as stated by BOEM (2017), the results of the modeling are expected to incorporate a reasonable margin of conservatism, and they represent use of the most credible, science-based methodologies and information available at this time. We believe it appropriate to incorporate conservatism to a reasonable extent in order to produce take estimates that would be sufficient to address the likely impacts of the activity and to allow for issuance of authorizations that would cover the expected requests by operators over the course of 5 years.
In order to provide an estimate of takes of marine mammals that could occur as a result of a reasonably expected level of geophysical survey activity in the GOM over the course of 5 years, we evaluated BOEM's 10-year level of effort predictions and the
In summary, BOEM provided estimated levels of effort for geophysical survey activity in the GOM for a notional ten-year period. Exposure estimates were then computed from modeled sound levels received by animats for several representative types of geophysical surveying. Because animals and acoustic sources move relative to the environment and each other, and the sound fields generated by the sources are shaped by various physical parameters, the sound levels received by an animal are a complex function of location and time. The basic modeling approach was to use acoustic models to compute the 3D sound fields and their variations in time. Animats were modeled moving through these fields to sample the sound levels in a manner similar to how real animals would experience these sounds. From the time histories of the received sound levels of all animats, the numbers of animals exposed to levels exceeding effects threshold criteria were determined and then adjusted by the number of animals expected in the area, based on density information, to estimate the potential number of real-world marine mammal exposures to levels above the defined criteria.
With the overall modeling goal to estimate exposure levels from future survey activity whose individual details such as exact location and duration are unknown, a primary concern was how to account for different survey types, locations and spatial extents, and durations. In Test Scenario 1, issues arising when estimating impacts during long-duration surveys were investigated and a method was suggested. The defined 24-hr integration window, or reset period, creates a scaling time-basis for impact analysis, and 24 hours is short relative to most surveys. Test Scenario 1 demonstrated that while scaling (multiplying) the average 24-hr exposure estimate by the number of days of a survey is appropriate for estimating the number of instances of exposure above threshold, this same number is likely an overestimate of the number of individual marine mammals exposed above threshold during that time period. The associated 30-day model runs resulted in lower numbers of animats exposed to levels exceeding the threshold because individual animats were only counted once in the 30-day period even when exposed above the threshold across multiple days, which allows for a more refined consideration of individual animal takes,
The parameters governing animal movement were obtained from short-duration events, such as several dives, and for this modeling effort did not include long-duration behavior like migration or periodically revisiting an area as part of a circulation pattern. These behaviors could be modeled, but there are no data available currently to support detailed modeling of this type of behavior in the GOM. Seven-day simulations were chosen to ensure differing environments would be sampled.
With any modeling exercise, uncertainty in the input parameters results in uncertainty in the output. Sources of uncertainty and their effects on exposure estimates were investigated in Test Scenario 2. The primary source of uncertainty in this project was the location of the animals at the times of the surveys, which drives the choice of using an agent-based modeling approach and Monte Carlo sampling. Density estimates assume a uniform, static distribution of animals over a survey area, although real world animal densities can fluctuate significantly. However, assuming many surveys will be conducted in many locations, the variations in density are expected to average toward the mean. Sources of uncertainty in the other modeling parameters were found to affect the variance of the modeling results, as opposed to their mean, and the use of mean input parameters is therefore justified by the same argument as using mean animal densities: With many surveys occurring over many locations, variations are expected to average toward the mean. The effects of the variability in many of the modeling parameters on exposure estimates were quantified using a resampling technique. It was found that uncertainty in parameters such as animal density and social group size had a profound effect on the distribution of the exposure estimates, but not on the mean exposure. That is, the distribution shape and range of the number of animals above threshold changed, but the mean number of animals above threshold remained the same.
We previously presented BOEM's 10-year activity projections under “Detailed Description of Activities” (Table 1), and identified representative “high,” “moderate,” and “low” effort years. Level of effort is currently significantly reduced in the GOM. A decrease in permit applications was seen over the 2016 calendar year and the trend in reduced exploration activity continued in 2017. However, BOEM states that they assume that future levels will return to previous levels. Therefore, the existing scenario levels, which contain projections based on BOEM's
For all mid-frequency cetaceans,
For other species (
This proposed rule has been designated as significant under Executive Order 12866. Accordingly, a draft regulatory impact analysis (RIA) has been prepared and is available for review online at:
Office of Management and Budget (OMB) Circular A-4 directs that the baseline for regulatory analysis should be the agency's best assessment of the state of the world in the absence of the proposed action. A-4 also provides that agencies may present multiple baselines where this would provide additional useful information to the public on the projected effects of the regulation. We are presenting two baselines for public information and comment, consistent with the A-4 provision allowing agencies to present multiple baselines. Thus, in addition to a baseline that reflects current assumed industry practices as agreed upon in the 2013 settlement agreement, NMFS is also presenting a baseline corresponding with geophysical activities in the GOM as carried out prior to the 2013 settlement agreement but without authorization from NMFS under the MMPA.
Estimated direct costs of the measures in the proposed regulations, relative to both baselines, are presented in Table 10. Details regarding cost estimation are available in the RIA. A qualitative evaluation of indirect costs related to the proposed regulations is also provided in the RIA. Note that these costs would be diffused across all operators receiving LOAs.
Under Section 101(a)(5)(A) of the MMPA, NMFS must set forth the permissible methods of taking pursuant to such activity, and other means of effecting the least practicable adverse 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 (“least practicable adverse impact”). Consideration of the availability of marine mammal species or stocks for taking for subsistence uses pertains only to Alaska, and is therefore not relevant here. NMFS does not have a regulatory definition for “least practicable adverse impact.” However, NMFS's implementing 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)). It is important to note that in some cases, certain mitigation may be necessary in order to ensure a “negligible impact” on an affected species or stock, which is a fundamental requirement of issuing an authorization—in these cases, consideration of practicability may be a lower priority for decision-making if impacts to marine mammal species or stocks would be greater than negligible in the measure's absence.
In evaluating how mitigation may or may not be appropriate to ensure the least practicable adverse impact on species or stocks and their habitat, we carefully consider two primary factors:
(1) The manner in which, and the degree to which, implementation of the measure(s) is expected to reduce impacts to marine mammal species or stocks, their habitat, and their availability for subsistence uses (when relevant). This analysis will consider such things as the nature of the potential adverse impact (such as likelihood, scope, and range), the likelihood that the measure will be effective if implemented, and the likelihood of successful implementation.
(2) The practicability of the measure for applicant implementation. Practicability of implementation may consider such things as cost, impact on operations, personnel safety, and practicality of implementation.
While the language of the least practicable adverse impact standard calls for minimizing impacts to affected species or stocks, we recognize that the reduction of impacts to those species or stocks accrues through the application of mitigation measures that limit impacts to individual animals. Accordingly, our analysis focuses on measures designed to avoid or minimize impacts on marine mammals from activities that are likely to increase the probability or severity of population-level effects, including auditory injury or disruption of important behaviors, such as foraging, breeding, or mother/calf interactions. See also 82 FR 19460 (April 27, 2017) and 83 FR 10954 (March 13, 2018) (discussion of least practicable adverse impact standard in proposed incidental take rule for Navy's Surveillance Towed Array Sensor System Low Frequency Sonar activities and Atlantic Fleet Testing and Training activities, respectively).
NMFS is aware of public statements that there is no scientific evidence that geophysical survey activities have caused adverse consequences to marine mammal stocks or populations, and that there are no known instances of injury to individual marine mammals as a result of such surveys. For example, BOEM stated publicly that “there has been no documented scientific evidence of noise from airguns . . . adversely affecting marine animal populations” (BOEM, 2014;
The MMPA defines “take” to include Level B (behavioral) harassment, which has been documented numerous times for marine mammals in the presence of airguns (in the form of avoidance of areas, notable changes in vocalization or movement patterns, or other shifts in important behaviors), as well as auditory injury (Level A harassment), for which there is also evidence from loud sound sources (
While direct evidence of impacts to species or stocks from a specified activity is rarely available, and additional study is still needed to describe how specific disturbance events affect the fitness of individuals of certain species, there have been improvements in understanding the process by which disturbance effects are translated to the population. With recent scientific advancements (both marine mammal energetic research and the development of energetic frameworks), the relative likelihood or degree of impacts on species or stocks may often be inferred given a detailed understanding of the activity, the environment, and the affected species or stocks. This same information is used in the development of mitigation measures and helps us understand how mitigation measures contribute to lessening effects (or the risk thereof) to species or stocks. We also acknowledge that there is always the potential that new information, or a new recommendation that we had not previously considered, becomes available and necessitates reevaluation of mitigation measures (which may be addressed through adaptive management) to see if further reduction of population impacts are possible and practicable.
In the evaluation of specific measures, the details of the specified activity will necessarily inform each of the two primary factors discussed above (expected reduction of impacts and practicability), and will be carefully considered to determine the types of mitigation that are appropriate under the least practicable adverse impact standard. Analysis of how a potential mitigation measure may reduce adverse impacts on a marine mammal stock or species and practicability of implementation are not issues that can be meaningfully evaluated through a yes/no lens. The manner in which, and the degree to which, implementation of a measure is expected to reduce impacts, as well as its practicability in terms of these considerations, can vary widely. For example, a time/area restriction could be of very high value for decreasing population-level impacts (
The emphasis given to a measure's ability to reduce the impacts on a species or stock considers the degree, likelihood, and context of the anticipated reduction of impacts to individuals as well as the status of the species or stock. The ultimate impact on any individual from a disturbance event (which informs the likelihood of adverse species- or stock-level effects) is dependent on the circumstances and associated contextual factors, such as duration of exposure to stressors. Though any proposed mitigation needs to be evaluated in the context of the specific activity and the species or stocks affected, measures with the following types of goals are often applied to reduce the likelihood or severity of adverse species- or stock-level impacts: Avoiding or minimizing injury or mortality; limiting interruption of known feeding, breeding, mother/calf, or resting behaviors; minimizing the abandonment of important habitat (temporally and spatially); minimizing the number of individuals subjected to these types of disruptions; and limiting degradation of habitat. Mitigating these types of effects is intended to reduce the likelihood that the activity will result in energetic or other types of impacts that are more likely to result in reduced reproductive success or survivorship. It is also important to consider the degree of impacts that were expected in the absence of mitigation in order to assess the added value of any potential measures. Finally, because the least practicable adverse impact standard authorizes NMFS to weigh a variety of factors when evaluating appropriate mitigation measures, it does not compel mitigation for every kind of individual take, even when practicable for implementation by the applicant.
The status of the species or stock is also relevant in evaluating the appropriateness of certain mitigation measures in the context of least practicable adverse impact. The following are examples of factors that may (either alone, or in combination) result in greater emphasis on the importance of a mitigation measure in reducing impacts on a species or stock: The stock is known to be decreasing or status is unknown, but believed to be declining; the known annual mortality (from any source) is approaching or exceeding the PBR level; the affected species or stock is a small, resident population; or the stock is involved in a UME or has other known vulnerabilities, such as recovering from an oil spill.
Habitat mitigation, particularly as it relates to rookeries, mating grounds, and areas of similar significance, is also relevant to achieving the standard and can include measures such as reducing impacts of the activity on known prey utilized in the activity area or reducing impacts on physical habitat. As with species- or stock-related mitigation, the emphasis given to a measure's ability to reduce impacts on a species or stock's habitat considers the degree, likelihood,
We consider available information indicating the likelihood of any measure to accomplish its objective. If evidence shows that a measure has not typically been effective or successful, then either that measure should be modified or the potential value of the measure to reduce effects is lowered.
Factors considered may include those such as cost, impact on operations, personnel safety, and practicality of implementation. In carrying out the MMPA's mandate, we apply the previously described context-specific balance between the manner in which and the degree to which measures are expected to reduce impacts to the affected species or stocks and their habitat and practicability for the applicant. The effects of concern, addressed previously in the “Potential Effects of the Specified Activity on Marine Mammals and Their Habitat” section, include auditory injury, severe behavioral reactions, disruptions of critical behaviors, and potentially detrimental chronic and/or cumulative effects to acoustic habitat (see discussion of this concept in the “Anticipated Effects on Marine Mammal Habitat” section). Here, we focus on measures with proven or reasonably presumed ability to avoid or reduce the intensity of acute exposures that may potentially result in these effects with an understanding of the drawbacks of these requirements, while also evaluating time-area restrictions that would avoid or reduce both acute and chronic impacts. To the extent of the information available to us, we consider practicability concerns, as well as potential undesired consequences of the measures,
In order to satisfy the MMPA's least practicable adverse impact standard, we propose a suite of basic mitigation protocols that are required regardless of the status of a stock. Additional or enhanced protections are proposed for species whose stocks are in poor health and/or are subject to some significant additional stressor that lessens that stock's ability to weather the effects of the specified activity without worsening its status. We reviewed the mitigation measures proposed in the petition, the requirements specified in BOEM's PEIS, seismic mitigation protocols required or recommended elsewhere (
For purposes of defining mitigation requirements, we differentiate here between requirements for two classes of airgun survey activity: Deep penetration and shallow penetration, with surveys using arrays greater than 400 in
As described previously in the “Marine Mammal Hearing” section, the upper limit of hearing for marine mammals is approximately 160 kHz; therefore, they would not be expected to detect signals from systems operating at frequencies of 200 kHz and greater. Sounds that are above the functional hearing range of marine animals may be audible if sufficiently loud (
We are aware of two studies (Deng
Our consideration of the two major points described above (
Avoidance or minimization of acute exposure is first and foremost dependent upon detection of animals present in the vicinity of the survey activity. Requirements necessary to adequately detect marine mammals incur costs, which we consider in scaling mitigation-related monitoring requirements relative to the expected effects of the specific activity (as described above, we bin activity types and detail below the proposed monitoring requirements associated with each). Visual monitoring is a critical component of any detection system, as evidenced by the inclusion of visual monitoring requirements in every set of protocols and recommendations we reviewed, and has long been accepted as such. However, visual monitoring is only effective during periods of good visibility and when animals are available for detection (
Acoustic monitoring is an equally critical component of an effective detection system, supplanting visual monitoring during periods of poor visibility and supplementing during periods of good visibility. There are multiple explanations of how marine mammals could be in a shutdown zone and yet go undetected by observers. Animals are missed because they are underwater (availability bias) or because they are available to be seen, but are missed by observers (perception and detection biases) (
PAM does have limitations,
Note that, although we propose requirements related only to observation of marine mammals, we hereafter use the generic term “protected species observer” (PSO). Monitoring by dedicated, trained marine mammal observers is required in all water depths and, for certain surveys, observers must be independent. Additionally, for some surveys, we propose to require that some PSOs have prior experience in the role. Independent observers are employed by a third-party observer provider; vessel crew may not serve as PSOs when independent observers are required. Dedicated observers are those who have no tasks other than to conduct observational effort, record observational data, and communicate with and instruct the geophysical survey operator (
NMFS expects to provide informal approval for specific training courses in consultation with BOEM and the Bureau of Safety and Environmental Enforcement (BSEE) as needed to approve PSO staffing plans. NMFS does not propose to formally administer any training program or to sanction any specific provider, but will approve courses that meet the curriculum and trainer requirements specified herein (see the “Proposed Monitoring and Reporting” section). We propose this in context of the need to ensure that PSOs have the necessary training to carry out their duties competently while also approving applicant staffing plans quickly. In order for PSOs to be approved, we propose that NMFS must review and approve PSO resumes accompanied by a relevant training course information packet that includes the name and qualifications (
We propose that all source vessels must carry a minimum of one experienced visual PSO, who shall be designated as the lead PSO, coordinate duty schedules and roles, and serve as primary point of contact for the operator. Experience is critical to best performance of the PSO team (
With regard to specific observational protocols, we are proposing to largely follow those described in Appendix B of BOEM's PEIS (BOEM, 2017). The lead PSO shall determine the most appropriate observation posts that will not interfere with navigation or operation of the vessel while affording an optimal, elevated view of the sea surface; these should be the highest elevation available on each vessel, with the maximum viewable range from the bow to 90 degrees to port or starboard of the vessel. PSOs shall coordinate to ensure 360° visual coverage around the vessel, and shall conduct visual observations using binoculars and the naked eye while free from distractions and in a consistent, systematic, and diligent manner. All source vessels must be equipped with pedestal-mounted “bigeye” binoculars that will be available for PSO use. Within these broad outlines, the lead PSO and PSO team will have discretion to determine the most appropriate vessel- and survey-specific system for implementing effective marine mammal observational effort. Any observations of marine mammals by crew members aboard any vessel associated with the survey, including receiver or chase vessels, should be relayed to the source vessel and to the PSO team.
We are proposing that all source vessels must use a towed PAM system for potential detection of marine mammals at all times when operating the sound source in waters deeper than 100 m. In shallower waters, only two
We are proposing that the system must be monitored at all times during use of the acoustic source, and acoustic monitoring must begin at least 30 minutes prior to ramp-up. PAM operators must be independent. Because the role of PAM operator is more technically complex than is the role of visual PSO, experience is more important (D. Epperson, BSEE, pers. comm.) and we are proposing that all source vessels shall carry a minimum of two experienced PAM operators, which is a stricter requirement than for visual PSOs. PAM operators shall communicate all detections to visual PSOs, when visual PSOs are on duty, including any determination by the PSO regarding species identification, distance, and bearing and the degree of confidence in the determination. Further detail regarding PAM system requirements may be found in the “Proposed Monitoring and Reporting” section, later in this document. The effectiveness of PAM depends to a certain extent on the equipment and methods used and competency of the PAM operator, but no established standards are currently in place. We do offer some specifications later in this document and would require that applicants follow any standards that are established in the future.
Visual monitoring must begin at least 30 minutes prior to ramp-up (described below) and must continue until one hour after use of the acoustic source ceases or until 30 minutes past sunset. If any marine mammal is observed at any distance from the vessel, a PSO would record the observation and monitor the animal's position (including latitude/longitude of the vessel and relative bearing and estimated distance to the animal) until the animal dives or moves out of visual range of the observer. A PSO would continue to observe the area to watch for the animal to resurface or for additional animals that may surface in the area. Visual PSOs shall communicate all observations to PAM operators, including any determination by the PSO regarding species identification, distance, and bearing and the degree of confidence in the determination.
As noted previously, all source vessels must carry a minimum of one experienced visual PSO and two experienced PAM operators. The observer designated as lead PSO (including the full team of visual PSOs and PAM operators) must have experience as a visual PSO. The applicant may determine how many additional PSOs are required to adequately fulfill the requirements specified here. To summarize, these requirements are: (1) 24-Hour acoustic monitoring during use of the acoustic source in waters deeper than 100 m; (2) visual monitoring during use of the acoustic source by two PSOs during all daylight hours, with one visual PSO on-duty during nighttime ramp-ups; (3) maximum of two consecutive hours on watch followed by a minimum of one hour off watch for visual PSOs and a maximum of four consecutive hours on watch followed by a minimum of two consecutive hours off watch for PAM operators; and (4) maximum of 12 hours of observational effort per 24-hour period for any PSO, regardless of duties. We invite comment on the mitigation-related monitoring requirements proposed for deep penetration airgun survey operations.
Deep-water HRG surveys would be required to employ a minimum of one independent visual PSO during all daylight operations, in the same manner as was described for airgun surveys. Shallow-water HRG surveys would be required to employ a minimum of one visual PSO, which may be a crew member. PSOs employed during shallow-water HRG surveys would only be required during a pre-clearance period. PAM would not be required for any HRG survey.
• Daylight hours and sea state is less than or equal to Beaufort sea state (BSS) 4;
• No marine mammals (excluding delphinids) detected solely by PAM in the exclusion zone (see below) in the previous two hours;
• NMFS is notified via email as soon as practicable with the time and location in which operations began without an active PAM system; and
• Operations with an active acoustic source, but without an operating PAM system, do not exceed a cumulative total of four hours in any 24-hour period.
The use of visual observers has historically been required by BOEM; therefore, the RIA does not assess the costs associated with our proposal to continue this requirement. The use of PAM came into use in the GOM via an incentive scheme introduced in MMS's 2007 Notice to Lessees concerning “Implementation of Seismic Survey Mitigation Measures and Protected Species Observer Program” (NTL No. 2007-G02), which allowed nighttime start-ups conditional upon use of PAM. More recently, use of PAM in the GOM was expanded pursuant to the terms of the 2013 settlement agreement (as amended and extended through stipulated agreements) referenced above, in which industry parties agreed to use PAM in water depths greater than 100 m during times of reduced visibility. The RIA considers the likely incremental costs of our proposal to require the use of PAM at all times in waters greater than 100 meters in depth and associated shutdowns for detections of “whales” (
In consideration of the expected benefits of the expanded PAM requirements in reducing the probability or severity of impacts to marine mammals species or stocks and the practicability for applicant implementation (
For deep penetration airgun surveys, we are proposing that the PSOs shall establish and monitor a 500-m exclusion zone and additional 500-m buffer zone (total 1 km) during the pre-clearance period and a 500-m exclusion zone during the ramp-up and operational periods. PSOs should focus their observational effort within this 1-km zone, although animals observed at greater distances should be recorded and mitigation action taken as necessary (see below). For shallow penetration airgun surveys, we are proposing that the PSO shall establish and monitor a 200-m exclusion zone with additional 200-m buffer (total 400 m zone) during the pre-clearance period and a 200-m exclusion zone during the ramp-up (for small arrays only, versus single airguns) and operational periods. These zones would be based upon radial distance from any element of the airgun array or from a single airgun (rather than being based on the center of the array or around the vessel itself). During use of the acoustic source, occurrence of marine mammals within the buffer zone (but outside the exclusion zone) would be communicated to the operator to prepare for the potential shutdown of the acoustic source. Use of the buffer zone in relation to ramp-up is discussed under “Ramp-up.” Further detail regarding the exclusion zone and shutdown requirements is given under “Exclusion Zone and Shutdown Requirements.”
For deep-water non-airgun HRG surveys, the PSO would establish and monitor a 400-m zone during the pre-clearance period and a 200-m exclusion zone during the operational periods (the latter as required under BOEM's HRG protocol). For shallow-water non-airgun HRG surveys, the PSO would establish and monitor and 200-m pre-clearance zone (no shutdowns required during operational periods).
Ramp-up of an acoustic source is intended to provide a gradual increase in sound levels, enabling animals to move away from the source if the signal is sufficiently aversive prior to its reaching full intensity. We are proposing that ramp-up is required for all airgun surveys (unless using only one airgun), but is not required for non-airgun HRG surveys, as the types of acoustic sources used in such surveys are not typically amenable to “ramping up” the acoustic output in the way that multi-element airgun surveys are. We infer on the basis of behavioral avoidance studies and observations that this measure results in some reduced potential for auditory injury and/or more severe behavioral reactions. Stone (2015a) reported on behavioral observations during airgun surveys from 1994-2010, stating that detection rates of cetaceans during ramp-up were significantly lower than when the airguns were not firing and on surveys with large arrays (defined in that study as greater than 500 in
The ramp-up procedure involves a step-wise increase in the number of airguns firing and total array volume until all operational airguns are activated and the full volume is achieved. Ramp-up would be required at all times as part of the activation of the acoustic source (including source tests; see “Miscellaneous Protocols” for more detail) and may occur at times of poor visibility, assuming appropriate acoustic monitoring with no detections in the 30 minutes prior to beginning ramp-up. Acoustic source activation should only occur at night where operational planning cannot reasonably avoid such circumstances. For example, a nighttime initial ramp-up following port departure is reasonably avoidable and may not occur. Ramp-up may occur at night following acoustic source deactivation due to line turn or mechanical difficulty. The operator must notify a designated PSO of the planned start of ramp-up as agreed-upon with the lead PSO; the notification time should not be less than 60 minutes prior to the planned ramp-up. A designated
We are proposing that ramp-up procedures follow the recommendations of IAGC (2015). Ramp-up would begin by activating a single airgun (
During deep penetration airgun surveys, we are proposing that PSOs must monitor a 1,000-m zone (or to the distance visible if less than 1,000 m) for a minimum of 30 minutes prior to ramp-up (
The pre-clearance period may occur during any vessel activity (
The 500-m radial distance of the standard exclusion zone is expected to contain sound levels exceeding peak pressure injury criteria for all hearing groups other than, potentially, high-frequency cetaceans, while also providing a consistent, reasonably observable zone within which PSOs would typically be able to conduct effective observational effort. Although significantly greater distances may be observed from an elevated platform under good conditions, we believe that 500 m is likely regularly attainable for PSOs using the naked eye during typical conditions. In addition, an exclusion zone is expected to be helpful in avoiding more severe behavioral responses. Behavioral response to an acoustic stimulus is determined not only by received level but by context (
Use of monitoring and shutdown or power-down measures within defined exclusion zone distances is inherently an essentially instantaneous proposition—a rule or set of rules that requires mitigation action upon detection of an animal. This indicates that definition of an exclusion zone on the basis of cumulative sound exposure level (cSEL) thresholds, which require that an animal accumulate some level of sound energy exposure over some period of time (
Cumulative SEL thresholds are more relevant for purposes of modeling the potential for auditory injury than they are for dictating real-time mitigation, though they can be informative (especially in a relative sense). We recognize the importance of the accumulation of sound energy to an understanding of the potential for auditory injury and that it is likely that, at least for low-frequency cetaceans, some potential auditory injury is likely impossible to mitigate and should be considered for authorization.
Considering both the dual-metric thresholds described previously (and shown in Table 7) and hearing group-specific marine mammal auditory weighting functions in the context of the airgun sources considered here, auditory injury zones indicated by the peak pressure metric are expected to be predominant for both mid- and high-frequency cetaceans, while zones indicated by cSEL criteria are expected to be predominant for low-frequency cetaceans. Assuming a source level of 255.2 dB 0-pk SPL for the notional 8,000 in
Consideration of auditory injury zones based on cSEL criteria are dependent on the animal's applied hearing range and how that overlaps with the frequencies produced by the sound source of interest in relation to marine mammal auditory weighting functions (NMFS, 2016). As noted above, these are expected to be predominant for low-frequency cetaceans because their most susceptible hearing range overlaps the low frequencies produced by airguns, while the modeling indicates that zones based on peak pressure criteria dominate for mid- and high-frequency cetaceans. In order to evaluate notional zone sizes and to incorporate the technical guidance's weighting functions over a seismic array's full acoustic band, we obtained unweighted spectrum data (modeled in 1 Hz bands) for a reasonably equivalent acoustic source (
We also assessed the potential for injury based on the accumulation of energy resulting from use of the single airgun and, assuming a source level of 207.8 dB SEL, there would be no realistic zone within which injury would occur. On the basis of this finding as well as the potential zone sizes based on the peak pressure criteria described above, we do not expect any reasonable potential for auditory injury resulting from use of the single airgun. No potential injurious exposures were predicted for single airgun surveys (Zeddies
We expect that the proposed 500-m exclusion zone would typically contain the entirety of any potential injury zone for mid-frequency cetaceans (realistically, there is no such zone), while the zones within which injury could occur may be larger for high-frequency cetaceans (on the basis of peak pressure and depending on the specific array) and for low-frequency cetaceans (on the basis of cumulative sound exposure). These findings indicate that auditory injury is unlikely for mid-frequency cetaceans.
In summary, our intent in prescribing a standard exclusion zone distance is to (1) encompass zones for most species within which auditory injury could occur on the basis of instantaneous exposure; (2) provide additional protection from the potential for more severe behavioral reactions (
The best available scientific evidence indicates that auditory injury as a result of airgun sources is extremely unlikely for mid-frequency cetaceans, primarily due to a relative lack of sensitivity and susceptibility to noise-induced hearing loss at the frequency range output by airguns (
While dolphins are observed voluntarily approaching source vessels (
Additionally, increased shutdowns resulting from such a measure would require source vessels to revisit the missed track line to reacquire data, resulting in an overall increase in the total sound energy input to the marine environment and an increase in the total duration over which the survey is active in a given area.
Instead of shutdown, if a dolphin of the indicated genera (
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We request comment on both proposals and other variations of these proposals, including our interpretation of the data and any other data that support the necessary findings regarding small dolphins for no shutdown and no power-down or no shutdown but a power-down.
Although other mid-frequency hearing specialists (
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We request comment on both proposals and other variations of these proposals, including our interpretation of the data and any other data that support the necessary findings regarding initiating shutdown for certain circumstances at any distance or within 1 km. The variations in regulatory text for these proposals can be found in “Alternative Regulatory Text,” later in this preamble, and in the regulatory text at the end of the document.
Circumstances triggering Proposal 1 or Proposal 2 include:
• Upon detection (visual or acoustic) of a Bryde's whale. On the basis of the findings of NMFS's status review (described in a NOAA technical memorandum; Rosel
• Upon observation of a large whale (
• Upon acoustic detection of a sperm whale. Sperm whales are not necessarily expected to display physical avoidance of sound sources (
Sperm whales in the GOM spend the majority of their time foraging, engaging in dive cycles consisting of deep dives of approximately 45 minutes followed by shorter surface intervals (resting bouts) of approximately 10 minutes (Watwood
Miller
The income breeding strategy used by sperm whales requires stable or predictable environments that enable continuous energy acquisition throughout the year, at rates of up to thousands of kilograms of prey per day (Irvine
Sperm whales in the northern GOM have a relatively small population abundance, and with a relatively narrow distribution that overlaps almost completely with areas of current and future geophysical survey activity and other oil and gas industry activity. Further, most resident female sperm whale movements in the GOM range within smaller areas—approximately 200 km around a core home range—although larger individual and group movements were also observed (Jochens
Multiple lines of evidence indicate that sperm whales in the northern GOM are somewhat isolated from global sperm whale populations (Jochens
We also considered requirement of shutdown upon visual detection of sperm whales. Here, we assume that acoustic detections of sperm whales would most likely be representative of the foraging behavior we intend to minimize disruption of, while visual observations of sperm whales would represent resting between bouts of such behavior. Occurrence of resting sperm whales at distances beyond the exclusion zone may not indicate a need to implement shutdown. We consider these assumptions in conjunction with an assessment of the costs and operational feasibility of these measures in “Practicability,” below.
• Upon observation (visual or acoustic) of a beaked whale or
In the GOM, we expect that the optimum detection range of sperm whales in low-noise conditions is likely to be approximately 2-3 km. This relatively short detection range is likely due to the propagation conditions resulting when a relatively warmer mixed surface layer provides a strong negative sound velocity profile, causing strong downward refraction of acoustic rays. While the maximum detection
As the signal (in this case, a sperm whale click) propagates from its source (the whale) through the environment to a receiver (a hydrophone), its intensity (acoustic power within a unit area) is reduced due to acoustic energy divergence and attenuation (absorption and scattering). By the time the whale click reaches the hydrophone, its received intensity level is greatly reduced from its original source level. In addition, for the received level to be detected by the hydrophone, the signal-to-noise ratio (received level minus the background noise spectral density) must be above a certain detection threshold,
Based on various studies (Madsen and Mohl, 2000; Mohl
In the presence of an airgun survey, the background noise level is expected to be significantly increased as a result of the reverberant field generated from intense pulses (Guerra
However, we recognize that the addition of sperm whale shutdowns based on visual detections beyond the exclusion zone would result in a larger estimated additional cost per year. Based on these costs, and our previous discussion of assumptions related to acoustic versus visual detections of sperm whales, we preliminarily do not believe the addition of shutdowns for sperm whales based on visual detections at any distance to be warranted, and request any information from the public that would be relevant to this determination. For this proposed rule, we preliminarily determine that the addition of the proposed shutdown measures described above are warranted when their likely ability to reduce the probability or severity of impacts on species or stocks and their habitat is considered along with their practicability.
Upon implementation of shutdown, the source may be reactivated after the animal(s) has been observed exiting the exclusion zone or following a 30-minute clearance period with no further observation of the animal(s). Where there is no relevant zone (
If the acoustic source is shut down for reasons other than mitigation (
Power-down, as defined here, refers to reducing the array to a single element as a substitute for full shutdown. We address use of a single airgun as a “mitigation source” below. In a power-down scenario, it is assumed that reducing the size of the array to a single element reduces the ensonified area such that an observed animal is outside of any area within which injury or more severe behavioral reactions could occur. Zeddies
Mitigation sources may be separate individual airguns or may be an airgun of the smallest volume in the array, and have historically been used when the full array is not being used (
In light of the available information, we think it more appropriate to acknowledge the limitations of visual observations—even under good conditions, not all animals will be observed and cryptic species may not be observed at all—and recognize that while visual observation is a common sense measure it should not be determinative of when survey effort may occur. Given the lack of proven efficacy of visual observation in preventing auditory injury, we do not believe that its absence should imply such potentially detrimental impacts on marine mammals. Therefore, use of a mitigation source is not a sensible substitute component of seismic mitigation protocols. We also believe that consideration of mitigation sources in the past has reflected an outdated balance, in which the possible prevention of relatively few instances of auditory injury is outweighed by many more instances of unnecessary behavioral disturbance of animals and degradation of acoustic habitat.
The acoustic source must be deactivated when not acquiring data or preparing to acquire data, except as necessary for testing. Unnecessary use of the acoustic source should be avoided. Firing of the acoustic source at any volume above the stated production volume would not be authorized; the operator must provide information to the lead PSO at regular intervals confirming the firing volume.
Testing of the acoustic source involving all elements requires normal mitigation protocols (
We encourage the applicant companies and operators to pursue the following objectives in designing, tuning, and operating acoustic sources: (1) Use the minimum amount of energy necessary to achieve operational objectives (
Below we provide discussion of various restriction areas that were considered during development of the proposed regulations. Because the purpose of these areas is to reduce the likelihood of exposing animals within the designated areas to noise from airgun surveys that is likely to result in harassment (
The restriction is intended specifically to avoid additional stressors to bottlenose dolphin populations during the time period believed to be of greatest importance as a reproductive period. BOEM proposed a similar coastal restriction on airgun survey effort in the petition submitted in support of industry, and NMFS agrees that this is appropriate. Coastal dolphin stocks, particularly the northern coastal stock, were heavily impacted by the DWH oil spill. As described previously, NOAA estimates that potentially 23 percent of western coastal dolphins and 82 percent of northern coastal dolphins were exposed to DWH oil, resulting in an array of long-term health impacts (including reproductive failure) and possible population reductions of 5 percent and 50 percent for the western and northern stocks, respectively (DWH MMIQT, 2015). For the northern coastal stock, it is estimated that these population-level impacts could require 39 years to recovery, in the absence of other additional stressors.
NMFS's subject matter experts identified a reasonable range that in their professional judgment encompasses an important reproductive period for bottlenose dolphins in these coastal waters. Expert interpretation of the long-term data for neonate strandings is that February-April are the primary months that animals are born in the northern GOM, and that fewer but similar numbers are born in January and May. This refers to long-term averages and in any particular year the peak reproductive period can shift earlier or later. While pregnant mothers may be susceptible to the impacts of noise, we believe that neonates and/or calves are likely most susceptible, because behavioral disruption could have more severe energetic effects for lactating mothers and/or lead to disruption of mother-calf bonding and ultimate effects on rates of neonate and/or calf survivorship. Therefore, we believe that February through May represents a reasonable best estimate of the time period of most sensitivity for bottlenose dolphins in coastal waters.
While none of the dolphin strandings or deaths have been attributed to airgun survey activities, stocks in the area are stressed, and studies have shown that marine mammals react to underwater noise. Behavioral disturbance or stress may reduce fitness for individual animals and/or may exacerbate existing declines in reproductive health and survivorship. For example, stressors such as noise and pollutants can induce responses involving the neuroendocrine system, which controls reactions to stress and regulates many body processes (NAS, 2017), and there is strong evidence that petroleum-associated chemicals can adversely affect the endocrine system, providing a potential pathway for interactions with other stressors (Mohr
While various population abundance estimates are available (
The small population size, restricted range, and low genetic diversity alone place these whales at significant risk of extinction (IWC, 2017), which has been exacerbated by the effects of the DWH oil spill. Additionally, Bryde's whale dive and foraging behavior places them at heightened risk of being struck by vessels and/or entangled in fishing gear (Soldevilla
LaBrecque
Given the likely condition of this population, and in the absence of a full habitat characterization and more knowledge about why Bryde's whales occur where they do, we analyzed a year-round restriction that covered the full area of Bryde's whale sightings. We request comment on our interpretation of the data and our evaluated alternative of year-round restrictions on airgun surveys in Area 3 (Figure 5). In addition, we present three less-restrictive alternatives, including seasonal restrictions and no restrictions for Area 3 with differing requirements for monitoring. We request comment on all proposals and other variations of these proposals, including our interpretation of the data and any other data that support the necessary findings regarding time-area restrictions for Bryde's whales.
•
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The variations in regulatory text for these proposals can be found in “Alternative Regulatory Text,” later in this preamble, and in the regulatory text at the end of the document.
Sightings of both beaked whales and sperm whales are very dense in this area, and it is possible—based on unpublished observations of calves here—that sperm whales use this area as a calving area (K. Mullin, pers. comm.).
The area aligns well with a portion of the predicted 25 percent core abundance area for beaked whales in the GOM, and overlaps with portions of the sperm whale 25 percent core abundance area (Roberts
Based on satellite tracking studies conducted by Jochens
Beaked whales are typically deep divers, foraging for mesopelagic squid and fish, and are often found in deep water near high-relief bathymetric features, such as slopes, canyons, and escarpments where these prey are found (
In order to quantitatively evaluate this large area and produce a more refined prospective restriction area, we considered the outputs of habitat-based predictive density models (Roberts
To determine core abundance areas, we follow a three-step process:
• Determine the predicted total abundance of a species/time period by adding up all cells of the density raster (grid) for the species/time period. For the Roberts
• Sort the cells of the species/time period density raster from highest density to the lowest.
• Sum and select the raster cells from highest to lowest until a certain percentage of the total abundance is reached.
The selected cells represent the smallest area that represents a given percentage of abundance. We created a range of core abundance areas for sperm and beaked whales, and found that there was good agreement between the outputs of the two models at a range of approximately 15 to 20 percent core abundance for sperm whales in concert with a 25 percent core abundance threshold for beaked whales. On this basis, we defined a restriction area for evaluation as follows, in two adjacent but distinct areas (which would likely be joined from an operational perspective): (1) An area bounded by 90° W and 88° W (E-W) and the 500- and 1,000-fathom isobaths (N-S), and (2) an area bounded by five sets of coordinates (Area 2, Figure 5).
We are not aware of any records of marine mammal entanglement in towed arrays, streamers, or other towed acoustic sources. Therefore, we do not believe there is evidence to indicate that there is any meaningful entanglement risk posed by those activities. However, the use of OBNs or similar equipment requiring the use of tethers or connecting lines does pose a meaningful entanglement risk. Multiple marine taxa are susceptible to entanglement in underwater lines and, in 2014, an Atlantic spotted dolphin was entangled in a nylon nodal tether line and killed during a GOM OBN survey.
In order to avoid the reasonable potential for entanglement in such lines, one must generally seek to apply common sense, including use of stiffer lines that are taut and are not positively-buoyant, and are therefore less likely to wrap or loop around animals, and secure bottom lines. Specifically, we propose that operators conducting OBN surveys adhere to the following requirements: (1) Use negatively buoyant coated wire-core tether cable (
These proposed measures generally follow those described in BOEM's PEIS (BOEM, 2017). These measures apply to all vessels associated with any proposed survey activity (
1. Vessel operators and crews must maintain a vigilant watch for all marine mammals and slow down or stop their vessel or alter course, as appropriate and regardless of vessel size, to avoid striking any marine mammal. A visual observer aboard the vessel must monitor a vessel strike avoidance zone around the vessel, according to the parameters stated below, to ensure the potential for strike is minimized. Visual observers monitoring the vessel strike avoidance zone can be either third-party observers or crew members, but crew members responsible for these duties must be provided sufficient training to distinguish marine mammals from other phenomena and broadly to identify a marine mammal as a baleen whale, sperm whale, or other marine mammal.
2. All vessels, regardless of size, must observe a 10 kn speed restriction within the EPA restriction area described previously. It is critically important to avoid vessel strike of a Bryde's whale, as single mortalities over time can be devastating for such small populations. Further, Bryde's whales engage in shallow nocturnal diving, spending significant amounts of time near the surface at night and increasing the risk of strike when vessels are transiting Bryde's whale habitat (Soldevilla
3. Vessel speeds must also be reduced to 10 kn or less when mother/calf pairs, pods, or large assemblages of cetaceans are observed near a vessel. A single cetacean at the surface may indicate the presence of submerged animals in the
4. All vessels must maintain a minimum separation distance of 500 yards (yd) (457 m) from baleen whales. Our intention is to be precautionary in prescribing avoidance measures to avoid the potential for strike of Bryde's whales—the only baleen whale that would be expected with any regularity in the GOM—but we do not expect that crew members standing watch would be able to reliably identify baleen whales to species in the GOM. The following avoidance measures should be taken if a baleen whale is within 500 yd of any vessel:
a. While underway, the vessel operator should steer a course away from the whale at 10 kn or less until the minimum separation distance has been established.
b. If a whale is spotted in the path of a vessel or within 500 yd of a vessel underway, the operator should reduce speed and shift engines to neutral. The operator should re-engage engines only after the whale has moved out of the path of the vessel and is more than 500 yd away. If the whale is still within 500 yd of the vessel, the vessel should select a course away from the whale's course at a speed of 10 kn or less. The recommendation to shift engines to neutral does not apply to any vessel towing gear due to safety concerns.
c. This procedure should also be followed if a whale is spotted while a vessel is stationary. Whenever possible, a vessel should remain parallel to the whale's course while maintaining the 500-yd distance as it travels, avoiding abrupt changes in direction until the whale is no longer in the area.
5. All vessels must maintain a minimum separation distance of 100 yd (91 m) from sperm whales. The following avoidance measures should be taken if a sperm whale is within 100 yd of any vessel:
a. The vessel underway should reduce speed and shift the engine to neutral, and should not engage the engines until the whale has moved outside of the vessel's path and the minimum separation distance has been established. This does not apply to any vessel towing gear.
b. If a vessel is stationary, the vessel should not engage engines until the whale has moved out of the vessel's path and beyond 100 yd.
6. All vessels must attempt to maintain a minimum separation distance of 50 yd (46 m) from all other marine mammals, with an exception made for those animals that approach the vessel. If an animal is encountered during transit, a vessel should attempt to remain parallel to the animal's course, avoiding excessive speed or abrupt changes in course.
Any permits issued by BOEM would include guidance for the handling and disposal of marine trash and debris, similar to BSEE NTL 2015-G03 (“Marine Trash and Debris Awareness and Elimination”) (BSEE, 2015; BOEM, 2017). If there were an LOA applicant for an activity not requiring a BOEM permit, NMFS would also require adherence to this guidance.
Based on our evaluation of the mitigation measures described in this section, as well as other measures considered by NMFS, we have preliminarily determined those mitigation measures that provide the means of effecting the least practicable adverse impact on the affected species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance. We request comment on all proposals and other variations of these proposals, including our interpretation of the data and any other data that support the necessary findings.
In order to issue an LOA for an activity, Section 101(a)(5)(A) of the MMPA states that NMFS must set forth requirements pertaining to the monitoring and reporting of the authorized taking. NMFS's MMPA implementing regulations further describe the information that an applicant should provide when requesting an authorization (50 CFR 216.104(a)(13)), including the means of accomplishing the necessary monitoring and reporting that will result in increased knowledge of the species and the level of taking or impacts on populations of marine mammals.
Section 101(a)(5)(A) allows that incidental taking may be authorized only if the total of such taking contemplated over the course of five years will have a negligible impact on affected species or stocks (a finding based on impacts to annual rates of recruitment and survival) and, further, section 101(a)(5)(B) requires that authorizations issued pursuant to 101(a)(5)(A) be withdrawn or suspended if the total taking is having, or may have, more than a negligible impact (or such information may inform decisions on requests for LOAs under the specific regulations). Therefore, it is clear that the necessary requirements pertaining to monitoring and reporting must address the total annual impacts to marine mammal species or stocks. Effective reporting is critical both to compliance as well as ensuring that the most value is obtained from the required monitoring.
These proposed requirements are described below under “Data Collection” and “LOA Reporting.” Additional comprehensive reporting, across LOA-holders on an annual basis,
More specifically, monitoring and reporting requirements should contribute to improved understanding of one or more of the following:
• Occurrence of marine mammal species in action area (
• 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.
All PSO resumes must be submitted to NMFS, and PSOs must be approved by NMFS after a review of their qualifications. NMFS expects to maintain a list of approved PSOs, which will minimize review time for previously approved PSOs with current experience. These qualifications include whether the individual has successfully completed the necessary training (see “Training,” below) and, if relevant, whether the individual has the requisite experience (and is in good standing). PSOs should provide a current resume and information related to PSO training; submitted resumes should not include superfluous information. Information related to PSO training should include (1) a course information packet that includes the name and qualifications (
• A bachelor's degree from an accredited college or university with a major in one of the natural sciences and a minimum of 30 semester hours or equivalent in the biological sciences and at least one undergraduate course in math or statistics;
• Experience and ability to conduct field observations and collect data according to assigned protocols (may include academic experience; required for visual PSOs only) and experience with data entry on computers;
• Visual acuity in both eyes (correction is permissible) sufficient for discernment of moving targets at the water's surface with ability to estimate target size and distance; use of binoculars may be necessary to correctly identify the target (required for visual PSOs only);
• Experience or training in the field identification of marine mammals, including the identification of behaviors (required for visual PSOs only);
• Sufficient training, orientation, or experience with the survey operation to ensure personal safety during observations;
• Writing skills sufficient to prepare a report of observations (
• Ability to communicate orally, by radio or in person, with survey personnel to provide real-time information on marine mammals observed in the area as necessary; and
• Successful completion of relevant training (described below), including completion of all required coursework and passing (80 percent or greater) a written and/or oral examination developed for the training program.
The educational requirements may be waived if the PSO has acquired the relevant skills through alternate experience. Requests for such a waiver must include written justification, and prospective PSOs granted waivers must satisfy training requirements described below. Alternate experience that may be considered includes, but is not limited to, the following:
• Secondary education and/or experience comparable to PSO duties;
• Previous work experience conducting academic, commercial, or government-sponsored marine mammal surveys; and
• Previous work experience as a PSO; the PSO should demonstrate good standing and consistently good performance of PSO duties.
• Life at sea, duties, and authorities;
• Ethics, conflicts of interest, standards of conduct, and data confidentiality;
• Offshore survival and safety training;
• Overview of oil and gas activities (including geophysical data acquisition operations, theory, and principles) and types of relevant sound source technology and equipment;
• Overview of the MMPA and ESA as they relate to protection of marine mammals;
• Mitigation, monitoring, and reporting requirements as they pertain to geophysical surveys;
• Marine mammal identification, biology and behavior;
• Background on underwater sound;
• Visual surveying protocols, distance calculations and determination, cues, and search methods for locating and tracking different marine mammal species (visual PSOs only);
• Optimized deployment and configuration of PAM equipment to ensure effective detections of cetaceans for mitigation purposes (PAM operators only);
• Detection and identification of vocalizing species or cetacean groups (PAM operators only);
• Measuring distance and bearing of vocalizing cetaceans while accounting for vessel movement (PAM operators only);
• Data recording and protocols, including standard forms and reports, determining range, distance, direction, and bearing of marine mammals and vessels; recording GPS location coordinates, weather conditions, Beaufort wind force and sea state, etc.;
• Proficiency with relevant software tools;
• Field communication/support with appropriate personnel, and using communication devices (
• Reporting of violations, noncompliance, and coercion; and
• Conflict resolution.
PAM operators should regularly refresh their detection skills through practice with simulation-modeling software, and should keep up to date with training on the latest software/hardware advances.
The lead PSO is responsible for establishing and maintaining clear lines of communication with vessel crew. The vessel operator shall work with the lead PSO to accomplish this and shall ensure any necessary briefings are provided for vessel crew to understand mitigation requirements and protocols. While on duty, PSOs will continually scan the water surface in all directions around the acoustic source and vessel for presence of marine mammals, using a combination of the naked eye and high-quality binoculars (bigeye binoculars must be provided during deep penetration airgun surveys; see below), from optimum vantage points for unimpaired visual observations with minimum distractions. PSOs will collect observational data for all marine mammals observed, regardless of distance from the vessel, including species, group size, presence of calves,
For all deep penetration airgun surveys and deep-water surveys (
Other required equipment, which should be made available to PSOs by the third-party observer provider, includes reticle binoculars (
Individuals implementing the monitoring protocol will assess its effectiveness using an adaptive approach. Monitoring biologists will use their best professional judgment throughout implementation and seek improvements to these methods when deemed appropriate. Any modifications to protocol will be coordinated through an adaptive management process.
Use of PAM is required for deep penetration airgun surveys. Monitoring of a towed PAM system is required at all times, from 30 minutes prior to ramp-up and throughout all use of the acoustic source. Towed PAM systems generally consist of hardware (
Our requirement to use PAM refers to the use of calibrated hydrophone arrays with full system redundancy to detect, identify and estimate distance and bearing to vocalizing cetaceans, to the extent possible. Multi-hydrophone (
In the absence of a formally defined set of prescriptions addressing any of these three facets of PAM technology, all applicants must provide a PAM plan including description of the hardware and software proposed for use prior to proceeding with any survey where PAM is required. As recommended by Thode
In coordination with vessel crew, the lead PAM operator will be responsible for deployment, retrieval, and testing and optimization of the hydrophone array. While on duty, the PAM operator must diligently listen to received signals and/or monitoring display screens in order to detect vocalizing cetaceans, except as required to attend to PAM equipment. The PAM operator must use appropriate sample analysis and filtering techniques and, as described below, must report all cetacean detections. While not required prior to development of formal standards for PAM use, we recommend that vessel self-noise assessments are undertaken during mobilization in order to optimize PAM array configuration according to the specific noise characteristics of the vessel and equipment involved, and to refine expectations for distance/bearing estimations for cetacean species during the survey. Copies of any vessel self-noise assessment reports must be included with the summary trip report.
PSOs must use standardized data forms, whether hard copy or electronic. PSOs will record detailed information about any implementation of mitigation requirements, including the distance of animals to the acoustic source and description of specific actions that ensued, the behavior of the animal(s), any observed changes in behavior before and after implementation of mitigation, and if shutdown was implemented, the length of time before any subsequent ramp-up of the acoustic source to resume survey. If required mitigation was not implemented, PSOs should submit a description of the circumstances. We require that, at a minimum, the following information be reported:
• Vessel names (source vessel and other vessels associated with survey) and call signs;
• PSO names and affiliations;
• Dates of departures and returns to port with port name;
• Dates and times (Greenwich Mean Time) of survey effort and times corresponding with PSO effort;
• Vessel location (latitude/longitude) when survey effort begins and ends; vessel location at beginning and end of visual PSO duty shifts;
• Vessel heading and speed at beginning and end of visual PSO duty shifts and upon any line change;
• Environmental conditions while on visual survey (at beginning and end of PSO shift and whenever conditions change significantly), including wind speed and direction, Beaufort sea state, Beaufort wind force, swell height, weather conditions, cloud cover, sun glare, and overall visibility to the horizon;
• Factors that may be contributing to impaired observations during each PSO shift change or as needed as environmental conditions change (
• Survey activity information, such as acoustic source power output while in operation, number and volume of airguns operating in the array, tow depth of the array, and any other notes of significance (
• If a marine mammal is sighted, the following information should be recorded:
○ Watch status (sighting made by PSO on/off effort, opportunistic, crew, alternate vessel/platform);
○ PSO who sighted the animal;
○ Time of sighting;
○ Vessel location at time of sighting;
○ Water depth;
○ Direction of vessel's travel (compass direction);
○ Direction of animal's travel relative to the vessel;
○ Pace of the animal;
○ Estimated distance to the animal and its heading relative to vessel at initial sighting;
○ Identification of the animal (
○ Estimated number of animals (high/low/best);
○ Estimated number of animals by cohort (adults, yearlings, juveniles, calves, group composition, etc.);
○ Description (as many distinguishing features as possible of each individual seen, including length, shape, color, pattern, scars or markings, shape and size of dorsal fin, shape of head, and blow characteristics);
○ Detailed behavior observations (
○ Animal's closest point of approach (CPA) and/or closest distance from the acoustic source;
○ Platform activity at time of sighting (
○ Description of any actions implemented in response to the sighting (
• If a marine mammal is detected while using the PAM system, the following information should be recorded:
○ An acoustic encounter identification number, and whether the detection was linked with a visual sighting;
○ Time when first and last heard;
○ Types and nature of sounds heard (
○ Any additional information recorded such as water depth of the hydrophone array, bearing of the animal to the vessel (if determinable), species or taxonomic group (if determinable), spectrogram screenshot, and any other notable information.
PSO effort, survey details, and sightings data should be recorded continuously during surveys and reports prepared each day during which survey effort is conducted. These reports would include amount and location of line-kms surveyed, all marine mammal observations with closest approach distance, and corrected numbers of marine mammals “taken.” We propose submission of such reports to NMFS within 90 days of survey completion or following expiration of an issued LOA. In the event that an LOA is issued for a period exceeding one year, annual reports would be submitted during the period of validity.
There are multiple reasons why marine mammals may be present and yet be undetected by observers. Animals are missed because they are underwater (availability bias) or because they are available to be seen, but are missed by observers (perception and detection biases) (
This method incorporates
In the absence of a line-transect analysis, the Commission suggests taking estimates of
The species discussed in Barlow (2015) may be different from those observed during a geophysical survey, but data from similar species can be used. Since
The probability of detecting a group of cetaceans can therefore be expressed as:
If there are
The number of animals seen within each BSS should be summed for each Level B harassment zone. That total number then must be scaled by the distance to the Level B harassment threshold relative to the truncation distance to estimate the total number of animals potentially taken during a given survey. Examples of the application of this process are given in the Commission's letter, relevant portions of which are available online at:
As noted, a draft report must be submitted to NMFS within 90 days of the completion of survey effort or following expiration of the LOA (whichever comes first), or annually (if a multi-year LOA is issued), and must include all information described above under “Data Collection.” The report will describe the operations conducted and sightings of marine mammals near the operations. The report will provide full documentation of methods, results, and interpretation pertaining to all monitoring. The report will summarize the dates and locations of survey operations, and all marine mammal sightings (dates, times, locations, activities, associated survey activities); information regarding locations where the acoustic source was used must be provided. The LOA-holder shall provide geo-referenced time-stamped vessel tracklines for all time periods in which airguns (full array or single) were operating. Tracklines should include points recording any change in airgun status (
The report will also include estimates of the number of takes based on the observations and in consideration of the detectability of the marine mammal species observed (as described above). Applicants must provide an estimate of the number (by species) of marine mammals that may have been exposed (based on observational data and accounting for animals present but unavailable for sighting) to the survey activity within areas associated with the relevant frequency-weighted sound fields (
Individual LOA-holders will be responsible for collecting and submitting monitoring data to NMFS, as described above. In addition, on an annual basis, LOA holders will also collectively be responsible for compilation and analysis of those data for inclusion in subsequent annual synthesis reports. Individual LOA-holders may collaborate to produce this report or may elect to have their trade associations support the production of such a report. These reports would summarize the data presented in the individual LOA-holder reports, provide analysis of these synthesized results, discuss the implementation of required mitigation, and present any recommendations. This comprehensive annual report would be the basis of an annual adaptive management process (described below in “Adaptive Management”). The following topics should be described in comprehensive reporting:
• Summary of geophysical survey activity by survey type, geographic zone (
• Summary of monitoring effort (on-effort hours and/or distance) by acoustic source status, location, and visibility conditions (for both visual and acoustic monitoring);
• Summary of mitigation measures implemented (
• Sighting rates of marine mammals during periods with and without acoustic source activities and other variables that could affect detectability of marine mammals, such as:
○ Initial sighting distances of marine mammals relative to source status;
○ Closest point of approach of marine mammals relative to source status;
○ Observed behaviors and types of movements of marine mammals relative to source status;
○ Distribution/presence of marine mammals around the survey vessel relative to source status;
○ Analysis of the effects of various factors influencing the detectability of marine mammals (
○ Estimates of the number of marine mammals taken by harassment, corrected for animals potentially missed by observers;
• Summary and conclusions from monitoring in previous year; and
• Recommendations for adaptive management.
Each annual comprehensive report should cover one full year of monitoring effort and must be submitted for review by October 1 of each year. Therefore, to allow for adequate preparation, each
In the event that the specified activity clearly causes the take of a marine mammal in a manner not permitted by the authorization (if issued), such as a serious injury or mortality, the LOA-holder shall immediately cease the specified activities and immediately report the take to NMFS. The report must include the following information:
• Time, date, and location (latitude/longitude) of the incident;
• Name and type of vessel involved;
• Vessel's speed during and leading up to the incident;
• Description of the incident;
• Status of all sound source use in the 24 hours preceding the incident;
• Water depth;
• Environmental conditions (
• Description of all marine mammal observations in the 24 hours preceding the incident;
• Species identification or description of the animal(s) involved;
• Fate of the animal(s); and
• Photographs or video footage of the animal(s) (if equipment is available).
The LOA-holder shall not resume its activities until NMFS is able to review the circumstances of the prohibited take. NMFS would work with the LOA-holder to determine what is necessary to minimize the likelihood of further prohibited take and ensure MMPA compliance. The LOA-holder may not resume their activities until notified by NMFS.
In the event that the LOA-holder discovers an injured or dead marine mammal, and the lead PSO determines that the cause of the injury or death is unknown and the death is relatively recent (
In the event that the LOA-holder discovers an injured or dead marine mammal, and the lead PSO determines that the injury or death is not associated with or related to the specified activities (
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 (
For each potential activity-related stressor, we consider the potential impacts on affected marine mammals and the likely significance of those impacts to the affected stock or population as a whole. Potential risk due to vessel collision and related mitigation measures as well as potential risk due to entanglement and contaminant spills were addressed under “Proposed Mitigation” and “Potential Effects of the Specified Activity on Marine Mammals” and are not discussed further, as there are minimal risks expected from these potential stressors.
The “specified activity” for these regulations is a broad program of geophysical survey activity that could occur at any time of year in U.S. waters of the GOM. In recognition of the broad scale of this activity in terms of geographic and temporal scales, we propose use of a new analytical framework—first described by Ellison
As described previously, Zeddies
Generally, this approach is a relativistic risk assessment that provides an interpretation of the exposure estimates within the context of key biological and population parameters (
Spectral, temporal, and spatial overlaps between survey activities and animal distribution are the primary factors that drive the type, magnitude, and severity of potential effects on marine mammals, and these considerations are integrated into both the severity and vulnerability assessments. In discussion with BOEM and NMFS, the EWG developed a strategic approach to balance the weight of these considerations between the two assessments, specifying and clarifying where and how the interactions between potential disturbance and species within these dimensions are evaluated. Overall ratings are then considered in conjunction with our proposed mitigation strategy (and any additional relevant contextual information) to ultimately inform our preliminary determinations. Elements of this approach are subjective and relative within the context of this program of projected actions and, overall, the analysis necessarily requires the application of professional judgment.
However, because habitat-based density models (Roberts
• Very high—Level A takes greater than 1.5 or 0.3 percent (the latter figure is used for endangered species) of zone-specific estimated population abundance.
• High—0.75-1.5 or 0.15-0.3 percent of zone-specific population.
• Moderate—0.375-0.75 or 0.075-0.15 percent of zone-specific population.
• Low—0.075-0.375 or 0.015-0.075 percent of zone-specific population.
• Very low—less than 0.075 or less than 0.015 percent of zone-specific population.
Relative severity scores by zone (Figure 2) and species for high, moderate, and low annual activity scenarios are shown in Tables 4-7 of the EWG report. However, as described previously, we do not believe that Level A harassment is likely to actually occur for mid-frequency cetaceans and therefore do not predict any take by Level A harassment for these species. The risk presented by Level A harassment to mid-frequency species is therefore expected to be none to very low.
Due to the combination of density estimates and effort projections, the predicted takes by Level A harassment (accounting for aversion) for both Bryde's whale and
The test scenario modeled six representative GOM species/guilds: Bryde's whale, sperm whale, beaked whales, bottlenose dolphin,
As was done in evaluating severity of Level A harassment, the scaled Level B harassment takes were rated through a population-dependent binning system. For each species, scaled takes were divided by the zone-specific predicted abundance, and these proportions were used to evaluate the relative severity of modeled exposures based on the distribution of values across species to evaluate behavioral risk across species—a simple, logical means of evaluating relative risk across species and areas. Relative risk ratings using percent of area population size were defined as follows:
• Very high—Adjusted behavioral takes greater than 800 percent of zone-specific population;
• High—Adjusted behavioral takes 400-800 percent of zone-specific population;
• Moderate—Adjusted behavioral takes 200-400 percent of zone-specific population;
• Low—Adjusted behavioral takes 100-200 percent of zone-specific population; and
• Very low—Adjusted behavioral takes less than 100 percent of zone-specific population.
Results of severity ranking for Level B harassment are shown in Tables 8-10 of Southall
Vulnerability rating seeks to evaluate the relative risk of a predicted effect given species-typical and population-specific parameters (
In the final step of the framework, severity and vulnerability ratings are integrated to provide relative impact ratings of overall risk. The likely severity of effect was assessed as the percentage of total population affected based on scaled modeled Level B harassment takes relative to zone population size. There is no risk when there is no survey activity in a given zone for a given effort scenario, and zones predicted to contain abundance of less of five or less individuals of a species were also considered to have de minimis risk. Severity and vulnerability assessments each produce a numerical rating (1-5) corresponding with the qualitative rating (
Overall, the results of the risk assessment show that (as expected), risk is highly correlated with effort and density. Areas where little or no survey activity is predicted to occur or areas within which few or no animals of a particular species are believed to occur have very low or no potential risk of negatively affecting marine mammals, as seen across activity scenarios in Zones 1, 3, and 4. Areas with consistently high levels of effort (Zones 2, 5, 6, and 7) are generally predicted to have higher overall evaluated risk across all species. However, fewer species of animals are expected to be present in Zone 2, where we primarily expect shelf species such as bottlenose and Atlantic spotted dolphins. In Zone 7, animals are expected to be subject to less other chronic noise and non-noise stressors, which is reflected in the vulnerability scoring for that zone. Therefore, despite consistently high levels of projected effort, overall rankings for that zone are lower than for Zones 5 and 6.
Zones 5 and 6 were the only zones with “very high” levels of risk due to behavioral disturbance, identified for three species of particular concern in Zone 5 (Bryde's, beaked, and sperm whales) and two in Zone 6 (beaked and sperm whales). Projected effort levels were sufficiently high in Zone 5 that the rankings were not generally sensitive to activity scenario, while in Zone 6 the highest rankings were associated with the high activity scenario. As particularly sensitive species, beaked whales and sperm whales consistently receive relatively high severity scores. Bryde's whales receive very high vulnerability scoring across zones, due in large part to the differential susceptibility to masking, while sperm whales were also typically ranked as being highly vulnerable. Relatively high levels of risk were also identified for other species in some contexts, and these are generally explained by the interaction of specific factors related to survey effort concentration and areas of heightened geographic distribution or specific factors related to population trends or zone-related differences in vulnerability. When considered across the entire GOM and all activity scenarios, the only species considered to have relatively high risk are the sperm whale and beaked whales, while the Bryde's whale and melon-headed whales have relatively moderate risk.
Although the scores generated by the EWG framework, and further aggregated across zones as described by NMFS above, are species-specific, additional stock-specific information can be gleaned through the zone-specific nature of the analysis in that, for example with bottlenose dolphins, the zones align with stock range edges. These species-specific risk scores are broadly applied in NMFS's negligible impact analysis to all of the multiple stocks that are analyzed in this rule (Table 3), however, NMFS is also considering additional stock-specific information in our analysis, where appropriate, as indicated in our “Description of Marine Mammals in the Area of the Specified Activity,” “Potential Effects of the Specified Activity on Marine Mammals and Their Habitat,” and “Proposed Mitigation” sections (
In order to more fully place the predicted amount of take into meaningful context, it is useful to understand the duration of exposure at or above a given level of received sound, as well as the likely number of repeated exposures across days. While a momentary exposure above the criteria for Level B harassment counts as an instance of take, that accounting does not make any distinction between fleeting exposures and more severe encounters in which an animal may be exposed to that received level of sound for a longer period of time. However, this information is meaningful to an understanding of the likely severity of the exposure, which is relevant to the negligible impact evaluation, and is not directly incorporated into the risk assessment framework described above. For example, for bottlenose dolphin exposed to noise from 3D WAZ surveys in Zone 6, the modeling report shows that approximately 72 takes (Level B harassment) would be expected to occur in a 24-hr period. However, each animat modeled has a record or time history of received levels of sound over the course of the modeled 24-hr period. The 50th percentile of the cumulative distribution function indicates that the time spent exposed to levels of sound above 160 dB rms SPL (
Additionally, as we discussed in the “Estimated Take” section for Test Scenario 1, by comparing exposure estimates generated by multiplying 24-hr exposure estimates by the total number of survey days versus modeling for a full 30-day survey duration for six representative species, we were able to refine the exposure estimates to better reflect the number of individuals exposed above threshold. Using this same comparison and scalar ratios described above, we are able to predict an average number of days each of the representative species modeled in the test scenario were exposed above the Level B harassment thresholds. As with the duration of exposures discussed above, the number of repeated exposures is important to our understanding of the severity of effects. Specifically, for example, the ratio for beaked whales indicates that the 30-day modeling showed that approximately 10 percent as many individual beaked whales could be expected to be exposed above harassment thresholds as was reflected in the results given by multiplying average 24-hr exposure results by the survey duration (
We expect that Level A harassment could occur for low-frequency species (
We consider the relative impact ratings described above in conjunction with our proposed mitigation and other relevant contextual information in order to produce a final assessment of impact to the stock or species,
These proposed measures benefit both the primary species for which they were designed and the species that may benefit secondarily by likely reducing
The endangered sperm whale and the Bryde's whale received special consideration in our development of proposed mitigation. The alternative of a year-round closure alternative with a 6-km buffer is designed to avoid impacts to the Bryde's whale by completely avoiding known habitat. Survey activities must avoid all areas where the Bryde's whale is found, and we propose to require shutdown of the acoustic source upon observation of any Bryde's whale at any distance. The Bryde's whale is proposed for listing as endangered, has a very low population size, is more sensitive to the low frequencies output by airguns, and faces significant additional stressors. Therefore, regardless of impact rating, we believe that the year-round closure alternative and 6-km buffer described previously would allow us to make the necessary negligible impact finding. We preliminarily find, were this alternative finalized, that the total potential marine mammal take from the projected survey activities will have a negligible impact on the Bryde's whale.
While the economic analysis accompanying this proposed rule indicates that a CPA restriction benefiting sperm whales would not be practicable, we propose to require a shutdown of the acoustic source upon any acoustic detection of sperm whales. We also propose shutdown requirements upon any detection of beaked whales or
The risk assessment process rates impacts as moderate or less for all other affected species. Therefore, in consideration of the proposed mitigation, we preliminarily find that the total potential marine mammal take from the projected survey activities will have a negligible impact on all other affected species, including all affected stocks of bottlenose dolphin.
In summary and as described above, the following factors primarily support our preliminary determination that the impacts resulting from this activity are not expected to adversely affect the affected species or stocks through effects on annual rates of recruitment or survival:
• No mortality is anticipated or authorized;
• Level A harassment not expected for species other than Bryde's whale and
• Risk assessment process rates impacts as moderate or less, for most species in most places and higher risk species have associated mitigation to lessen impacts;
• Known habitat for Bryde's whales protected;
• Shutdown requirements for species of concern (Bryde's whale, sperm whale, beaked whales,
• Modeling resulted in daily exposures totaling 3-35 minutes, which, in most situations, is likely insufficient time to result in disruptions of behavior that raise concerns about fitness consequences.
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 proposed monitoring and mitigation measures, with a year-round closure in Bryde's whale habitat (Area 3; Figure 5), we preliminarily find that the total marine mammal take from the proposed activity will have a negligible impact on all affected marine mammal species or stocks.
The MMPA does not define “small numbers.” NMFS's and the U.S. Fish and Wildlife Service's joint 1989 implementing regulations defined small numbers as a portion of a marine mammal species or stock whose taking would have a negligible impact on that species or stock. This definition was invalidated in
To maintain an interpretation of small numbers as a proportion of a species or stock that does not conflate with negligible impact, we propose the following framework. A plain reading of “small” implies as corollary that there also could be “medium” or “large” numbers of animals from the species or stock taken. We therefore propose a simple approach that establishes three equal bins corresponding to small, medium, and large numbers of animals: Small is comprised of 1-33 percent, medium 34-66 percent, and large 67-100 percent of the population abundance.
NMFS's practice for making small numbers determinations is to compare the number of individuals estimated to be taken against the best available abundance estimate for that species or stock. Although NMFS's implementing regulations require applications for incidental take to include an estimate of the marine mammals to be taken, there is nothing in paragraphs (A) or (D) of section 101(a)(5) that requires NMFS to quantify or estimate numbers of marine mammals to be taken for purposes of evaluating whether the number is small.
When sufficient quantitative information is not available to estimate the number of individuals that might be taken (typically due to insufficient information about presence, density, or daily or seasonal movement patterns of the species in an area), we consider other factors, such as the spatial scale of the specified activity footprint as compared with the range of the affected species or stock and/or the duration of the activity in order to infer the relative proportion of the affected species or stock that might reasonably be expected to be taken by the activity. For example, an activity that is limited to a small spatial scale (
Another circumstance in which NMFS considers it appropriate to make a small numbers finding in the absence of a quantitative estimate is in the case of a species or stock that may potentially be taken but is either rarely encountered or only expected to be taken on rare occasions. In that circumstance, one or two assumed encounters with a group of animals (meaning a group that is traveling together or aggregated, and thus exposed to a stressor at the same approximate time) could reasonably be considered small numbers, regardless of consideration of the proportion of the stock (if known), as rare brief encounters resulting in take of one or two groups should be considered small relative to the range and distribution of any stock.
In summary, when quantitative take estimates of individual marine mammals are available or inferable through consideration of additional factors, and the number of animals taken is one third or less of the best available abundance estimate for the species or stock, NMFS would consider it to be of small numbers. When quantitative take estimates are not available, NMFS will examine other factors, such as the spatial extent of the take zone compared to the species or stock range and/or the duration of the activity to determine if the take will likely be small relative to the abundance of the affected species or stocks. Last, NMFS may appropriately find that one or two predicted group encounters will result in small numbers of take relative to the range and distribution of a species, regardless of the estimated proportion of the abundance.
Neither the MMPA nor NMFS's implementing regulations address whether the small numbers determination should be based upon the total annual taking for all activities occurring under incidental take regulations or to individual LOAs issued thereunder. The MMPA does not define small numbers or explain how to apply the term in either paragraph (A) or (D) of section 101(a)(5), including how to apply the term in a way that allows for consistency between those two very similar provisions. NMFS has not previously made a clear and deliberate policy choice or specifically explored applying the small numbers finding to each individual LOA under regulations that cover multiple concurrent LOA holders. Here we propose a reasonable interpretation of how to make a small numbers determination based on a permissible interpretation of the statute.
Specifically, section 101(a)(5)(A)(i)(I) explicitly states that the negligible impact determination for a specified activity must take into account the total taking over the five-year period, but the small numbers language is not tied explicitly to the same language. As the provision is structured, the small numbers language is not framed as a standard for the issuance of the authorization, but rather appears in the chapeau as a limitation on what the Secretary may allow. The regulatory vehicle for authorizing (
Given NMFS's discretion in light of the ambiguities in the statute regarding how to apply the small numbers standard, and the clear benefits of application as described here, we have determined that the small numbers finding should be applied to the annual take authorized in each LOA. To demonstrate why this approach is preferred, we first describe below why it is beneficial to NMFS, the public, and the resource (marine mammals) to utilize section 101(a)(5)(A) for multiple activities, where possible.
• From a resource protection standpoint, it is more protective to conduct a comprehensive negligible impact analysis that considers all of the activities covered under the rule and ensures that the total combined taking from those activities will have a negligible impact on the affected marine mammal species or stocks and no unmitigable adverse impact on subsistence uses. Furthermore, mitigation and monitoring are more effective when considered across all activity and years covered under regulations.
• From an agency resource standpoint, it ultimately will save significant time and effort to cover multi-year activities under a rule instead of multiple incidental harassment authorizations (IHAs). While regulations require more analysis up front, additional public comment and internal review, and additional time to promulgate compared to a single IHA, they are effective for up to five years and can cover multiple actors within a year. The process of issuing individual LOAs under incidental take regulations utilizes the analysis, public comment, and review that was conducted for the regulations, and takes significantly less time than it takes to issue an IHA.
• From an applicant standpoint, incidental take regulations offer more regulatory certainty than IHAs (five years versus one year) and significant cost savings, both in time and environmental compliance analysis and documentation, especially for situations like here, where multiple applicants will be applying for individual LOAs under regulations. In the case of this proposed rule, the certainty afforded by the promulgation of a regulatory framework (
A review of IHAs we have issued suggests that bundling together two or three IHAs that might be ideal subjects for a combined incidental take regulation (
Our conclusion is that NMFS can appropriately elect to make a “small numbers” finding based on the estimated annual take in individual LOAs issued under the rule. This approach does not affect the negligible impact analysis, which is the biologically relevant inquiry and based on the total annual estimated taking for all activities the regulations will govern. Making the small numbers finding based on the estimated annual take in individual LOAs allows NMFS to take advantage of the associated administrative and environmental benefits of utilizing section 101(a)(5)(A) that would be precluded in many cases if small numbers were required to be applied to the total annual taking under the regulations.
Although this application of small numbers may be argued as being less protective of marine mammals, NMFS disagrees. As specifically differentiated from the negligible impact finding, the small numbers standard has little biological relevance. The negligible impact determination, which does have biological significance, is still controlling, and the total annual taking authorized across all LOAs under an incidental take regulation still could not exceed the overall amount analyzed for the negligible impact determination. Moreover, to the extent that this process is perceived as less protective than applying the small numbers standard across all activity occurring annually under the regulations (in that the small numbers standard can be met more readily under our proposed approach), that perception ignores the fact that applicants could always opt to pursue an IHA to circumvent a more restrictive approach to applying small numbers under section 101(A)(5)(A) (in cases where there is no serious injury or mortality).
In this proposed rule, up-to-date species information is available, and sophisticated models have been used to estimate take in a manner that will allow for quantitative comparison of the take of individuals versus the best available abundance estimates for the species or stocks. Specifically, while the modeling effort utilized in the rule enumerates the estimated instances of takes that will occur across days as the result of the operation of certain survey types in certain areas, the modeling report also includes the evaluation of a test scenario that allows for a reasonable modification of those generalized take estimates to better estimate the number of individuals that will be taken within one survey. LOA applicants using modeling results from the rule to inform their applications will be able to reasonably estimate the number of marine mammal individuals taken by their proposed activities. LOA applications that do not use the modeling provided in the rule to estimate take for their activities will need to be independently reviewed, and applicants will be required to ensure that their estimates adequately inform the small numbers finding. Additionally, if applicants use the modeling provided by this rule to estimate take, additional public input will not be deemed necessary (unless other conditions necessitating public review exist, as described in the “Letters of Authorization” section); if they do not, however, NMFS will publish a notice in the
The regulations governing the take of marine mammals incidental to geophysical survey activities would contain an adaptive management component. The comprehensive reporting requirements associated with this proposed rule (see the “Proposed Monitoring and Reporting” section) are designed to provide NMFS with monitoring data from the previous year to allow consideration of whether any changes are appropriate. The use of adaptive management allows NMFS to consider new information from different sources to determine (with input from the LOA-holders regarding practicability) on an annual or biennial basis if mitigation or monitoring measures should be modified (including additions or deletions). Mitigation measures could be modified if new data suggests that such modifications would have a reasonable likelihood of reducing adverse effects to marine mammal species or stocks or their habitat and if the measures are practicable. The adaptive management process and associated reporting requirements would serve as the basis for evaluating performance and compliance.
The following are some of the possible sources of applicable data to be considered through the adaptive management process: (1) Results from monitoring reports, as required by MMPA authorizations; (2) results from general marine mammal and sound research; and (3) any information which reveals that marine mammals may have been taken in a manner, extent, or number not authorized by these regulations or subsequent LOAs or that the specified activity may be having more than a negligible impact on affected stocks.
Under this proposed rule, NMFS proposes an annual adaptive management process involving BOEM, BSEE, and industry operators (including geophysical companies as well as exploration and production companies). Industry operators may elect to be represented in this process by their respective trade associations. NMFS, BOEM, and BSEE (
Data collection and reporting by individual LOA-holders would occur on an ongoing basis, per the terms of issued LOAs. In a given annual cycle, we propose that the comprehensive annual report would summarize and synthesize the LOA-specific reports received from
NMFS's MMPA implementing regulations require that applicants for incidental take authorizations describe the suggested means of coordinating research opportunities, plans, and activities relating to reducing incidental taking and evaluating its effects (50 CFR 216.104(a)(14)). Such coordination can serve as an effective supplement to the monitoring and reporting required pursuant to issued LOAs and/or incidental take regulations. We expect that relevant research efforts will inform the annual adaptive management process describe above, and that levels and types of research efforts will change from year to year in response to identified needs and evolutions in knowledge, emerging trends in the economy and available funding, and available scientific and technological resources. Here, we describe examples of relevant research efforts, which may not be predictive of any future levels and types of research efforts. Research occurring in locations other than the GOM may be relevant to understanding the effects of geophysical surveys on marine mammals or marine mammal populations or the effectiveness of mitigation.
• Analyses of existing PSO data: The GOM is one of three regions currently being reviewed under a JIP contract, initiated in 2016, to assess the utility of existing PSO data. Visual PSO and PAM data through 2015 are being examined for quality and consistency, and assessments will be made about the data's utility in the validation of risk modeling, assessing behavioral responses, and the potential for deriving animal density and distribution information. This work will complement and reinforce similar efforts by BOEM (see below). An earlier JIP study resulted in standardizing the basic data recording formats used by vessel operators in the UK and other jurisdictions (
• Acoustic measurements and modeling: The JIP has funded measurement of the acoustic output of both single airgun sources as well as airgun arrays that help increase confidence in the source and propagation models used in the GOM. These include extensive near-field, mid-field, and far-field in-water acoustic measurements (conducted in Norwegian waters in 2007-2010) of the most commonly used single-source and two-element configurations over a range of volumes, depths, and pressures with the objective of measuring acoustic output at higher frequencies up to 50 kHz. More recently, measurements of the sound field from a fully operational airgun array in the GOM have been completed, with fully analyzed data products anticipated in 2018. Additionally, the JIP is funding work into the development of standard procedures for underwater noise measurements for activities related to offshore oil and gas exploration and production, to ensure that processing of selected acoustic metrics used to describe the characteristics of a sound signal propagating in water can be analyzed in a consistent and systematic manner, and is funding a review of available marine acoustic propagation models.
• PAMGuard: Industry has funded ongoing development and at-sea testing of this now-standard, open source real-time PAM software to improve mitigation capabilities during operations. More information and the software itself is available online at
• Alternative technology: Pursuant to the terms of a settlement agreement (as amended) concerning pending litigation between the Natural Resources Defense Council
• Advanced dive behavior tag technology development: The JIP co-funded, with BOEM's predecessor agency (MMS) and the U.S. Navy's Office of Naval Research (ONR), initial development of advanced dive behavior tracking technology that has been used to study sperm whale diving and foraging behavior in the GOM.
• Effects of sound on marine mammal hearing: The JIP funds multiple hearing research projects specifically focused on defining the impacts of seismic sound sources on the hearing systems of various marine mammal species,
• Behavioral response study: The JIP and BOEM jointly funded a study examining how humpback whales respond to airgun sound in general and to the ramp-up procedure specifically (Behavioral Response of Australian Humpback Whales to Seismic Surveys (BRAHSS)). The experimental design progressed from using a single airgun source to a fully operational commercial array with a ramp-up procedure, and involved treatment and control groups, a pre-trial statistical power analysis, a range of exposures, and a four-stage ramp-up design. For more details of the study and results, please see Cato
• Analyses of existing PSO data: MMS previously funded an analysis of GOM PSO data from 2002-2008 (Barkaszi
• Development of PAM standards: As discussed in “Proposed Monitoring and Reporting,” BSEE is working with Scripps Institute of Oceanography to develop standards for towed PAM systems.
• Passive acoustic monitoring: BOEM is funding a fixed PAM array for 5 years. Hydrophones will be deployed, maintained, and redeployed on a regular schedule throughout the GOM. Placement will include shelf, slope and deep water depths as well as all planning areas in order to gather a comprehensive data set representative of the entire GOM. This program is expected to establish a relative baseline for ambient noise in the GOM against which to evaluate potential future noise impacts from permitted activities as well as characterize the sound budget from other kinds of noise already occurring in the GOM (
• Sperm whale studies: The Sperm Whale Acoustic Monitoring Program (SWAMP) began in 2000 with joint support from MMS, ONR, and NMFS and laid the groundwork for future study by developing new methods for studying sperm whale behavior and their responses to sound. Subsequently, the Sperm Whale Seismic Study (SWSS) began in 2002 to evaluate potential effects of geophysical exploration on sperm whales in the GOM (
• GoMMAPPS: BOEM is supporting a multi-year, multi-disciplinary study of marine protected species in the GOM (Gulf of Mexico Marine Assessment Program for Protected Species (GoMMAPPS)), which is patterned after the successful Atlantic Marine Assessment Program for Protected Species (AMAPPS) that began in 2010 and has provided valuable information on the seasonal distribution and abundance of protected species in U.S. waters of the Atlantic Ocean. The overall goals are to improve our understanding of living marine resource abundance, distribution, habitat use, and behavior in the GOM to facilitate appropriate mitigation and monitoring of potential impacts from human activities, including geophysical survey activities. The study will utilize a variety of methods, depending on target species, including aerial surveys, shipboard surveys, satellite tagging and tracking, and genetic analyses. GoMMAPPS is a joint partnership of BOEM, NMFS, the U.S. Fish and Wildlife Service, and the U.S. Geological Survey. More information is available online at (
• Workshops: BOEM has funded various workshops, including a 2012 workshop focused on mitigation and monitoring associated with seismic surveys and a 2013 workshop concerning quieting technologies for reducing noise during seismic surveying (BOEM, 2014).
There are no relevant subsistence uses of marine mammals implicated by these actions. Therefore, we have 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 (16 U.S.C. 1531
Under issued incidental take regulations, industry operators would be able to apply for and obtain LOAs, as described in NMFS's MMPA implementing regulations (50 CFR 216.106). LOAs may be issued for multiple years, depending on the degree of specificity with which an operator can describe their planned survey activities. Because the specified activity described herein does not provide actual specifics of the timing, location, and survey design for activities that would be the subject of issued LOAs, such requests must include, at minimum, the information described at 50 CFR 216.104(a)(1 and 2), and should include an affirmation of intent to adhere to the mitigation, monitoring, and reporting requirements described in the regulations. The level of effort proposed by an operator would be used to develop an LOA-specific take estimate based on the results of Zeddies
Technologies continue to evolve to meet the technical, environmental, and economic challenges of oil and gas development. The use of “new and unusual technologies” (NUT),
• Has the technology or hardware been used previously or extensively in the U.S. GOM under operating conditions similar to those anticipated for the activities proposed by the operator? If so, the technology would not be considered a NUT;
• Does the technology function in a manner that potentially causes different impacts to the environment than similar equipment or procedures did in the past? If
• Does the technology have a significantly different interface with the environment than similar equipment or procedures did in the past? If so, the technology would be considered a NUT; and
• Does the technology include operating characteristics that are outside established performance parameters? If so, the technology would be considered a NUT.
We would consult with BOEM as well as with NMFS's Endangered Species Act Interagency Cooperation Division regarding the level of review necessary for issuance of an LOA in which a NUT is proposed for use.
Please see Table 11 for a summary of mitigation measures with alternatives for consideration, for which alternative regulatory text is presented here.
• Based on our analyses-to-date (“Proposed Mitigation” and “Negligible Impact Analysis and Preliminary Determination”), we evaluated a year-round restriction on airgun surveys in Area 3 (Figure 5), and our preliminary finding of negligible impact on the Gulf of Mexico stock of Bryde's whale is based on a year-round restriction in this area. Alternative regulatory text at § 217.184(e)(2) for this proposal would read: “No use of airguns may occur within the area bounded by the 100- and 400-m isobaths, from 87.5° W to 27.5° N (buffered by 6 km).”
For our proposals of no restriction or a seasonal restriction, but with the addition of a requirement for BOEM and/or members or representatives of the oil and gas industry to ensure real-time detection of Bryde's whales across the area of potential impact including real-time communication of detections to survey operators, which would be used to initiate shutdowns to ensure that survey operations do not take place when a Bryde's whale is within 6 km of the acoustic source, the proposed regulatory text would be the following. For the three-month restriction, we are proposing using a moored listening array and thus the alternative regulatory text at § 217.184(e)(2) would read: “No use of airguns may occur within the area bounded by the 100- and 400-m isobaths, from 87.5° W to 27.5° N (buffered by 6 km), during June through August. During September through May, LOA-holders conducting airgun surveys must monitor the area of potential impact using a moored passive listening array and may not use airguns when Bryde's whales are detected within 6 km of the acoustic source.” For no restriction plus a requirement of real-time detection using the moored array in the area of impact alone, alternative regulatory text at § 217.184(e)(2) would read: “In the area bounded by the 100- and 400-m isobaths, from 87.5° W to 27.5° N (buffered by 6 km), LOA-holders conducting airgun surveys must monitor a moored passive listening array and may not use airguns when a confirmed or potential Bryde's whale is detected within 6 km of the acoustic source.”
The proposal of a three-month seasonal restriction on airgun surveys in Area 3 with no additional monitoring requirement is included in the regulatory text at the end of this document, following the preamble.
As mentioned in the “Proposed Mitigation” section, we are interested in public comment on these proposals, including any data that may support the necessary findings regarding potential impacts to the GOM Bryde's whale for these proposals, as well as any additional alternative proposals that could vary the time period or length of seasonal closure from what NMFS has proposed.
For the proposal requiring shutdown upon a confirmed acoustic detection of sperm whales within 1 km or upon a confirmed visual or acoustic detection of Bryde's whales, large whales with calf, beaked whales, or
For the proposal waiving the shutdown or power-down requirement upon detection of small dolphins within a 500-m exclusion zone, regulatory text at § 217.184(b)(8)(iii) would read: “This shutdown requirement is waived for dolphins of the following genera:
The other proposals discussed in the “Proposed Mitigation” section for detection of Bryde's whales, beaked whales, sperm whales,
NMFS requests comment on the issuance of incidental take regulations that do not apply to BOEM's Eastern Planning Area. In the regulatory text, 217.180(b) would be replaced with the following text: “The taking of marine mammals by oil and gas industry operators may be authorized in a Letter of Authorization (LOA) only if it occurs within the Bureau of Ocean Energy Management's Western or Central Planning Areas in the Gulf of Mexico.” Under this alternative scope, NMFS would continue working on a programmatic approach to the authorization of take incidental to geophysical survey operations in the Eastern Planning Area, but applicants could apply for individual permits (IHAs) until that process is completed.
This revision of scope, if it occurred, would result in less impacts to affected species or stocks of marine mammals relative to what was considered in the analyses presented previously in this preamble. Based on the analysis included in the preceding sections, if no other changes are made to the scope of the rule or the required mitigation measures analyzed in the preceding sections (
NMFS requests interested persons to submit comments, information, and suggestions concerning the proposed rule and regulations, including the variations of the proposed rule, two economic baselines, and other information provided in the Regulatory Impact Analysis and associated appendices (
Pursuant to the procedures established to implement Executive Order 12866, the Office of Management and Budget has determined that this proposed rule is significant. Accordingly, a regulatory impact analysis (RIA) has been prepared and is available for review online at:
The proposed rule would require new mitigation measures relative to the baseline and, thus, new costs for survey operators. However, the proposed rule would also alleviate the regulatory burden of implementing minimum separation distance requirements for deep penetration airgun surveys. The proposed rule also would result in indirect (but non-monetized) costs as a result of the proposed time-area restrictions. However, we do not believe that these would be significant, as described in the RIA and in the “Proposed Mitigation” section. Moreover, as described in the RIA, total costs related to compliance for survey activities are small compared with expenditures on other aspects of oil and gas industry operations, and direct compliance costs of the regulatory requirements are unlikely to result in materially reduced oil and gas activities in the GOM.
The proposed rule would also result in certain non-monetized benefits. The protection of marine mammals afforded by this rule (pursuant to the requirements of the MMPA) would benefit the regional economic value of marine mammals via tourism and recreation to some extent, as mitigation measures applied to geophysical survey activities in the GOM region are expected to benefit the marine mammal populations that support this economic activity in the GOM. In addition, some degree of benefits can be expected to accrue solely via ecological benefits to marine mammals and other wildlife as a result of the proposed regulatory requirements. The published literature (described in the RIA) is clear that healthy populations of marine mammals and other co-existing species benefit regional economies and provide social welfare benefits to people; however, it does not provide a basis for quantitatively valuing the cost of anticipated incremental changes in environmental disturbance and marine mammal harassment associated with the proposed rule.
Notably, the proposed rule would also afford significant benefit to the regulated industry by providing an efficient framework within which to achieve compliance with the MMPA, and the attendant regulatory certainty. In particular, cost savings may be generated by the reduced administrative effort required to obtain an LOA under the framework established by a rule compared to what would be required to obtain an incidental harassment authorization (IHA) under section 101(a)(5)(D). Absent the rule, survey operators in the GOM would likely be required to apply for an IHA. Although not monetized in the RIA, NMFS's analysis indicates that the upfront work associated with the rule (
We prepared an initial regulatory flexibility analysis (IRFA), as required by Section 603 of the Regulatory Flexibility Act (RFA), for this proposed rule. The IRFA describes the economic effects this proposed rule, if adopted, would have on small entities. A description of this action, why it is being considered, the objectives of, and legal basis for this proposed rule are contained in the preamble of this proposed rule. A copy of the full analysis is available online at
This proposed rule is expected to directly regulate businesses that conduct geophysical surveys in the GOM with the potential to incidentally take marine mammals. Some of these businesses may be defined as small entities. The IRFA identifies these businesses as well as potential indirect impacts to small business boat owners and operators, who would not be directly regulated by the rule, but who may be involved in the implementation of the survey activities. The IRFA found that, for ten years of relevant permit data (2006-2015), 62 U.S. based-companies applied for 284 permits for relevant surveys, in 15 different industry NAICS codes. The IRFA also found that, for the period 2012-2014, 33 U.S.-flagged vessels operated under contract to permit applicants; the parent companies and primary NAICS codes under which those vessels operated were also identified where possible.
Of the total number of relevant survey applications from 2006-2015, 12 percent (75 applications) were put forth by small entities. In total, 34 U.S.-based small businesses applied for relevant permits in the GOM between 2006-2015, representing only 12 percent of permit applications during this period.
Using this information, the IRFA finds that small entities would participate in approximately 33 to 57 surveys over the five years, or approximately 7 to 11 surveys annually, and that approximately 15 to 26 small companies will likely apply for relevant permits over the five years (approximately 3 to 5 small companies each year). The future distribution of small companies by industry is not known, but the historical pattern suggests that companies involved in crude petroleum and natural gas extraction (NAICS 211111) and support activities for oil and gas (213112) will conduct the majority of the surveys by small companies.
Annual median revenues for small entities who applied for relevant permits were $12.26 million. Incremental costs of the proposed rule for non-airgun surveys, which comprised most of the HRG surveys (95 percent are forecast to be non-airgun, as opposed to airgun, surveys), are anticipated to range from $5,700 to $12,300 per survey. Airgun HRG survey costs are anticipated to range from $25,800 to $37,500 per survey. Approximately four small entities are anticipated to be involved in survey activities annually over the five years. As such, impacts would not be universally experienced by all small entities, and would depend on the specific survey types the companies engaged in. Incremental impacts for HRG surveys, which historically comprised most small business surveys, are anticipated to increase costs to small entities by one percent or less of annual revenues. For those entities engaged in other types of surveys, costs could comprise a larger portion of annual revenues.
In summary, the IRFA finds: (1) In the majority of cases (88 percent), survey permit applicants are large businesses; (2) When the permit applicants are small businesses, the majority of the time (63 percent) they are oil and gas extractors (NAICS 211111); (3) Together these permits (for large businesses and small businesses with high annual revenues for which rule costs are a small fraction) account for 96 percent of the survey permits; (4) While small entities in other industries occasionally apply for permits (four percent historically), these businesses are quite small, with average annual revenues in the millions or even less. Given their size, it is unlikely that these permit applicants bear survey costs; otherwise it would be reflected in their annual revenues (
NMFS's RIA evaluates the incremental regulatory impact of the proposed rule, as well as the incremental regulatory impact of a more stringent alternative to the mitigation, monitoring, and reporting requirements of the proposed rule. NMFS is requesting comment on the costs of these proposed incidental take regulations on small entities, with the goal of ensuring a thorough consideration and discussion at the final rule stage. We request comments on the analysis of entities affected, as well as information on regulatory alternatives that would simultaneously reduce the burden on small entities and afford appropriate protections to affected marine mammal species and stocks.
This proposed rule contains a collection-of-information requirement subject to the provisions of the Paperwork Reduction Act (PRA). Notwithstanding any other provision of law, no person is required to respond to nor shall a person be subject to a penalty for failure to comply with a collection of information subject to the requirements of the PRA unless that collection of information displays a currently valid OMB control number. These requirements have been approved by OMB under control number 0648-0151, currently under application for renewal, and include applications for regulations, subsequent LOAs, and reports. Send comments regarding any aspect of this data collection, including suggestions for reducing the burden, to NMFS and the OMB Desk Officer (see
Exports, Fish, Imports, Indians, Labeling, Marine mammals, Penalties, Reporting and recordkeeping requirements, Seafood, Transportation.
For reasons set forth in the preamble, 50 CFR part 217 is proposed to be amended as follows:
16 U.S.C. 1361
(a) Regulations in this subpart apply only to oil and gas industry operators (LOA-holders), and those persons authorized to conduct activities on their behalf, for the taking of marine mammals that occurs in the area outlined in paragraph (b) of this section and that occurs incidental to geophysical survey activities.
(b) The taking of marine mammals by oil and gas industry operators may be authorized in a Letter of Authorization (LOA) only if it occurs within the Gulf of Mexico.
Regulations in this subpart are effective from [EFFECTIVE DATE OF FINAL RULE] through [DATE 5 YEARS AFTER EFFECTIVE DATE OF FINAL RULE].
Under LOAs issued pursuant to § 216.106 of this chapter and § 217.186, LOA-holders may incidentally, but not intentionally, take marine mammals within the area described in § 217.180(b) by Level A and Level B harassment associated with geophysical survey activities, provided the activity is in compliance with all terms, conditions, and requirements of the regulations in this subpart and the appropriate LOA.
Notwithstanding takings contemplated in § 217.180 and § 217.182, and authorized by a LOA issued under § 216.106 of this chapter and § 217.186, no person in connection with the activities described in § 217.180 may:
(a) Violate, or fail to comply with, the terms, conditions, and requirements of this subpart or a LOA issued under § 216.106 of this chapter and § 217.186;
(b) Take any marine mammal not specified in such LOAs;
(c) Take any marine mammal specified in such LOAs in any manner other than as specified;
(d) Take a marine mammal specified in such LOAs if NMFS determines such taking results in more than a negligible impact on the species or stocks of such marine mammal; or
(e) Take a marine mammal specified in such LOAs if NMFS determines such taking results in an unmitigable adverse impact on the species or stock of such marine mammal for taking for subsistence uses.
When conducting the activities identified in § 217.180, the mitigation measures contained in any LOA issued under § 216.106 of this chapter and § 217.186 must be implemented. These mitigation measures shall include but are not limited to:
(a) General conditions:
(1) A copy of any issued LOA must be in the possession of the LOA-holder, the vessel operator and other relevant personnel, the lead protected species observer (PSO), and any other relevant designees of the LOA-holder operating under the authority of the LOA.
(2) The LOA-holder shall ensure that the vessel operator and other relevant vessel personnel are briefed on all responsibilities, communication procedures, marine mammal monitoring protocol, operational procedures, and LOA requirements prior to the start of survey activity, and when relevant new personnel join the survey operations. The LOA-holder shall instruct relevant vessel personnel with regard to the authority of the protected species monitoring team, and shall ensure that relevant vessel personnel and protected species monitoring team participate in a joint onboard briefing led by the vessel operator and lead PSO to ensure that responsibilities, communication procedures, marine mammal monitoring protocol, operational procedures, and LOA requirements are clearly understood. This briefing must be repeated when relevant new personnel join the survey operations.
(b) Deep penetration airgun surveys:
(1) Deep penetration airgun surveys are defined as surveys using airgun arrays with total volume greater than 400 in
(2) The LOA-holder must use independent, dedicated, trained PSOs, meaning that the PSOs must be employed by a third-party observer provider, may have no tasks other than to conduct observational effort, record observational data, and communicate with and instruct relevant vessel crew with regard to the presence of marine mammals and mitigation requirements (including brief alerts regarding maritime hazards), and must have successfully completed an approved PSO training course. NMFS will maintain a list of approved PSOs and, for PSOs not on the list, NMFS must review and approve PSO resumes accompanied by a relevant training course information packet that includes the name and qualifications (
(3) At least one visual PSO and two acoustic PSOs must have a minimum of 90 days at-sea experience working in those roles, respectively, during a deep penetration seismic survey, with no more than eighteen months elapsed since the conclusion of the at-sea experience. One visual PSO with such experience shall be designated as the lead for the entire protected species observation team. The lead shall coordinate duty schedules and roles for the PSO team and serve as primary point of contact for the vessel operator. To the maximum extent practicable, the lead PSO shall devise the duty schedule such that experienced PSOs are on duty with those PSOs with appropriate training but who have not yet gained relevant experience.
(4) Visual observation:
(i) During survey operations (
(ii) Visual monitoring must begin not less than 30 minutes prior to ramp-up and must continue until one hour after use of the acoustic source ceases or until 30 minutes past sunset.
(iii) Visual PSOs shall coordinate to ensure 360° visual coverage around the vessel from the most appropriate observation posts, and shall conduct visual observations using binoculars and the naked eye while free from distractions and in a consistent, systematic, and diligent manner.
(iv) Visual PSOs shall immediately communicate all observations to acoustic PSOs, including any determination by the PSO regarding species identification, distance, and bearing and the degree of confidence in the determination.
(v) Visual PSOs may be on watch for a maximum of two consecutive hours followed by a break of at least one hour between watches and may conduct a maximum of 12 hours of observation per 24-hour period.
(vi) Any observations of marine mammals by crew members aboard any vessel associated with the survey shall be relayed to the PSO team.
(vii) During good conditions (
(5) Acoustic observation:
(i) All surveys must use a towed passive acoustic monitoring (PAM) system at all times when operating in waters deeper than 100 m, which must be monitored beginning at least 30 minutes prior to ramp-up and at all times during use of the acoustic source.
(ii) Acoustic PSOs shall immediately communicate all detections to visual PSOs, when visual PSOs are on duty, including any determination by the PSO regarding species identification, distance, and bearing and the degree of confidence in the determination.
(iii) Acoustic PSOs may be on watch for a maximum of four consecutive hours followed by a break of at least two hours between watches and may conduct a maximum of 12 hours of observation per 24-hour period.
(iv) Survey activity may continue for brief periods of time when the PAM system malfunctions or is damaged. Activity may continue for 30 minutes without PAM while the PAM operator diagnoses the issue. If the diagnosis indicates that the PAM system must be repaired to solve the problem, operations may continue for an additional two hours without acoustic monitoring under the following conditions:
(A) Daylight hours and sea state is less than or equal to BSS 4;
(B) No marine mammals (excluding delphinids) detected solely by PAM in the exclusion zone in the previous two hours;
(C) NMFS is notified via email as soon as practicable with the time and location in which operations began without an active PAM system; and
(D) Operations with an active acoustic source, but without an operating PAM system, do not exceed a cumulative total of four hours in any 24-hour period.
(6) Exclusion Zone and Buffer Zone—The PSOs shall establish and monitor a 500-m exclusion zone and additional 500-m buffer zone. These zones shall be based upon radial distance from any element of the airgun array (rather than being based on the center of the array or around the vessel itself). During use of the acoustic source, occurrence of marine mammals within the buffer zone (but outside the exclusion zone) shall be communicated to the operator to prepare for the potential shutdown of the acoustic source. PSOs must monitor the 1,000-m zone for a minimum of 30 minutes prior to ramp-up (
(7) Ramp-up—A ramp-up procedure, involving a step-wise increase in the number of airguns firing and total array volume until all operational airguns are activated and the full volume is achieved, is required at all times as part of the activation of the acoustic source. Ramp-up may not be initiated if any marine mammal is within the designated exclusion zone or buffer zone. If a marine mammal is observed within these zones during the pre-clearance period, ramp-up may not begin until the animal(s) has been observed exiting the 1,000-m zone or until an additional time period has elapsed with no further sightings (
(8) Shutdown requirements:
(i) Any PSO on duty has the authority to delay the start of survey operations or to call for shutdown of the acoustic source pursuant to the requirements of this subpart. When shutdown is called for by a PSO, the acoustic source must be immediately deactivated and any dispute resolved only following deactivation. The operator must establish and maintain clear lines of communication directly between PSOs on duty and crew controlling the acoustic source to ensure that shutdown commands are conveyed swiftly while allowing PSOs to maintain watch. When there is certainty regarding the need for mitigation action on the basis of either visual or acoustic detection alone, the relevant PSO(s) must call for such action immediately. When there is uncertainty regarding the nature of the observation, all on duty PSOs must agree upon the mitigation action. When only the acoustic PSO is on duty and there is uncertainty regarding the need for mitigation action on the basis of a detection, the PSO may request that the acoustic source be shut down as a precaution.
(ii) Upon completion of ramp-up, if a marine mammal appears within, enters, or is clearly on a course to enter the exclusion zone, the acoustic source must be shut down (
(iii) This shutdown requirement is waived for dolphins of the following genera:
(iv) Shutdown of the acoustic source is required upon detection (visual or acoustic) of a baleen whale, beaked whale, or
(v) Shutdown of the acoustic source is required upon observation of a whale (
(vi) Upon implementation of shutdown, the source may be reactivated after the animal(s) has been observed exiting the exclusion zone or following a 30-minute clearance period with no further observation of the animal(s). Where there is no relevant zone (
(vii) If the acoustic source is shut down for reasons other than mitigation (
(9) Miscellaneous protocols:
(i) The acoustic source must be deactivated when not acquiring data or preparing to acquire data, except as
(ii) Testing of the acoustic source involving all elements requires normal mitigation protocols (
(c) Shallow penetration surveys:
(1) Shallow penetration surveys are defined as surveys using airgun arrays with total volume equal to or less than 400 in
(2) LOA-holders shall follow the requirements defined for deep penetration airgun surveys at § 217.184(b), with the following exceptions:
(i) Use of a towed PAM system is not required except to begin use of the airgun(s) at night in waters deeper than 100 m. Use of a PAM system is required for nighttime start-up, with monitoring by a trained and experienced acoustic PSO during a 30-minute pre-clearance period and during the ramp-up period (if applicable). The required acoustic PSO may be a crew member.
(ii) Ramp-up is not required for shallow penetration surveys using only a single airgun or boomer.
(iii) The exclusion zone shall be established at a distance of 200 m, with an additional 200-m buffer monitored during pre-clearance.
(iv) No shutdown or power-down action is required upon detection of the dolphin genera described at § 217.184(b)(8)(iii) for surveys using a single airgun or boomer.
(v) Shutdowns are not required for observations beyond the exclusion zone under any circumstance.
(d) Non-airgun surveys:
(1) Non-airgun surveys are defined as surveys using an acoustic source other than an airgun(s) or boomer that operates at frequencies less than 200 kHz (
(2) LOA-holders conducting non-airgun surveys shall follow the requirements defined for shallow penetration surveys at § 217.184(c), with the following exceptions:
(i) Use of a towed PAM system is not required under any circumstances;
(ii) Ramp-up is not required under any circumstances;
(iii) Non-airgun surveys shall employ a minimum of one trained and experienced independent visual PSO during all daylight operations (as described at § 217.184(b)) when operating in waters deeper than 200 m. In waters shallower than 200 m, non-airgun surveys shall employ one trained visual PSO, who may be a crew member, to monitor the exclusion zone and buffer during the pre-clearance period; and
(iv) No shutdown or power-down action is required upon detection of the dolphin genera described at § 217.184(b)(8)(iii).
(e) Restriction areas:
(1) From February 1 through May 31, no use of airguns may occur shoreward of the 20-m isobath (buffered by 13 km).
(2) No use of airguns may occur within the area bounded by the 100- and 400-m isobaths, from 87.5° W to 27.5° N (buffered by 6 km), during June through August.
(3) No use of airguns may occur within the area bounded by the 200- and 2,000-m isobaths from the northern border of BOEM's Howell Hook leasing area to 81.5° W (buffered by 9 km).
(f) To avoid the risk of entanglement, LOA-holders conducting surveys using ocean-bottom nodes or similar gear must:
(1) Use negatively buoyant coated wire-core tether cable;
(2) Retrieve all lines immediately following completion of the survey;
(3) Attach acoustic pingers directly to the coated tether cable; acoustic releases should not be used; and
(4) Employ a third-party PSO aboard the node retrieval vessel in order to document any unexpected marine mammal entanglement.
(g) To avoid the risk of vessel strike, LOA-holders must adhere to the following requirements:
(1) Vessel operators and crews must maintain a vigilant watch for all marine mammals and slow down or stop their vessel or alter course, as appropriate and regardless of vessel size, to avoid striking any marine mammal. A visual observer aboard the vessel must monitor a vessel strike avoidance zone around the vessel, which shall be defined according to the parameters stated in this subsection, to ensure the potential for strike is minimized. Visual observers monitoring the vessel strike avoidance zone can be either third-party observers or crew members, but crew members responsible for these duties must be provided sufficient training to distinguish marine mammals from other phenomena and broadly to identify a marine mammal as a baleen whale, sperm whale, or other marine mammal;
(2) All vessels, regardless of size, must observe a 10 kn speed restriction within the restriction area described previously at § 217.184(e)(2);
(3) Vessel speeds must also be reduced to 10 kn or less when mother/calf pairs, pods, or large assemblages of cetaceans are observed near a vessel;
(4) All vessels must maintain a minimum separation distance of 500 yd (457 m) from baleen whales;
(5) All vessels must maintain a minimum separation distance of 100 yd (91 m) from sperm whales;
(6) All vessels must attempt to maintain a minimum separation distance of 50 yd (46 m) from all other marine mammals, with an exception made for those animals that approach the vessel;
(7) When cetaceans are sighted while a vessel is underway, vessels shall attempt to remain parallel to the animal's course, and shall avoid excessive speed or abrupt changes in direction until the animal has left the area; and
(8) If cetaceans are sighted in a vessel's path or in close proximity to a moving vessel, the vessel shall reduce speed and shift the engine to neutral, not engaging the engines until animals are clear of the area. This does not apply to any vessel towing gear.
(a) LOA-holders must provide bigeye binoculars (
(b) PSOs must also be equipped with reticle binoculars (
(c) PSO qualifications:
(1) PSOs must successfully complete relevant training, including completion of all required coursework and passing (80 percent or greater) a written and/or oral examination developed for the training program.
(2) PSOs must have successfully attained a bachelor's degree from an accredited college or university with a major in one of the natural sciences and a minimum of 30 semester hours or equivalent in the biological sciences and at least one undergraduate course in math or statistics. The educational requirements may be waived by NMFS if the PSO has acquired the relevant skills through alternate experience. Requests for such a waiver shall be submitted to NMFS and must include written justification. Requests shall be granted or denied (with justification) by NMFS within one week of receipt of submitted information. Alternate experience that may be considered includes, but is not limited to:
(i) Secondary education and/or experience comparable to PSO duties;
(ii) Previous work experience conducting academic, commercial, or government-sponsored marine mammal surveys; or
(iii) Previous work experience as a PSO; the PSO should demonstrate good standing and consistently good performance of PSO duties.
(d) Data collection—PSOs must use standardized data forms, whether hard copy or electronic. PSOs shall record detailed information about any implementation of mitigation requirements, including the distance of animals to the acoustic source and description of specific actions that ensued, the behavior of the animal(s), any observed changes in behavior before and after implementation of mitigation, and if shutdown was implemented, the length of time before any subsequent ramp-up of the acoustic source to resume survey. If required mitigation was not implemented, PSOs should record a description of the circumstances. We require that, at a minimum, the following information be recorded:
(1) Vessel names (source vessel and other vessels associated with survey) and call signs;
(2) PSO names and affiliations;
(3) Dates of departures and returns to port with port name;
(4) Dates and times (Greenwich Mean Time) of survey effort and times corresponding with PSO effort;
(5) Vessel location (latitude/longitude) when survey effort begins and ends; vessel location at beginning and end of visual PSO duty shifts;
(6) Vessel heading and speed at beginning and end of visual PSO duty shifts and upon any line change;
(7) Environmental conditions while on visual survey (at beginning and end of PSO shift and whenever conditions change significantly), including wind speed and direction, Beaufort sea state, Beaufort wind force, swell height, weather conditions, cloud cover, sun glare, and overall visibility to the horizon;
(8) Factors that may be contributing to impaired observations during each PSO shift change or as needed as environmental conditions change (
(9) Survey activity information, such as acoustic source power output while in operation, number and volume of airguns operating in the array, tow depth of the array, and any other notes of significance (
(10) If a marine mammal is sighted, the following information should be recorded:
(i) Watch status (sighting made by PSO on/off effort, opportunistic, crew, alternate vessel/platform);
(ii) PSO who sighted the animal;
(iii) Time of sighting;
(iv) Vessel location at time of sighting;
(v) Water depth;
(vi) Direction of vessel's travel (compass direction);
(vii) Direction of animal's travel relative to the vessel;
(viii) Pace of the animal;
(ix) Estimated distance to the animal and its heading relative to vessel at initial sighting;
(x) Identification of the animal (
(xi) Estimated number of animals (high/low/best);
(xii) Estimated number of animals by cohort (adults, yearlings, juveniles, calves, group composition, etc.);
(xiii) Description (as many distinguishing features as possible of each individual seen, including length, shape, color, pattern, scars or markings, shape and size of dorsal fin, shape of head, and blow characteristics);
(xiv) Detailed behavior observations (
(xv) Animal's closest point of approach (CPA) and/or closest distance from the center point of the acoustic source;
(xvi) Platform activity at time of sighting (
(xvii) Description of any actions implemented in response to the sighting (
(11) If a marine mammal is detected while using the PAM system, the following information should be recorded:
(i) An acoustic encounter identification number, and whether the detection was linked with a visual sighting;
(ii) Time when first and last heard;
(iii) Types and nature of sounds heard (
(iv) Any additional information recorded such as water depth of the hydrophone array, bearing of the animal to the vessel (if determinable), species or taxonomic group (if determinable), spectrogram screenshot, and any other notable information.
(e) LOA-holders shall provide to NMFS within 90 days of survey conclusion geo-referenced time-stamped vessel tracklines for all time periods in which airguns were operating. Tracklines should include points recording any change in airgun status (
(f) Reporting:
(1) Annual reporting: LOA-holders shall submit an annual summary report to NMFS on all activities and monitoring results within 90 days of the completion of the survey or expiration of the LOA, whichever comes sooner. The report must describe all activities conducted and sightings of marine mammals near the activities, must provide full documentation of methods, results, and interpretation pertaining to all monitoring, and must summarize the dates and locations of survey operations and all marine mammal sightings (dates, times, locations, activities, associated survey activities). Geospatial data regarding locations where the acoustic source was used, provided to NMFS under subparagraph § 217.185(e), must
(2) Comprehensive reporting: LOA-holders shall contribute to the compilation and analysis of data for inclusion in an annual synthesis report addressing all data collected and reported through annual reporting in each calendar year. The synthesis period shall include all annual reports deemed to be final by NMFS from July 1 of one year through June 30 of the subsequent year. The report must be submitted to NMFS by October 1 of each year.
(g) Reporting of injured or dead marine mammals:
(1) In the unanticipated event that the activity defined in § 217.180 clearly causes the take of a marine mammal in a prohibited manner, the LOA-holder shall immediately cease such activity and report the incident to the Office of Protected Resources (OPR), NMFS, and to the Southeast Regional Stranding Coordinator, NMFS. Activities shall not resume until NMFS is able to review the circumstances of the prohibited take. NMFS will work with the LOA-holder to determine what measures are necessary to minimize the likelihood of further prohibited take and ensure MMPA compliance. The LOA-holder may not resume their activities until notified by NMFS. The report must include the following information:
(i) Time, date, and location (latitude/longitude) of the incident;
(ii) Name and type of vessel involved;
(iii) Vessel's speed during and leading up to the incident;
(iv) Description of the incident;
(v) Status of all sound source use in the 24 hours preceding the incident;
(vi) Water depth;
(vii) Environmental conditions (
(viii) Description of all marine mammal observations in the 24 hours preceding the incident;
(ix) Species identification or description of the animal(s) involved;
(x) Fate of the animal(s); and
(xii) Photographs or video footage of the animal(s).
(2) In the event that the LOA-holder discovers an injured or dead marine mammal and determines that the cause of the injury or death is unknown and the death is relatively recent (
(3) In the event that the LOA-holder discovers an injured or dead marine mammal and determines that the injury or death is not associated with or related to the activities defined in § 217.180 (
(a) To incidentally take marine mammals pursuant to these regulations, prospective LOA-holders must apply for and obtain a LOA.
(b) A LOA, unless suspended or revoked, may be effective for a period not to exceed the expiration date of these regulations.
(c) In the event of projected changes to the activity or to mitigation and monitoring measures required by a LOA, the LOA-holder must apply for and obtain a modification of the LOA as described in § 217.187.
(d) The LOA shall set forth:
(1) Permissible methods of incidental taking;
(2) Means of effecting the least practicable adverse impact (
(3) Requirements for monitoring and reporting.
(e) Issuance of the LOA shall be based on a determination that the level of taking will be consistent with the findings made for the total taking allowable under these regulations and a determination that the amount of take authorized under the LOA is of no more than small numbers.
(f) For LOA issuance, where either:
(1) The conclusions put forth in an application (
(2) The proposed activity or anticipated impacts vary substantively in scope or nature from those analyzed in the preamble to the rule, NMFS may publish a notice of proposed LOA in the
(g) Notice of issuance or denial of a LOA shall be published in the
(a) A LOA issued under § 216.106 of this chapter and § 217.186 for the activity identified in § 217.180 shall be modified upon request by the applicant, provided that:
(1) The proposed specified activity and mitigation, monitoring, and reporting measures, as well as the anticipated impacts, are the same as those described and analyzed for these regulations (excluding changes made pursuant to the adaptive management provision in paragraph (c)(1) of this section); and
(2) NMFS determines that the mitigation, monitoring, and reporting measures required by the previous LOA under these regulations were implemented.
(b) For LOA modification requests by the applicant that include changes to the activity or the mitigation, monitoring, or reporting (excluding changes made pursuant to the adaptive management provision in paragraph (c)(1) of this section) that result in more than a minor change in the total estimated number of takes (or distribution by species or years), NMFS may publish a notice of proposed LOA in the
(c) A LOA issued under § 216.106 of this chapter and § 217.186 for the activity identified in § 217.180 may be modified by NMFS under the following circumstances:
(1) Adaptive Management—NMFS may modify (including augment) the existing mitigation, monitoring, or reporting measures (after consulting with the LOA-holder regarding the practicability of the modifications) if doing so is practicable and creates a
(i) Possible sources of data that could contribute to the decision to modify the mitigation, monitoring, or reporting measures in a LOA:
(A) Results from monitoring from previous years;
(B) Results from other marine mammal and/or sound research or studies; and
(C) Any information that reveals marine mammals may have been taken in a manner, extent or number not authorized by these regulations or subsequent LOAs.
(ii) If, through adaptive management, the modifications to the mitigation, monitoring, or reporting measures are substantial, NMFS will publish a notice of proposed LOA in the
(2) Emergencies—If NMFS determines that an emergency exists that poses a significant risk to the well-being of the species or stocks of marine mammals specified in a LOA issued pursuant to § 216.106 of this chapter and § 217.186, a LOA may be modified without prior notice or opportunity for public comment. Notice would be published in the
Office of Personnel Management.
Notice.
As required by section 3132(b)(4) of title 5, United States Code, this gives notice of all positions in the Senior Executive Service (SES) that were career reserved during calendar year 2017.
Phyllis Proctor, Senior Executive Resources Services, Senior Executive Services and Performance Management, Employee Services, 202-606-2246.
Below is a list of titles of SES positions that were career reserved at any time during calendar year 2017, regardless of whether those positions were still career reserved as of December 31, 2017. Section 3132(b)(4) of title 5, United States Code, requires that the head of each agency publish such lists by March 1 of the following year. The Office of Personnel Management is publishing a consolidated list for all agencies.
5 U.S.C. 3132.
(a) coordinate the activities of executive departments and agencies (agencies) regarding ocean-related matters to ensure effective management of ocean, coastal, and Great Lakes waters and to provide economic, security, and environmental benefits for present and future generations of Americans;
(b) continue to promote the lawful use of the ocean by agencies, including United States Armed Forces;
(c) exercise rights and jurisdiction and perform duties in accordance with applicable domestic law and—if consistent with applicable domestic law—international law, including customary international law;
(d) facilitate the economic growth of coastal communities and promote ocean industries, which employ millions of Americans, advance ocean science and technology, feed the American people, transport American goods, expand recreational opportunities, and enhance America's energy security;
(e) ensure that Federal regulations and management decisions do not prevent productive and sustainable use of ocean, coastal, and Great Lakes waters;
(f) modernize the acquisition, distribution, and use of the best available ocean-related science and knowledge, in partnership with marine industries; the ocean science and technology community; State, tribal, and local governments; and other ocean stakeholders, to inform decisions and enhance entrepreneurial opportunity; and
(g) facilitate, as appropriate, coordination, consultation, and collaboration regarding ocean-related matters, consistent with applicable law, among Federal, State, tribal, and local governments, marine industries, the ocean science
(a) “Ocean-related matters” means management, science, and technology matters involving the ocean, coastal, and Great Lakes waters of the United States (including its territories and possessions), and related seabed, subsoil, waters superadjacent to the seabed, and natural resources.
(b) “Regional ocean partnership” means a regional organization of coastal or Great Lakes States, territories, or possessions voluntarily convened by governors to address cross-jurisdictional ocean matters, or the functional equivalent of such a regional ocean organization designated by the governor or governors of a State or States.
(1) The Chairman of the Council on Environmental Quality (CEQ) and the Director of the Office of Science and Technology Policy (OSTP), who shall serve as Co-Chairs;
(2) The Secretary of State, Secretary of Defense, Attorney General, Secretary of the Interior, Secretary of Agriculture, Secretary of Commerce, Secretary of Transportation, Secretary of Energy, Secretary of Homeland Security, Administrator of the Environmental Protection Agency, Director of the Office of Management and Budget, Administrator of the National Aeronautics and Space Administration, Director of the National Science Foundation, Director of National Intelligence, Chairman of the Joint Chiefs of Staff, Under Secretary of Commerce for Oceans and Atmosphere, Assistant Secretary of the Army (Civil Works), and Commandant of the Coast Guard;
(3) The Assistants to the President for National Security Affairs, Homeland Security and Counterterrorism, Domestic Policy, and Economic Policy;
(4) A representative from the Office of the Vice President designated by the Vice President; and
(5) Such other officers or employees of the Federal Government as the Co-Chairs may from time to time designate.
(b) The Co-Chairs, in coordination with the Assistants to the President for National Security Affairs, Homeland Security and Counterterrorism, Domestic Policy, and Economic Policy, shall regularly convene and preside at meetings of the Committee, determine its agenda, and direct its work, and shall establish and direct subcommittees of the Committee as appropriate. The Committee shall, as appropriate, establish subcommittees with responsibility for advising the Committee on matters pertaining to ocean science and technology and ocean-resource management.
(1) a civilian official appointed by the President;
(2) a member of the Senior Executive Service or the Senior Intelligence Service;
(3) a general officer or flag officer; or
(4) an employee of the Office of the Vice President.
(a) provide advice regarding policies concerning ocean-related matters to:
(b) engage and collaborate, under existing laws and regulations, with stakeholders, including regional ocean partnerships, to address ocean-related matters that may require interagency or intergovernmental solutions;
(c) coordinate the timely public release of unclassified data and other information related to the ocean, coasts, and Great Lakes that agencies collect, and support the common information management systems, such as the Marine Cadastre, that organize and disseminate this information;
(d) coordinate and inform the ocean policy-making process and identify priority ocean research and technology needs, to facilitate:
(e) coordinate and ensure Federal participation in projects conducted under the National Oceanographic Partnership Program through the Committee's members, as appropriate, to maximize the effectiveness of agency investments in ocean research; and
(f) obtain information and advice concerning ocean-related matters from:
(b) This order shall be implemented consistent with applicable law and subject to the availability of appropriations.
(c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.
| 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 |