| Page Range | 71571-71975 | |
| FR Document |
| Page and Subject | |
|---|---|
| 81 FR 71639 - Atlantic Highly Migratory Species; Atlantic Bluefin Tuna Fisheries | |
| 81 FR 71573 - Coordinating Efforts To Prepare the Nation for Space Weather Events | |
| 81 FR 71571 - Charitable Fundraising | |
| 81 FR 71763 - Government in the Sunshine Act Meeting Notice | |
| 81 FR 71717 - Sunshine Act Meeting Notice | |
| 81 FR 71765 - Certain Computer Cables, Chargers, Adapters, Peripheral Devices and Packaging Containing the Same; Issuance of a Limited Exclusion Order; Termination of the Investigation | |
| 81 FR 71709 - Taking and Importing Marine Mammals; Taking Marine Mammals Incidental to Fisheries Research | |
| 81 FR 71712 - Availability of the Fiscal Year 2015 Inventory of Contracted Services | |
| 81 FR 71791 - Submission for OMB Review; Comment Request | |
| 81 FR 71612 - Drawbridge Operation Regulation; Atlantic Intracoastal Waterway (AIWW), Wrightsville Beach, NC and Northeast Cape Fear River, Wilmington, NC | |
| 81 FR 71711 - Information Collection Requirement; Defense Federal Acquisition Regulation Supplement (DFARS); Administrative Matters | |
| 81 FR 71790 - Hazardous Materials: International Standards on the Transport of Dangerous Goods | |
| 81 FR 71760 - Minor Boundary Revision at Big Thicket National Preserve | |
| 81 FR 71705 - Steel Concrete Reinforcing Bar From the Republic of Turkey: Initiation of Countervailing Duty Investigation | |
| 81 FR 71750 - Implementation of the Privacy Act of 1974, as Amended; Notice Amendment for Computerized Homes Underwriting Management System/Loan Application Management System | |
| 81 FR 71762 - Abbreviated Final Environmental Impact Statement for the Fire Island National Seashore General Management Plan | |
| 81 FR 71755 - 30-Day Notice of Proposed Information Collection: HOME Investment Partnership Program | |
| 81 FR 71724 - Access to Confidential Business Information by Abt Associates, Inc. and Its Identified Subcontractor, Versar, Inc. | |
| 81 FR 71702 - Application(s) for Duty-Free Entry of Scientific Instruments | |
| 81 FR 71703 - Certain Uncoated Paper From Portugal: Initiation and Preliminary Results of Antidumping Duty Changed Circumstances Review | |
| 81 FR 71697 - Steel Concrete Reinforcing Bar From Japan, Taiwan and the Republic of Turkey: Initiation of Less-Than-Fair-Value Investigations | |
| 81 FR 71784 - Regional Meeting of the Binational Bridges and Border Crossings Group in San Diego, California | |
| 81 FR 71613 - Participation by Disadvantaged Business Enterprises in Procurements Under EPA Financial Assistance Agreements | |
| 81 FR 71725 - Proposed Prospective Purchaser Agreement for the Willow Run Powertrain Site in Ypsilanti, Michigan | |
| 81 FR 71633 - Metaldehyde; Pesticide Tolerances | |
| 81 FR 71723 - Pesticide Product Registration; Receipt of Applications for New Uses | |
| 81 FR 71689 - Notice of Solicitation of Applications for the Rural Energy for America Program for Federal Fiscal Year 2017 | |
| 81 FR 71661 - National Emission Standards for Hazardous Air Pollutant Emissions: Petroleum Refinery Sector | |
| 81 FR 71722 - Receipt of Information Under the Toxic Substances Control Act | |
| 81 FR 71721 - Combined Notice of Filings | |
| 81 FR 71722 - Combined Notice of Filings | |
| 81 FR 71715 - Combined Notice of Filings #1 | |
| 81 FR 71719 - Terra-Gen Mojave Windfarms, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request For Blanket Section 204 Authorization | |
| 81 FR 71714 - DifWind Farms LTD VI; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization | |
| 81 FR 71722 - Portal Ridge Solar C, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization | |
| 81 FR 71721 - Portal Ridge Solar B, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization | |
| 81 FR 71717 - Illinois Power Generating Company; Notice of Institution of Section 206 Proceeding and Refund Effective Date | |
| 81 FR 71719 - Combined Notice of Filings #1 | |
| 81 FR 71716 - Combined Notice of Filings #1 | |
| 81 FR 71668 - Receipt of Several Pesticide Petitions Filed for Residues of Pesticide Chemicals in or on Various Commodities | |
| 81 FR 71735 - Proposed Revised Vaccine Information Materials for MMR (Measles, Mumps, and Rubella and MMRV (Measles, Mumps, Rubella, and Varicella) Vaccines | |
| 81 FR 71605 - Order Establishing De Minimis Threshold Phase-In Termination Date | |
| 81 FR 71712 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Federal Perkins Loan Program Regulations and General Provisions Regulations | |
| 81 FR 71653 - Rule Recognizing Privileged Communications Between Clients and Patent Practitioners at the Patent Trial and Appeal Board | |
| 81 FR 71641 - Fisheries of the Exclusive Economic Zone Off Alaska; Pacific Ocean Perch in the Central Regulatory Area of the Gulf of Alaska | |
| 81 FR 71641 - Fisheries of the Northeastern United States; Northeast Skate Complex; Adjustment to the Skate Bait Inseason Possession Limit | |
| 81 FR 71642 - Fisheries of the Exclusive Economic Zone Off Alaska; Sablefish in the Central Regulatory Area of the Gulf of Alaska | |
| 81 FR 71710 - Magnuson-Stevens Act Provisions; General Provisions for Domestic Fisheries; Application for Exempted Fishing Permits | |
| 81 FR 71714 - Application To Export Electric Energy; Tenaska Power Services Co. | |
| 81 FR 71713 - Agency Information Collection Extension | |
| 81 FR 71770 - Advisory Committee On Reactor Safeguards (ACRS) Meeting of the ACRS Subcommittee On Economic Simplified Boiling Water Reactors (ESBWR); Notice of Meeting | |
| 81 FR 71767 - Bulk Manufacturer of Controlled Substances Application: Johnson Matthey Inc. | |
| 81 FR 71696 - Dairyland Power Cooperative: Notice of Intent To Prepare an Environmental Impact Statement and Hold Public Scoping Meetings | |
| 81 FR 71766 - Importer of Controlled Substances Application: Anderson Brecon, Inc. | |
| 81 FR 71730 - Notice to All Interested Parties of the Termination of the Receivership of 10372-Mountain Heritage Bank Clayton, Georgia | |
| 81 FR 71730 - Proposed Agency Information Collection Activities; Comment Request | |
| 81 FR 71760 - Notice of Inventory Completion: U.S. Department of the Interior, Bureau of Land Management, Nevada State Office, Reno, NV | |
| 81 FR 71763 - Notice of Intent To Repatriate Cultural Items: Stearns History Museum, Saint Cloud, MN | |
| 81 FR 71766 - Importer of Controlled Substances Application: Johnson Matthey Inc. | |
| 81 FR 71697 - Discontinuance of Information Collection 0694-0009: Triangular Transactions “Stamp” Covered by a U.S. Import Certificate | |
| 81 FR 71769 - LaCrosseSolutions, LLC; La Crosse Boiling Water Reactor Partial Site Release | |
| 81 FR 71733 - Submission for OMB Review; Debarment and Suspension and Other Responsibility Matters | |
| 81 FR 71789 - Reports, Forms, and Record Keeping Requirements; Agency Information Collection Activity Under OMB Review | |
| 81 FR 71788 - Transfer of Federally Assisted Facility | |
| 81 FR 71736 - Proposed Information Collection Activity; Comment Request | |
| 81 FR 71748 - Navigation Safety Advisory Council | |
| 81 FR 71784 - Buy America Nationwide Waiver Notification for Commercially Available Off-the-Shelf (COTS) Products With Steel or Iron Components and for Steel Tie Wire Permanently Incorporated in Precast Concrete Products | |
| 81 FR 71759 - Notice of Public Meeting: Resource Advisory Council (RAC) to the Boise District, Bureau of Land Management, U.S. Department of the Interior | |
| 81 FR 71759 - Filing of Plats of Survey: Oregon/Washington | |
| 81 FR 71768 - Membership of the National Endowment for the Arts Senior Executive Service Performance Review Board | |
| 81 FR 71758 - Information Collection Request Sent to the Office of Management and Budget (OMB) for Approval; Revealing Opportunities for Local-Level Stakeholder Engagement and Social Science Inquiry in Landscape Conservation Design | |
| 81 FR 71749 - Agency Information Collection Activities: Registration for Classification as a Refugee, Form I-590; Revision of a Currently Approved Collection | |
| 81 FR 71647 - Internet Communication Disclaimers; Reopening of Comment Period and Notice of Hearing | |
| 81 FR 71749 - Agency Information Collection Activities: Application for Employment Authorization for Abused Nonimmigrant Spouse, Form I-765V; New Collection | |
| 81 FR 71713 - Environmental Management Site-Specific Advisory Board, Portsmouth | |
| 81 FR 71746 - Performance Review Board Members | |
| 81 FR 71792 - Request for Citizens Coinage Advisory Committee Membership Applications; Correction | |
| 81 FR 71784 - Petition for Exemption; Summary of Petition Received; Air Tractor Inc. | |
| 81 FR 71764 - Certain Integrated Circuits With Voltage Regulators and Products Containing Same; Institution of Investigation | |
| 81 FR 71765 - Certain Hospital Beds, and Components Thereof; Commission's Determination Not To Review an Initial Determination Terminating the Investigation Based on Settlement; Termination of the Investigation | |
| 81 FR 71737 - Mallinckrodt Pharmaceuticals; Proposal To Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets; Opportunity for a Hearing | |
| 81 FR 71741 - Kremers Urban Pharmaceuticals Inc.; Proposal To Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets; Opportunity for a Hearing | |
| 81 FR 71783 - North Carolina Disaster #NC-00081 | |
| 81 FR 71710 - Mid-Atlantic Fishery Management Council (MAFMC); Meeting | |
| 81 FR 71778 - Proposed Collection; Comment Request | |
| 81 FR 71777 - Submission for OMB Review; Comment Request | |
| 81 FR 71774 - Self-Regulatory Organizations; The Depository Trust Company; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Clarify Certain Rules Provisions Relating to Pledges | |
| 81 FR 71776 - Self-Regulatory Organizations; NASDAQ PHLX LLC; Notice of Designation of a Longer Period for Commission Action on Proposed Rule Change To Delete or Amend Rule Language Relating to Specialists and Registered Options Traders | |
| 81 FR 71772 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend the Fees Schedule | |
| 81 FR 71791 - Senior Executive Service; Combined Performance Review Board (PRB) | |
| 81 FR 71771 - Self-Regulatory Organizations; New York Stock Exchange LLC; Order Instituting Proceedings To Determine Whether To Approve or Disapprove a Proposed Rule Change, as Modified by Amendments No. 1 and 2, Allowing the Exchange To Trade Pursuant to Unlisted Trading Privileges Any NMS Stock Listed on Another National Securities Exchange; Establishing Listing and Trading Requirements for Exchange Traded Products; and Adopting New Equity Trading Rules Relating to Trading Halts of Securities Traded Pursuant to UTP on the Pillar Platform | |
| 81 FR 71778 - Self-Regulatory Organizations; Bats BZX Exchange, Inc.; Order Instituting Proceedings To Determine Whether To Approve or Disapprove a Proposed Rule Change to BZX Rule 14.11(e)(4), Commodity-Based Trust Shares, To List and Trade Winklevoss Bitcoin Shares Issued by the Winklevoss Bitcoin Trust | |
| 81 FR 71782 - IOWA Disaster #IA-00067 | |
| 81 FR 71767 - Agency Information Collection Activities; Comment Request; Information Collections: Report of Construction Contractor's Wage Rates | |
| 81 FR 71782 - Northcreek Mezzanine Fund II, L.P.; Notice Seeking Exemption Under Section 312 of the Small Business Investment Act, Conflicts of Interest | |
| 81 FR 71783 - HAWAII Disaster #HI-00040 | |
| 81 FR 71657 - Determination of Rates and Terms for Making and Distributing Phonorecords (Phonorecords III); Comment Period Extension | |
| 81 FR 71745 - Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; National Practitioner Data Bank Attestation of Reports by Hospitals, Medical Malpractice Payers, Health Plans, and Certain Other Health Care Entities | |
| 81 FR 71790 - Mutual Savings Association Advisory Committee | |
| 81 FR 71747 - Office of The Director, Office of Science Policy, Office of Biotechnology Activities; Amended Notice of Meeting | |
| 81 FR 71747 - National Institute of General Medical Sciences; Notice of Closed Meeting | |
| 81 FR 71747 - National Institute on Drug Abuse; Notice of Closed Meetings | |
| 81 FR 71726 - Information Collection Being Reviewed by the Federal Communications Commission | |
| 81 FR 71729 - Information Collection Being Reviewed by the Federal Communications Commission | |
| 81 FR 71728 - Information Collection Being Submitted for Review and Approval to the Office of Management and Budget | |
| 81 FR 71644 - Post-Employment Conflict of Interest Restrictions; Revision of Departmental Component Designations | |
| 81 FR 71672 - Atlantic Highly Migratory Species; Atlantic Shark Management Measures; Proposed Amendment 5b | |
| 81 FR 71689 - Notice of Proposed Changes to Section I of the Wisconsin Field Office Technical Guide | |
| 81 FR 71658 - Veterans' Mortgage Life Insurance-Coverage Amendment | |
| 81 FR 71638 - NASA Federal Acquisition Regulation Supplement | |
| 81 FR 71648 - Amendments to the Regulation Regarding the List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness | |
| 81 FR 71610 - Medical Devices; Physical Medicine Devices; Classification of the Upper Extremity Prosthesis Including a Simultaneously Powered Elbow and/or Shoulder With Greater Than Two Simultaneous Powered Degrees of Freedom and Controlled by Non-Implanted Electrical Components | |
| 81 FR 71768 - Membership of the National Science Board's Senior Executive Service Performance Review Board | |
| 81 FR 71579 - New Equipment Contract, RUS Contract Form 395 for Telecommunications and Broadband Borrowers | |
| 81 FR 71670 - Endangered and Threatened Wildlife and Plants; Proposed Rule for the North American Wolverine | |
| 81 FR 71631 - Air Plan Approval; Ohio; Removal of Gasoline Vapor Recovery Requirements | |
| 81 FR 71613 - Revisions to Public Notice Provisions in Clean Air Act Permitting Programs | |
| 81 FR 71946 - Cross-Border Application of the Registration Thresholds and External Business Conduct Standards Applicable to Swap Dealers and Major Swap Participants | |
| 81 FR 71794 - Energy Conservation Program: Energy Conservation Standards for General Service Lamps | |
| 81 FR 71591 - Airworthiness Directives; Sikorsky Aircraft Corporation Helicopters | |
| 81 FR 71818 - Agricultural Conservation Easement Program | |
| 81 FR 71858 - Magnuson-Stevens Act Provisions; National Standard Guidelines | |
| 81 FR 71593 - Airworthiness Directives; Airbus Airplanes | |
| 81 FR 71596 - Airworthiness Directives; Airbus Airplanes | |
| 81 FR 71906 - Review of the National Ambient Air Quality Standards for Lead | |
| 81 FR 71589 - Airworthiness Directives; The Boeing Company Airplanes | |
| 81 FR 71602 - Airworthiness Directives; Airbus Airplanes | |
| 81 FR 71586 - Airworthiness Directives; Dassault Aviation Airplanes |
Commodity Credit Corporation
Natural Resources Conservation Service
Rural Business-Cooperative Service
Rural Utilities Service
Industry and Security Bureau
International Trade Administration
National Oceanic and Atmospheric Administration
Patent and Trademark Office
Defense Acquisition Regulations System
Federal Energy Regulatory Commission
Centers for Disease Control and Prevention
Children and Families Administration
Food and Drug Administration
Health Resources and Services Administration
National Institutes of Health
Coast Guard
U.S. Citizenship and Immigration Services
Fish and Wildlife Service
Land Management Bureau
National Park Service
Drug Enforcement Administration
Wage and Hour Division
Copyright Royalty Board
National Endowment for the Arts
Federal Aviation Administration
Federal Highway Administration
Federal Transit Administration
National Highway Traffic Safety Administration
Pipeline and Hazardous Materials Safety Administration
Comptroller of the Currency
Engraving and Printing Bureau
United States Mint
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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Rural Utilities Service, USDA.
Final rule.
The Rural Utilities Service (RUS), an agency of the United States Department of Agriculture (USDA), hereinafter referred to as RUS or the Agency, is issuing a final rule to streamline the contractual process for equipment procurement by replacing type-specific equipment contracts, RUS Forms 397, 398, 525, 545, and associated documents (Forms 231, 396, 396a, 517, 525a, 744, 752a, 754, and addenda) with a new, unified Equipment Contract, RUS Contract Form 395 and associated close-out documents (Forms 395a, 395b, 395c and 395d) and by removing construction standards RUS Forms 397b, 397c, 397d, 397f, 397g, 397h. On October 1, 2015, RUS published a Request for Comments in the
This final rule is effective October 18, 2016.
Aylene Mafnas, Chief, Engineering Branch, Policy and Outreach Division, Rural Utilities Service, Telecommunications Program, U.S. Department of Agriculture, STOP 1599, 1400 Independence Ave. SW., Washington, DC 20250-1550, Telephone number: (202) 690-4673.
This final rule has been determined to be not significant for the purposes of Executive Order 12866, Regulatory Planning and Review, and therefore has not been reviewed by the Office of Management and Budget (OMB).
This final rule has been reviewed under Executive Order 12988, Civil Justice Reform. The Agency has determined that this rule meets the applicable standards provided in section 3 of the Executive Order. In addition, all state and local laws and regulations that are in conflict with this rule will be preempted. No retroactive effect will be given to this rule and, in accordance with section 212(e) of the Department of Agriculture Reorganization Act of 1994 (7 U.S.C. 6912(e)), administrative appeal procedures must be exhausted before an action against the Department or its agencies may be initiated.
This final rule is not subject to the requirements of Executive Order 12372, “Intergovernmental Review”, as implemented under USDA's regulations at 7 CFR part 3015.
RUS has determined that this final rule will not have a significant economic impact on a substantial number of small entities, as defined in the Regulatory Flexibility Act (5 U.S.C. 601
This final rule has been examined under Agency environmental regulations at 7 CFR part 1794. The Administrator has determined that this is not a major Federal action significantly affecting the environment. Therefore, in accordance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321
The Catalog of Federal Domestic Assistance (CFDA) number assigned to this program is 10.851. The Catalog is available on the Internet at
This final rule contains no Federal mandates (under the regulatory provisions of Title II of the Unfunded Mandates Reform Act of 1995) for State, local, and tribal governments or the private sector. Therefore, this rule is not subject to the requirements of sections 202 and 205 of the Unfunded Mandates Reform Act of 1995.
RUS is committed to the E-Government Act, which requires Government agencies in general to provide the public the option of submitting information or transacting business electronically to the maximum extent possible.
The policies contained in this final rule do not have any substantial direct effect on 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. Nor does this final rule impose substantial direct compliance costs on state and local governments. Therefore, consultation with the states is not required.
Executive Order 13175 imposes requirements on RUS in the development of regulatory policies that have tribal implications or preempt tribal laws. RUS has determined that this rule does not have a substantial direct effect on one or more Indian tribes(s) or on either the relationship or the distribution of powers and responsibilities between the Federal Government and Indian tribes. Thus, this final rule is not subject to the requirements of Executive Order 13175. If a tribe determines that this final rule has implications of which RUS is not aware and would like to engage in consultation with RUS on this rule,
In accordance with Federal civil rights law and U.S. Department of Agriculture (USDA) civil rights regulations and policies, the USDA, its Agencies, offices, and employees, and institutions participating in or administering USDA programs are prohibited from discriminating based on race, color, national origin, religion, sex, gender identity (including gender expression), sexual orientation, disability, age, marital status, family/parental status, income derived from a public assistance program, political beliefs, or reprisal or retaliation for prior civil rights activity, in any program or activity conducted or funded by USDA (not all bases apply to all programs). Remedies and complaint filing deadlines vary by program or incident.
Persons with disabilities who require alternative means of communication for program information (
To file a program discrimination complaint, complete the USDA Program Discrimination Complaint Form, AD-3027, found online at
USDA is an equal opportunity provider, employer, and lender.
The information collection and recordkeeping requirements contained in this final rule are pending approval by OMB pursuant to the Paperwork Reduction Act 1995 (44 U.S.C. Chapter 35) under control number 0572-NEW. The paperwork contained in this rule will not be effective until approved by OMB.
Rural Development is a mission area within the U.S. Department of Agriculture comprising the Rural Utilities Service, Rural Housing Service and Rural Business/Cooperative Service. Rural Development's mission is to increase economic opportunity and improve the quality of life for all rural Americans. Rural Development meets its mission by providing loans, loan guarantees, grants and technical assistance through more than 40 programs aimed at creating and improving housing, businesses and infrastructure throughout rural America.
The Rural Utilities Service (RUS) loan, loan guarantee and grant programs act as a catalyst for economic and community development. By financing improvements to rural electric, water and waste, and telecom and broadband infrastructure, RUS also plays a significant role in improving other measures of quality of life in rural America, including public health and safety, environmental protection, conservation and cultural and historic preservation.
In order to continue to facilitate the programmatic interest of the Rural Electrification Act of 1936 (the “RE Act”), as amended (7 U.S.C. 901
RUS may, from time to time, promulgate new contract forms or revise or eliminate existing contract forms. In so doing, RUS is required by 7 CFR 1755.29, to publish a notice of rulemaking in the
In response to changes in competition, legislation, technologies, and regulation which have resulted in changes to business practices in the communications industry, RUS has undertaken a comprehensive review of its Telecommunications and Broadband Programs' contracts and contracting procedures. The purpose of this undertaking is to streamline the contractual process for equipment procurement and improve the customer service provided to the RUS rural telecommunications and broadband borrowers.
Under this rulemaking, the new equipment contract RUS Contract Form 395 and the associated close-out documents (Forms 395a, 395b, 395c and 395d)
On February 12, 2014, RUS published a proposed rule in the
Comments specifically concerning the new contract were submitted by Osmose Communications Services, LLC and by ACE, The Association of Communications Engineers. Two (2) comments were submitted on behalf of Osmose Communications Services, LLC and twenty-four (24) comments on behalf of ACE. Additionally, the Bloom Corporation submitted general comments non-related to the RUS Contract Form 395.
Comments
Communications equipment, Loan programs—Telecommunications, Reporting and recordkeeping requirements, Rural areas, and Telephone.
Loan programs—Telecommunications; Reporting and recordkeeping requirements, Rural areas, and Telecommunications.
For the reasons set forth in the preamble, the Rural Utilities Service is amending Chapter XVII of Title 7 of the Code of Federal Regulations as follows:
5 U.S.C. 501, 7 U.S.C. 901
(a) Materials, equipment, and construction financed with loan funds must meet the standards and specifications established by RUS in 7 CFR 1755.97 which lists the RUS Bulletins containing the standards and specifications for telephone facilities.
The revision reads as follows:
(c) The appropriate standards and specifications listed in 7 CFR part 1755 shall be included in the P&S. When RUS has not prepared standards and specifications, the borrower shall use all appropriate project specific engineering requirements and specifications prepared by the borrower's engineer. The specifications prepared by the borrower's engineer and based on appropriate project specific engineering requirements shall be subject to review and approval by RUS for all major construction, including major projects which would be exempted from RUS approval under paragraph (e) of this section.
(a) RUS construction contract Forms 257, 395, and 515, contain provisions for subcontracting. Reference should be made to the individual contracts for the amounts and conditions under which a contractor may subcontract work under the contract.
(c) As stated in contract Forms 257, 395, and 515, the contractor shall bear full responsibility for the acts and omissions of the subcontractor and is not relieved of any obligations to the borrower and to the Government under the contract.
(c) A statement that construction used was in accordance with specifications published by RUS covering the construction which were in effect when the contract was executed, or in the absence of such specifications, that it meets other applicable specifications and standards and that it meets all applicable national and local code requirements as to strength and safety.
(b) Terms used in this subpart are defined in § 1753.2 and Equipment Contract, RUS Contract Form 395 (RUS Contract Form 395).
(c) Borrowers shall use RUS Contract Form 395, and associated RUS Form 395a, Equipment Contract Certificate of Completion (Including Installation), when the firm supplying the equipment will install it and RUS Contract Form 395 and associated RUS Form 395b, Equipment Contract Certificate of Completion (Not Including Installation) when the supplier of the equipment will not be installing it. In either case the appropriate specifications shall be included in the contract.
(e) The borrower shall take sealed competitive bids for all central office equipment to be purchased under RUS Contract Form 395 using the procedure set forth in Sec. 1753.38(a), unless RUS approval to negotiate is obtained.
(g) Materials and equipment must meet the standards and general specifications approved by RUS.
(a)
(2) The P&S shall specify the delivery and completion time required for each exchange.
(3) P&S for equipment to be provided under an Equipment Contract, RUS Contract Form 395 (RUS Contract Form 395) contract without installation shall require the supplier to provide specific installation information and a detailed bonding and grounding plan to be utilized by the engineer, borrower, and others responsible for the installation of the equipment.
(b)
The revisions read as follows:
(a) * * *
(1) * * *
(i) After RUS approval of the specifications and equipment requirements (required only for projects expected to exceed $500,000 or 25% of the loan, whichever is less), the borrower shall send “Notice and Instructions to Bidders” to suppliers with central office equipment.
(iii) Equipment Contract, RUS Contract Form 395 (RUS Contract Form 395) shall be used, except that the “Notice” shall state that prior to the bid opening a technical session will be conducted with each supplier to resolve any questions related to the technical proposal submitted by the supplier. The suppliers' technical proposals should be requested for presentation 30 days in advance of the bid opening to enable sufficient time to make the technical evaluation.
(2) * * *
(i) * * *
(J) Some types of equipment contain software. RUS Contract Form 395 indicates whether the equipment contains software and whether the software contract stipulations are applicable.
(K) * * *
(v) After evaluation of the technical proposals and RUS approval of the changes to P&S (required only for projects that are expected to exceed $500,000 or 25% of the loan, whichever is less), sealed bids shall be solicited from only those bidders whose technical proposals meet P&S requirements. When fewer than three bidders are adjudged qualified by the borrower to bid, RUS approval must be obtained to proceed. Generally, RUS will grant such approval only if the borrower can demonstrate to the satisfaction of RUS that a good faith effort was made to obtain at least three competitive bids.
(b) * * *
(10) Installation of the central office equipment and materials provided under RUS Contract Form 395 may be made in accordance with subpart I, if applicable, or by an approved Force Account Proposal (FAP).
(d) * * *
(3) If RUS approval was required by paragraph (d)(2) of this section, upon RUS approval the purchase may be made using RUS Contract Form 395, or when applicable, the procedures contained in subpart I of this part.
(5) Installation of the central office equipment and materials procured by RUS Contract Form 395 without installation may be made in accordance with subpart I, if applicable, or by an approved FAP.
Closeout of Equipment Contract, RUS Contract Form 395 (RUS Contract Form 395) (including or not including installation) shall be conducted as follows:
(a)
(b)
(c)
(d)
(1) Obtain from the engineer a certification of partial closeout; and
(2) Submit one copy of the summary to RUS with an FRS.
(e)
(f) Once RUS approval has been obtained for any required amendments, the borrower shall obtain certifications from the engineer that the project and all required documentation are satisfactory and complete. The requirements for the final contract certification are contained in § 1753.18.
(g) Once these certifications have been received, final payment shall be made according to the payment terms of the contract. Copies of the certifications shall be submitted with the FRS, requesting the remaining funds on the contract.
(a) This subpart implements and explains the provisions of the Loan Documents setting forth the requirements and the procedures to be followed by borrowers in purchasing and installing special equipment financed with loan funds.
(b) Terms used in this subpart are defined in § 1753.2 and Equipment Contract, RUS Contract Form 395 (RUS Contract Form 395).
(c) Borrowers must obtain RUS review and approval of the LD for their telephone systems. Applications of equipment not included in an approved LD must conform to the modernization plan as required by 7 CFR part 1751, subpart B, and must be submitted to RUS for review and approval.
(d) RUS Contract Form 395 and applicable specifications shall be used for the purchase of special equipment for major construction on a furnish-and-install basis, as well as on a furnish-only basis.
(e) The procedures provided in subpart I, if applicable, or a FAP approved by RUS may be used for the installation of special equipment purchased with a RUS Contract Form 395 contract not including installation.
(f) For special equipment purchases for minor construction, the borrower may at its option use the Methods of Minor Construction procedures contained in subpart I or the purchase procedures contained in this subpart H.
(g) Some types of special equipment contain software. RUS Contract Form 395 indicates whether the equipment contains software and whether the software contract stipulations are applicable.
(a) Equipment Contract, RUS Contract Form 395 shall be used to purchase equipment on a furnish-and-install basis, as well as on a furnish-only basis.
(b) The equipment specifications must accompany the equipment contract form and each specification consists of performance specifications, installation requirements (if applicable), and application engineering requirements.
The revisions read as follows:
(a) * * *
(9) The specifications for the various applications of equipment is prepared by the RUS borrower's engineer and based on generally accepted engineering considerations and practices found in the Telecommunications Industry.
(d) * * *
(2) Acceptance tests for RUS Contract Form 395 without installation. (Upon completion of the installation and alignment of the equipment (under this contract the installation alignment will be by other than the seller) the borrower shall perform all the inspections and tests outlined in the specifications.
The revision reads as follows:
(d) * * *
(2) All standard RUS procedures are followed, including the application of RUS construction practices (see § 1753.6).
7 U.S.C. 901
(c) * * *
(25) RUS Form 395, October 18, 2016, Equipment Contract.
(26) RUS Form 395a, October 18, 2016, Equipment Contract Certificate of Completion (Including Installation).
(27) RUS Form 395b, October 18, 2016, Equipment Contract Certificate of Completion (Not Including Installation).
(28) RUS Form 395c, October 18, 2016, Certificate of Contractor and Indemnity Agreement.
(29) RUS Form 395d, October 18, 2016, Results of Acceptance Tests.
(30) RUS Form 506, issued 3-97, Statement of Engineering Fee—Telecommunications.
(31) RUS Form 515, issued September 17, 2001, Telecommunications Systems Construction Contract (Labor and Materials).
(32) RUS Form 526, issued 8-66, Construction Contract Amendment.
(33) RUS Form 527, issued 3-71, Statement of Construction, Telephone System “Outside Plant”.
(34) RUS Form 553, issued 5-67, Check List for Review of Plans and Specifications.
(35) RUS Form 724, issued 10-63, Final Inventory, Telephone Construction Contract.
(36) RUS Form 724a, issued 4-61, Final Inventory, Telephone Construction—Telephone Construction Contract (Labor and Materials), columns 1-8.
(37) RUS Form 724b, issued 3-61, Final Inventory, Telephone Construction Contract (Labor and Materials), columns 9-14.
(38) RUS Form 771, issued 10-75, Summary of Work Orders (Inspected by RUS Field Engineer).
(39) RUS Form 771a, issued 10-75, Summary of Work Orders (Inspected by Licensed Engineer or Borrower's Staff Engineer).
(40) RUS Form 773, issued 12-90, Miscellaneous Construction Work and Maintenance Services Contract.
(41) RUS Form 787, issued 8-63, Supplement A to Construction Contract.
(42) RUS Form 817, issued 6-60, Final Inventory, Telephone Force Account Construction.
(43) RUS Form 817a, issued 6-60, Final Inventory, Telephone Force Account Construction, columns 1-8.
(44) RUS Form 817b, issued 6-60, Final Inventory, Telephone Force Account Construction, Columns 9-14.
(45) RUS Form 835, issued 3-66, Preloan Engineering Service Contract, Telephone System Design.
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Final rule.
We are adopting a new airworthiness directive (AD) for certain Dassault Aviation Model MYSTERE-FALCON 50, MYSTERE-FALCON 900, FALCON 900EX, FALCON 2000, and FALCON 2000EX airplanes. This AD was prompted by a report of an in-flight lightning strike to the WHELEN anti-collision light located on the top of the vertical fin tip that caused severe damage and resulted in the loss of some airplane functions. This AD requires modification of the anti-collision light bonding. We are issuing this AD to prevent loss of electrical power and essential airplane functions, and possible reduced control of the airplane.
This AD is effective November 22, 2016.
The Director of the Federal Register approved the incorporation by reference of certain publications listed in this AD as of November 22, 2016.
For service information identified in this final rule, 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, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone 425-227-1137; fax 425-227-1139.
We issued a supplemental notice of proposed rulemaking (SNPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain Dassault Aviation Model MYSTERE-FALCON 50, MYSTERE-FALCON 900, FALCON 900EX, FALCON 2000, and FALCON 2000EX airplanes. The SNPRM published in the
The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2015-0006, dated January 15, 2015 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Dassault Aviation Model MYSTERE-FALCON 50, MYSTERE-FALCON 900, FALCON 900EX, FALCON 2000, and FALCON 2000EX airplanes. The MCAI states:
An occurrence was reported where a Falcon 2000 aeroplane experienced an in-flight lightning strike, which caused severe damage and induced the loss of some aeroplane functions. The investigation results revealed that the entering point of the lightning was at the WHELEN anti-collision light located on the top of the vertical fin tip.
When the lightning strike hit the anti-collision light, an electric arc occurred between the aeroplane structure and the anti-collision light and created a conductive path by which the lightning current entered inside the aeroplane. Further analysis has determined that the electrical bonding between the WHELEN anti-collision light, Part Number (P/N) 01-0790044-09, and the fin tip fairing or the No. 2 engine air intake cover is insufficient to withstand a lightning strike.
In case of severe lightning, this condition, if not corrected, could lead to an unsafe condition (loss of electrical power and/or of essential functions) possibly resulting in reduced control of the aeroplane.
To address this potential unsafe condition, Dassault Aviation developed a modification (mod) to improve the WHELEN anti-collision light bonding when the anti-collision light is located on top of the vertical fin tip or on No. 2 engine air intake cover, and issued several Service Bulletins (SB) to modify all affected aeroplanes in service.
For the reasons described above, this [EASA] AD requires modification of the anti-collision light bonding.
We gave the public the opportunity to participate in developing this AD. We received no comments on the SNPRM or on the determination of the cost to the public.
We reviewed the relevant data and determined that air safety and the public interest require adopting this AD as proposed except for minor editorial changes. We have determined that these minor changes:
• Are consistent with the intent that was proposed in the SNPRM for correcting the unsafe condition; and
• Do not add any additional burden upon the public than was already proposed in the SNPRM.
We reviewed the following service information.
• Dassault Service Bulletin F50-481, Revision 1 (also referred to as 481-R1), dated January 26, 2015.
• Dassault Service Bulletin F900-372, Revision 1 (also referred to as 372-R1), dated January 26, 2015.
• Dassault Service Bulletin F900-378, Revision 1 (also referred to as 378-R1), dated January 26, 2015.
• Dassault Service Bulletin F900EX-285, Revision 1 (also referred to as 285-R1), dated January 26, 2015.
• Dassault Service Bulletin F900EX-305, Revision 1 (also referred to as 305-R1), dated January 26, 2015.
• Dassault Service Bulletin F2000-337, Revision 1 (also referred to as 337-R1), dated January 26, 2015.
• Dassault Service Bulletin F2000EX-108, Revision 1 (also referred to as 108-R1), dated January 26, 2015.
The service information describes procedures for modifying the anti-collision light bonding. These documents are distinct since they apply to different airplane models in different configurations. 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
We estimate that this AD affects 778 airplanes of U.S. registry.
We also estimate that it would take about 12 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Required parts would cost about $801 per product. Based on these figures, we estimate the cost of this AD on U.S. operators to be $1,416,738, or $1,821 per product.
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.
We determined that this AD will not have federalism implications under Executive Order 13132. This AD will 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 that this AD:
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 amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This AD is effective November 22, 2016.
None.
This AD applies to Dassault Aviation airplanes, certificated in any category, identified in figure 1 to paragraph (c) of this AD.
Air Transport Association (ATA) of America Code 33, Lights.
This AD was prompted by a report of an in-flight lightning strike to the WHELEN anti-collision light located on the top of the vertical fin tip that caused severe damage and resulted in the loss of some airplane functions. We are issuing this AD to prevent loss of electrical power and essential airplane functions, and possible reduced control of the airplane.
Comply with this AD within the compliance times specified, unless already done.
Within 24 months after the effective date of this AD, modify the anti-collision light bonding, in accordance with the Accomplishment Instructions of the applicable service information specified in paragraphs (g)(1) through (g)(7) of this AD.
(1) For Model MYSTERE-FALCON 50 airplanes: Dassault Service Bulletin F50-481, Revision 1 (also referred to as 481-R1), dated January 26, 2015.
(2) For Model MYSTERE-FALCON 900 airplanes with the WHELEN system installed on the vertical fin tip: Dassault Service Bulletin F900-372, Revision 1 (also referred to as 372-R1), dated January 26, 2015.
(3) For Model MYSTERE-FALCON 900 airplanes with the WHELEN system installed on the S-duct cowl: Dassault Service Bulletin F900-378, Revision 1 (also referred to as 378-R1), dated January 26, 2015.
(4) For Model FALCON 900EX airplanes with the WHELEN system installed on the vertical fin tip: Dassault Service Bulletin F900EX-285, Revision 1 (also referred to as 285-R1), dated January 26, 2015.
(5) For Model FALCON 900EX airplanes with the WHELEN system installed on the S-duct cowl: Dassault Service Bulletin F900EX-305, Revision 1 (also referred to as 305-R1), dated January 26, 2015.
(6) For Model FALCON 2000 airplanes: Dassault Service Bulletin F2000-337, Revision 1 (also referred to as 337-R1), dated January 26, 2015.
(7) For Model FALCON 2000EX airplanes: Dassault Service Bulletin F2000EX-108, Revision 1 (also referred to as 108-R1), dated January 26, 2015.
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 the applicable service information identified in paragraphs (h)(1) through (h)(7) of this AD.
(1) For Model MYSTERE-FALCON 50 airplanes: Dassault Service Bulletin F50-481, dated August 22, 2007.
(2) For Model MYSTERE-FALCON 900 airplanes with the WHELEN system installed on the vertical fin tip: Dassault Service Bulletin F900-372, dated August 22, 2007.
(3) For Model MYSTERE-FALCON 900 airplanes with the WHELEN system installed on the S-duct cowl: Dassault Service Bulletin F900-378, dated September 19, 2007.
(4) For Model FALCON 900EX airplanes with the WHELEN system installed on the vertical fin tip: Dassault Service Bulletin F900EX-285, dated July 18, 2007.
(5) For Model FALCON 900EX airplanes with the WHELEN system installed on the S-duct cowl: Dassault Service Bulletin F900EX-305, dated September 19, 2007.
(6) For Model FALCON 2000 airplanes: Dassault Service Bulletin F2000-337, dated July 25, 2007.
(7) For Model FALCON 2000EX airplanes: Dassault Service Bulletin F2000EX-108, dated July 25, 2007.
The following provisions also apply to this AD:
(1)
(2)
(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA Airworthiness Directive 2015-0006, dated January 15, 2015, for related information. This MCAI may be found in the AD docket on the Internet at
(2) Service information identified in this AD that is not incorporated by reference is available at the addresses specified in paragraphs (k)(3) and (k)(4) of this AD.
(1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this service information as applicable to do the actions required by this AD, unless this AD specifies otherwise.
(i) Dassault Service Bulletin F50-481, Revision 1 (also referred to as 481-R1), dated January 26, 2015.
(ii) Dassault Service Bulletin F900-372, Revision 1 (also referred to as 372-R1), dated January 26, 2015.
(iii) Dassault Service Bulletin F900-378, Revision 1 (also referred to as 378-R1), dated January 26, 2015.
(iv) Dassault Service Bulletin F900EX-285, Revision 1 (also referred to as 285-R1), dated January 26, 2015.
(v) Dassault Service Bulletin F900EX-305, Revision 1 (also referred to as 305-R1), dated January 26, 2015.
(vi) Dassault Service Bulletin F2000-337, Revision 1 (also referred to as 337-R1), dated January 26, 2015.
(vii) Dassault Service Bulletin F2000EX-108, Revision 1 (also referred to as 108-R1), dated January 26, 2015.
(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
(4) You may view this service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.
(5) You may view this service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
Federal Aviation Administration (FAA), DOT.
Final rule.
We are adopting a new airworthiness directive (AD) for certain The Boeing Company Model 767-200, -300, and -400ER series airplanes. This AD was prompted by an evaluation by the design approval holder (DAH) indicating that the skin lap splice is subject to widespread fatigue damage (WFD). This AD requires repetitive external detailed and surface high frequency eddy current (HFEC) inspections of the outer skin for cracking around fastener heads common to the inboard fastener row of the skin lap splice and corrective action. We are issuing this AD to detect and correct fatigue cracking of the skin lap splice, which could grow and result in possible rapid decompression and reduced structural integrity of the airplane.
This AD is effective November 22, 2016.
The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of November 22, 2016.
For service information identified in this final rule, contact Boeing Commercial Airplanes, Attention: Data & Services Management, P. O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone: 206-544-5000, extension 1; fax: 206-766-5680; Internet
You may examine the AD docket on the Internet at
Wayne Lockett, Aerospace Engineer, Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office (ACO), 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-6447; fax: 425-917-6590; email:
We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain The Boeing Company Model 767-200, -300, and -400ER series airplanes. The NPRM published in the
We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the NPRM and the FAA's response to each comment. Boeing stated that it supports the NPRM.
Aviation Partners Boeing stated that accomplishing the supplemental type certificate (STC) ST01920SE does not affect the actions specified in the NPRM.
We concur with the commenter. We have redesignated paragraph (c) of this AD as (c)(1) and added new paragraph (c)(2) to this AD to state that installation of STC ST01920SE does not affect the ability to accomplish the actions required by this final rule. Therefore, for airplanes on which STC ST01920SE is installed, a “change in product” alternative method of compliance (AMOC) approval request is not necessary to comply with the requirements of 14 CFR 39.17.
United Airlines (UAL) requested that we revise the repetitive inspection intervals for any repair accomplished using the structural repair manual (SRM) specified in Part 2 of Boeing Alert Service Bulletin 767-53A0260, dated August 26, 2014. UAL commented that a Zone B repair is Category B, and per the SRM inspections, the airplanes would have an initial inspection at 25,000 total flight cycles after airplane delivery. UAL stated that the initial inspection compliance time for the proposed rule is 40,000 total flight cycles, and if a repair is accomplished at this time, it is already over the initial inspection threshold specified in the SRM.
We agree with the commenter's request. There is a conflict between the initial inspection thresholds in Boeing Alert Service Bulletin 767-53A0260, dated August 26, 2014, and the Category B repair specified in the SRM. We are working with Boeing to revise the conflicting compliance times for the SRM repairs. We have added a new paragraph (h) in this AD, which provides clarification that the post-repair damage tolerance inspections are not required by this AD, but are airworthiness limitations (ALIs), and those inspections are required by maintenance and operational rules. Any deviation from the post-repair ALI inspections will need FAA approval,
UAL requested that we clarify the note in paragraph 3.B.l. of the Accomplishment Instructions of Boeing Alert Service Bulletin 767-53A0260, dated August 26, 2014, to state that inspections for any repair accomplished as a result of Part 1 findings are to be inspected per the Part 1 inspection requirements and that these supersede the SRM inspection requirements. UAL stated that the note in Paragraph 3.B.1. of the Accomplishment Instructions of Boeing Alert Service Bulletin 767-53A0260, dated August 26, 2014, currently states that it is not necessary to repeat the Part 1 inspections in areas covered by a previously approved repair.
We disagree with the commenter's request. Note (a) in paragraph 1.E, “Compliance,” and the note in paragraph 3.B.1. of the Accomplishment Instructions of Boeing Alert Service Bulletin 767-53A0260, dated August 26, 2014, specify terminating action for the AD-mandated inspections for the area under an approved repair. The repairs are evaluated under their own damage tolerance inspection program. The post-repair inspection program is different from the baseline inspections specified in Part 1 of Boeing Alert Service Bulletin 767-53A0260, dated August 26, 2014. Post-repair damage tolerance inspections for any approved repair are ALIs, and these inspections are required by maintenance and operational rules. It is therefore unnecessary to mandate them in this AD. Deviations from these inspections require FAA approval, but do not require an AMOC. We have not changed this AD in this regard.
We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting this AD with the changes described previously and minor editorial changes. We have determined that these minor changes:
• Are consistent with the intent that was proposed in the NPRM for correcting the unsafe condition; and
• Do not add any additional burden upon the public than was already proposed in the NPRM.
We also determined that these changes will not increase the economic burden on any operator or increase the scope of this AD.
We reviewed Boeing Alert Service Bulletin 767-53A0260, dated August 26, 2014. The service information describes procedures for a detailed inspection and a surface HFEC inspection at section 41, stringer S-2R skin lap splice from body station (STA) 368 to STA 434, for any cracking, and repair. 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
We estimate that this AD affects 356 airplanes of U.S. registry.
We estimate the following costs to comply with this AD:
We have received no definitive data that will enable us to provide cost estimates for the on-condition actions specified in this 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 AD will not have federalism implications under Executive Order 13132. This AD will 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 that this AD:
(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),
(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 amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This AD is effective November 22, 2016.
None.
(1) This AD applies to the Boeing Company Model 767-200, -300, and -400ER series airplanes, certificated in any category, as identified in Boeing Alert Service Bulletin 767-53A0260, dated August 26, 2014.
(2) Installation of Supplemental Type Certificate (STC) ST01920SE (
Air Transport Association (ATA) of America Code 53, Fuselage.
This AD was prompted by an evaluation by the design approval holder indicating that the skin lap splice is subject to widespread fatigue damage. We are issuing this AD to detect and correct fatigue cracking of this skin lap splice, which could grow and result in possible rapid decompression and reduced structural integrity of the airplane.
Comply with this AD within the compliance times specified, unless already done.
At the applicable time specified in paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 767-53A0260, dated August 26, 2014, except as required by paragraph (i) of this AD: Do a detailed inspection and a surface high frequency eddy current (HFEC) inspection at section 41, stringer S-2R skin lap splice from body station (STA) 368 to STA 434, for any cracking, and do all applicable corrective actions, in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin 767-53A0260, dated August 26, 2014. Do all applicable corrective actions before further flight. Repeat the inspections thereafter at the applicable times specified in paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 767-53A0260, dated August 26, 2014. If any existing external repair is found in the inspection area, then the inspections in Part 1 of the Accomplishment Instructions of Boeing Alert Service Bulletin 767-53A0260, dated August 26, 2014, are not required in the area hidden by the repair, provided that the repair was previously approved by the Manager, Seattle Aircraft Certification Office (ACO), or by the Authorized Representative of the Boeing Commercial Airplanes Organization Designation Authorization (ODA), or installed as specified in Part 2 of the Accomplishment Instructions of Boeing Alert Service Bulletin 767-53A0260, dated August 26, 2014. Inspections in Part 1 of the Accomplishment Instructions of Boeing Alert Service Bulletin 767-53A0260, dated August 26, 2014, remain applicable in areas not hidden by the repair.
Repairs identified in Part 2 of Boeing Alert Service Bulletin 767-53A0260, dated August 26, 2014, specify post-repair airworthiness limitation inspections for compliance with 14 CFR 25.57l(a)(3) at the repaired locations, which support compliance with 14 CFR 121.1109(c)(2) or 129.109(b)(2). As airworthiness limitations, these inspections are required by maintenance and operational rules. It is therefore unnecessary to mandate them in this AD. Deviations from these inspections require FAA approval, but do not require an AMOC.
Where Boeing Alert Service Bulletin 767-53A0260, dated August 26, 2014, specifies a compliance time “after the original issue date of this service bulletin,” this AD requires compliance within the specified compliance time after the effective date of this AD.
(1) The Manager, Seattle ACO, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the ACO, send it to the attention of the person identified in paragraph (k) of this AD. Information may be emailed to:
(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.
(3) An AMOC that provides an acceptable level of safety may be used for any repair, modification, or alteration required by this AD if it is approved by the Boeing Commercial Airplanes ODA that has been authorized by the Manager, Seattle ACO, to make those findings. To be approved, the repair method, modification deviation, or alteration deviation must meet the certification basis of the airplane, and the approval must specifically refer to this AD.
(4) Except as required by paragraph (i) of this AD: For service information that contains steps that are labeled as Required for Compliance (RC), the provisions of paragraphs (j)(4)(i) and (j)(4)(ii) apply.
(i) The steps labeled as RC, including substeps under an RC step and any figures identified in an RC step, must be done to comply with the AD. If a step or substep is labeled “RC Exempt,” then the RC requirement is removed from that step or substep. An AMOC is required for any deviations to RC steps, including substeps and identified figures.
(ii) Steps not labeled as RC may be deviated from using accepted methods in accordance with the operator's maintenance or inspection program without obtaining approval of an AMOC, provided the RC steps, including substeps and identified figures, can still be done as specified, and the airplane can be put back in an airworthy condition.
For more information about this AD, contact Wayne Lockett, Aerospace Engineer, Airframe Branch, ANM-120S, FAA, Seattle ACO, 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-6447; fax: 425-917-6590; email:
(1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this service information as applicable to do the actions required by this AD, unless the AD specifies otherwise.
(i) Boeing Alert Service Bulletin 767-53A0260, dated August 26, 2014.
(ii) Reserved.
(3) For Boeing service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Data & Services Management, P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone: 206-544-5000, extension 1; fax: 206-766-5680; Internet
(4) You may view this referenced service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.
(5) You may view this service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
Federal Aviation Administration (FAA), DOT.
Final rule.
We are adopting a new airworthiness directive (AD) for Sikorsky Aircraft Corporation (Sikorsky)
This AD is effective November 22, 2016.
The Director of the Federal Register approved the incorporation by reference of a certain document listed in this AD as of November 22, 2016.
For service information identified in this final rule, contact Sikorsky Aircraft Corporation, Customer Service Engineering, 124 Quarry Road, Trumbull, CT 06611; telephone 1-800-Winged-S or 203-416-4299; email
You may examine the AD docket on the Internet at
Kris Greer, Aviation Safety Engineer, Boston Aircraft Certification Office, Engine & Propeller Directorate, 1200 District Avenue, Burlington, Massachusetts 01803; telephone (781) 238-7799; email
On May 13, 2016, at 81 FR 29817, the
The NPRM proposed to require altering the fire bottle inertia switch wiring to disable the automatic feature of the fire extinguishing system and performing a cartridge functional test. The proposed requirements were intended to prevent an unintentional and undetected fire bottle discharge and subsequent unavailability of fire suppression in the event of a fire.
Since the NPRM was issued, the email address for Sikorsky has changed. We have revised this email address throughout this final rule.
We gave the public the opportunity to participate in developing this AD, but we did not receive any comments on the NPRM.
We have reviewed the relevant information and determined that an unsafe condition exists and is likely to exist or develop on other products of the same type design and that air safety and the public interest require adopting the AD requirements as proposed.
We reviewed Sikorsky Alert Service Bulletin 92-26-005A, Revision A, dated June 27, 2014 (ASB 92-26-005A). ASB 92-26-005A specifies performing a one-time alteration of the fire bottle inertia switch wiring to disable the automatic actuation feature of the fire extinguishing system. ASB 92-26-005A includes figures that depict the wiring and electrical connector pin changes.
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
We also reviewed Sikorsky Alert Service Bulletin 92-26-005, Basic Issue, dated June 18, 2014 (ASB 92-26-005). ASB 92-26-005 contains the same procedures as ASB 92-26-005A. However, ASB 92-26-005A contains an additional figure.
This AD has a compliance date within 90 days, and the service information has a calendar date, which has already passed. This AD does not require performing a cartridge functional test prior to alteration. The service information does specify performing a cartridge functional test prior to alteration.
We estimate that this AD will affect 80 helicopters of U.S. Registry.
We estimate that operators may incur the following costs to comply with this AD. Labor costs are estimated at $85 per work-hour. Altering the fire bottle switch and performing a cartridge functional test will take about 2 work-hours. No parts are needed for an estimated cost of $170 per helicopter and $13,600 for the U.S. fleet.
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 AD will not have federalism implications under Executive Order 13132. This AD will 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 that this AD:
(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);
(3) Will not affect intrastate aviation in Alaska to the extent that it justifies making a regulatory distinction; 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.
We prepared an economic evaluation of the estimated costs to comply with this AD and placed it in the AD docket.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This AD applies to Model S-92A helicopters, serial number 920006 through 920250, certificated in any category.
This AD defines the unsafe condition as inadvertent tripping of a fire bottle inertia-switch. This condition results in an unintentional and undetected fire bottle discharge and subsequent unavailability of fire suppression in the event of a fire.
This AD becomes effective November 22, 2016.
You are responsible for performing each action required by this AD within the specified compliance time unless it has already been accomplished prior to that time.
Within 90 days:
(1) Alter each fire bottle inertia switch by following the Accomplishment Instructions, paragraph 3.B., of Sikorsky Alert Service Bulletin 92-26-005A, Revision A, dated June 27, 2014.
(2) Perform a cartridge functional test.
Compliance with Sikorsky Alert Service Bulletin 92-26-005, Basic Issue, dated June 18, 2014, before the effective date of this AD is considered acceptable for compliance with the actions specified in paragraph (e) of this AD.
(1) The Manager, Boston Aircraft Certification Office, FAA, may approve AMOCs for this AD. Send your proposal to: Kris Greer, Aviation Safety Engineer, Boston Aircraft Certification Office, Engine & Propeller Directorate,1200 District Avenue, Burlington, Massachusetts 01803; telephone (781) 238-7799; email
(2) For operations conducted under a 14 CFR part 119 operating certificate or under 14 CFR part 91, subpart K, we suggest that you notify your principal inspector, or lacking a principal inspector, the manager of the local flight standards district office or certificate holding district office before operating any aircraft complying with this AD through an AMOC.
Sikorsky Alert Service Bulletin 92-26-005, Basic Issue, dated June 18, 2014, which is not incorporated by reference, contains additional information about the subject of this final rule. For service information identified in this final rule, contact Sikorsky Aircraft Corporation, Customer Service Engineering, 124 Quarry Road, Trumbull, CT 06611; telephone 1-800-Winged-S or 203-416-4299; email
Joint Aircraft Service Component (JASC) Code: 2621 Fire Bottle, Fixed.
(1) The Director of the Federal Register approved the incorporation by reference of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this service information as applicable to do the actions required by this AD, unless the AD specifies otherwise.
(i) Sikorsky Alert Service Bulletin 92-26-005A, Revision A, dated June 27, 2014.
(ii) Reserved.
(3) For Sikorsky service information identified in this final rule, contact Sikorsky Aircraft Corporation, Customer Service Engineering, 124 Quarry Road, Trumbull, CT 06611; telephone 1-800-Winged-S or 203-416-4299; email
(4) You may view this service information at FAA, Office of the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room 6N-321, Fort Worth, TX 76177. For information on the availability of this material at the FAA, call (817) 222-5110.
(5) You may view this service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call (202) 741-6030, or go to:
Federal Aviation Administration (FAA), DOT.
Final rule.
We are adopting a new airworthiness directive (AD) for all Airbus Model A330-200 Freighter, -200, and -300 series airplanes; and Airbus Model A340-200, -300, -500, and -600 series airplanes. This AD was prompted by reports of fuel leaking through fuel pump electrical connectors and of fuel pump electrical connector damage caused by the build-up of moisture behind the electrical connectors. This AD requires an inspection of the fuel pumps to identify their part numbers and replacement of affected pumps. We are issuing this AD to prevent a potential ignition source and a fuel leak through damaged fuel pump electrical connectors, which creates a flammability risk in an area adjacent to the fuel tank.
This AD is effective November 22, 2016.
The Director of the Federal Register approved the incorporation by reference of certain publications listed in this AD as of November 22, 2016.
For service information identified in this final rule, contact Airbus SAS, Airworthiness Office—EAL, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 45 80; email
You may examine the AD docket on the Internet at
Vladimir Ulyanov, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone: 425-227-1138; fax: 425-227-1149.
We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to all Airbus Model A330-200 Freighter, -200, and -300 series airplanes; and Airbus Model A340-200, -300, -500, and -600 series airplanes. The NPRM published in the
The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2015-0194, dated September 22, 2015, to correct an unsafe condition for all Airbus Model A330-200 Freighter, -200, and -300 series airplanes; and Airbus Model A340-200, -300, -500, and -600 series airplanes. The MCAI states:
Operators reported cases of fuel leak through fuel pump electrical connectors. Subsequent investigation revealed fuel pump electrical connector damage caused by moisture build up behind the electrical connector.
This condition, if not detected and corrected, could create concurrently an ignition source and fuel leak as a result of a single failure, resulting in exposure to a flammability risk in an adjacent area to the fuel tank.
To address this unsafe condition, Airbus published Service Bulletins (SB) A330-28-3127, SB A340-28-4138 and SB A340-28-5060, providing inspection/identification instructions, and instructions for replacement of the fuel pumps.
For the reasons described above, this [EASA] AD requires identification and replacement of the affected fuel pumps.
You may examine the MCAI in the AD docket on the Internet at
We gave the public the opportunity to participate in developing this AD. The following presents the comment received on the NPRM and the FAA's response to the comment.
American Airlines (AAL) requested that we clarify which groups of pumps paragraphs (h)(1) and (h)(2) of the proposed AD are intended to control. Where individual items begin with “All of the affected pumps. . . .” AAL explained that paragraph (h) of the proposed AD must be intended to refer to all of the affected pumps on each airplane. AAL pointed out that this language creates a requirement for all airplanes that have one or more pumps having part number (P/N) 568-1-28300-001 or 568-1-28300-002 installed to be modified in accordance with the service information within 72 months. AAL asserted that consistent references to “each affected pump” confuse that interpretation and seem to imply that each pump is treated separately. If the intent is to control the compliance time for replacement at the pump level, AAL stated that it would be more efficient to simply state that -001 and -002 pumps must be replaced within 72 months, while -100 and -101 pumps must be replaced within 96 months. If the intent is to control the compliance time at the airplane level, AAL stated that the language throughout paragraph (h) of the proposed AD should be revised to reflect that intent; American provided some example language.
We agree that this AD should specify the compliance times at the airplane level. Therefore, we have revised paragraphs (h)(1) and (h)(2) of this AD by replacing the text in the beginning of the sentences, “For affected fuel pumps that have . . . , ” with the text “For airplanes with fuel pumps that have . . .” in order to clearly identify the airplane configuration.
We reviewed the relevant data, considered the comment received, and determined that air safety and the public interest require adopting this AD with the changes described previously and minor editorial changes. We have determined that these minor changes:
• Are consistent with the intent that was proposed in the NPRM for correcting the unsafe condition; and
• Do not add any additional burden upon the public than was already proposed in the NPRM.
We also determined that these changes will not increase the economic burden on any operator or increase the scope of this AD.
Airbus has issued the following service information:
• Airbus Service Bulletin A330-28-3127, Revision 02, dated April 14, 2016.
• Airbus Service Bulletin A340-28-4138, Revision 01, dated September 24, 2015.
• Airbus Service Bulletin A340-28-5060, Revision 01, dated September 24, 2015.
The service information describes procedures to identify and replace affected fuel pumps with serviceable fuel pumps. These documents are distinct since they apply to different airplane models. 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
We estimate that this AD affects 99 airplanes of U.S. registry.
We also estimate that it will take about 4 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Based on these figures, we estimate the cost of this AD on U.S. operators to be $33,660, or $340 per product.
In addition, we estimate that any necessary follow-on actions would take about 17 work-hours and require parts costing $10,400, for a cost of $11,845 per product. We have no way of determining the number of airplanes that might need these actions.
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.
We determined that this AD will not have federalism implications under Executive Order 13132. This AD will 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 that this AD:
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 amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This AD is effective November 22, 2016.
None.
This AD applies to Airbus Model A330-223F and -243F airplanes; Model A330-201, -202, -203, -223, and -243 airplanes; Model A330-301, -302, -303, -321, -322, -323, -341, -342, and -343 airplanes; Model A340-211, -212, and -213 airplanes; Model A340-311, -312, and -313 airplanes; Model A340-541 and A340-642 airplanes; certificated in any category; all manufacturer serial numbers.
Air Transport Association (ATA) of America Code 28, Fuel.
This AD was prompted by reports of fuel leaking through fuel pump electrical connectors and of fuel pump electrical connector damage caused by the build-up of moisture behind the electrical connectors. Electrical connections that become damaged by moisture can create an ignition source and a fuel leak. We are issuing this AD to prevent a potential ignition source and a fuel leak through damaged fuel pump electrical connectors, which creates a flammability risk in an area adjacent to the fuel tank.
Comply with this AD within the compliance times specified, unless already done.
Within 48 months after the effective date of this AD, inspect each fuel pump to identify the part number, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A330-28-3127, Revision 02, dated April 14, 2016; Airbus Service Bulletin A340-28-4138, Revision 01, dated September 24, 2015; or Airbus Service Bulletin A340-28-5060, Revision 01, dated September 24, 2015; as applicable to airplane model. A review of airplane delivery or maintenance records is acceptable in lieu of this inspection if the part number of the fuel pump can be conclusively determined from that review.
If, during the inspection required by paragraph (g) of this AD, it is determined that any affected fuel pump is installed: Within the compliance time specified in paragraph (h)(1) or (h)(2) of this AD, depending on the configuration of the affected fuel pumps installed, replace each affected fuel pump with a serviceable fuel pump, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A330-28-3127, Revision 02, dated April 14, 2016; Airbus Service Bulletin A340-28-4138, Revision 01, dated September 24, 2015; or Airbus Service Bulletin A340-28-5060, Revision 01, dated September 24, 2015; as applicable to airplane model.
(1) For airplanes with fuel pumps that have a part number or combination of part numbers that are specified in paragraphs (h)(1)(i) through (h)(1)(vi) of this AD: Do the replacement within 72 months after the effective date of this AD.
(i) All installed fuel pumps have P/N 568-1-28300-001.
(ii) All installed fuel pumps have P/N 568-1-28300-002.
(iii) Installed fuel pumps have a combination of P/Ns 568-1-28300-001 and 568-1-28300-002.
(iv) Installed fuel pumps have a combination of P/Ns 568-1-28300-001 and 568-1-28300-101.
(v) Installed fuel pumps have a combination of P/Ns 568-1-28300-002 and 568-1-28300-101.
(vi) Installed fuel pumps have a combination of P/Ns 568-1-28300-001, 568-1-28300-002, and 568-1-28300-101.
(2) For airplanes with fuel pumps that have a part number or combination of part numbers that are specified in paragraphs (h)(2)(i) through (h)(2)(iii) of this AD: Do the replacement within 96 months after the effective date of this AD.
(i) All installed fuel pumps have P/N 568-1-28300-100.
(ii) All installed fuel pumps have P/N 568-1-28300-101.
(iii) Installed fuel pumps have a combination of P/Ns 568-1-28300-100 and 568-1-28300-101.
(1) For the purpose of this AD, an “affected fuel pump” is defined as any pump having P/N 568-1-28300-001, 568-1-28300-002, 568-1-28300-100, or 568-1-28300-101.
(2) For the purpose of this AD, a “serviceable fuel pump” is a pump having a part number not listed in paragraph (i)(1) of this AD.
Although Airbus Service Bulletin A330-28-3127, Revision 02, dated April 14, 2016; Airbus Service Bulletin A340-28-4138, Revision 01, dated September 24, 2015; and Airbus Service Bulletin A340-28-5060, Revision 01, dated September 24, 2015; specify submitting certain information to the manufacturer, and specifies that action as “RC” (Required for Compliance), this AD does not include that requirement.
After the identification of the fuel pump part numbers required by paragraph (g) of this AD, comply with the prohibition
(1) For an airplane that does not have an affected fuel pump installed: After the identification of the fuel pump part numbers required by paragraph (g) of this AD, no person may install an affected fuel pump on the airplane.
(2) For an airplane that has an affected fuel pump installed: After modification of the airplane as required by paragraph (h) of this AD, no person may install an affected fuel pump on the airplane.
This paragraph provides credit for actions required by paragraphs (g) and (h) of this AD, if those actions were performed before the effective date of this AD using the applicable service information specified in paragraphs (l)(1), (l)(2), (l)(3), and (l)(4) of this AD. This service information is not incorporated by reference in this AD.
(1) Airbus Service Bulletin A330-28-3127, dated July 14, 2015.
(2) Airbus Service Bulletin A330-28-3127, Revision 01, dated September 24, 2015.
(3) Airbus Service Bulletin A340-28-4138, dated July 14, 2015.
(4) Airbus Service Bulletin A340-28-5060, dated July 14, 2015.
The following provisions also apply to this AD:
(1)
(2)
(3)
(1) Refer to Continuing Airworthiness Information (MCAI) EASA AD 2015-0194, dated September 22, 2015, for related information. You may examine the MCAI on the Internet at
(1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this service information as applicable to do the actions required by this AD, unless this AD specifies otherwise.
(i) Airbus Service Bulletin A330-28-3127, Revision 02, dated April 14, 2016.
(ii) Airbus Service Bulletin A340-28-4138, Revision 01, dated September 24, 2015.
(iii) Airbus Service Bulletin A340-28-5060, Revision 01, dated September 24, 2015.
(3) For service information identified in this AD, contact Airbus SAS, Airworthiness Office—EAL, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone: +33 5 61 93 36 96; fax: +33 5 61 93 45 80; email:
(4) You may view this service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.
(5) You may view this service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Final rule.
We are superseding Airworthiness Directive (AD) 95-21-09 for all Airbus Model A300 series airplanes, and Airbus Model A300 B4-600, B4-600R, and F4-600R series airplanes, and Model A300 C4-605R Variant F airplanes (collectively called Model A300-600 series airplanes). AD 95-21-09 required repetitive inspections for cracking of the No. 2 flap beams, and replacement of the flap beams, if necessary; and provided optional modifications for extending certain inspection thresholds, and an optional terminating modification for certain inspections. This new AD requires reduced compliance times for inspections and also reduces the number of airplanes affected. This AD was prompted by a determination that the compliance times must be reduced. We are issuing this AD to detect and correct cracking of the No. 2 flap beams, which could result in rupture of the flap beams and reduced structural integrity of the airplane.
This AD is effective November 22, 2016.
The Director of the Federal Register approved the incorporation by reference of certain publications listed in this AD as of November 22, 2016.
The Director of the Federal Register approved the incorporation by reference of certain other publications listed in this AD as of November 17, 1995 (60 FR 53847, October 18, 1995).
For service information identified in this final rule, contact Airbus SAS, Airworthiness Office—EAW, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51; email
You may examine the AD docket on the Internet at
Dan Rodina, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone 425-227-2125; fax 425-227-1149.
We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 95-21-09, Amendment 39-9395 (60 FR 53847, October 18, 1995) (“AD 95-21-09”). AD 95-21-09 applied to all Airbus Model A300 and A300-600 series airplanes. The NPRM published in the
The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2013-0234R2, dated October 7, 2013 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Airbus Model A300 and A300-600 series airplanes. The MCAI states:
Fatigue and “fail safe” tests developed on a test specimen confirmed that cracks may appear and propagate from the bolt holes of the base member and the side members of flap beam No. 2.
The development of such cracks, if not detected, could result in a rupture of flap beams No. 2, which could adversely affect the structural integrity of the airframe.
To address this potential unsafe condition, Airbus issued Service Bulletin (SB) A300-57-0116 and SB A300-57-6005 and DGAC [Direction Générale de l'Aviation Civile] France issued AD 1986-187-076(B), later revised, to require a repetitive inspection programme [and corrective action] for A300 and A300-600 aeroplanes. [French AD 86-187-076(B)R3, dated March 2, 1994, corresponds to FAA AD 95-21-09, which superseded FAA AD 85-07-04, Amendment 39-5027 (50 FR 13013, April 2, 1985).]
For A300 aeroplanes, and in the frame of the Extended Service Goal (ESG) exercise, it was shown that design changes (Airbus Mod. 4740/Airbus SB A300-57-0128 or Airbus Mod. 5815/Airbus SB A300-57-0141) were not sufficient to enable full ESG life without inspections.
For A300-600 aeroplanes, since DGAC France AD 1986-187-076(B) was issued, a fleet survey and updated Fatigue and Damage Tolerance analyses have been performed in order to substantiate the second A300-600 ESG2 exercise. Airbus SB A300-57-6005 has been revised accordingly to decrease the inspection thresholds and intervals.
For the reasons described above, this [EASA] AD retains the requirements of DGAC France AD 1986-187-076(B)R4, which is superseded, and requires those inspections to be accomplished at reduced thresholds and intervals.
This [EASA] AD has been revised to correct typographical errors in some compliance times defined in Appendix 1, Tables 1 and 2.
The MCAI also reduces the number of airplanes identified in the applicability by exempting certain Model A300-600 airplanes on which certain Airbus modifications have been embodied. You may examine the MCAI in the AD docket on the Internet at
We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the NPRM and the FAA's response to each comment.
United Parcel Service (UPS) requested that the applicability exceptions in paragraphs (c)(3) and (c)(4) of the proposed AD be revised to remove Airbus Modifications 11133 and 12699 as exceptions. UPS stated that the exceptions provided in paragraphs (c)(3) and (c)(4) of the proposed AD are inconsistent with the effectivity specified in the service information referenced in the NPRM. UPS pointed out that the effectivity of Airbus Service Bulletin A300-57-6005, Revision 06, dated November 14, 2013, applies to airplanes with manufacturer serial number (MSN) 775 and subsequent, with MSN 775 as the production cut-in for Airbus Modification 11133. UPS asserted that this service bulletin's effectivity also does not list all post-modification 11133 and 12699 airplanes. UPS stated that the determining factor for the service information effectivity is whether an airplane is approved for the extended service goal (ESG-2) operational life or not. UPS also pointed out that the effectivity of Airbus Service Bulletin A300-57-6005, Revision 06, dated November 14, 2013, does not include Model A300 F4-622 airplanes that are in a UPS configuration (Airbus Modifications 11133, 12047, 12048, 12050, but not 12699), which would mean UPS would need to request an alternative method of compliance (AMOC) or other means to show compliance for those airplanes.
We acknowledge the concern UPS identified regarding the clarity of the AD applicability. Therefore, we have revised the applicability to match the related MCAI, which should address UPS's concern. We do not intend for this AD to affect UPS's specified A300 F4-622R configuration (Airbus Modifications 11133, 12047, 12048, 12050, but not 12699). We have revised paragraph (c)(4) of this AD accordingly. However, we do not agree to delete references to both Airbus Modifications 11133 and 12699 from the applicability of this AD since there are airplanes with these modifications in the worldwide fleet that might be imported and placed on the U.S. Register. Therefore, we have not removed references to Airbus Modifications 11133 and 12699 from paragraphs (c)(3) and (c)(4) of this AD.
UPS requested that paragraph (l)(2) of the proposed AD be revised to remove a typographical error that resulted in listing Model A300 F4-622R airplanes twice.
We agree that there was a typographical error, as described by UPS. We have removed the redundant reference in this AD.
We added new paragraph (m) to this AD to specify clearly the required calculation method for establishing the average flight times (AFT) for the compliance times for certain inspections required by this AD. We also redesignated subsequent paragraphs.
We reviewed the available data, including the comments received, and determined that air safety and the public interest require adopting this AD with the changes described previously
• Are consistent with the intent that was proposed in the NPRM for correcting the unsafe condition; and
• Do not add any additional burden upon the public than was already proposed in the NPRM.
Airbus has issued Service Bulletins A300-57-0116, Revision 07, dated September 19, 2011, including Appendixes A and B; and A300-57-6005, Revision 06, dated November 14, 2013. This service information describes procedures for ultrasonic inspections of the No. 2 flap beam base and side members. These documents are distinct since they apply to different airplane models. 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
We estimate that this AD affects 49 airplanes of U.S. registry.
The actions required by AD 95-21-09 and retained in this AD, take about 6 work-hours per product, at an average labor rate of $85 per work-hour. Required parts cost about $0 per product. Based on these figures, the estimated cost of the actions that were required by AD 95-21-09 is $510 per product, per inspection cycle.
We also estimate that it takes about 6 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Based on these figures, we estimate the cost of this AD on U.S. operators to be $24,990 per inspection cycle, or $510 per product, per inspection cycle.
We have received no definitive data that would enable us to provide cost estimates for the on-condition actions specified in this 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.
We determined that this AD will not have federalism implications under Executive Order 13132. This AD will 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 that this AD:
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 amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This AD is effective November 22, 2016.
This AD replaces AD 95-21-09, Amendment 39-9395 (60 FR 53847, October 18, 1995) (“AD 95-21-09”).
This AD applies to the Airbus airplanes identified in paragraphs (c)(1) through (c)(5) of this AD, certificated in any category.
(1) Airbus Model A300 B2-1A, B2-1C, B2K-3C, B2-203, B4-2C, B4-103, and B4-203 airplanes, all manufacturer serial numbers (MSNs).
(2) Airbus Model A300 B4-601, B4-603, B4-620, B4-622, B4-605R, and B4-622R airplanes, all MSNs.
(3) Airbus Model A300 F4-605R, all MSNs, except those airplanes on which both Airbus Modifications 11133 and 12699 have been embodied.
(4) Airbus Model A300 F4-622R airplanes, all MSNs, except those airplanes on which the modifications identified in paragraph (c)(4)(i) or (c)(4)(ii) of this AD have been embodied.
(i) All Airbus Modifications 11133, 12047, 12048, and 12050 have been embodied.
(ii) Both Airbus Modifications 11133 and 12699 have been embodied.
(5) Airbus Model A300 C4-605R Variant F airplanes, all MSNs.
Air Transport Association (ATA) of America Code 57, Wings.
This AD was prompted by a determination that the compliance times must be reduced. We are issuing this AD to detect and correct cracking of the No. 2 flap beams, which could result in rupture of the flap beams and reduced structural integrity of the airplane.
Comply with this AD within the compliance times specified, unless already done.
This paragraph restates the requirements of paragraph (a) of AD 95-21-09, with Note 3 of AD 95-21-09 incorporated and additional terminating provisions. For Model A300 series airplanes: Prior to the accumulation of 15,000 total landings, or within the next 120 days after May 9, 1985 (the effective date of AD 85-07-04, Amendment 39-5027 (50 FR 13013, April 2, 1985) (“AD 85-07-04”)), whichever occurs later, inspect for cracking of the base steel member and light alloy side members of the No. 2 flap beams, left hand and right hand, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A300-57-116, Revision 6, dated July 16, 1993. Accomplishing the requirements of paragraph (h) or (l) of this AD terminates the requirements of this paragraph. Measurement of crack length is performed by measurement of the probe displacement (perpendicular to symmetry plane of beam) between defect indication appearance and its complete disappearance. The bolt hole indication should not be interpreted as an indication of a defect. These two indications appear very close together because the defects originate from the bolt holes.
(1) If no cracking is detected: Except as provided by paragraph (i) of this AD, repeat the inspection at intervals not to exceed 1,700 landings until the requirements of paragraph (h) or (l) of this AD are accomplished.
(2) If any crack is detected that is less than or equal to 4 millimeters (mm): Repeat the inspection at intervals not to exceed 250 landings, until the requirements of paragraph (h) or (l) of this AD are accomplished.
(3) If any crack is detected that exceeds 4 mm: Prior to further flight, replace the flap beam in accordance with the Accomplishment Instructions of Airbus Service Bulletin A300-57-116, Revision 6, dated July 16, 1993, and prior to the accumulation of 15,000 flight cycles on the replaced flap beam, perform the ultrasonic inspection as required by paragraph (h) or (l) of this AD.
This paragraph restates the requirements of paragraph (b) of AD 95-21-09, with additional terminating provisions. For Model A300 series airplanes: Prior to the accumulation of 15,000 total landings, or within the next 1,000 landings after November 17, 1995 (the effective date of AD 95-21-09), whichever occurs later, perform an ultrasonic inspection to detect cracking of the No. 2 flap beams, in accordance with Airbus Service Bulletin A300-57-116, Revision 6, dated July 16, 1993. Accomplishment of this inspection terminates the inspections required by paragraph (g) of this AD. Accomplishment of the requirements of paragraph (l) of this AD terminates the requirements of this paragraph.
(1) If no cracking is detected: Except as provided by paragraph (i) of this AD, repeat the ultrasonic inspections thereafter at intervals not to exceed 1,700 landings.
(2) If any crack is detected beyond the bolt hole, and that crack is less than or equal to 4 mm in length: Repeat the ultrasonic inspections thereafter at intervals not to exceed 250 landings.
(3) If any crack is detected beyond the bolt hole and that crack is greater than 4 mm in length: Prior to further flight, replace the flap beam in accordance with Airbus Service Bulletin A300-57-116, Revision 6, dated July 16, 1993; and prior to the accumulation of 15,000 flight cycles on the replaced flap beam, perform the ultrasonic inspection as required by this paragraph.
This paragraph restates the provisions of paragraph (c) of AD 95-21-09, with changes to compliance extension. For Model A300 series airplanes: After accomplishing the initial inspection required by paragraph (h) of this AD, accomplishment of either paragraph (i)(1) or (i)(2) of this AD before the effective date of this AD extends the fatigue life of the No. 2 flap track beam as specified in those paragraphs, provided that no cracking is detected during any inspection required by paragraph (g) or (h) of this AD.
(1) Removal of any damage and the installation of larger diameter bolts on the No. 2 flap track beam (Modification No. 4740), in accordance with Airbus Service Bulletin A300-57-128, Revision 3, dated January 26, 1990, extends the interval for the first repetitive inspection required by paragraph (h) of this AD from 1,700 landings to 12,000 landings, provided that Modification No. 4740 is accomplished prior to the accumulation of 16,700 total landings on the flap beams. Following accomplishment of the first repetitive inspection, subsequent repetitive inspections shall be performed at intervals not to exceed 1,700 landings.
(2) Cold working of the bolt holes and the installation of larger diameter bolts on the No. 2 flap track beam (Modification No. 5815), in accordance with Airbus Service Bulletin A300-57-141, Revision 7, dated July 16, 1993, extends the interval for the first repetitive inspection required by paragraph (h) of this AD from 1,700 landings to the interval specified in paragraph (i)(2)(i) or (i)(2)(ii) of this AD.
(i) If interference fit bolts that are
(ii) If interference fit bolts that are
This paragraph restates the requirements of paragraph (d) of AD 95-21-09, with terminating provisions. For Model A300-600 series airplanes: Prior to the accumulation of 15,000 total landings, or within the next 1,000 landings after November 17, 1995 (the effective date of AD 95-21-09), whichever occurs later, perform an ultrasonic inspection to detect cracking of the No. 2 flap track beams, in accordance with Airbus Service Bulletin A300-57-6005, Revision 2, dated December 16, 1993. Accomplishing the actions required by paragraph (l) of this AD terminates the requirements of this paragraph.
(1) If no cracking is detected, repeat the ultrasonic inspections thereafter at intervals not to exceed 1,700 landings.
(2) If any crack is detected beyond the bolt hole and that crack is less than or equal to 4 mm in length: Repeat the ultrasonic inspections thereafter at intervals not to exceed 250 landings.
(3) If any crack is detected beyond the bolt hole and that crack is greater than 4 mm in length: Prior to further flight, replace the flap beam in accordance with Airbus Service Bulletin A300-57-6005, Revision 2, dated December 16, 1993, and prior to the accumulation of 15,000 landings on the replaced flap beam, perform the ultrasonic inspection required by paragraph (j) of this AD.
This paragraph restates the provisions of paragraph (e) of AD 95-21-09, with Note 5 of AD 95-21-09 incorporated and changes to terminating action. For Model A300-600 series airplanes: Installation of oversized transition fit bolts in cold-worked holes, in accordance with Airbus Service Bulletin A300-57-6006, Revision 4, dated July 25, 1994 (Modification No. 5815), constitutes terminating action for the repetitive inspection requirements of paragraph (j) of this AD, provided that no cracking is detected during any inspection required by paragraph (j) of this AD, and provided that the installation is accomplished prior to the accumulation of 15,000 total landings and before the effective date of this AD. If any bolt requires oversizing above
At the applicable time specified in paragraph (l)(1) or (l)(2) of this AD and, thereafter at intervals not to exceed those defined in table 3 to paragraph (l) of this AD, as applicable, accomplish an ultrasonic inspection for cracking of the steel base member and the aluminum side members' flap beam on the left-hand (LH) and right-hand (RH) sides, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A300-57-0116, Revision 07, dated September 19, 2011, including Appendixes A and B; or Airbus Service Bulletin A300-57-6005, Revision 06, dated November 14, 2013; as applicable. For the purposes of this AD, average flight time
(1) For Model A300 B2-1A, B2-1C, B2K-3C, B2-203, B4-2C, B4-103, and B4-203 airplanes (referred to as Model A300 series airplanes): Within the applicable compliance time defined in table 1 to paragraph (l) of this AD.
(2) For Model A300 B4-601, B4-603, B4-620, B4-622, B4-605R, B4-622R, F4-605R, F4-622R airplanes, and Model A300 C4-605R Variant F airplanes (referred to as Model A300-600 series airplanes): At the later of the times specified in paragraphs (l)(2)(i) and (l)(2)(ii) of this AD.
(i) Within the compliance time defined in table 2 to paragraph (l) of this AD.
(ii) Within 300 flight cycles or 640 flight hours after the effective date of this AD, whichever occurs first.
For the purpose of this AD, the AFT must be established as specified in paragraphs (m)(1), (m)(2), and (m)(3) of this AD.
(1) For the initial inspection, the average flight time is the total accumulated flight hours, counted from take-off to touch-down, divided by the total accumulated flight cycles at the effective date of this AD.
(2) For the first repeated inspection interval, the average flight time is the total accumulated flight hours divided by the total accumulated flight cycles at the time of the inspection threshold.
(3) For all inspection intervals onward, the average flight time is the flight hours divided by the flight cycles accumulated between the last two inspections.
If any crack is found during any inspection required by paragraph (l) of this AD: Before further flight, replace the flap beam using a method approved by the Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA; or the European Aviation Safety Agency (EASA); or Airbus's EASA Design Organization Approval (DOA). Replacement of the flap beam does not constitute terminating action for the inspections required by paragraph (l) of this AD.
(1) This paragraph provides credit for inspections required by paragraph (g) of this AD, if those inspections were performed before November 17, 1995 (the effective date of AD 95-21-09) using Airbus Service Bulletin A300-57-116, Revision 1, dated August 27, 1983; Revision 2, dated April 24, 1984; Revision 3, dated July 20, 1984; Revision 4, dated August 13, 1986; or Revision 5, dated July 10, 1989; as applicable.
(2) This paragraph provides credit for actions required by paragraph (l) of this AD, if those actions were performed before the effective date of this AD using the applicable service information identified in paragraphs (o)(2)(i) through (o)(2)(x) of this AD.
(i) Airbus Service Bulletin A300-57-6005, Revision 2, dated December 16, 1993, which was previously incorporated by reference on November 17, 1995 (60 FR 53847, October 18, 1995).
(ii) Airbus Service Bulletin A300-57-6005, Revision 03, dated November 25, 1997.
(iii) Airbus Service Bulletin A300-57-6005, Revision 04, dated October 25, 1999.
(iv) Airbus Service Bulletin A300-57-6005, Revision 05, dated April 25, 2013.
(v) Airbus Service Bulletin A300-57-116, Revision 1, dated August 27, 1983.
(vi) Airbus Service Bulletin A300-57-116, Revision 2, dated April 24, 1984.
(vii) Airbus Service Bulletin A300-57-116, Revision 3, dated July 20, 1984.
(viii) Airbus Service Bulletin A300-57-116, Revision 4, dated August 13, 1986.
(ix) Airbus Service Bulletin A300-57-116, Revision 5, dated July 10, 1989.
(x) Airbus Service Bulletin A300-57-116, Revision 6, dated July 16, 1993, which was previously incorporated by reference on November 17, 1995 (60 FR 53847, October 18, 1995).
The following provisions also apply to this AD:
(1)
(i) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.
(ii) AMOCs approved previously for AD 95-21-09, are approved as AMOCs for the corresponding provisions of paragraphs (g) through (j) of this AD.
(2)
(3)
(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA AD 2013-0234R2, dated October 7, 2013, for related information. This MCAI may be found in the AD docket on the Internet at
(2) Service information identified in this AD that is not incorporated by reference is available at the addresses specified in paragraphs (r)(5) and (r)(6) of this AD.
(1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this service information as applicable to do the actions required by this AD, unless this AD specifies otherwise.
(3) The following service information was approved for IBR on November 22, 2016.
(i) Airbus Service Bulletin A300-57-0116, Revision 07, dated September 19, 2011, including Appendixes A and B. Only the first page of Appendixes A and B of this document are identified as appendixes.
(ii) Airbus Service Bulletin A300-57-6005, Revision 06, dated November 14, 2013.
(4) The following service information was approved for IBR on November 17, 1995 (60 FR 53847, October 18, 1995).
(i) Airbus Service Bulletin A300-57-116, Revision 6, dated July 16, 1993, which contains the following effective pages: Pages 1 through 11 of this document are identified as Revision 6, dated July 16, 1993.
(ii) Airbus Service Bulletin A300-57-128, Revision 3, dated January 26, 1990, which contains the following effective pages: Page 1 is identified as Revision 3, dated January 26, 1990; pages 2 through 5 are identified as Revision 1, dated February 7, 1986; and pages 6 through 14 are identified as the original issue, dated August 27, 1983.
(iii) Airbus Service Bulletin A300-57-141, Revision 7, dated July 16, 1993, which contains the following effective pages: Pages 1 through 24 of this document are identified as Revision 7, dated July 16, 1993.
(iv) Airbus Service Bulletin A300-57-6005, Revision 2, dated December 16, 1993, which contains the following effective pages: Pages 1 through 4 are identified as Revision 2, dated December 16, 1993; pages 5 through 7 and 9 are identified as Revision 1, dated February 26, 1993; and page 8 is identified as the original issue, dated August 13, 1986.
(v) Airbus Service Bulletin A300-57-6006, Revision 4, dated July 25, 1994, which contains the following effective pages: Pages 1, 2, 5, and 7 are identified as Revision 4, dated July 25, 1994; and pages 3, 4, 6, and 8 through 20 are identified as Revision 3, dated December 16, 1993.
(5) For service information identified in this AD, contact Airbus SAS, Airworthiness Office—EAW, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51; email
(6) You may view this service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.
(7) You may view this service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Final rule.
We are adopting a new airworthiness directive (AD) for certain Airbus Model A318 and A319 series airplanes; Model A320-211, -212, -214, -231, -232, and -233 airplanes; and Model A321 series airplanes. This AD was prompted by a report of cracks found during maintenance inspections on certain lugs of the 10VU rack side fittings in the cockpit. This AD requires repetitive inspections for cracking of the lugs on the 10VU rack side fittings, and repair of any cracking. We are issuing this AD to prevent reading difficulties of flight-critical information displayed to the flightcrew during a critical phase of flight, such as an approach or takeoff, which could result in loss of airplane control at an altitude insufficient for recovery.
This AD is effective November 22, 2016.
The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of November 22, 2016.
For service information identified in this final rule, contact Airbus, Airworthiness Office—EIAS, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51; email
You may examine the AD docket on the Internet at
Sanjay Ralhan, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone 425-227-1405; fax 425-227-1149.
We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain Airbus Model A318, A319, A320, and A321 series airplanes. The NPRM published in the
The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2015-0170, dated August 18, 2015 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Airbus Model A318 and A319 series airplanes; Model A320-211, -212, -214, -231, -232, and -233 airplanes; and Model A321 series airplanes. The MCAI states:
During an unscheduled maintenance operation on an A330 aeroplane, the 10VU rack was removed for access and cracks were discovered on 10VU rack side fittings on lugs 1, 3, and 4. As a similar design is installed on A320 family aeroplanes, a sampling review was done to determine the possible fleet impact. The result showed that several aeroplanes had cracked or broken 10VU rack side fittings.
This condition, if not detected and corrected, could lead to a high vibration level on the primary flight- and navigation displays during critical flight phases (takeoff and landing), possibly creating reading difficulties for the crew.
Prompted by these findings, Airbus developed mod 35869 to reinforce the affected rack fitting lugs. For in-service aeroplanes, Airbus published Service Bulletin (SB) A320-92-1087 to provide inspection and repair instructions.
For the reasons described above, this [EASA] AD requires repetitive detailed inspections (DET) of the affected 10VU rack fitting lugs and, depending on findings, accomplishment of a repair.
We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the NPRM and the FAA's response to each comment.
Airbus asked that we revise the unsafe condition by stating that the NPRM is intended to prevent “reading difficulties of flight-critical information,” and not “loss of flight-critical information.” Airbus stated that this clarification would correspond with the language specified in EASA AD 2015-0170, dated August 18, 2015.
We agree with the commenter's request, for the reason provided. We have clarified the unsafe condition in the
Delta Airlines (DAL) asked that the compliance time specified in the NPRM be extended from 24 to 36 months. DAL stated that the subject cracking issue has been known for over five years; however, the FAA just recently took regulatory action. DAL added that there have been no in-service reports of issues related to safety of flight due to the cracking condition. DAL noted that the unsafe condition of vibration during a critical phase of flight is theoretical and not based on actual testing or experience. In light of this, DAL stated that the 24-month time limit is unwarranted, and should be extended to 36 months to allow more time so the inspection can be accomplished during a hangar visit.
We do not agree with the commenter's request. In developing an appropriate compliance time for the actions specified in this AD, we considered the safety implications and normal maintenance schedules for the timely accomplishment of the specified actions. We have determined that the proposed 24-month compliance time will ensure an acceptable level of safety and allow the actions to be done during scheduled maintenance intervals for most affected operators. However, affected operators may request an alternative method of compliance (AMOC) for an extension of the compliance time under the provisions of paragraph (i)(1) of this AD by submitting data and analysis substantiating that the change would provide an acceptable level of safety. We have not changed this AD in this regard.
DAL asked that the proposed mandatory reporting requirement in paragraph (h) of the proposed AD be removed. DAL understands that Airbus wants to gather necessary in-service information; however, the airworthiness of the airplane does not depend on mandatory reporting. DAL stated that the airplane would be airworthy and public safety would be maintained without the mandatory reporting requirement. DAL added that requiring reporting places an unfair burden on operators of Airbus airplanes compared to operators of airplanes produced by other manufacturers, particularly when there are no findings, because reporting is mandated for the benefit of the original equipment manufacturer. DAL concluded that the reporting should not be mandated through this regulatory action.
We do not agree with the commenter's request to remove the reporting requirement in paragraph (h) of this AD. We disagree that public safety would be maintained without the mandatory reporting requirement. Reporting is necessary for the airframe manufacturer to determine the extent of the cracking of the lugs on the 10VU rack side fittings, and to ascertain any necessary follow-up actions. Therefore, we have not changed this AD in this regard.
DAL asked for clarification of the format necessary to report the inspection results specified in paragraph (h) of the proposed AD. DAL asked if the reporting form located in the back of Airbus Service Bulletin A320-92-1087, Revision 02, dated November 25, 2014, must be used or if the report can be submitted using another format.
While we recommend that operators use the form in Figure A-FRAAA—Sheet 02, titled “Inspection Report,” of Airbus Service Bulletin A320-92-1087, Revision 02, dated November 25, 2014, this AD does not require use of that form. We have changed paragraph (h) of this AD to clarify our intent.
DAL also noted that it disagrees with having to determine and report the supplemental type certificate (STC) status for equipment attached to the 10VU rack, as specified in Figure A-FRAAA—Sheet 02, titled “Inspection Report,” of Airbus Service Bulletin A320-92-1087, Revision 02, dated November 25, 2014. DAL stated that STC equipment should be addressed in a separate regulatory action.
We agree with the comment. As previously indicated, the referenced form is not specifically required by this AD, and we have changed paragraph (h) of this AD to clarify our intent.
DAL and United Airlines (UAL) asked for clarification on returning damaged parts to Airbus. DAL stated that if the reporting form must be used, it disagrees with sending all damaged parts to Airbus. UAL stated that the NPRM proposes requiring reporting inspection findings to Airbus, and Figure A-FRAAA—Sheet 02, titled “Inspection Report” of Airbus Service Bulletin A320-92-1087, Revision 02, dated November 25, 2014, specifies that damaged lugs are to be sent to Airbus for investigation. UAL noted that it will try to deliver damaged parts, but added that this should not be an AD requirement since parts shipment will increase cost and the operator cannot guarantee delivery.
We agree that clarification is necessary. Although the note contained in Figure A-FRAAA—Sheet 02, titled “Inspection Report,” of Airbus Service Bulletin A320-92-1087, Revision 02, dated November 25, 2014, specifies “If lugs have been replaced the removed part should be sent to Airbus for investigation,” this AD does not include that requirement. We have included this
UAL asked that we approve using the current version of the Airbus repair drawing, as called out in Airbus Service Bulletin A320-92-1087, Revision 02, dated November 25, 2014. UAL noted that this repair drawing is the latest version and may be revised without revision of Airbus Service Bulletin A320-92-1087, Revision 02, dated November 25, 2014.
For clarification, we agree that the current version of the repair drawing can be used. We have not changed this AD in this regard.
DAL asked that we change the repair estimate in the `Costs of Compliance' section of the NPRM, as specified in Airbus Service Bulletin A320-92-1087, Revision 02, dated November 25, 2014. DAL stated that the service information does not provide the cost of the parts, and Airbus does have the price of each part listed in the COMPA01 components. DAL added that the parts cost is $9,140 per airplane to accomplish the repair work. DAL asked that this cost be included in the cost of the repair, for a total of $16,280 per airplane.
We agree with the commenter's request, for the reason provided. We have changed the repair estimate in the `Costs of Compliance' section of this final rule accordingly.
We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting this AD with the changes described previously and minor editorial changes. We have determined that these minor changes:
• Are consistent with the intent that was proposed in the NPRM for correcting the unsafe condition; and
• Do not add any additional burden upon the public than was already proposed in the NPRM.
We also determined that these changes will not increase the economic burden on any operator or increase the scope of this AD.
We reviewed Airbus Service Bulletin A320-92-1087, Revision 02, dated November 25, 2014. The service information describes procedures for repetitive inspections for cracking of the lugs on the 10VU rack side fittings, and repair of any cracking. 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
We estimate that this AD affects 959 airplanes of U.S. registry.
We also estimate that it takes about 2 work-hours per product to comply with the basic requirements of this AD, and 1 work-hour per product to report inspection findings. The average labor rate is $85 per work-hour. Based on these figures, we estimate the cost of this AD on U.S. operators to be $244,545, or $255 per product.
In addition, we estimate that any necessary repair takes about 84 work-hours and require parts costing $9,140, for a cost of $16,280 per product. We have no way of determining the number of aircraft that might need these actions.
A federal agency may not conduct or sponsor, and a person is not required to respond to, nor shall a person be subject to penalty for failure to comply with a collection of information subject to the requirements of the Paperwork Reduction Act unless that collection of information displays a current valid OMB control number. The control number for the collection of information required by this AD is 2120-0056. The paperwork cost associated with this AD has been detailed in the Costs of Compliance section of this document and includes time for reviewing instructions, as well as completing and reviewing the collection of information. Therefore, all reporting associated with this AD is mandatory. Comments concerning the accuracy of this burden and suggestions for reducing the burden should be directed to the FAA at 800 Independence Ave. SW., Washington, DC 20591, ATTN: Information Collection Clearance Officer, AES-200.
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.
We determined that this AD will not have federalism implications under Executive Order 13132. This AD will 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 that this AD:
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 amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This AD is effective November 22, 2016.
None.
This AD applies to the Airbus airplanes identified in paragraphs (c)(1) through (c)(4) of this AD, certificated in any category;
(1) Airbus Model A318-111, -112, -121, and -122 airplanes.
(2) Airbus Model A319-111, -112, -113, -114, -115, -131, -132, and -133 airplanes.
(3) Airbus Model A320-211, -212, -214, -231, -232, and -233 airplanes.
(4) Airbus Model A321-111, -112, -131, -211, -212, -213, -231, and -232 airplanes.
Air Transport Association (ATA) of America Code 25, Equipment/Furnishings.
This AD was prompted by a report of cracks found during maintenance inspections on certain lugs of the 10VU rack side fittings in the cockpit. We are issuing this AD to prevent reading difficulties of flight-critical information displayed to the flightcrew during a critical phase of flight, such as an approach or takeoff, which could result in loss of airplane control at an altitude insufficient for recovery.
Comply with this AD within the compliance times specified, unless already done.
At the later of the times specified in paragraphs (g)(1) and (g)(2) of this AD: Do a detailed inspection for cracking of the lugs on the 10VU rack side fittings in the cockpit, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A320-92-1087, Revision 02, dated November 25, 2014. If any crack is found, before further flight, repair in accordance with the Accomplishment Instructions of Airbus Service Bulletin A320-92-1087, Revision 02, dated November 25, 2014. Repeat the inspection thereafter at intervals not to exceed 20,000 flight cycles or 40,000 flight hours, whichever occurs first. Repair of the 10VU rack lugs does not terminate the repetitive inspections required by this paragraph.
(1) Before the accumulation of 30,000 total flight cycles or 60,000 total flight hours, whichever occurs first since the airplane's first flight.
(2) Within 24 months after the effective date of this AD.
Submit a report of any findings (positive and negative) of any inspection required by paragraph (g) of this AD to Airbus Service Bulletin Reporting Online Application on Airbus World (
(1) If the inspection was done on or after the effective date of this AD: Submit the report within 90 days after the inspection.
(2) If the inspection was done before the effective date of this AD: Submit the report within 90 days after the effective date of this AD.
The following provisions also apply to this AD:
(1)
(2)
(3)
(4)
Refer to Mandatory Continuing Airworthiness Information (MCAI) European Aviation Safety Agency (EASA) Airworthiness Directive 2015-0170, dated August 18, 2015, for related information. This MCAI may be found in the AD docket on the Internet at
(1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this service information as applicable to do the actions required by this AD, unless this AD specifies otherwise.
(i) Airbus Service Bulletin A320-92-1087, Revision 02, dated November 25, 2014.
(ii) Reserved.
(3) For service information identified in this AD, contact Airbus, Airworthiness Office—EIAS, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51; email
(4) You may view this service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.
(5) You may view this service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
Commodity Futures Trading Commission.
Order.
With respect to the
Issued October 13, 2016.
Eileen T. Flaherty, Director, 202-418-5326,
The Dodd-Frank Wall Street Reform and Consumer Protection Act (“Dodd-Frank Act”)
This Order does not impact the
When the $3 billion
Staff issued for public comment a preliminary report concerning the
As discussed in the Staff Reports, the lack of certain metrics needed for evaluating different
The data analysis in the Staff Reports provided some insights into the effectiveness of the
However, as discussed above, the data available was not sufficient to assess whether, and to what extent, specific changes to the
The Commission also notes that it has not yet adopted a regulation on capital requirements for swap dealers, which is a significant component of swap dealer registration. The Commission believes it
Accordingly, the Commission believes that it is prudent to extend the phase-in period by one year, which may provide additional time for more information to become available to reassess the
For the reasons discussed above, and pursuant to its authority under Regulation 1.3(ggg)(4)(ii)(C)(
The Paperwork Reduction Act (“PRA”)
Section 15(a) of the Commodity Exchange Act (“CEA”) requires the Commission to consider the costs and benefits of its actions before promulgating a regulation under the CEA or issuing certain orders.
As discussed above, Regulation 1.3(ggg)(4)(i) provides an exception from the swap dealer definition for persons who engage in a
The $3 billion threshold, which, absent this Order, would be effective on December 31, 2017, sets the baseline for the Commission's consideration of the costs and benefits of this Order.
There are several policy objectives underlying swap dealer regulation and the
The Commission also considers policy objectives furthered by a
Extending the phase-in period by one year will delay realization of the policy benefits associated with the $3 billion
Section 15(a) of the CEA requires the Commission to consider the effects of its
Providing regulatory protections for swap counterparties who may be less experienced or knowledgeable about the swap products offered by swap dealers (particularly end-users who use swaps for hedging or investment purposes) is a fundamental policy goal advanced by the regulation of swap dealers. The Commission recognizes that the $3 billion
Other goals of swap dealer regulation are swap market transparency, orderliness, and efficiency. These benefits are achieved through regulations requiring, for example, swap dealers to keep trading records and report trades, provide counterparty disclosures about swap risks and pricing, and undertake portfolio reconciliation and compression exercises. Accordingly, the Commission notes that a lower
However, the Commission also recognizes that the efficiency and competitiveness of the swap market may be negatively impacted if the
The Commission preliminarily believes that a $3 billion
The Commission notes that a $3 billion
The Commission has not identified any other public purpose considerations for this Order.
Section 15(b) of the CEA requires the Commission to take into consideration the public interest to be protected by the antitrust laws and endeavor to take the least anticompetitive means of achieving the objectives of the CEA, in issuing any order or adopting any Commission rule or regulation. The Commission does not anticipate that the Order discussed herein will result in anti-competitive behavior.
In light of the foregoing,
The Commission retains the authority to condition further, modify, suspend, terminate, or otherwise restrict any of the terms of the Order provided herein, in its discretion.
On this matter, Chairman Massad and Commissioners Bowen and Giancarlo voted in the affirmative. No Commissioner voted in the negative.
I thank my fellow Commissioners for unanimously supporting this order, which extends the phase-in of the
The
This registration requirement is a pillar of the framework for swap regulation mandated by the Dodd-Frank Act. Congress required this framework because excessive risk related to over-the-counter derivatives contributed to the intensity of the worst financial crisis since the Great Depression, one which resulted in millions of American families losing their jobs, their homes and their savings. At the same time, Congress recognized that derivatives play an important role in enabling businesses to hedge risk. Therefore, getting this framework right is very important.
There are now more than 100 swap dealers provisionally registered with the CFTC, which include most of the largest global banking entities. Absent our action today, the threshold would have dropped from $8 billion to $3 billion at the end of 2017. That means firms would have been required to start determining whether their activity exceeds that lower threshold just a few months from now—in January of next year. Pushing back this date is a sensible and responsible step for several reasons.
First, our staff has completed the study required by the rule on the threshold. They estimated that lowering the threshold would not increase significantly the percentage of interest rate swaps (IRS) and credit default swaps (CDS) covered by swap dealer regulation, but it would require many additional firms to register. This might include some smaller banks whose swap activity is related to their commercial lending
In addition, I believe it makes sense to adopt a rule setting capital requirements for swap dealers before addressing the threshold. This rule, which is required by Dodd-Frank, is one of the most important in our regulation of swap dealers, and I am hoping the Commission can act on a reproposal of it soon. This one-year delay will also allow us to more fully assess how the new margin requirements are working.
These are just some of the reasons we have taken this action. I thank the CFTC staff for their hard work on this order and on this issue generally. And I again thank my fellow Commissioners for their support.
While we might disagree on the details of today's order, I think we can all agree on one thing: Today's action is very important to how the swaps industry operates and our system of financial regulation functions. If we do not accurately and appropriately set the mandatory level of trading for swap dealer registration, our entire regulatory regime for the swaps market will be weakened.
I know that a great deal has been said about the subject of the
Some of the most significant new regulatory requirements were crafted for what we now call swap dealers, those entities which had significant involvement in the swaps market.
Who has to register as a swap dealer is therefore one of the linchpins of the entire swaps regulatory regime. If the level of swap dealing activity is not sufficient to capture entities that should be registered as swap dealers, then many of our other rules, including margin and capital, will not apply to these entities, and the markets may not be adequately protected. On the other hand, if the level of swap dealing activity is too low, many entities, that do not pose a meaningful risk to the financial system, will be required to register as swap dealers, thereby unnecessarily burdening markets.
It was with this concern in mind that Congress required that we create a threshold for swap dealer registration. Dodd-Frank requires that the Commission shall exempt from designation as a swap dealer an entity that engages in a
As required, the Commission set that level in 2012. As part of a rulemaking released in May 2012, the Commission set the level of the
We have now published our final staff report on the
Today, the Commission is augmenting our efforts to get better data on this issue by extending the phase-in period of the threshold by one year. Because of the Commission's action, the threshold will continue to be at $8 billion until December 31, 2018. At that point, absent additional action by the Commission, the phase-in period will end and the threshold will be $3 billion.
I support this initiative to get additional data on this subject, and I do not support changing the threshold at this time. But I wish to make something clear: We need to see hard data backing up the opinions we will receive during this delay about why we should not just allow the threshold to be $3 billion as established in the rule. I know that there is a great deal of disagreement about this issue, and I do not think we will be able to reach a consensus unless we have real economic analysis and evidence to back up people's comments. If you believe the threshold should be changed to $8 billion, or some other amount, because of market conditions, please, provide us with supporting data. Or, if you believe that the threshold should be even lower, as low as the $150 million threshold that was once contemplated, please provide us with supporting data. If we stay focused on hard, economic analysis and an objective view about the state of the market, the final determination of the threshold will be more understandable and transparent. Given the years of existing discussion and analysis and the established process the Commission has created, we would do both a disservice to the industry and to the public to change the threshold now absent strong evidence for doing so.
I am sympathetic to the concerns that there may be onerous impacts on the market just because of this threshold. We know that cleared swaps are safer than uncleared swaps, which is why we have tried to encourage increased clearing of swaps. As such, I think there is some merit to modifying the threshold in the future by exempting cleared swaps from being counted in calculations of whether a firm is above it. If market participants or observers have strong thoughts on this idea or other ways that we might help make the $3 billion threshold less arduous, I encourage you to reach out to my office and my staff.
I believe we should receive empirical data that can justify where the threshold number needs to be. I therefore expect that, near the start of 2017, we will start to collect additional data from market participants regarding those portions of the swaps market for which we still lack full and detailed
Food and Drug Administration, HHS.
Final order.
The Food and Drug Administration (FDA) is classifying the Upper Extremity Prosthesis Including a Simultaneously Powered Elbow and/or Shoulder with Greater Than Two Simultaneous Powered Degrees of Freedom and Controlled by Non-Implanted Electrical Components into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the upper extremity prosthesis including a simultaneously powered elbow and/or shoulder with greater than two simultaneous powered degrees of freedom and controlled by non-implanted electrical components' classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
This order is effective October 18, 2016. The classification was applicable on May 9, 2014.
Michael Hoffmann, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2640, Silver Spring, MD, 20993-0002, 301-796-6476,
In accordance with section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were not in commercial distribution before May 28, 1976 (the date of enactment of the Medical Device Amendments of 1976), generally referred to as postamendments devices, are classified automatically by statute into class III without any FDA rulemaking process. These devices remain in class III and require premarket approval, unless and until the device is classified or reclassified into class I or II, or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i), to a predicate device that does not require premarket approval. The Agency determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations.
Section 513(f)(2) of the FD&C Act, as amended by section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144), provides two procedures by which a person may request FDA to classify a device under the criteria set forth in section 513(a)(1). Under the first procedure, the person submits a premarket notification under section 510(k) of the FD&C Act for a device that has not previously been classified and, within 30 days of receiving an order classifying the device into class III under section 513(f)(1), the person requests a classification under section 513(f)(2) of the FD&C Act. Under the second procedure, rather than first submitting a premarket notification under section 510(k) and then a request for classification under the first procedure, the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence and requests a classification under section 513(f)(2) of the FD&C Act. If the person submits a request to classify the device under this second procedure, FDA may decline to undertake the classification request if FDA identifies a legally marketed device that could provide a reasonable basis for review of substantial equivalence with the device or if FDA determines that the device submitted is not of “low-moderate risk” or that general controls would be inadequate to control the risks and special controls to mitigate the risks cannot be developed.
In response to a request to classify a device under either procedure provided by section 513(f)(2) of the FD&C Act, FDA shall classify the device by written order within 120 days. This classification will be the initial classification of the device. In accordance with section 513(f)(1) of the FD&C Act, FDA issued an order on May 18, 2012, classifying the DEKA Arm System into class III, because it was not substantially equivalent to a device that was introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976, or a device which was subsequently reclassified into class I or class II.
On June 15, 2012, DEKA Integrated Solutions Corporation submitted a request for classification of the DEKA Arm System under section 513(f)(2) of the FD&C Act. In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1). FDA classifies 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 to provide reasonable assurance of the safety and effectiveness of the device for its intended use. After review of the information submitted in the request, FDA determined that the device can be classified into class II with the establishment of special controls. FDA believes these special controls, in addition to general controls, will provide reasonable assurance of the safety and effectiveness of the device.
Therefore, on May 9, 2014, FDA issued an order to the requestor classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 890.3450.
Following the effective date of this final classification order, any firm submitting a premarket notification (510(k)) for an upper extremity prosthesis including a simultaneously powered elbow and/or shoulder with greater than two simultaneous powered degrees of freedom and controlled by non-implanted electrical components will need to comply with the special controls named in this final order. The device is assigned the generic name upper extremity prosthesis including a simultaneously powered elbow and/or shoulder with greater than two simultaneous powered degrees of freedom and controlled by non-implanted electrical components, and it is identified as a prescription device intended for medical purposes, and intended to replace a partially or fully amputated or congenitally absent upper extremity. It uses electronic inputs (other than simple, manually controlled electrical components such as switches) to provide greater than two independent and simultaneously powered degrees of freedom and includes a simultaneously
FDA has identified the following risks to health associated specifically with this type of device, as well as the mitigation measures required to mitigate these risks in table 1.
FDA believes that the special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of the safety and effectiveness.
An upper extremity prosthesis including a simultaneously powered elbow and/or shoulder with greater than two simultaneous powered degrees of freedom and controlled by non-implanted electrical components is not safe for use except under the supervision of a practitioner licensed by law to direct the use of the device. As such, the device is a prescription device and must satisfy prescription labeling requirements (see 21 CFR 801.109,
Section 510(m) of the FD&C Act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k) of the FD&C Act, if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. For this type of device, FDA has determined that premarket notification is necessary to provide reasonable assurance of the safety and effectiveness of the device. Therefore, this device type is not exempt from premarket notification requirements. Persons who intend to market this type of device must submit to FDA a premarket notification, prior to marketing the device, which contains information about the upper extremity prosthesis including a simultaneously powered elbow and/or shoulder with greater than two simultaneous powered degrees of freedom and controlled by non-implanted electrical components they intend to market.
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. 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 part 807, subpart E, regarding premarket notification submissions have been approved under OMB control number 0910-0120, and the collections of information in 21 CFR part 801, regarding labeling have been approved under OMB control number 0910-0485.
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 890 is amended as follows:
21 U.S.C. 351, 360, 360c, 360e, 360j, 360
(a)
(b)
(1) Appropriate analysis/testing must validate electronic compatibility, electrical safety, thermal safety, mechanical safety, battery performance and safety, and wireless performance, if applicable.
(2) Appropriate software verification, validation, and hazard analysis must be performed.
(3) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. Performance testing must include:
(i) Mechanical bench data, including durability testing, to demonstrate that the device will withstand forces, conditions, and environments encountered during use.
(ii) Simulated use testing to demonstrate performance of arm commands and available safeguard(s) under worst case conditions and after durability testing.
(iii) Verification and validation of force sensors and hand release button, if applicable, are necessary.
(iv) Device functionality in terms of flame retardant materials, liquid/particle ingress prevention, sensor and actuator performance, and motor and brake performance.
(v) The accuracy of the device features and safeguards.
(4) Non-clinical and clinical performance testing must demonstrate the accuracy of device features and safeguards.
(5) Elements of the device that may contact the patient must be demonstrated to be biocompatible.
(6) Documented clinical experience and human factors testing must demonstrate safe and effective use, capture any adverse events observed during clinical use and demonstrate the accuracy of device features and safeguards.
(7) Labeling for the Prosthetist and User Guide must include:
(i) Appropriate instructions, warning, cautions, limitations, and information related to the necessary safeguards of the device, including warning against activities that may put the user at greater risk (
(ii) Specific instructions and the clinical training needed for the safe use of the device, which includes:
(A) Instructions on assembling the device in all available configurations,
(B) Instructions on fitting the patient,
(C) Instructions and explanations of all available programs and how to program the device,
(D) Instructions and explanation of all controls, input, and outputs,
(E) Instructions on all available modes or states of the device,
(F) Instructions on all safety features of the device, and
(G) Instructions for maintaining the device.
(iii) Information on the patient population for which the device has been demonstrated to be effective.
(iv) A detailed summary of the non-clinical and clinical testing pertinent to use of the device.
Coast Guard, DHS.
Notice of deviation from drawbridge regulation.
The Coast Guard has issued a temporary deviation from the operating schedules that govern the S.R. 74 (Wrightsville Beach) Bridge across the Atlantic Intracoastal Waterway (AIWW), mile 283.1, at Wrightsville Beach, NC and the Isabel S. Holmes Bridge across the Northeast Cape Fear River, mile 1.0, at Wilmington, NC. The deviation is necessary to facilitate the 2016 PPD IRONMAN North Carolina “Beach2Battleship” Triathlon. This deviation allows these bridges to remain in their closed-to-navigation position.
The deviation is effective from 6:30 a.m. to 6 p.m. on October 22, 2016.
The docket for this deviation, [USCG-2016-0610] is available at
If you have questions on this temporary deviation, call or email Mr. Michael Thorogood, Bridge Administration Branch Fifth District, Coast Guard, telephone 757-398-6557, email
PPD Ironman North Carolina, on behalf of the North Carolina Department of Transportation, who owns the S.R. 74 (Wrightsville Beach) Bridge across the Atlantic Intracoastal Waterway (AIWW), mile 283.1, at Wrightsville Beach, NC and the Isabel S. Holmes Bridge across the Northeast Cape Fear River, mile 1.0, at Wilmington, NC, has requested a temporary deviation from the current operating regulations set out in 33 CFR 117.821(a)(4) and 33 CFR 117.829(a), respectively, to ensure the safety of the participants and spectators associated with the 2016 PPD IRONMAN North Carolina “Beach2Battleship” Triathlon.
Under this temporary deviation, the S.R. 74 (Wrightsville Beach) Bridge will be maintained in the closed-to-navigation position from 6:30 a.m. to 11
The Atlantic Intracoastal Waterway is used by a variety of vessels including, small commercial fishing vessels and recreational vessels. The Northeast Cape Fear River is used by a variety of vessels including, small commercial fishing vessels, recreational vessels, and tug and barge traffic. The Coast Guard has carefully coordinated the restrictions with waterway users in publishing this temporary deviation.
Vessels able to pass through these bridges in their closed positions may do so at any time. These bridges will be able to open for emergencies and there are no immediate alternative routes for vessels to pass. The Coast Guard will also inform the users of the waterway through our Local and Broadcast Notices to Mariners of the change in operating schedules for these bridges so that vessel operators can arrange their transits to minimize any impact caused by the temporary deviation.
In accordance with 33 CFR 117.35(e), these drawbridges must return to their regular operating schedules immediately at the end of the effective periods of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.
Environmental Protection Agency (EPA).
Withdrawal of direct final rule.
Because EPA received comments which could be construed as adverse, we are withdrawing the direct final rule to amend Part 33—Participation by Disadvantaged Business Enterprises in Procurements under EPA Financial Assistance Agreements published on July 28, 2016.
Effective October 18, 2016 the rule published in the
Teree Henderson, Office of the Administrator, Office of Small Business Programs (mail code: 1230A), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone number: 202-566-2222; fax number: 202-566-0548; email address:
On July 28, 2016, we published a direct final rule (81 FR 49539) and a parallel proposal (81 FR 49591) amending the provisions for Part 33—Participation by Disadvantaged Business Enterprises in Procurements under EPA Financial Assistance Agreements. These amendments were issued as a direct final rule, along with a parallel proposal to be used as the basis for final action in the event EPA received any adverse comments on the direct final amendments. Because EPA received comments which could be construed as adverse, we are withdrawing the direct final rule to amend the general provisions for part 33 published on July 28, 2016.
We stated in the direct final rule that if we received adverse comment by August 29, 2016, the direct final rule would not take effect and we would publish a timely withdrawal in the
Environmental protection, Grant programs.
Environmental Protection Agency (EPA).
Final rule.
The U.S. Environmental Protection Agency (EPA) is revising the public notice rule provisions for the New Source Review (NSR), title V and Outer Continental Shelf (OCS) permit programs of the Clean Air Act (CAA or Act) and corresponding onshore area (COA) determinations for implementation of the OCS air quality regulations. This final rule removes the mandatory requirement to provide public notice of a draft air permit (as well as certain other program actions) through publication in a newspaper. Instead, this final rule requires electronic notice (e-notice) for EPA actions (and actions by permitting authorities implementing the federal permitting rules) and allows for e-notice as an option for actions by permitting authorities implementing EPA-approved programs. When e-notice is provided, the final rule requires, at a minimum, electronic access (e-access) to the draft permit. However, this final rule does not preclude a permitting authority from supplementing e-notice with newspaper notice and/or additional means of notification to the public. The EPA anticipates that e-notice, which is already being practiced by many permitting authorities, will enable permitting authorities to communicate permitting and other affected actions to the public more quickly and efficiently and will provide cost savings over newspaper publication. The EPA further anticipates that e-access will expand access to permit-related documents.
The effective date of this final rule is November 17, 2016.
The EPA has established a docket for this action under Docket ID No. EPA-HQ-OAR-2015-0090. All documents in the docket are listed on the
For further general information on this rulemaking, contact Mr. Peter Keller, U.S. EPA, Office or Air Quality Planning and Standards, Air Quality Policy Division (C504-03), Research Triangle Park, NC 27711, telephone (919) 541-2065, email
Entities potentially affected by this final rule include permitting authorities responsible for the permitting of stationary and OCS sources of air pollution or for determining COA designation for implementation of the OCS air regulations. This includes the EPA Regions and both EPA-delegated and EPA-approved air permitting programs that are operated by state, local or tribal agencies. Entities also potentially affected by this final rule include owners and operators of stationary and OCS sources that are subject to air pollution permitting under the CAA, as well as members of the general public who would have an interest in knowing about permitting actions, public hearings and other agency actions.
In addition to being available in the docket, an electronic copy of this document will be posted at:
Upon its publication in the
The information presented in this document is organized as follows:
The CAA requires stationary sources of air pollution to obtain permits and authorizes the EPA to administer and oversee the permitting of such sources. To implement the CAA, the EPA promulgated permitting regulations for construction of sources pursuant to the NSR program under title I of the CAA, for operation of major and certain other sources of air pollutants under title V of the CAA and for sources located on the OCS under CAA section 328. These regulations are contained in 40 Code of Federal Regulations (CFR) parts 51, 52, 55, 70, 71 and 124, and cover the requirements for federal permit actions (
While the CAA requires permitting authorities to offer the opportunity for public participation in the processing of air permits and other actions, it does not specify the best or preferred method for providing notice to the public.
Given these developments, the EPA has recognized that newspaper notice is no longer the only, or in many cases the most effective, method of communicating permitting actions to the public and has issued rules allowing alternate methods of communication. For example, in 2011, the EPA issued the Tribal NSR rules that contained, among other things, requirements for noticing of permits in Indian country that provided for options other than newspaper and print media. 76 FR 38748 (July 1, 2011). The July 2011 Tribal NSR rule provides options such as Web posting and email lists among the methods that the permitting authority may use to provide adequate public notice of such permits.
Based on the foregoing and the EPA's objective to modernize, enhance and improve consistency in the public noticing provisions applicable to air permit actions, in December 2015 the EPA issued a proposed rule. 80 FR 81234 (Dec. 29, 2015). In that proposed rule, the EPA proposed to remove the mandatory requirement that draft permits for sources subject to the major NSR, title V or OCS programs and certain other actions be noticed in a newspaper of general circulation and instead allow (or in some cases require) the use of Internet postings to provide notice (
This section provides a brief summary of the requirements of the final rule. Further discussion of these requirements, including implementation and summaries of our responses to significant comments received on the proposed rule, are provided in subsequent sections.
In this final action, the EPA is revising the public notice provisions for the NSR, title V and OCS programs to remove the mandatory requirement to provide public notice of a draft permit (and certain other program actions) through publication in a newspaper of general circulation. This final rule requires the use of e-notice to provide public notice of draft permits for federal permits while allowing e-notice as an option for permits issued under EPA-approved programs. More specifically, to implement the shift from mandatory newspaper noticing to e-notice, this final rule includes revisions to the public notice provisions in 40 CFR 51.161 (state/tribal plan requirements); 40 CFR 51.165 (state/local/tribal NNSR permits); 40 CFR 51.166 (state/local/tribal PSD permits); 40 CFR 52.21 (EPA/delegated agency-issued PSD permits); 40 CFR part 70 (state/local/tribal title V operating permits); 40 CFR part 71 (EPA/delegated agency-issued title V operating permits); 40 CFR part 55 (EPA-issued OCS permits and COA designations); and the portions of 40 CFR part 124 applicable to EPA-issued PSD and OCS permits. This final action also requires that a permitting authority provide e-access when it adopts the e-notice method to provide public notice of a draft permit.
In order to satisfy the provision for e-notice of a draft permit, the permitting authority shall electronically post, for the duration of the public comment period, the following information on a publicly accessible Web site identified by the permitting authority: (1) Notice of availability of the draft permit for public comment; (2) Information on how to access the permit record (either electronically and/or physically); (3) Information on how to request and/or attend a public hearing on the draft permit; and (4) All other information currently required to be included in the public notice under the existing regulations. In addition, where already required by the current rules, the permitting authority shall maintain a mailing list of persons who request to be
In order to satisfy the requirement for e-access when e-notice is provided, the permitting authority shall electronically post, for the duration of the public comment period, the draft permit on a publicly accessible Web site identified by the permitting authority, which may include the permitting authority's public Web site, an online state permits register, or a publicly-available electronic document management Web site that allows for downloading documents. It is important to note that, while e-access in this final rule pertains to the availability of and access to the draft permit during the public comment period, nothing in this rule alters the requirement for a permitting authority to maintain a record of the permit action and to make it available to the public. Furthermore, nothing in this final rule affects a permitting authority's record retention policies and requirements. A permitting authority that is satisfying the rule requirements for e-access by posting the draft permit on a Web site must also provide the public with reasonable access to the other materials that support the permit decision (
For permits that are issued by the EPA or by a permitting authority that implements the EPA's federal permitting rules (
For the noticing of draft permits issued by permitting authorities with their own EPA-approved rules under 40 CFR part 51 or 70, this final rule removes the mandatory newspaper notice requirement for these programs and provides the option for the agency rules to require either: (1) E-notice and e-access as these terms are used in the context of this rule, or (2) newspaper notice with either electronic access (
Some of the regulatory sections affected by this final rule have a mailing list requirement and some do not. This rule includes regulatory revisions to amend the EPA's solicitation obligations associated with required mailing lists, but otherwise keeps the mailing list requirements in place. With respect to the EPA's mailing list obligations for the federal title V program, we are removing the specific language within 40 CFR 71.11(d)(3)(i)(E) and 71.27(d)(3)(i)(E) that requires the EPA to solicit mailing list membership through area lists and periodic publication in the public press.
Through guidance to permitting authorities issued in 2012, the EPA clarified its view on what constitutes public notice for minor NSR permit programs and what is considered adequate to meet the requirement of notice by prominent advertisement in 40 CFR 51.161(b)(3).
In addition, the EPA has determined that the limitation in Footnote 1 in the EPA's 2012 Memorandum, excluding synthetic minor permits, is no longer appropriate.
As proposed, the EPA is extending the use of e-notice methods to three non-permitting actions in this final rule. In each of the following cases, the regulatory provisions have previously required notice of the action by way of newspaper publication:
• The OCS air regulations in 40 CFR part 55 apply to more than just OCS permitting actions. Specifically, when the EPA makes a COA designation determination, it must do so by way of a process that allows for public comment on the draft determination. Through this final action, we are requiring e-notice of the COA designation determination.
• The existing federal PSD regulations contain a provision for permit rescission that only refers to newspaper notification. Specifically, paragraph 40 CFR 52.21(w)(4) requires that, if an agency rescinds a permit, it shall give adequate notice of the rescission, and that newspaper publication shall be considered adequate notice. In this final rule, the EPA is replacing the requirement for newspaper publication with a requirement that the Administrator notify the public of a permit rescission by e-notice.
• When the EPA takes action to administer and enforce an operating permits program in accordance with 40 CFR 71.4(g), it will publish a notice in the
As proposed, the EPA is not in this final rule revising the public participation requirements in the plantwide applicability limitation regulations, which reference the public participation procedures in 40 CFR 51.161; 40 CFR 51.165(f)(5); 40 CFR 51.166(w)(5); Appendix S to part 51 section IV.K.5; and 40 CFR 52.21(aa)(5). Additionally, this final rule does not change the requirements for NNSR, minor NSR, and synthetic minor NSR permits in Indian country that are contained in 40 CFR part 49 and already provide means of public noticing other than newspaper publication.
The EPA is not finalizing certain proposed revisions to paragraphs in 40 CFR parts 55, 51 and 71 that sought to clarify that the terms “send,” “mail” and “in writing” and variants of those terms may include email. Specifically, the EPA proposed to revise 40 CFR 51.166(q)(2)(iv), 40 CFR 55.5(f)(2) and (f)(4), 40 CFR 71.11(d)(3)(i) introductory text and 40 CFR 71.27(d)(3)(i) introductory text by adding a parenthetical indicating that those terms may include email. Without necessarily commenting on these specific provisions, one commenter generally urged EPA to avoid language in the rules that might limit the use of new communications tools and require subsequent revisions to enable permitting authorities to use them. With this idea in mind, upon further consideration, the EPA determined that the existing rule language in the subject paragraphs can reasonably be interpreted to include email and other forms of communication. The EPA also determined that adding the proposed parentheticals could unintentionally limit flexibility to apply additional communications tools or imply a different meaning elsewhere in the regulations where those same terms are used and EPA did not propose adding the parenthetical. Therefore, we are not finalizing those proposed revisions.
This section addresses implementation of this final rule and also recommends “best practices” for e-notice and e-access. As discussed in our responses to comments in Section V of this document, the EPA has expanded the list of best practices included in the proposed rule to address e-notice and e-access documentation and certification and measures to address periods of Web site unavailability (
Air permitting programs that implement the amended federal public notice provisions under 40 CFR parts 52, 55 and 124 are required to implement e-notice and e-access by the effective date of this final rule on November 17, 2016. This includes EPA Regions, air agencies that are delegated federal authority by the EPA to issue permits on behalf of the EPA (via a delegation agreement)
As described in our responses to comments in Section V of this document, the EPA did not receive any comments that identified specific details about technical issues that affected permitting authorities are facing that would likely impede their ability to implement e-notice and e-access by the effective date of this rule. While we acknowledge that certain air agencies may need time to change their respective statutes, rules, programs or policies to fully implement e-notice (
To the extent a permitting authority with an approved program, meeting the requirements of 40 CFR part 51, is using a consistent noticing method and wants to retain the same noticing method, there is no need to revise the applicable program rules. A permitting authority with an approved program that chooses e-notice and e-access as its consistent noticing method may need to revise its applicable program rules and seek the EPA's approval of the revision in order to begin to implement e-notice. Similarly, a permitting authority that implements rules that incorporate by reference the procedural requirements in the EPA's federal program regulations (40 CFR part 52), but does not provide that its rules automatically update upon the EPA amending its rules, will need to amend its regulations and seek the EPA's approval of those revisions in order to implement e-notice and e-access in lieu of newspaper notice. However, permitting authorities with NNSR programs approved under 40 CFR 51.165 have been subject to the public participation requirements at 40 CFR 51.161 and thus may be able to interpret their existing rules to currently allow for implementing e-notice in lieu of newspaper notice.
Under this final rule, it is voluntary for these permitting authorities to move to e-notice and e-access. Likewise, nothing in the final 40 CFR part 51 rules prevents a permitting authority from continuing or beginning to implement e-notice and e-access methods. However, depending on the permitting authority's rules, there may be ongoing obligations to continue with newspaper notices until the agency revises its permitting rules.
In accordance with 40 CFR 70.4(i), a program revision may be necessary when the relevant federal regulations are modified or supplemented. When 40 CFR part 70 is revised after the permitting authority program is approved, the EPA determines the need for conforming revisions. However, the approved program may initiate a program revision on its own initiative if the program revision is required to implement the revised 40 CFR part 70 rules.
In this final rule, the EPA supports the position that program revisions for converting part 70 programs to e-notice will generally be nonsubstantial given that the permitting authority needs only to revise its permitting rules to clarify its implementation of e-notice and e-access. It does not need to seek additional authority for giving notice by “other means.” In many cases, the permitting authority's current practice includes electronic posting of public notices and the draft permit, showing that it has adequate resources for implementing the revised 40 CFR part 70 notice requirements. Accordingly, we note that EPA Regional offices would generally expect to process approvals of these program revisions using
With regard to 40 CFR part 70, these final rule revisions remove only the mandatory aspect of newspaper noticing, allowing for the use of that method as a consistent method for general public notice, but also allowing e-notice as an alternative consistent method. All other obligations, such as the requirement to have or maintain a mailing list and provide notice by other means, as appropriate, remain unchanged. The EPA interprets the existing mailing list obligations to include either electronic or hardcopy mailing list or both.
With regard to the 40 CFR part 71 program revisions, a permitting authority that has delegated federal authority to administer the 40 CFR part 71 program will likely need to update its delegation agreement to update its notice procedures consistent with the e-notice requirement in the federal rules.
This final rule changes the requirements for PSD permits that the EPA issues in Indian country, as well as PSD permits that are issued by a tribe through a delegation agreement or by any tribe that has an approved TIP that incorporates by reference the public noticing requirements for PSD permits in the federal rules in 40 CFR part 124 (through incorporation of 40 CFR 52.21(q)). Since this final rule revises the noticing requirements in 40 CFR part 71, which applies to Indian country absent an approved 40 CFR part 70 program, the revisions would affect the public notice procedures for the majority of title V operating permits in tribal lands.
This section contains EPA-recommended best practices for e-notice and e-access. These best practices are not required to satisfy the e-notice and e-access provisions in this final rule, but may be helpful in the course of providing communication to the public about permitting actions. The recommended best practices for e-notice and e-access include:
• Providing notice of the final permit issuance on the Web site.
• Soliciting for the mailing list on the Web site (
• Providing options for email notification that enable subscribers to tailor the types of notifications they receive (
• Providing, where practicable, hyperlinks on the Web site that refers users to e-notice postings and/or newspaper postings, access to draft permit Web postings and postings of other permitting actions.
• Continued posting of the draft permit on the Web site beyond the date of the end of the public comment period (
• Posting the final permit on the Web site for a specific period of time after the issuance of the permit (
• Posting (or hyperlinking to) other key permit support documents on the agency Web site or on a publicly-available online document management site (
• Providing evidence or a certification of the posting of the e-notice and draft permit to the Web site in the permit record indicating the date(s) of the availability of the notice and draft permit on the Web site pursuant to applicable permitting authority regulations or policies. One example of such certification would be providing a printout of the applicable Web site pages and a “Memorandum to the File” by the permit writer documenting the date the e-notice was posted, the Web site address where the e-notice was posted and the date through which the posting remained available.
• Providing for alternative notice methods or public comment period extension in the event of prolonged Web site unavailability (
Since mid-2015, the EPA has been developing a National Public Notices Web site for publishing public notices for all EPA actions subject to such notice requirements. This project is expected to be completed and implemented by the end of 2016, providing a single location for all EPA public notices (
In addition, permitting authorities may wish to consider the recommendations provided by the National Environmental Justice Advisory Council (NEJAC) in a 2011 report
The EPA received 29 comments on the proposed rule. In this section, we summarize the major comments and our responses. For details of all the significant comments and our responses, please refer to the Response to Comments document in the docket for this rulemaking.
The EPA proposed to revise the public notice rule provisions for the NSR, title V and OCS permit programs of the CAA and the corresponding COA determinations for implementation of the OCS air quality regulations by removing the mandatory requirement to provide public notice of a draft air permit, as well as certain other program actions, through publication in a newspaper and instead provide for e-notice of these actions.
The EPA received numerous comments supporting the transition from newspaper publication to e-notice and the vast majority of commenters supported the proposal in general. All state and local agency commenters generally supported the proposal, stating that e-notice would: (1) Significantly improve communication with the public on permit actions in comparison to a one-day newspaper notice; (2) result in broader and better informed public participation; (3) reduce costs and conserve air agency resources; (4) improve public access by making permit actions immediately available through convenient and reliable electronic media outlets; (5) improve communication with EJ communities and other target audiences; (6) allow for information to be made available for an extended time period; and (7) provide flexibility for permitting authorities and sources by avoiding time delays associated with newspaper publication and allowing for faster correction of errors and rescheduling of events. Several of the state and local air agency commenters indicated that they currently provide e-notice and e-access for their draft permits and had realized many of the benefits cited. State agency commenters cited specific costs associated with newspaper publication of permit notices, ranging from $13,500 to $24,000 per year, and stated that they anticipated cost savings of similar magnitude after implementing e-notice.
Several commenters supported the EPA's conclusion that there have been substantial changes in technology, the media and the way the public accesses information. Commenters noted that electronic media, such as the Internet, have become the predominant means of communicating, generally making such media a more effective means of public notification than newspaper publication. Commenters noted that this conclusion applied not only to the public in general, but also for EJ communities. One commenter noted that EJ communities today obtain and share more information through the Internet than through newspaper circulation. One state commenter noted that they have been e-noticing draft PSD and title V permits in the same manner the EPA proposed for more than 10 years, and that they found e-notice to be a highly effective mechanism for communicating actions to the general public. Another commenter noted that they believe e-notices have been an effective and convenient way to communicate permitting-related information to the public, enabling broader and faster dissemination of information to the public as compared to newspaper notices. Another commenter noted that their district had already been encouraged to provide e-notice by EJ advocates, noting that such notices improve the level of available information and customer service offered to the public, including disadvantaged communities, by allowing the district to immediately make available bilingual copies of permitting action notices. Further, the commenter noted that public outreach initiatives cannot be nearly as effective with just newspaper notification.
Several commenters urged the EPA not to require permitting authorities that implement the federal permitting regulations to use solely e-notice, and rather to allow such agencies to retain the ability to provide alternative forms of notice, such as newspaper, in addition to the mandatory e-notice provisions. One commenter indicated that it was not entirely clear in the proposed language in 40 CFR 124.10 that such supplemental noticing methods were not precluded.
Three commenters, including a newspaper industry association (newspaper group), opposed the proposal to remove the mandatory newspaper publication requirements from the regulations and instead allow for e-notice. The newspaper group, while supporting the EPA's intention to provide e-notice of draft permits and certain other actions under the CAA, objected to the removal of mandatory newspaper publication requirements for public notices on several grounds. The commenter did not believe that e-notice constitutes sufficient notice and felt that the proposal would result in less public awareness of permits issued under the CAA. The commenter opined that the newspaper industry specialized in noticing and would generally provide a better method for noticing due to a much broader readership and ability to reach certain audiences. The commenter stated that relying solely on the Internet to provide public notice would disadvantage significant numbers of rural, elderly, low-income and/or less-educated Americans without Internet access. The commenter also contended that the proposal runs counter to over 200 years of tradition, suggesting that a public notice should be published by an independent third party, provide archiving ability, be accessible and be verifiable. The commenter further thought that the government's Web sites will not be as user-friendly as some newspapers that provide print and Internet notification. Finally, the commenter thought that the cost savings from eliminating newspaper notices is most likely illusory. Another commenter, representing a neighborhood organization, believed that e-notice would result in less notification and less citizen engagement in the decision process and that e-notice has not been shown to meet or exceed the standards established by newspaper publication.
We agree with the majority of commenters that e-notice meets the public notice requirements and that, compared to newspaper notice, e-notice is at least as effective and, in most cases, more effective, to provide notice to the public about draft air permits and other
With regard to the comments received opposing our proposal to remove the mandatory newspaper notice requirement for permit actions, we disagree that this shift will diminish the public notice process and its effectiveness. To the contrary, as noted previously, the majority of comments received support the shift to e-notice to meet the public notice regulatory requirements. Many of those commenters were state and local air agencies that cited specific experience in implementing e-notice that resulted in significant benefits in the public notice process, including reaching target communities such as EJ communities. The newspaper group alleges that e-notices are insufficient and cite to several studies that they claim support the effectiveness of newspaper advertisement. The EPA does not dispute the fact that newspaper advertisements, including public notices, may be effective in some cases, and this final rule does not preclude the use of newspaper public notices under any circumstances. However, recent studies strongly support the EPA's position that newspaper circulation has declined, and continues to decline, and that the Internet has become the predominant medium by which the public obtains information. The Pew Research Center estimates that daily circulation of printed newspapers declined 30 percent, from 62.3 million in 1990 to 43.4 million in 2010.
During the last decade, the federal government and many state governments have been gravitating toward Internet publishing of notices, announcements and other information, further supporting the adequacy of Internet publication of such notices. In the federal sphere, this trend is exemplified by: (1) The E-Government Act of 2002,
The EPA believes that in those instances when Internet posting is the sole notice provided, it will be fully adequate to meet the purpose for which notice is intended—to provide, to as many of the public at large as can reasonably be expected to be interested, access to important information regarding draft permits. In addition, Internet publishing provides the potential to reach unknown interested parties. Residents in a local jurisdiction may not subscribe to a local paper or happen to see a one-day posting in the legal notices section of the newspaper. At any given time, residents may be out of town and/or relying on the Internet for news. The fact that e-notices will remain on the Internet for the duration of the public comment period vastly increases the likelihood that interested parties will receive notice about draft permits. In addition, interested parties would not have the burden of traveling to a physical location to review a copy of the draft permit since that document would also be posted on the Internet. Given the widespread use of the Internet in our mobile society, the EPA believes that e-notice's reach will improve the public notice process and yield positive results. In addition, the EPA believes that e-access to draft permits will expand access to permit-related documents.
With regard to the comment that relying solely on the Internet to provide public notice would disadvantage significant numbers of rural, elderly, low-income and/or less-educated Americans without Internet access, the EPA is sensitive to this concern but does not agree that using the Internet to provide public notice of draft permits will adversely affect these groups. As previously noted, Internet access is widely available even for those who do not own a computer. According to a 2010 University of Washington study, those living below the poverty line had the highest use of library computers, with 44 percent having reported using public library computers and Internet access during the previous year.
The newspaper group claims that government Internet posting of public notices does not comport with a “long tradition” that a public notice must include four elements: The notice must be published by an independent third party, the publication must be capable of being archived at a reasonable cost, the notice must be accessible, and the notice must be verifiable. The newspaper group does not reference any statutory authority or case law to support the proposition that a public notice must include these four elements. The EPA notes that the applicable requirements for notice are encompassed in the constitutional due process standard governing public notice. The Supreme Court has held that, in providing public notice of governmental action, due process requires only that “the Government's effort be `reasonably calculated' to apprise a party of the pendency of the action.”
The element referenced in the newspaper group's comment requiring that notice be published by an independent third party presumes that newspapers, being independent of the government, provide the public with “an extra layer of confidence” in the notice compared to the government publishing the notice itself. But this argument mistakes why newspapers were used in the past and the role they serve in the notice process. Newspapers were historically used to provide public notice because, until the Internet, there was no comparable alternative method that was “reasonably calculated” to apprise a party of the pendency of a draft permit or other subject action. It had nothing to do with their status as an “independent and neutral third party.” In fact, for these purposes, there is nothing inherently beneficial about newspapers being independent from the government given that they merely act as a vehicle for publishing notices prepared and provided by the permitting authority. The commenter has not demonstrated that newspapers generally exercise independent editorial control over the content of legal notices or classified advertisements or that newspaper staff otherwise seek to check the veracity of what the newspaper company is paid to print in these sections of its publication.
In response to newspaper group's comments about the preservation of e-notices for future reference and verification of the e-notice posting, we note that permitting authorities have been required to keep and retain permit records (including, for example, a copy of the newspaper notice), and are required to continue to do so, in accordance with applicable record retention requirements. Therefore, we have included a best practice suggestion of evidence to include in the permit record, when e-notice and e-access are provided, to certify the date(s) of availability of the e-notice and draft permit postings on the Web site. In addition, in response to the newspaper group's claim that the EPA's Web site does not include hyperlinks to refer users to public notices, we have included a best practice suggestion that, where practicable, permitting authorities include hyperlinks on their Web site to e-notice and/or newspaper postings, postings of draft permits and other permitting actions. We also identified, in Section IV of this
The newspaper group claims that many newspapers have adopted a marketing strategy to publish print issues on the newspaper's Internet site. They believe the government's Internet sites will not be as user-friendly as the newspaper's dual method of print and Internet notification. They also claim that state press associations aggregate printed notices and post them on statewide public-notice Web sites. The EPA does not agree that posting draft permit notices on newspaper Web sites or press association Web sites is superior to posting them on a permitting authority's Web site. Online posting is not part of the EPA's contracts for publication of draft permit notices, so newspapers are under no obligation to make them freely available to the public online. Newspapers are likewise under no obligation to contract with state press associations for online posting of draft permit notices. Moreover, some newspaper Web sites restrict access to the full online version of the newspaper to print subscribers or those who pay for full online access. A potential interested party searching for a draft permit notice on such a Web site would either need a subscription to the newspaper that is publishing the Internet notice or would have to pay a daily access fee. The EPA believes it is unrealistic to assume that such a process would provide more effective notice than a freely available Web site that posts the desired notice as well as a copy of the draft permit, 24 hours a day, for the duration of the public comment period, in a searchable database.
The EPA disagrees with the newspaper group's claim that the cost savings to eliminate mandatory newspaper notices is illusory. The commenter makes a valid point that there are also costs involved in maintaining a Web site and posting information on the Internet. However, the commenter did not quantify the costs or show that they are greater than the costs of newspaper advertisements. Many state regulatory agencies have established Web sites for the purpose of serving broader communication objectives. So an appropriate cost comparison for purposes of this rule is the cost of adding e-notices for specific actions to a Web site infrastructure that an agency already maintains or might create for other reasons. State regulatory agencies with Web sites have budgets to cover the costs of running a Web site for various reasons (not just permitting). To the extent that there could be some additional cost to add permit notices to a Web site, those marginal costs would be offset by the savings realized by eliminating newspaper notices. As noted previously in the summary of comments in this section, air agency commenters cited specific costs associated with newspaper notices and anticipated cost-savings after implementing e-notice. In addition, most permitting authorities commented positively about the cost and other efficiencies that e-notice provides. The EPA believes it has demonstrated earlier how providing public notice through the Internet can—and indeed already does—reach more people, more easily, and more directly, than newspaper notice. Data from permitting authorities with real-world experience implementing pubic notice requirements under the current regulations (in many cases also including e-notice) supports the EPA's conclusion that e-notice will be at least as effective, and in most cases more effective, and cheaper overall than notice by newspaper.
In lieu of newspaper publication, we proposed to require e-notice for the noticing of air permits issued by the EPA and other permitting authorities that implement the federal air permitting rules. For permits issued by permitting authorities that implement their own rules approved by the EPA, the proposed rule provided the option for permitting authorities to use either e-notice or traditional newspaper notice. However, those permitting authorities must adopt a single, consistent noticing method for all of their affected permit actions in their air rules. Thus, we proposed that where a permit agency opts to post notices of draft permits on a Web site in lieu of newspaper publication, it must post all notices to that Web site in order to ensure that the public has a consistent and reliable location for all permit notices.
The majority of commenters supported the EPA's proposal to require a consistent noticing method. Several commenters indicated that it was critical for permitting authorities to use a consistent noticing method to avoid inconsistency in implementation and confusion on the part of the public in understanding how to access permit information. Several commenters also noted that it is important for permitting authorities to be allowed to use supplementary noticing methods when appropriate. Although two of these commenters indicated that they understood that the rule language, as proposed, would not preclude the use of additional, supplemental means of public notice, others seemed to be confused on this point and therefore objected to the proposed consistent noticing method requirement on the same grounds.
Some commenters did not support the proposed requirement to use a consistent noticing method and instead favored alternative approaches or increased flexibility. One of these commenters indicated that, in some cases, traditional newspaper publication may be appropriate or necessary, and that some permitting authorities may have technical or budgetary constraints affecting their ability to provide e-notice and e-access while some may also have a statutory requirement for newspaper notice. That commenter urged the EPA to provide flexibility for a permitting authority to choose the type of notice that is appropriate for the location and circumstances of a project. Another commenter stated that forcing a state to make a formal commitment to a single form of public notice, whether electronic or print, defeats the purpose of public notice and also questioned how a state would “adopt” a “consistent noticing method.” Two commenters supported media neutral, flexible approaches based on a “method reasonably likely to provide routine and ready access to the public” as opposed to only one “consistent noticing method.” Finally, one commenter favoring a flexible approach indicated that a consistent noticing method does not work in states with diverse
The EPA is finalizing the requirement for authorities to use a consistent noticing method as proposed. We agree with commenters that believe that the random use of alternative notice methods for different permit actions could confuse the public in their efforts to access air permit public notices. In response to the negative comments received that seem to have interpreted the requirement for using a consistent noticing method for public notice of draft permit actions as precluding the use of additional noticing mechanisms, we would like to clarify that, consistent with the proposed rule, nothing in this final rule prohibits or precludes a permitting authority from using additional, supplemental forms of notice, including newspaper publication. Indeed, several state and local permitting agency commenters indicated that they already practice multiple forms of public notice on such permit actions, including both e-notice and newspaper publication and in some cases additional parallel forms of notice. Such permitting authorities that implement EPA-approved permitting rules would be required to adopt a consistent noticing method (
Those commenters who argued for flexibility to choose the noticing method on a permit-by-permit basis have not shown how the “consistent noticing method” requirement frustrates the goals they seek to achieve through this flexibility. As discussed previously, the rule does not preclude using multiple methods of public notice, as long as the consistent method is still one of the methods used. These commenters have not shown any detrimental effect that would result to the commenters or the public from requiring permitting authorities to use one consistent method of notice for all draft permits. The benefits derived from the flexibility sought by these commenters does not eliminate the benefits that result from a consistent noticing method—ensuring that interested parties can rely on one form of notice in all cases and will not miss notices because of continuous changes in noticing methods.
The EPA does not intend for the rule to preclude a permitting authority from subsequently changing its “consistent noticing method” on a programmatic basis. For example, if a state permitting authority follows a particular noticing method and then decides that a different form of notice would be more effective going forward, the state may revise its regulations to change its consistent method. Regarding the concern about how a state would “adopt” a consistent method, this rule makes clear that such method should be specified in EPA-approved permitting regulations for the appropriate jurisdiction.
The EPA proposed that permitting authorities that implement the federal permitting rules, including the EPA and other permitting authorities that have been delegated the authority to implement the federal permitting rules, would be required to adopt e-notice as the consistent noticing method. We proposed this approach because we believe that e-notice represents the best current practice for noticing major source air permit actions. Accordingly, while the proposed rule made e-notice optional for permitting authorities implementing EPA-approved permitting rules, we did not extend the same flexibility to the EPA and other air agencies that implement the federal permitting rules.
We received one comment opposing the requirement that permitting authorities implementing the federal permitting rules be required to adopt e-notice as the consistent noticing method. The commenter believed that such programs should have the same option as EPA-approved programs to choose e-notice or newspaper on a programmatic basis, allowing the permitting agency to determine the best method for communicating with the public. The same commenter further indicated that providing this option would allow for transition to e-notice at a pace consistent with available resources.
We are maintaining the requirement that permitting authorities implementing the federal permitting rules use e-notice as their consistent noticing method consistent with the proposal and our stated objective to implement these best practices. As discussed further in Section V of this document, the EPA did not receive any comments demonstrating that one or more affected permitting authorities have infrastructure and/or resource constraints that would render them unable to implement e-notice and e-access as of the effective date of the final rule or that implementation would cause a significant additional burden. With regard to the equity point raised by the commenter, delegated permitting authorities are, by definition, not the same as EPA-approved permitting authorities. A permitting authority that elects to administer the federal program under a delegation agreement accepts the obligation to apply the EPA's regulations.
The EPA proposed to require that, when a permitting authority adopts the e-notice approach, it also must provide e-access. In the context of this rule, e-access means that the permitting authority must make the draft permit available electronically (
Several commenters supported e-notice with e-access and further recommended that e-access be provided using commonly available, free software. One commenter noted that e-access was important to increasing overall project awareness and providing for more effective public review and comment. Another commenter agreed with the EPA's proposed approach to limit e-access to the draft permit, and agreed that the method of making available other elements of the permit record should be left to the permitting authority to avoid potential resource constraints.
Commenters opposed to the proposed mandatory e-access requirement generally cited resource and information technology infrastructure constraints, stating that the requirement should be for e-notice only due to the added burden associated with posting additional records without sufficient time, infrastructure or economic capability to do so. Two commenters noted that the addition of e-access makes the rule more stringent than existing law.
The EPA is finalizing the requirement that permitting authorities that adopt e-notice also adopt e-access consistent with the proposed rule. The EPA believes that coupling e-notice and e-access provides the affected public with ready and efficient access to both the notice and the draft permit, and that such access supports informed public participation in the permitting process. Further, the EPA believes that the additional scanning and/or uploading of the draft permit to meet the e-access requirement would be minimally burdensome. We agree with the commenters that recommended that e-access be provided using commonly available, free software, and our assessment indicates that this is the current practice of permitting authorities that provide e-access to elements of their draft permit records. Therefore, we do not believe that rule language requiring the use of commonly available, free software for providing e-access is necessary and the final rule does not contain such a requirement.
We disagree with the comments that the requirement to provide e-access makes the noticing rules more stringent in a way with which permitting authorities are not readily capable of complying or that is contrary to law. The CAA does not prescribe the means or content of a public notice under the permitting programs addressed in the final rule. Comments received from state and local air agencies confirm that many of these agencies already provide e-access, and in some cases provide e-access to significantly more elements of the permit record than just the draft permit. Thus, we see the requirement for e-access as a logical and appropriate extension of the current requirement to make elements of the permit record available at a location. In addition, the EPA notes that the rule provides that access to documents supporting a draft permit may be provided at a physical location such as a public library. Based on comments received, the EPA believes that the e-access requirement for simply providing, at a minimum, e-access to the draft permit can be readily met by permitting authorities.
The EPA did not propose a transition period for technological or other reasons, and proposed instead that once the e-notice rule becomes effective, e-notice and e-access would be required for covered actions by permitting authorities that implement the federal program rules under 40 CFR parts 52, 55, 71 and 124. This includes EPA Regions, permitting authorities that are delegated authority by the EPA to issue permits on behalf of the EPA (via a delegation agreement), and permitting authorities that have their own rules approved by the EPA in a SIP where the SIP incorporates by reference the federal program procedures and automatically updates when the EPA's rules are amended. Under this rule, these programs will be required to implement e-notice and e-access, with the exception of states that are delegated authority to issue permits under part 55.
The EPA received three comments expressing concern about the proposed effective date of the final rule and the need for additional transition time for implementation. One industry association commenter stated that establishing electronic notification systems and Web sites for e-access requires careful planning, development and testing, and recommended a one year implementation timeframe. Another industry association commenter noted that the support of e-access capabilities typically necessitates substantive changes to an agency's Web site which will stretch far past the effective date of the rule. Another commenter indicated that a local air agency has several rules that mandate newspaper notice and requested a six month transition to allow for amendment of its rules.
The EPA is retaining the proposed effective date of the final rule. As discussed previously, the EPA did not receive any comments demonstrating that one or more affected permitting authorities have infrastructure and/or resource constraints that would render them unable to implement e-notice and e-access as of the effective date of the final rule or that implementation would cause a significant additional burden. Industry commenters only conveyed a general concern and did not identify any specific affected permitting authorities that would be unable to meet the final rule requirements in accordance with the proposed effective date. The other commenter, a local air agency with a partially-delegated permitting program, said a transition is necessary to allow for agency rule changes. However, that same commenter indicated that the agency already practices e-notice and e-access on its own Web site. Therefore, it seems this air agency would not be required to implement any changes to its rules to comply with its obligations as a delegated permitting program after the final rule becomes effective. To the extent that a delegated permitting authority must separately comply with a state requirement to provide notice via a newspaper, nothing in this rule precludes a permitting authority from continuing to comply with such a state requirement while at the same time satisfying the federal requirement for e-notice under this regulation. This rule does not preclude delegated permitting authorities from continuing to provide newspaper notice, either on a discretionary basis or as required separately by state law and/or rule. Under the amended rules, such a permitting authority should be able to transition away from mandatory newspaper noticing over a period of time without any need for a delay in realizing the benefits of e-notice for EPA-issued permits or permits issued by other air agencies that administer delegated programs.
With regard to permitting authorities that administer EPA-approved permitting programs, this rule does not necessarily require any changes to those programs, and air agencies that wish to make changes have discretion to do so. An approved state whose rules currently require newspaper publication for all draft permits is not required by the rule to make any changes to its public notice requirements. To the extent such a state elects to replace newspaper notice with e-notice, this rule establishes no timetable for the state to make this transition. The state may continue providing newspaper notices until it can complete changes to its regulations to remove a mandatory newspaper publication requirement. Thus, with respect to rule changes by air agencies with EPA-approved programs that elect to implement e-notice alone (
In the proposed rule, the EPA noted that there may be temporary instances of Web site failure or failure in the availability for public review of the posted e-notice and the draft permit (e-access). This raises the question about what constitutes a significant interruption in time sufficient to require an extension of the public comment period or other measure(s) to cover the period of interruption. The EPA stated in the proposal that the requirement that e-notice and e-access postings be maintained “for the duration of the comment period” should not be interpreted as a requirement for uninterrupted access. However, we sought comment on the EPA's proposed approach for the phrase “for the duration of the comment period.” The EPA also solicited comments regarding whether we should include a provision in the regulations that allows a permitting authority to use an alternative noticing (and/or access) method to reach the affected public when the Web site is unavailable.
Several commenters indicated that they felt temporary alternative notice methods were unnecessary. Some of these commenters recommended that the notice be extended for the duration of the downtime of the Web site. Several commenters noted that having the draft permit and public notice available on the Web site during the comment period, compared to the single day publication in the newspaper, results in a significant increase in public access to the proposed permitting action, even if Web site outages occur, and thus temporary alternative notice/access methods should not be required. Commenters also believed that any inability to provide e-notice would likely be resolved quickly and the public would have sufficient access to a draft permit during the comment period despite temporary Web site outages. Several commenters supported the EPA's position that “for the duration of the comment period” should not be interpreted as a requirement for uninterrupted access. One commenter suggested that the requirement for 30-day notice is satisfied when the notice first appears and noted that there is nothing in the statute or current regulations that requires continuous notice.
Several commenters also favored rule requirements for temporary alternative noticing. One commenter suggested that alternative noticing criteria should be built into the rules to ensure that Web site interruptions do not have a significant impact on public's ability to review and comment or on the permitting schedule, and that it was critical that agencies have the flexibility to choose their own approach and not be left with the sole option of extending the public notice period when there is a significant Web site interruption. Two commenters suggested that a definition of “the duration of the public comment period” should be added to the rule.
The EPA is not finalizing any specific requirements regarding temporary alternative noticing of permit actions to address the temporary unavailability of the notice and/or draft permit due to Web site outages, nor are we specifically defining “the duration of the public comment period.” We do not believe that, in general, there are, or will be, significant issues with e-notice and e-access availability on Web sites used by permitting authorities, and we believe that permitting authorities are in the best position to determine the appropriate methods to address any situations that may arise on specific permitting actions. In addition, we agree that there is no statutory requirement for continuous notice of a draft permit during the entire duration of the comment period. While there is significant added value in posting a notice throughout the comment period, we do not see a need for the EPA to define “the duration of the public comment period” as a requirement for uninterrupted access. We support the flexibility for the permitting authority to enact measures to address Web site unavailability, including possibly extending the public comment period. We have addressed this in the “best practices” in Section IV of this document.
The proposed rule did not specifically address documenting and/or certifying the posting of an e-notice to a Web site for the duration of the comment period. However, the EPA received comments on this topic.
Several commenters supported the need for documentation and/or certification of the e-notice in the administrative record for the draft permit, further stating that it is critical that states document this information in the event the decision is challenged. Two commenters suggested that the EPA could address this issue in “best practices” and provided specific examples.
We agree with commenters that it is important for permitting authorities to establish a record that they have provided notice of a draft permit and the opportunity for public comment, but we do not believe a specific certification requirement is necessary. EPA rules have not required a certification of public notice and nothing in the CAA requires it. The EPA has addressed documentation of e-notices in the “best practices” in Section IV of this document. We support flexibility for permitting authorities to comply with their specific statutory, policy or regulatory provisions for e-notice and e-access and to ensure that there is adequate documentation of the notice in the administrative record for the draft permit.
In the proposed rule, we indicated our intent to clarify that the EPA's 2012 Memorandum's interpretation of prominent advertisement in 40 CFR 51.161(b)(3) as media neutral also applies to 40 CFR 51.161(b)(1). More specifically, we proposed that allowing e-access (
In addition, in issuing the EPA's 2012 Memorandum, the EPA indicated that our interpretation of the term prominent
All commenters supported the extension of the interpretation in the EPA's 2012 Memorandum to synthetic minor NSR permits. One commenter recommended that the EPA either propose changes to 40 CFR 51.161(b)(1) similar to what was proposed for the other sections of the CFR in the rule proposal or expand the EPA's existing interpretation of “media neutral” notification for minor NSR programs to specifically indicate that information available electronically meets the requirements of 40 CFR 51.161(b)(1).
The EPA agrees that we should revise the text of 40 CFR 51.161(b)(1) similar to what was proposed for other sections of the CFR. This better communicates our view that Internet posting of this information is sufficient to meet the subject records availability requirements under the existing rule language. The EPA does not agree, however, that it needs to propose the revised text before adopting it in this final rule. The proposed rule provided adequate notice of the EPA's intent to clarify that the requirements of 40 CFR 51.161(b)(1) are satisfied by making the information available electronically. We received no adverse comments on this point. The text the EPA is adding to 40 CFR 51.161(b)(1) is similar to the text the EPA proposed to add to 40 CFR 51.166(q)(2)(ii). We received no adverse comments regarding that text. Therefore, in this final rule, the EPA is revising 40 CFR 51.161(b)(1) to add the following: “This requirement may be met by making these materials available at a physical location or on a public Web site identified by the State or local agency.”
This final rule preamble also serves to extend the EPA's media neutral interpretation of prominent advertisement under 40 CFR 51.161 to synthetic minor permits. The EPA will attach a notification to the electronic version of the EPA's 2012 Memorandum indicating that the media neutral interpretation also applies to synthetic minor permits.
The 1990 CAA Amendments generally require that the EPA or the permitting authority provide adequate procedural opportunities for the general public to have informed participation in the air permitting process in the areas affected by a proposed permit. These areas include EJ communities.
The effectiveness of noticing methods for reaching underserved and EJ communities is a substantial concern to the EPA. A 2011 report issued by the NEJAC found that publication in the legal section of a regional newspaper is antiquated and ineffective, and is not ideal for providing notice to affected EJ communities. Regarding public participation, the report recommends the following to the EPA: “To ensure meaningful public participation, the public notice and outreach process must include direct communication in appropriate languages through telephone calls and mailings to EJ and tribal communities, press releases, radio announcements, electronic and regular mail, Web site postings and the posting of signs.”
This action is not a significant action and was, therefore, not submitted to the OMB for review.
This action does not impose any new information collection burden under the PRA. This final rule revises regulations to address public noticing method requirements for draft permits for certain sources of air pollution. It is important to note that the final rule revisions do not require air agencies that implement the permitting program through an EPA-approved title V program or SIP to use e-notice. These agencies may continue to provide notice by newspaper publication or they may adopt e-notice as their consistent notification method. Only in the latter case would an air agency be required to revise the title V program rules or undertake a SIP revision. For EPA-delegated agencies, and for agencies that incorporate by reference the federal rules and their rules automatically update, no rulemaking action is required by the agency to adopt the e-notice requirements. However, if any of these agencies decides to retain newspaper publication as their consistent notification method, they could request removal of delegation, revise their program rules consistent with the rules for state programs (
This action has no burden on industry sources since permitting authorities are responsible for the noticing of permits. Therefore, the final rule revisions do not contain any information collection activities.
I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. This action will not impose any requirements directly on small entities. This final rule revises regulations to address public noticing method requirements for draft permits for certain sources of air pollution.
This action does not contain any unfunded federal mandate as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly affect small governments. This final action imposes no enforceable duty on any state, local or tribal governments, or the private sector.
This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.
This final action does not have tribal implications, as specified in Executive Order 13175. It will not have substantial direct effect on tribal governments, 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, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this action.
The EPA interprets Executive Order 13045 as applying to those regulatory actions that concern environmental health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. This action is not subject to Executive Order 13045 because it does not concern an environmental health risk or safety risk.
This action is not subject to Executive Order 13211 because it is not a significant regulatory action under Executive Order 12866.
The final rulemaking does not involve technical standards.
The EPA believes the human health or environmental risk addressed by this action will not have potential disproportionately high and adverse human health or environmental effects on minority, low-income or indigenous populations. The results of this evaluation are contained in Section VI of this document titled “Environmental Justice Considerations.”
This action is subject to the CRA, and the EPA will submit a rule report to each House of Congress and to the Comptroller General of the United States. This action is not a “major rule” as defined by 5 U.S.C. 804(2).
Under section 307(b)(1) of the CAA, petitions for judicial review of any nationally applicable regulation, or any action the Administrator “finds and publishes” as based on a determination of nationwide scope or effect must be filed in the United States Court of Appeals for the District of Columbia Circuit within 60 days of the date the promulgation, approval, or action appears in the
The statutory authority for this action is provided by 23 U.S.C. 101; 42 U.S.C. 6901,
Environmental protection, Administrative practice and procedure, Air pollution control, Reporting and recordkeeping requirements.
Environmental protection, Administrative practice and procedure, Air pollution control, Incorporation by reference, Reporting and recordkeeping requirements.
Environmental protection, Administrative practice and procedure, Air pollution control, Incorporation by reference, Reporting and recordkeeping requirements.
Environmental protection, Administrative practice and procedure, Air pollution control, Reporting and recordkeeping requirements.
Environmental protection, Administrative practice and procedure, Air pollution control, Reporting and recordkeeping requirements.
Environmental protection, Administrative practice and procedure, Air pollution control, Reporting and recordkeeping requirements.
For the reasons stated in the preamble, title 40, chapter I of the Code of Federal Regulations is amended as follows:
23 U.S.C. 101; 42 U.S.C. 7401-7671q.
(b) * * *
(1) Availability for public inspection in at least one location in the area affected of the information submitted by the owner or operator and of the State or local agency's analysis of the effect on air quality. This requirement may be met by making these materials available at a physical location or on a public Web site identified by the State or local agency;
(i)
(1) Post the information in paragraphs (i)(1)(i) through (iii) of this section, for the duration of the public comment period, on a public Web site identified by the reviewing authority.
(i) A notice of availability of the draft permit for public comment;
(ii) The draft permit; and
(iii) Information on how to access the administrative record for the draft permit.
(2) Publish a notice of availability of the draft permit for public comment in a newspaper of general circulation in the area where the source is located. The notice shall include information on how to access the draft permit and the administrative record for the draft permit.
(q) * * *
(2) * * *
(ii) Make available in at least one location in each region in which the proposed source would be constructed, a copy of all materials the applicant submitted, a copy of the preliminary determination, and a copy or summary of other materials, if any, considered in making the preliminary determination. This requirement may be met by making these materials available at a physical location or on a public Web site identified by the reviewing authority.
(iii) Notify the public, by advertisement in a newspaper of general circulation in each region in which the proposed source would be constructed, of the application, the preliminary determination, the degree of increment consumption that is expected from the source or modification, and of the opportunity for comment at a public hearing as well as through written public comment. Alternatively, these notifications may be made on a public Web site identified by the reviewing authority. However, the reviewing authority's selected notification method (
(vi) Consider all written comments submitted within a time specified in the notice of public comment and all comments received at any public hearing in making a final decision on the approvability of the application. The reviewing authority shall make all comments available for public inspection at the same physical location or on the same Web site where the reviewing authority made available preconstruction information relating to the proposed source or modification.
(viii) Notify the applicant in writing of the final determination and make such notification available for public inspection at the same location or on the same Web site where the reviewing authority made available preconstruction information and public comments relating to the proposed source or modification.
42 U.S.C. 7401,
(q)
(w) * * *
(4) If the Administrator rescinds a permit under this paragraph, the Administrator shall post a notice of the rescission determination on a public Web site identified by the Administrator within 60 days of the rescission.
Section 328 of the Clean Air Act (42 U.S.C. 7401,
(f) * * *
(1) * * *
(i) Make available, in at least one location in the NOA and in the area requesting COA designation, which may be a public Web site identified by the Administrator, a copy of all materials submitted by the requester, a copy of the Administrator's preliminary determination, and a copy or summary of other materials, if any, considered by the Administrator in making the preliminary determination; and
(ii) Notify the public, by prominent advertisement in a newspaper of general circulation in the NOA and the area requesting COA designation or on a public Web site identified by the Administrator, of a 30-day opportunity for written public comment on the available information and the Administrator's preliminary COA designation.
(a) * * *
(3)
(f) * * *
(4) * * *
(ii) Make available, in at least one location in the COA and NOA, which may be a public Web site identified by the Administrator or delegated agency, a copy of all materials submitted by the requester, a copy of the preliminary determination, and a copy or summary of other materials, if any, considered in making the preliminary determination.
(iii) Notify the public, by prominent advertisement in a newspaper of general circulation in the COA and NOA or on a public Web site identified by the Administrator or delegated agency, of a 30-day opportunity for written public comment on the information submitted by the owner or operator and on the preliminary determination.
42 U.S.C. 7401,
(h) * * *
(1) Notice shall be given by one of the following methods: By publishing the notice in a newspaper of general circulation in the area where the source is located (or in a State publication designed to give general public notice) or by posting the notice, for the duration of the public comment period, on a public Web site identified by the permitting authority, if the permitting authority has selected Web site noticing as its “consistent noticing method.” The consistent noticing method shall be used for all draft permits subject to notice under this paragraph. If Web site noticing is selected as the consistent noticing method, the draft permit shall also be posted, for the duration of the public comment period, on a public Web site identified by the permitting authority. In addition, notice shall be given to persons on a mailing list developed by the permitting authority using generally accepted methods (
(2) The notice shall identify the affected facility; the name and address of the permittee; the name and address of the permitting authority processing the permit; the activity or activities involved in the permit action; the emissions change involved in any permit modification; the name, address, and telephone number of a person (or an email or Web site address) from whom interested persons may obtain additional information, including copies of the permit draft, the application, all relevant supporting materials, including those set forth in § 70.4(b)(3)(viii) of this part, and all other materials available to the permitting authority (except for publicly-available materials and publications) that are relevant to the permit decision; a brief description of the comment procedures required by this part; and the time and place of any hearing that may be held, including a statement of procedures to request a hearing (unless a hearing has already been scheduled);
42 U.S.C. 7401,
(g)
(d) * * *
(3) * * *
(i) * * *
(E) Persons on a mailing list, including those who request in writing to be on the list. As part of this requirement, the permitting authority shall notify the public of the opportunity to be put on the mailing list by way of generally accepted methods (
(ii) By posting a notice on a public Web site identified by the permitting authority for the duration of the public comment period. The notice shall be consistent with paragraph (d)(4)(i) of this section and be accompanied by a copy of the draft permit.
(4) * * *
(i) * * *
(G) The physical location and/or Web site address of the administrative record, the times at which the record will be open for public inspection, and a statement that all data submitted by the applicant are available as part of the administrative record; and
(d) * * *
(3) * * *
(i) * * *
(E) Persons on a mailing list, including those who request in writing to be on the list. As part of this requirement, the Administrator shall notify the public of the opportunity to be put on the mailing list by way of generally accepted methods (
(ii) By posting a notice on a public Web site identified by the Administrator for the duration of the public comment period. The notice shall be consistent with paragraph (d)(4)(i) of this section and be accompanied by a copy of the draft permit.
(4) * * *
(i) * * *
(F) A brief description of the comment procedures required by paragraphs (e) and (f) of this section and the time and place of any hearing that will be held, including a statement of procedures to request a hearing (unless a hearing has already been scheduled) and other procedures by which the public may participate in the final permit decision;
(G) Any additional information considered necessary or proper; and
(H) The physical location and/or Web site address of the administrative record, the times at which the record will be open for public inspection and a statement that all data submitted by the applicant are available as part of the administrative record.
Resource Conservation and Recovery Act, 42 U.S.C. 6901
(c) * * *
(2) * * *
(iii) For PSD permits:
(A) In lieu of the requirement in paragraphs (c)(1)(ix)(B) and (C) of this section regarding soliciting persons for “area lists” and notifying the public of the opportunity to be on a mailing list, the Director may use generally accepted methods (
(B) In lieu of the requirement in paragraph (c)(2)(i) of this section to publish a notice in a daily or weekly newspaper, the Director shall notify the public by posting the following information, for the duration of the public comment period, on a public Web site identified by the Director: A notice of availability of the draft permit for public comment (or the denial of the permit application), the draft permit, information on how to access the administrative record, and information on how to request and/or attend a public hearing on the draft permit.
(C) In lieu of the requirement in paragraph (d)(1)(vi) of this section to specify a location of the administrative record for the draft permit, the Director may post the administrative record on an identified public Web site.
Environmental Protection Agency (EPA).
Final rule.
The Environmental Protection Agency (EPA) is approving, as a revision under the Clean Air Act (CAA) to the Ohio state implementation plan (SIP), submittals from the Ohio Environmental Protection Agency (Ohio EPA) dated July 15, 2015, and February 29, 2016. The revision addresses the state's Stage II vapor recovery (Stage II) program for the Cleveland, Cincinnati, and Dayton ozone areas in Ohio. The revision removes Stage II requirements for the three areas as a component of the Ohio ozone SIP. The revision also includes a demonstration that addresses emission
This final rule is effective on November 17, 2016.
EPA has established a docket for this action under Docket ID No. EPA-R05-OAR-2015-0522. All documents in the docket are listed in the
Francisco J. Acevedo, Mobile Source Program Manager, Control Strategies Section, Air Programs Branch (AR-18J), Environmental Protection Agency, Region 5, 77 West Jackson Boulevard, Chicago, Illinois 60604, (312) 886-6061,
Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA.
On June 30, 2016, at 81 FR 42597, EPA proposed to approve amendments to OAC 3745-21-09 (DDD) that remove Stage II requirements from the Ohio ozone SIP and allow gasoline dispensing facilities currently implementing Stage II in the Cleveland, Cincinnati and Dayton areas to decommission their systems by 2017. The revision included amended copies of OAC 3745-21-09 (DDD), as adopted on April 29, 2013, and January 17, 2014; a summary of Ohio-specific calculations, based on EPA guidance, used to calculate program benefits and demonstrate widespread use of onboard refueling vapor recovery (ORVR) in Ohio; and a CAA section 110(l) demonstration that includes documentation that analyzes the period, 2013-2017, when Stage II requirements were waived in Ohio but widespread use of ORVR has not yet occurred.
EPA provided a 30-day review and comment period on the proposed action. The comment period closed on August 1, 2016. EPA received no comments.
EPA is approving revisions to the Ohio ozone SIP submitted by the state dated July 15, 2015, and February 29, 2016, for the state's Stage II program in Ohio. EPA finds that the revisions will not interfere with any applicable requirement concerning attainment, reasonable further progress or any other applicable CAA requirement.
In this rule, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is finalizing the incorporation by reference of the Ohio Regulations described in the amendments to 40 CFR part 52 set forth below. Therefore, these materials have been approved by EPA for inclusion in the SIP, have been incorporated by reference by EPA into that plan, are fully federally enforceable under sections 110 and 113 of the CAA as of the effective date of the final rulemaking of EPA's approval, and will be incorporated by reference by the Director of the Federal Register in the next update to the SIP compilation.
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable Federal regulations 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);
• 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, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Nitrogen oxides, Ozone, Volatile organic compounds.
40 CFR part 52 is amended as follows:
42 U.S.C. 7401
(c) * * *
Environmental Protection Agency (EPA).
Final rule.
This regulation establishes tolerances with regional registration for residues of metaldehyde in or on multiple commodities which are identified and discussed later in this document. Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
This regulation is effective October 18, 2016. Objections and requests for hearings must be received on or before December 19, 2016, 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-2015-0558, is available at
Michael Goodis, Acting Director, 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-2015-0558 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before December 19, 2016. 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-2015-0558, 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 made certain modifications to the petitioned-for crop tolerances. The reason for these changes are explained in Unit IV.C.
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .”
Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for metaldehyde including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with metaldehyde follows.
EPA has evaluated the available toxicity database 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 toxicity profile of metaldehyde shows that the principal toxic effects are clinical signs of neurotoxicity. The dog is the most sensitive species for the neurotoxic effects. The nervous system effects observed in subchronic and chronic oral toxicity studies include: (1) Neurotoxic signs,
The liver is a target organ following subchronic and chronic oral exposure to metaldehyde as evidenced by increased liver weight, increased incidence of liver lesions,
Developmental toxicity was not observed in the rat or rabbit developmental toxicity studies. Maternal toxicity was not observed in the rabbit, although maternal toxicity was observed in the rat, as evidenced by clinical signs including ataxia, tremors, and twitching at the highest dose tested (HDT). In the rat reproductive toxicity study, mortality and clinical signs,
In chronic feeding studies in mice and rats, benign liver tumors were seen in both sexes of mice and in female rats. The Agency has determined that quantification of risk using a non-linear Reference Dose (RfD) approach for metaldehyde will adequately account for all chronic toxicity, including carcinogenicity, that could result from exposure to metaldehyde. That conclusion is based on the following considerations: (1) The tumors found are commonly seen in the mouse; (2) the liver tumors (adenomas) in both species were benign; (3) metaldehyde is not mutagenic; (4) no carcinogenic response was seen in the male rat; (5) incidence of adenomas at the high-dose in the
Specific information on the studies received and the nature of the adverse effects caused by metaldehyde as well as the NOAEL and the 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 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 PAD or a 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 metaldehyde 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 metaldehyde. In estimating acute dietary exposure, EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID), Version 3.16, which incorporates 2003-2008 food consumption data 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 tolerance-level residues for all commodities and 100 percent crop treated (PCT). In addition, the Agency assumed processing factors to be 1.0 for all commodities except for tomato, dried; tomato, juice; cranberry, juice; and high fructose corn syrup; for these commodities, DEEM default processing factors were used.
ii.
iii.
iv.
2.
The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for metaldehyde in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of metaldehyde. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at
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 metaldehyde for acute exposures are estimated to be 205 parts per billion (ppb) for surface water and 1880 ppb for ground water. Chronic exposures for non-cancer assessments are estimated to be 136 ppb for surface water and 915 ppb for ground water.
For acute dietary risk assessment, the full distribution of ground water concentrations from the PRZM-GW model was used to assess the contribution from drinking water.
For chronic dietary risk assessment, the water concentration of value 915 ppb was used to assess the contribution from drinking water.
3.
Metaldehyde is currently registered for the following uses that could result in residential exposures: Residential ornamentals and lawn/turf applications. EPA assessed residential exposure using the following assumptions and exposure factors: For adult residential handlers, EPA conducted a short-term exposure assessment of metaldehyde for adults based on the inhalation route, incorporating the maximum labeled application rate, and unit exposure values and estimates for area treated/amount handled taken from the 2012 Residential Standard Operating Procedures (SOPs). The scenario resulting in the highest adult exposure in a residential setting was hand dispersal of granules, which was used in the short-term aggregate assessment. Additional scenarios assessed included; loading and applying distinct metaldehyde product types,
For children, the highest estimated metaldehyde exposure resulted from post-application incidental oral exposures of short-term duration from hand-to-mouth and object-to-mouth contact with treated turf, and short- and intermediate-term exposures from treated soil. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at
4.
EPA has not found metaldehyde to share a common mechanism of toxicity with any other substances, and metaldehyde does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that metaldehyde 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 Web site at
1.
2.
3.
i. The toxicity database for metaldehyde is complete;
ii. Although there are indications of neurotoxicity from exposure to metaldehyde, there are clear NOAELs/LOAELS for these effects, and Points of Departure selected for risk assessment are protective for these effects. EPA has determined that the acute and developmental neurotoxicity studies are not needed, nor are additional uncertainty factors (UFs) necessary to account for neurotoxicity. There were no indications of neurotoxic effects in developing rats or rabbits in either the developmental or reproductive studies. Although there were some effects in adult rats, those effects occurred at doses much higher than in the dog study. The dog is the more sensitive species for neurotoxic effects and points of departure (30 mg/kg/day and 10 mg/kg/day) are based on the chronic dog oral toxicity study, which EPA considers to be protective of any neurotoxicity at higher dose levels.
iii. There is no evidence that metaldehyde results in increased susceptibility following
iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on established and proposed tolerance-level residues, 100 PCT, default processing factors, and EDWCs from chronic ground water (worst case) models to assess exposure to metaldehyde in drinking water. EPA used similarly conservative assumptions to assess exposure to adult handlers, and post application exposure of children (including incidental oral exposure of toddlers). These assessments will not underestimate the exposure and risks posed by metaldehyde based on the current and proposed use patterns.
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.
Metaldehyde 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 metaldehyde. 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 1400 for adults and 580 for children. Because EPA's level of concern for metaldehyde
4.
5.
6.
Adequate enforcement methodology (gas chromatography with mass spectrometry (GC/MS) method (EN-CAS
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 metaldehyde.
For hop, dried cones, the analytical method was not successfully validated at the proposed tolerance level of 0.05 ppm. Therefore, EPA is establishing the tolerance level for this commodity at the lowest validated LOQ for hops of 0.10 ppm. In addition, the commodity definition proposed as “beet, garden, tops” is corrected to read: “beet, garden, leaves”.
Therefore, tolerances are established for residues of metaldehyde, 2,4,6,8-tetramethyl-1,3,5,7-tetroxocane, in or on beet, garden, leaves at 0.08 ppm; beet, garden, roots at 0.05 ppm; hop, dried cones at 0.10 ppm; rutabaga, roots at 0.05 ppm; turnip, greens at 0.08 ppm; turnip, roots at 0.05 ppm; wheat, forage at 0.05 ppm; wheat, grain at 0.05 ppm; wheat, hay at 0.05 ppm and wheat, straw at 0.05 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) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). 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.
(c) * * *
National Aeronautics and Space Administration.
Technical amendments.
NASA is making technical amendments to the NASA FAR Supplement (NFS) to provide needed editorial changes.
Manuel Quinones, NASA, Office of Procurement, Contract and Grant Policy Division, via email at
As part of NASA's retrospective review of existing regulations NASA is conducting periodic reviews of the NASA FAR Supplement (NFS) to ensure the accuracy of information disseminated to the acquisition community. This rule makes administrative changes to the NFS to correct typographical errors as well as inadvertent omissions from prior rulemaking actions. A summary of changes follows:
• Section 1816.406-70(c) is revised to correct a typographical error.
• Section 1823.7001(c) is revised by replacing the word “clause” with the word “provision.”
• Section 1832.908 is revised to add a clause prescription inadvertently omitted.
• Section 1845.107-70(e) is revised to replace the word “property” with “equipment” and paragraph (m) is revised to replace the term “NASA owned property” with “NASA real property.”
• Section 1852.217-72 is revised to correct the clause date.
• Section 1852.223-73 is revised to replace the word “clause” with the word “provision.”
• Section 1852.231-71 is revised to correct the clause date.
Government procurement.
Accordingly, 48 CFR parts 1816, 1823, 1832, 1845, and 1852 are amended as follows:
51 U.S.C. 20113(a) and 48 CFR chapter 1.
(c)(2) When the clause at FAR 52.232-25, Prompt Payment, is used in such contracts with the Canadian Commercial Corporation (CCC), insert “17th” in lieu of “30th” in paragraphs (a)(1)(i)(A) and (B) and (a)(1)(ii).
51 U.S.C. 20113(a) and 48 CFR chapter 1.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; inseason General category bluefin tuna quota transfer and retention limit adjustment.
NMFS is transferring 18 metric tons (mt) of Atlantic bluefin tuna (BFT) quota from the Harpoon category and 67 mt from the Reserve category to the General category for the remainder of the 2016 fishing year. These transfers result in adjusted 2016 quotas of 676.7 mt, 20.6 mt, and 8.6 mt for the General, Harpoon, and Reserve category quotas, respectively. NMFS also is adjusting the Atlantic tunas General category BFT daily retention limit from four large medium or giant BFT per vessel per day/trip to two large medium or giant BFT per vessel per day/trip for the remainder of the 2016 fishing year. This action is based on consideration of the regulatory determination criteria regarding inseason adjustments and applies to Atlantic tunas General category (commercial) permitted vessels and Highly Migratory Species (HMS) Charter/Headboat category permitted vessels when fishing commercially for BFT.
The quota transfer is effective October 14, 2016, through December 31, 2016. The General category retention limit adjustment is effective October 17, 2016, through December 31, 2016.
Sarah McLaughlin or Brad McHale, 978-281-9260.
Regulations implemented under the authority of the Atlantic Tunas Convention Act (ATCA; 16 U.S.C. 971
The base quota for the General category is 466.7 mt. See § 635.27(a). Each of the General category time periods (January through March, June through August, September, October through November, and December) is allocated a portion of the annual General category quota. Based on the General category base quota of 466.7 mt, the subquotas for each time period are as follows: 24.7 mt for January; 233.3 mt for June through August; 123.7 mt for September; 60.7 mt for October through November; and 24.3 mt for December. Any unused General category quota rolls forward within the fishing year, which coincides with the calendar year, from one time period to the next, and is available for use in subsequent time periods. On December 14, 2015, NMFS published an inseason action transferring 24.3 mt of BFT quota from the December 2016 subquota to the January 2016 subquota period (80 FR 77264). To date this year, NMFS has published three actions that have adjusted and/or distributed the available 2016 Reserve category quota, which is currently 75.6 mt (81 FR 19, January 4, 2016; 81 FR 60286, September 1, 2016; and 81 FR 70369, October 12, 2016).
The 2016 General category fishery was open January 1, 2016, through March 31, 2016, reopened June 1, 2016, and remains open until December 31, 2016, or until the adjusted General category quota is reached, whichever comes first.
NMFS recently took a similar action (81 FR 70369, October 12, 2016) which reduced the daily retention limit from five to four large medium or giant BFT per vessel as well as transferred 125 mt of BFT quota to the General category from the Reserve category to meet the same objectives stated below. Based on continued fish availability, catch rates, effort, as well as other determination criteria, NMFS is taking this action with the same intent.
Under § 635.27(a)(9), NMFS has the authority to transfer quota among fishing categories or subcategories, after considering 14 determination criteria provided under § 635.27(a)(8), including five new criteria added in Amendment 7.
NMFS has considered all of the relevant determination criteria and their applicability to this inseason quota transfer and change in retention limit in the General category fishery. The criteria and their application are discussed below.
For the inseason quota transfer, NMFS considered the usefulness of information obtained from catches in the particular category for biological sampling and monitoring of the status of the stock (§ 635.27(a)(8)(i)). Biological samples collected from BFT landed by General category fishermen and provided by tuna dealers provide NMFS with valuable parts and data for ongoing scientific studies of BFT age and growth, migration, and reproductive status. Additional opportunity to land BFT in the General Category would support the continued collection of a broad range of data for these studies and for stock monitoring purposes.
NMFS also considered the catches of the General category quota to date and the likelihood of closure of that segment of the fishery if no adjustment is made (§ 635.27(a)(8)(ii)). As of October 11, 2016, the General category has landed approximately 537 mt of its adjusted 2016 quota of 591.7 mt. Without a quota transfer, NMFS would have to close the 2016 General category fishery for the remainder of the year, while unused quota remains in the Harpoon and Reserve categories. Regarding the projected ability of the vessels fishing under the particular category quota (here, the General category) to harvest the additional amount of BFT before the end of the fishing year (§ 635.27(a)(8)(iii)), NMFS considered catches during the winter fishery in the last several years. General category landings in the winter BFT fishery, which typically begins in December or January each year, are highly variable and depend on availability of commercial-sized BFT. Commercial-sized BFT have continued to be available to General category vessels currently, and General category vessels should be able to harvest the additional amount (85 mt) of quota before the end of the fishing year.
NMFS also considered the estimated amounts by which quotas for other gear categories of the fishery might be exceeded (§ 635.27(a)(8)(iv)) and the ability to account for all 2016 landings and dead discards. Overall, approximately 60 percent of the total of the currently available commercial BFT
Another principal consideration is the objective of providing opportunities to harvest the full annual U.S. BFT quota without exceeding it based on the goals of the 2006 Consolidated HMS FMP and Amendment 7, including to achieve optimum yield on a continuing basis and to optimize the ability of all permit categories to harvest their full BFT quota allocations (§ 635.27(a)(8)(vi)). This transfer is consistent with the quotas established and analyzed in the most recent BFT quota final rule (80 FR 52198, August 28, 2015) and with objectives of the 2006 Consolidated HMS FMP and amendments, and is not expected to negatively impact stock health or to affect the stock in ways not already analyzed in those documents (§ 635.27(a)(8)(v) and (x)).
Based on the considerations above, NMFS is transferring 18 mt of Harpoon category quota and 67 mt of Reserve category quota to the General category for the remainder of 2016, resulting in adjusted General, Harpoon, and Reserve category quotas for 2016 of 676.7 mt, 20.6 mt, and 23.6 mt, respectively. NMFS will close the 2016 General category fishery for the remainder of the year when the adjusted General category quota of 676.7 mt has been reached.
Under § 635.23(a)(4), NMFS may increase or decrease the daily retention limit of large medium and giant BFT over a range of zero to a maximum of five per vessel based on consideration of the relevant criteria provided under § 635.27(a)(8), and listed above. NMFS adjusted the daily retention limit for the 2016 January subquota period (which closed March 31) from the default level of one large medium or giant BFT to three large medium or giant BFT in December 2016 (80 FR 77264, December 14, 2015). NMFS adjusted the daily retention limit to five large medium or giant BFT for the June through August 2016 subquota period (81 FR 29501, May 12, 2016), and again for the September, October through November, and December periods (81 FR 59153, August 29, 2016); and recently to four large medium or giant BFT (81 FR 70369, October 12, 2016). NMFS has considered the relevant criteria and their applicability to the General category BFT retention limit for the remainder of the fishing year.
As described above with regard to the quota transfer, additional opportunity to land BFT would support the continued collection of a broad range of data for the biological studies and for stock monitoring purposes (§ 635.27(a)(8)(i)). Regarding the effects of the adjustment on BFT stock rebuilding and the effects of the adjustment on accomplishing the objectives of the fishery management plan (§ 635.27(a)(8)(v) and (x)), this action would be taken consistent with the previously implemented and analyzed quotas, and it is not expected to negatively impact stock health or otherwise affect the stock in ways not previously analyzed. It is also supported by the Environmental Analysis for the 2011 final rule regarding General and Harpoon category management measures, which established the current range over which NMFS may set the General category daily retention limit (
As described above, a principal consideration is the objective of providing opportunities to harvest the available U.S. BFT quota without exceeding that quota, based on the goals of the 2006 Consolidated HMS FMP and Amendment 7. The retention limit currently is four fish. NMFS is setting the retention limit at two fish through this action because, given the expected level of fishing effort and catch rates, a continued level of four fish may lead to exceeding the adjusted category quota, and less than two would likely result in underharvest.
Based on these considerations, NMFS has determined that a two-fish General category retention limit is warranted for the remainder of the year. It would provide a reasonable opportunity to harvest the U.S. quota of BFT without exceeding it, while maintaining an equitable distribution of fishing opportunities, help optimize the ability of the General category to harvest its available quota, allow collection of a broad range of data for stock monitoring purposes, and be consistent with the objectives of the 2006 Consolidated HMS FMP and amendments. Therefore, NMFS adjusts the General category retention limit from four to two large medium or giant BFT per vessel per day/trip, effective October 17, 2016, through December 31, 2016.
Regardless of the duration of a fishing trip, the daily retention limit applies upon landing. For example (and specific to the limit that will apply through the end of the year), whether a vessel fishing under the General category limit takes a two-day trip or makes two trips in one day, the day/trip limit of two fish applies and may not be exceeded upon landing. This General category retention limit is effective in all areas, except for the Gulf of Mexico, where NMFS prohibits targeted fishing for BFT, and applies to those vessels permitted in the General category, as well as to those HMS Charter/Headboat permitted vessels fishing commercially for BFT.
NMFS will continue to monitor the BFT fishery closely. Dealers are required to submit landing reports within 24 hours of a dealer receiving BFT. General, HMS Charter/Headboat, Harpoon, and Angling category vessel owners are required to report the catch of all BFT retained or discarded dead, within 24 hours of the landing(s) or end of each trip, by accessing
The Assistant Administrator for NMFS (AA) finds that it is impracticable and contrary to the public interest to provide prior notice of, and an opportunity for public comment on, this action for the following reasons:
The regulations implementing the 2006 Consolidated HMS FMP and amendments provide for inseason retention limit adjustments to respond to the unpredictable nature of BFT availability on the fishing grounds, the migratory nature of this species, and the regional variations in the BFT fishery. Affording prior notice and an opportunity for public comment to implement the quota transfer and daily retention limit for the remainder of the year is impracticable as NMFS must react as quickly as possible to updated data and information that then requires
Delays in adjusting the retention limit may result in the available quota being exceeded and NMFS needing to close the fishery earlier than otherwise would be necessary under a lower limit. This could adversely affect those General and HMS Charter/Headboat category vessels that would otherwise have an opportunity to harvest BFT under retention limits set in response to the most recent data available. Limited opportunities to harvest the respective quotas may have negative social and economic impacts for U.S. fishermen that depend upon catching the available quota within the time periods designated in the 2006 Consolidated HMS FMP, as amended. Adjustment of the retention limit needs to be effective as soon as possible to extend fishing opportunities for fishermen in geographic areas with access to the fishery only during this time period. Therefore, the AA finds good cause under 5 U.S.C. 553(b)(B) to waive prior notice and the opportunity for public comment. For these reasons, there is good cause under 5 U.S.C. 553(d) to waive the 30-day delay in effectiveness.
This action is being taken under §§ 635.23(a)(4) and 635.27(a)(9), and is exempt from review under Executive Order 12866.
16 U.S.C. 971
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; inseason adjustment.
We announce the reduction of the commercial per-trip skate bait possession limit from 25,000 lb (11,340 kg) to 9,307 lb (4,222 kg) whole weight through October 31, 2016. This action is required to prevent the skate bait Season 2 quota from being exceeded. This announcement informs the public that the skate bait possession limit is reduced.
Effective October 17, 2016, through October 31, 2016.
William Whitmore, Fishery Policy Analyst, 978-281-9182.
The bait skate fishery is managed primarily through the Northeast Skate Complex Fishery Management Plan. The regulations describing the process to adjust inseason commercial possession limits of skate bait are described at 50 CFR 648.322(b) and (d). When the National Marine Fisheries Service Regional Administrator, Greater Atlantic Region projects that 90 percent of the skate bait fishery seasonal quota has been landed, the Regional Administrator is required to reduce the skate bait trip limit unless such a reduction would be expected to prevent attainment of the seasonal quota or annual TAL. The current skate bait trip limit is 25,000 lb (11,340 kg) and the current skate wing trip limit is 9,307 lb (4,222 kg) whole weight, 4,100 lb (1,860 kg) skate wings.
Based on commercial landings data reported through October 1, 2016, the skate bait fishery is projected to reach or exceed 90 percent of the Season 2 quota on or around October 15, 2016. Further, catch projections indicate that retaining the current skate bait possession limits would result in 109 percent of the Season 2 quota being harvested. Additional projections indicate that the annual TAL is likely to be attained in Season 3, even with this season 2 possession limit reduction. Therefore, consistent with § 648.322(b) and (d) we are reducing the skate wing trip limit from 25,000 lb (11,340 kg) to 9,307 lb (4,222 kg) whole weight [4,100 lb (1,860 kg) skate wings] to prevent the season 2 quota from being exceeded. Beginning October 17, 2016, no person may possess on board or land more than 9,307 lb (4,222 kg) of skate bait per trip for the remainder of Season 2 (
This action is taken under 50 CFR part 648 and is exempt from review under Executive Order 12866.
16 U.S.C. 1801
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; closure.
NMFS is prohibiting retention of the incidental catch allowance for Pacific Ocean perch in the Central Regulatory Area of the Gulf of Alaska (GOA). This action is necessary because the 2016 total allowable catch of Pacific Ocean perch apportioned to the incidental catch allowance in the Central Regulatory Area of the GOA has been reached.
Effective 1200 hours, Alaska local time (A.l.t.), October 14, 2016, through 2400 hours, A.l.t., December 31, 2016.
Josh Keaton, 907-586-7228.
NMFS manages the groundfish fishery in the GOA exclusive economic zone according to the Fishery Management Plan for Groundfish of the Gulf of Alaska (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.
The 2016 total allowable catch (TAC) of Pacific Ocean perch apportioned to the incidental catch allowance in the Central Regulatory Area of the GOA is 1,500 metric tons (mt) as established by the final 2016 and 2017 harvest specifications for groundfish of the GOA (81 FR 14740; March 18, 2016).
In accordance with § 679.20(d)(2), the Administrator, Alaska Region, NMFS (Regional Administrator), has determined that the 2016 TAC of Pacific Ocean perch apportioned to the incidental catch allowance in the Central Regulatory Area of the GOA has been reached. Therefore, NMFS is requiring that catches of the incidental catch allowance for Pacific ocean perch in the Central Regulatory Area of the GOA be treated as prohibited species in accordance with § 679.21(b). This closure does not apply to fishing by vessels participating in the cooperative fishery of the Rockfish Program for the Central GOA.
This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay prohibiting retention of the incidental catch allowance for Pacific Ocean perch in the Central Regulatory Area of the GOA. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of October 12, 2016.
The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.
This action is required by § 679.20 and § 679.21 and is exempt from review under Executive Order 12866.
16 U.S.C. 1801
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; closure.
NMFS is prohibiting retention of sablefish by vessels using trawl gear and not participating in the cooperative fishery of the Rockfish Program in the Central Regulatory Area of the Gulf of Alaska (GOA). This action is necessary because the 2016 total allowable catch of sablefish allocated to vessels using trawl gear and not participating in the cooperative fishery of the Rockfish Program in the Central Regulatory Area of the GOA has been reached.
Effective 1200 hours, Alaska local time (A.l.t.), October 14, 2016, through 2400 hours, A.l.t., December 31, 2016.
Josh Keaton, 907-586-7228.
NMFS manages the groundfish fishery in the GOA exclusive economic zone according to the Fishery Management Plan for Groundfish of the Gulf of Alaska (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.
The 2016 total allowable catch (TAC) of sablefish by vessels using trawl gear and not participating in the cooperative fishery of the Rockfish Program in the Central Regulatory Area of the GOA is 391 metric tons (mt) as established by the final 2016 and 2017 harvest specifications for groundfish of the GOA (81 FR 14740, March 18, 2016).
In accordance with § 679.20(d)(2), the Administrator, Alaska Region, NMFS (Regional Administrator), has determined that the 2016 TAC of sablefish by vessels using trawl gear and not participating in the cooperative fishery of the Rockfish Program in the Central Regulatory Area of the GOA has been reached. Therefore, NMFS is requiring that sablefish by vessels using trawl gear and not participating in the cooperative fishery of the Rockfish Program in the Central Regulatory Area of the GOA be treated as prohibited species in accordance with § 679.21(b). This closure does not apply to fishing by vessels participating in the cooperative fishery of the Rockfish Program for the Central Regulatory Area of the GOA.
This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay prohibiting the retention of sablefish by vessels using trawl gear and not participating in the cooperative fishery of the Rockfish Program in the Central Regulatory Area of the GOA. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of October 12, 2016.
The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.
This action is required by § 679.20 and § 679.21 and is exempt from review under Executive Order 12866.
16 U.S.C. 1801
Office of Government Ethics.
Proposed rule.
The U.S. Office of Government Ethics (OGE) is issuing a proposed rule to revise the component designations of two agencies for purposes of the one-year post-employment conflict of interest restriction for senior employees. Specifically, OGE is proposing to revoke two existing component designations and add five new component designations, based on the recommendations of the agencies concerned.
Written comments are invited and must be received on or before November 17, 2016.
You may submit comments, in writing, to OGE on this proposed rule, identified by RIN 3209-AA14, by any of the following methods:
Kimberly L. Sikora Panza, Associate Counsel, Office of Government Ethics, Suite 500, 1201 New York Avenue NW., Washington, DC 20005-3917; Telephone: (202) 482-9300; TTY: (800) 877-8339; FAX: (202) 482-9237.
The Director of OGE (Director) is authorized by 18 U.S.C. 207(h) to designate distinct and separate departmental or agency components in the executive branch for purposes of 18 U.S.C. 207(c), the one-year post-employment conflict of interest restriction for senior employees. The representational bar of 18 U.S.C. 207(c) usually extends to the whole of any department or agency in which a former senior employee served in any capacity during the year prior to termination from a senior employee position. However, 18 U.S.C. 207(h) provides that whenever the Director determines that an agency or bureau within a department or agency in the executive branch exercises functions which are distinct and separate from the remaining functions of the department or agency and there exists no potential for use of undue influence or unfair advantage based on past Government service, the Director shall by rule designate such agency or bureau as a separate component of that department or agency. As a result, a former senior employee who served in a “parent” department or agency is not barred by 18 U.S.C. 207(c) from making communications to or appearances before any employees of any designated component of that parent, but is barred as to employees of that parent or of other components that have not been separately designated. Moreover, a former senior employee who served in a designated component of a parent department or agency is barred from communicating to or making an appearance before any employee of that component, but is not barred as to any employee of the parent, of another designated component, or of any other agency or bureau of the parent that has not been designated.
Under 18 U.S.C. 207(h)(2), component designations do not apply to persons employed at a rate of pay specified in or fixed according to subchapter II of 5 U.S.C. chapter 53 (the Executive Schedule). Component designations are listed in appendix B to 5 CFR part 2641.
The Director regularly reviews the component designations and determinations and, in consultation with the department or agency concerned, makes such additions and deletions as are necessary. Specifically, the Director “shall, by rule, make or revoke a component designation after considering the recommendation of the designated agency ethics official.” 5 CFR 2641.302(e)(3). Before designating an agency component as distinct and separate for purposes of 18 U.S.C. 207(c), the Director must find that there exists no potential for use of undue influence or unfair advantage based on past Government service, and that the component is an agency or bureau, within a parent agency, that exercises functions which are distinct and separate from the functions of the parent agency and from the functions of other components of that parent. 5 CFR 2641.302(c).
Pursuant to the procedures prescribed in 5 CFR 2641.302(e), two agencies have forwarded written requests to OGE to amend their listings in appendix B. After carefully reviewing the requested changes in light of the criteria in 18 U.S.C. 207(h) as implemented in 5 CFR 2641.302(c), OGE is proposing to grant these requests and amend appendix B as explained below.
The Department of Labor has requested that OGE revoke the designation of the Employment Standards Administration (ESA) in appendix B to part 2641, and in the place of ESA designate the Office of Federal Contract Compliance Programs (OFCCP), Office of Labor Management Standards (OLMS), Office of Workers' Compensation Programs (OWCP), and the Wage and Hour Division (WHD) as distinct and separate components of the Department of Labor for purposes of 18 U.S.C. 207(c). These four entities were the major program components of ESA until November 8, 2009, when the Secretary of the Department of Labor dissolved ESA into its constituent components. OFCCP, OLMS, OWCP,
OFCCP enforces, for the benefit of job seekers and wage earners, the contractual promise of affirmative action and equal employment opportunity required of those who do business with the Federal Government (Government contractors and subcontractors). Specifically, OFCCP administers and enforces three legal authorities requiring equal employment opportunity: Executive Order 11246, as amended; Section 503 of the Rehabilitation Act of 1973, as amended; and the Vietnam Era Veterans' Readjustment Assistance Act of 1974, as amended, 38 U.S.C. 4212. These authorities prohibit Federal contractors and subcontractors from discriminating on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, and protected veteran status, and also require Federal contractors and subcontractors to take affirmative action to ensure equal employment opportunity in their employment processes.
OLMS administers and enforces most provisions of the Labor-Management Reporting and Disclosure Act of 1959 (LMRDA). The LMRDA is a law that promotes union democracy and financial integrity in private sector labor unions through standards for union officer elections and union trusteeships and safeguards for union assets, and also promotes labor union and labor-management transparency through certain reporting and disclosure requirements. In addition to the LMRDA, OLMS administers provisions of the Civil Service Reform Act of 1978 and the Foreign Service Act of 1980 relating to standards of conduct for Federal employee organizations, which are comparable to LMRDA requirements. OLMS' role as an independent enforcement agency overseeing unions gives it a unique and critical role within the Department of Labor with a key stakeholder.
OWCP administers four major disability compensation programs that provide wage replacement benefits, medical treatment, vocational rehabilitation, and other benefits to certain workers or their dependents who experience work-related injury or occupational disease. Specifically, the OWCP administers the Energy Employees Occupational Illness Compensation Program, the Federal Employees' Compensation Program, the Longshore and Harbor Workers' Compensation Program, and the Coal Mine Workers' Compensation Program, each of which serve specific employee groups by mitigating the financial burden resulting from workplace injury.
WHD enforces the federal minimum wage, overtime pay, recordkeeping, and child labor requirements of the Fair Labor Standards Act. WHD also enforces the Migrant and Seasonal Agricultural Worker Protection Act, the Employee Polygraph Protection Act, the Family and Medical Leave Act, the wage garnishment provisions of the Consumer Credit Protection Act, and various employment standards and worker protections provided in several immigration-related statutes. WHD also administers and enforces the prevailing wage requirements of the Davis Bacon Act and the Service Contract Act, and other statues applicable to federal contracts for construction and the provision of goods and services.
According to the Department of Labor, the functions of OFCCP, OLMS, OWCP, and WHD are distinct and separate from each other, and also distinct and separate from every other agency within the Department. This distinction was previously recognized when OGE designated the now-abolished parent agency, ESA, as a separate component of the Department of Labor for purposes of 18 U.S.C. 207(c). The action that abolished the ESA left OFCCP, OLMS, OWCP, and WHD in its place. The four departments were each created by distinct authorities that are separate not only from each other but also from the organic statute for the Department of Labor; have been explicitly delegated distinct responsibilities following dissolution of the ESA; exercise distinct and separate functions to implement and enforce distinct and separate statutes; as noted above, are each headed by a political appointee who reports directly to the Secretary of Labor; and are relatively the same size as other components designated by the Department of Labor in appendix B to part 2641. Given the manner in which OFCCP, OLMS, OWCP, and WHD work independently from other component agencies and the general management of the Department of Labor, there exists no potential for the use of undue influence or unfair advantage based on past Government service.
Accordingly, OGE is proposing to grant the request of the Department of Labor and is proposing to amend the agency's listing in appendix B to part 2641 to remove the ESA from the component designation list and to designate OFCCP, OLMS, OWCP, and WHD as new components for purposes of 18 U.S.C. 207(c).
The Department of Transportation has requested that OGE designate the Pipeline and Hazardous Materials Safety Administration (PHMSA) as a distinct and separate component of the Department of Transportation for purposes of 18 U.S.C. 207(c). Created pursuant to the Norman Y. Mineta Research and Special Programs Improvements Act of 2004, PHMSA is responsible for regulating safety in pipeline transportation and hazardous materials transportation,
According to the Department of Transportation, PHMSA is responsible for exercising functions that are distinct and separate from the Department of Transportation and from the functions of other Operating Administrations within the agency. PHMSA is the only mode within DOT charged with regulating pipeline safety. It is also the only mode with the primary delegated authority to regulate hazardous material packaging, and is responsible for drafting all hazardous material regulations. In light of the distinct and separate functions of PHMSA, there is no potential for the use of undue influence or unfair advantage based on based on past Government service. PHMSA is comparable in size to several other Department of Transportation divisions that are currently designated as separate components in appendix B to part 2641, and with the designation of PHMSA, each of the Operating Administrations of the Department of Transportation will be designated as separate components for purposes of 18 U.S.C. 207(c).
Accordingly, OGE is proposing to grant the request of the Department of Transportation and amend the listing in appendix B to part 2641 to designate the Pipeline and Hazardous Materials Safety Administration as a new component for purposes of 18 U.S.C. 207(c).
The Department of Transportation also has requested revocation of the designation of the Surface Transportation Board (STB) in appendix B to part 2641. The STB, the successor to the Interstate Commerce Commission, was established in 1996 as an independent entity within the Department of Transportation. On December 28, 2015, the Surface Transportation Board Reauthorization Act of 2015 (Pub. L. 114-110) established the STB as a wholly-
As indicated in 5 CFR 2641.302(f), a designation “shall be effective on the date the rule creating the designation is published in the
As also indicated in 5 CFR 2641.302(f), revocation of a component designation is effective 90 days after the publication in the
As Director of the Office of Government Ethics, I certify under the Regulatory Flexibility Act (5 U.S.C. chapter 6) that this proposed rule will not have a significant economic impact on a substantial number of small entities because it affects only Federal departments and agencies and current and former Federal employees.
The Paperwork Reduction Act (44 U.S.C. chapter 35) does not apply to this proposed rule because it does not contain information collection requirements that require the approval of the Office of Management and Budget.
For purposes of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. chapter 25, subchapter II), this proposed rule would not significantly or uniquely affect small governments and will not result in increased expenditures by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (as adjusted for inflation) in any one year.
The proposed rule is not a major rule as defined in 5 U.S.C. chapter 8, Congressional Review of Agency Rulemaking.
In promulgating this rule, the Office of Government Ethics has adhered to the regulatory philosophy and the applicable principles of regulation set forth in Executive Orders 12866 and 13563. This proposed rule has not been reviewed by the Office of Management and Budget under Executive Order 12866 because it is not a “significant” regulatory action for the purposes of that order.
As Director of the Office of Government Ethics, I have reviewed this proposed rule in light of section 3 of Executive Order 12988, Civil Justice Reform, and certify that it meets the applicable standards provided therein.
Conflict of interests, Government employees.
Accordingly, for the reasons set forth in the preamble, the Office of Government Ethics proposes to amend 5 CFR part 2641, as set forth below:
5 U.S.C. App. (Ethics in Government Act of 1978); 18 U.S.C. 207; E.O. 12674, 54 FR 15159, 3 CFR, 1989 Comp., p. 215, as modified by E.O. 12731, 55 FR 42547, 3 CFR, 1990 Comp., p. 306.
The revisions read as follows:
Bureau of Labor Statistics.
Employee Benefits Security Administration (formerly Pension and Welfare Benefits Administration) (effective May 16, 1997).
Employment and Training Administration.
Employment Standards Administration (expires 90 days after the date of publication of the final rule in the
Mine Safety and Health Administration.
Occupational Safety and Health Administration.
Office of Disability Employment Policy (effective January 30, 2003).
Office of Federal Contract Compliance Programs (effective upon publication of the final rule in the
Office of Labor Management Standards (effective upon publication of the final rule in the
Office of Workers' Compensation Programs (effective upon publication of the final rule in the
Pension Benefit Guaranty Corporation (effective May 25, 2011).
Wage and Hour Division (effective upon publication of the final rule in the
Federal Aviation Administration.
Federal Highway Administration.
Federal Motor Carrier Safety Administration (effective January 30, 2003).
Federal Railroad Administration.
Federal Transit Administration.
Maritime Administration.
National Highway Traffic Safety Administration.
Pipeline and Hazardous Materials Safety Administration (effective upon publication of the final rule in the
Saint Lawrence Seaway Development Corporation.
Surface Transportation Board (effective May 16, 1997; expires 90 days after the date of publication of the final rule in the
Federal Election Commission.
Reopening of comment period and notice of hearing.
On October 13, 2011, the Federal Election Commission published an Advance Notice of Proposed Rulemaking (“ANPRM”) seeking comment on whether to begin a rulemaking to revise its regulations concerning disclaimers on certain internet communications and, if so, on what changes should be made to those rules. The Commission has decided to reopen the comment period to receive additional comments in light of legal and technological developments since that notice was published. The Commission is also announcing a public hearing.
The comment period for the ANPRM published October 13, 2011 (76 FR 63567) is reopened. Comments must be received on or before December 19, 2016. The Commission will hold a hearing on these issues on February 1, 2017. Anyone wishing to testify at the hearing must file timely written comments and must include in the written comments a request to testify.
All comments must be in writing. Commenters are encouraged to submit comments electronically via the Commission's Web site at
Each commenter must provide, at a minimum, his or her first name, last name, city, state, and zip code. All properly submitted comments, including attachments, will become part of the public record, and the Commission will make comments available for public viewing on the Commission's Web site and in the Commission's Public Records Office. Accordingly, commenters should not provide in their comments any information that they do not wish to make public, such as a home street address, personal email address, date of birth, phone number, social security number, driver's license number, or any information that is restricted from disclosure, such as trade secrets or commercial or financial information that is privileged or confidential.
Mr. Neven F. Stipanovic, Acting Assistant General Counsel, or Ms. Jessica Selinkoff, Attorney, 999 E Street NW., Washington, DC 20463, (202) 694-1650 or (800) 424-9530.
On October 13, 2011, the Commission published in the
As discussed in the ANPRM, a “disclaimer” is a statement that must appear on certain communications to identify who paid for it and, where applicable, whether the communication was authorized by a candidate. 52 U.S.C. 30120(a); 11 CFR 110.11. With some exceptions, the Act and Commission regulations require disclaimers for public communications: (1) Made by a political committee; (2) that expressly advocate the election or defeat of a clearly identified federal candidate; or (3) that solicit a contribution. 52 U.S.C. 30120(a); 11 CFR 110.11(a). While the term “public communication” generally does not include internet communications, it does include “communications placed for a fee on another person's Web site.” 11 CFR 100.26.
Commission regulations set forth certain exceptions to the general disclaimer requirements. For example, disclaimers are not required for communications placed on “[b]umper stickers, pins, buttons, pens, and similar small items upon which the disclaimer cannot be conveniently printed.” 11 CFR 110.11(f)(1)(i) (the “small items exception”). Nor are disclaimers required for “[s]kywriting, water towers, wearing apparel, or other means of displaying an advertisement of such a nature that the inclusion of a disclaimer would be impracticable.” 11 CFR 110.11(f)(1)(ii) (the “impracticable exception”).
As discussed in the ANPRM, some internet advertisements are so character-limited that providing all the disclaimer information required by the Act may take up much of the available ad characters.
Since the publication of the ANPRM, the Commission has considered these issues in new factual contexts.
• How campaigns, parties, and other political committees, voters, and others disseminate and receive electoral information via the internet and other technologies, including any data or experiences in purchasing, selling, or distributing small or character-limited advertisements on Web sites, apps, and mobile devices;
• any challenges in complying with the existing disclaimer rules as applied to internet communications;
• the technological or other characteristics that might define a “small” internet advertisement;
• how a disclaimer requirement or exception for “small” internet advertisements might be implemented;
• the informational benefits of disclaimers on internet communications to assist voters in identifying the source of advertising so they are better “able to evaluate the arguments to which they are being subjected”;
• the informational benefits of disclaimers on internet communications, including Web sites and social media pages, to avoid voter confusion and reduce the incidence of solicitations that appear to be for candidates but are actually for non-candidate committees; and
• the extent to which the Commission's consideration of disclaimer requirements should take into account current or anticipated models of internet advertising.
The Commission also invites additional comments on any issues discussed in the ANPRM and is particularly interested in comments addressing advertisements on internet-enabled applications and devices (such as apps, eReaders, and wearable technology). Given the speed at which technological advances are developing, the Commission welcomes comments that address possible regulatory approaches that might minimize the need for serial revisions to the Commission's rules in order to adapt to new or emerging technologies.
On behalf of the Commission.
Food and Drug Administration, HHS.
Proposed rule.
The Food and Drug Administration (FDA or the Agency) is proposing to amend its regulations to revise the list of drug products that have been withdrawn or removed from the market because the drug products or components of such drug products have been found to be unsafe or not effective. Drugs appearing on this list may not be compounded under the exemptions provided by sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). Specifically, the proposed rule would add three entries to this list of drug products.
Submit either electronic or written comments on the proposed rule by January 3, 2017.
You may submit comments as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Edisa Gozun, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 5199, Silver Spring, MD 20993-0002, 301-796-3110.
FDA is proposing to amend its regulations to revise the list of drug products that have been withdrawn or removed from the market because the drug products or components of such drug products have been found to be unsafe or not effective (referred to as “the withdrawn or removed list” or “the list”) (§ 216.24 (21 CFR 216.24)). Drugs appearing on the withdrawn or removed list may not be compounded under the exemptions provided by sections 503A and 503B of the FD&C Act (21 U.S.C. 353a and 353b).
The Agency is proposing to add three entries (all drug products containing aprotinin, all drug products containing bromocriptine mesylate, and all intravenous drug products containing greater than a 16 milligram (mg) single dose of ondansetron hydrochloride) as described in this document to the list in § 216.24 of drug products that cannot be compounded for human use under the exemptions provided by either section 503A or 503B of the FD&C Act because they have been withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective.
We are proposing that the following drugs that have been withdrawn or removed from the market because such drug products have been found to be unsafe or not effective be added to the list in § 216.24. The specific entries proposed for addition to the list for each of these drugs are provided as follows:
The Agency is not aware of any routine use of the drug products that FDA is proposing to add to the the withdrawn or removed list and, therefore, does not estimate any compliance costs or loss of sales as a result of the prohibition against compounding these drug products for human use. The Agency has determined that this rulemaking is not a significant regulatory action as defined by Executive Order 12866.
Section 503A of the FD&C Act describes the conditions that must be satisfied for human drug products compounded by a licensed pharmacist or licensed physician to be exempt from the following three sections of the FD&C Act: (1) Section 501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)) (concerning current good manufacturing practice); (2) section 502(f)(1) (21 U.S.C. 352(f)(1)) (concerning the labeling of drugs with adequate directions for use); and (3) section 505 (21 U.S.C. 355) (concerning the approval of drugs under new drug applications (NDAs) or abbreviated new drug applications (ANDAs)).
In addition, section 503B of the FD&C Act describes the conditions that must be satisfied for a drug compounded for human use by or under the direct supervision of a licensed pharmacist in an outsourcing facility to be exempt from three sections of the FD&C Act: (1) Section 502(f)(1), (2) section 505, and (3) section 582 (21 U.S.C. 360eee-1) (concerning drug supply chain security).
One of the conditions that must be satisfied to qualify for the exemptions under both sections 503A and 503B of the FD&C Act is that the compounder does not compound a drug product that appears on a list published by the Secretary of drug products that have been withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective (withdrawn or removed list) (see sections 503A(b)(1)(C), 503B(a)(4), and 503B(a)(11) of the FD&C Act).
The drug products listed in § 216.24 (the withdrawn or removed list) have been withdrawn or removed from the market because they have been found to be unsafe or not effective and are ineligible for the exemptions set forth in sections 503A and 503B of the FD&C Act. A drug product that is included in the list codified at § 216.24 is not eligible for the exemptions provided in section 503A(a) of the FD&C Act, and is subject to sections 501(a)(2)(B), 502(f)(1), and 505 of the FD&C Act, in addition to other applicable provisions, if compounded. In addition, a drug that is included in the list codified at § 216.24 cannot qualify for the exemptions provided in section 503B(a) of the FD&C Act, and is subject to sections 502(f)(1), 505, and 582 of the FD&C Act, in addition to other applicable provisions, if compounded.
Following the addition of section 503A to the FD&C Act on November 21, 1997, through the enactment of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115), FDA proposed a rule in the
In the
Following the addition of section 503B to the FD&C Act on November 27, 2013, through the enactment of the Drug Quality and Security Act (Pub. L. 113-54), FDA proposed to amend the list in § 216.24 on July 2, 2014 (79 FR 37687); FDA published the final rule to amend § 216.24 in the
FDA is proposing to amend § 216.24 to add three drug products, described in the following paragraphs, that have been withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective.
As with the 1999 final rule establishing the original list, and the 2016 final rule revising that list, the primary focus of this proposed rule is on drug products that have been withdrawn or removed from the market because they have been found to be unsafe. FDA may propose at a later date to add other drug products to the list that have been withdrawn or removed from the market because they have been found to be not effective, or to update the list as new information becomes available to the Agency regarding products that were removed from the market because they have been found to be unsafe.
The following drugs proposed for inclusion in § 216.24 are arranged alphabetically by the established names of the active ingredients contained in the drug products that have been withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective. For some of the drug products, the proprietary or trade names of some or all of the drug products that contained the active ingredient are also given in the preamble paragraphs describing the withdrawn or removed drug products. In some cases, the withdrawn or removed drug products are identified according to the established name of the active ingredient, listed as a particular salt or ester of the active moiety. The following list includes the specific drug entry FDA is proposing to add to § 216.24, as well as a brief summary of the reasons why each drug is being proposed for inclusion.
Bayer suspended marketing of aprotinin (TRASYLOL, NDA 20304) in November 2007 for safety reasons. TRASYLOL, NDA 20304, was approved on December 29, 1993. The indication for TRASYLOL, NDA 20304, was for “prophylactic use to reduce perioperative blood loss and the need for blood transfusion in patients undergoing cardiopulmonary bypass in the course of coronary artery bypass graft surgery who are at increased risk for blood loss and blood transfusion.” Prominent known adverse reactions associated with the use of the drug included anaphylactic reactions (with some deaths reported) and impaired renal function. In January 2006, Mangano et al. published a report that described the results from a retrospective analysis of the use of aprotinin compared to two other antifibrinolytic drugs (tranexamic acid and aminocaproic acid) or no antifibrinolytic drugs in 4,374 patients undergoing cardiac surgery (Ref. 1). The conclusions were that there was a statistically greater likelihood of the development of renal dysfunction and the need for hemodialysis, stroke, encephalopathy, myocardial infarction, and congestive heart failure in patients treated with aprotinin than with the other antifibrinolytic drugs or no antifibrinolytic drugs. On February 8, 2006, FDA issued a Public Health Advisory on TRASYLOL, NDA 20304, that called attention to this new information (Ref. 2). On September 21, 2006, FDA convened a meeting of its Cardiovascular and Renal Advisory Committee to evaluate these and other data for the drug (see
Bromocriptine mesylate was associated with risks of hypertension, seizures, and cardiovascular accidents, and the unfavorable benefit-risk balance was specific to the use of bromocriptine mesylate for the prevention of physiological lactation. In 1980, PARLODEL (bromocriptine mesylate) was approved for the prevention of physiological lactation as an acceptable alternative to estrogenic therapy. Subsequently, FDA received postmarket reports of serious and life-threatening adverse reactions (hypertension, seizures, and cerebrovascular accidents) associated with the use of bromocriptine mesylate to suppress lactation. According to the approved labeling for PARLODEL, dated July 15, 1988 (Ref. 9), serious adverse reactions reported in postpartum women included 50 cases of hypertension, 38 cases of seizures (including 4 cases of status epilepticus), 15 cases of strokes, and 3 cases of myocardial infarction. These cases were discussed at a 1989 Fertility and Maternal Health Drugs Advisory Committee meeting (Ref. 10). FDA presented reports of its safety findings, which included 28 reports of hypertension, 36 reports of seizures, and 19 reports of cerebrovascular accidents. FDA had received 85 cases of serious adverse events, including 10 deaths, since the approval of bromocriptine mesylate for lactation suppression in 1980 (August 23, 1994 (59 FR 43347)). The Fertility and Maternal Health Drugs Advisory Committee recommended that no drug then labeled for lactation suppression including bromocriptine mesylate be used for this indication. FDA subsequently asked that all manufacturers of these drugs voluntarily remove this indication from drug labeling. All but Sandoz, the manufacturer of PARLODEL, complied with FDA's request. In a document published in the
Ondansetron (ondansetron hydrochloride (HCl)) Injection, USP, 32 mg, in 50 milliliters (mL), single intravenous (IV) dose, was associated with a specific type of irregular heart rhythm called QT interval prolongation, and the data suggest that any dose above the maximum recommendation of 16 mg per dose intravenously has the potential for increased risk of QT prolongation. In September 2011, FDA issued a Drug Safety Communication noting concerns that the 32 mg single IV dose of ZOFRAN (ondansetron HCl) and generic versions of that product could increase the risk of abnormal changes in the electrical activity of the heart, which could result in a potentially fatal abnormal heart rhythm (Ref. 11). Based on data subsequently collected from a study conducted at FDA's request by ZOFRAN's sponsor, GlaxoSmithKline (GSK), that identified a significant QT prolongation effect in connection with the 32 mg single IV dose, FDA approved GSK's supplemental application to remove the 32 mg single IV dose information from the labeling for ZOFRAN and has worked with manufacturers of all 32 mg single IV dose ondansetron HCl products to have them removed from the market. On June 29, 2012, FDA issued a Drug Safety Communication to notify health care professionals that the 32 mg single IV dose of ondansetron HCl, indicated for prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy in adult patients, should be avoided due to the risk of QT interval prolongation, which can lead to Torsades de Pointes, an abnormal, potentially fatal heart rhythm (Ref. 12). Subsequently, FDA informed the holders of one NDA and four ANDAs for ondansetron HCl that the Agency believes that, in light of the safety concern associated with ondansetron HCl in the 32 mg single IV dose, these drug products should be removed from the market. The application holders agreed to voluntarily remove their respective 32 mg single IV dose ondansetron HCl products from the market and requested that FDA withdraw approval of their respective applications under 21 CFR 314.150(d). On December 4, 2012, FDA issued an updated Drug Safety Communication alerting health care professionals that these products would be removed from the market because of their potential for serious cardiac risks (Ref. 13). In the
On June 17, 2015, FDA presented these three proposed entries to the Pharmacy Compounding Advisory Committee (see the
The Pharmacy Compounding Advisory Committee voted in favor of including each of FDA's four proposed entries on the list. Although an open public hearing session was scheduled at this meeting to allow members of the public to present their views and opinions on the proposed entries to the committee members and the Agency prior to the vote by the Pharmacy Compounding Advisory Committee, no members of the public signed up to participate. A transcript of the June 2015 Pharmacy Compounding Advisory Committee meeting and briefing information that includes reviews and background on the proposed entries may be found at the Division of Dockets Management (see
Sections 503A and 503B of the FD&C Act provide the principal legal authority for this proposed rule. As described previously in the Background section of this document, section 503A of the FD&C Act describes the conditions that must be satisfied for human drug products compounded by a licensed pharmacist or licensed physician to be exempt from three sections of the FD&C Act (sections 501(a)(2)(B), 502(f)(1), and 505). One of the conditions that must be satisfied to qualify for the exemptions under section 503A of the FD&C Act is that the licensed pharmacist or licensed physician does not compound a drug product that appears on a list published by the Secretary in the
Section 503B of the FD&C Act describes the conditions that must be satisfied for a drug compounded for human use by or under the direct supervision of a licensed pharmacist in an outsourcing facility to be exempt from three sections of the FD&C Act (sections 502(f)(1), 505, and 582). One of the conditions in section 503B of the FD&C Act that must be satisfied to qualify for the exemptions is that the drug does not appear on a list published by the Secretary of drugs that have been withdrawn or removed from the market because such drugs or components of such drugs have been found to be unsafe or not effective (see section 503B(a)(4)). To be eligible for the exemptions in section 503B, a drug must be compounded in an outsourcing facility in which the compounding of drugs occurs only in accordance with section 503B, including as provided in section 503B(a)(4).
Thus, sections 503A and 503B of the FD&C Act, in conjunction with our general rulemaking authority in section 701(a) of the FD&C Act (21 U.S.C. 371(a)), serve as our principal legal authority for this proposed rule revising FDA's regulations on drug products withdrawn or removed from the market because the drug product or a component of the drug product have been found to be unsafe or not effective in § 216.24.
We have determined under 21 CFR 25.30(h) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
We have examined the impacts of the proposed rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct us to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). We believe that this proposed rule is not a significant regulatory action as defined by Executive Order 12866.
The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because small businesses are not expected to incur any compliance costs or loss of sales due to this regulation, we propose to certify that the proposed rule will not have a significant economic impact on a substantial number of small entities.
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires us to prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $146 million, using the most current (2015) Implicit Price Deflator for the Gross Domestic Product. We do not expect this proposed rule to result in any 1-year expenditure that would meet or exceed this amount.
This proposed rule would amend § 216.24 concerning human drug compounding. Specifically, the proposed rule would add to or modify the list of drug products that may not be compounded under the exemptions provided by sections 503A and 503B of the FD&C Act because the drug products have been withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective (see section II of this document). We are proposing to add three entries to the list. We are not aware of any routine compounding for human use of the drug products that are the subject of this proposed rule, and therefore do not estimate any compliance costs or loss of sales if the proposal is adopted. However, we invite the submission of comments and solicit current compounding usage data for these drug products, if they are compounded for human use.
Unless we certify that a rule will not have a significant economic impact on a substantial number of small entities, the Regulatory Flexibility Act requires us to analyze regulatory options to minimize any significant economic impact of a regulation on small entities. Most pharmacies meet the Small Business Administration definition of a small entity, which is defined as having annual sales less than $25.5 million for this industry. We are not aware of any routine compounding of these drug products and do not estimate any compliance costs or loss of sales to small businesses as a result of the prohibition against compounding these drug products. Therefore, we propose to certify that this proposed rule will not have a significant economic impact on a substantial number of small entities.
FDA tentatively concludes that this proposed rule contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.
We have analyzed this proposed rule in accordance with the principles set forth in Executive Order 13132. We have determined that this proposed rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, we conclude that the rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required.
The following references are on display in the Division of Dockets Management (see
Drugs, Prescription drugs.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, it is proposed that 21 CFR part 216 be amended as follows:
21 U.S.C. 351, 352, 353a, 353b, 355, and 371.
Patent Trial and Appeal Board, United States Patent and Trademark Office, U.S. Department of Commerce.
Proposed rule.
This proposed rule would amend the rules of practice before the Patent Trial and Appeal Board to recognize that, in connection with discovery conducted in certain proceedings at the United States Patent and Trademark Office (USPTO or Office), communications between U.S.
Comments should be sent by electronic mail message over the Internet addressed to:
Comments may also be sent by electronic mail message over the Internet via the Federal eRulemaking Portal at
Although comments may be submitted by postal mail, the Office prefers to receive comments by electronic mail message to be able to more easily share all comments with the public. The Office prefers the comments to be submitted in plain text, but also accepts comments submitted in ADOBE® portable document format or MICROSOFT WORD® format. Comments not submitted electronically should be submitted on paper in a format that accommodates digital scanning into ADOBE® portable document format.
The comments will be available for public inspection at the Office of Policy and International Affairs, currently located in Madison East, Second Floor, 600 Dulany Street, Alexandria, Virginia. Comments also will be available for viewing via the Office's Internet Web site at
Soma Saha, Patent Attorney, by email at
In February 2015, the USPTO held a roundtable and solicited comments on attorney-client privilege issues.
The USPTO administers various proceedings that entail discovery procedures, namely the IPR, PGR, and transitional program for CBM patents. In addition, the derivation proceedings provided for by the Leahy-Smith America Invents Act, Public Law 112-29, 125 Stat. 284 (2011) (AIA) permit discovery. Questions regarding privilege issues may arise in the course of discovery, and as some roundtable commenters noted, rules regarding privilege for U.S. patent agents and foreign practitioners during discovery in PTAB proceedings are not well defined.
The rules governing PTAB practice likewise do not address this matter, and when it arises, PTAB Administrative Law Judges make legal determinations as to which communications may be protected from disclosure on a case-by-case basis, based on common law.
The Office has strong policy reasons to establish a privilege rule governing trial proceedings before PTAB. Such a rule would help ensure consistent outcomes with respect to privilege matters that arise at the Office, would improve public understanding of how privilege questions are decided before PTAB, and would help further judicial economy by providing PTAB judges with a clear, concise statement of when privilege applies.
Those responding to the request universally agreed that a privilege rule for PTAB proceedings should be promulgated. Respondents overwhelmingly favored promulgating such a rule, with some noting that it would lead to clarity and consistency and “can reduce uncertainty and mitigate discovery costs.”
Commenters said it “would be particularly useful for patent agents['] communications to be explicitly protected in the discovery rules for post-grant proceedings (
According to these comments, “[t]his approach would provide the greatest uniformity and certainty, and avoid the need for the PTAB to engage in complex fact based analysis regarding application of the privilege under the common law.”
The privilege should be as broad as the ordinary attorney-client privilege. It should cover not only U.S. patent agents, but also foreign legal representatives. While the best solution would be a privilege that applied in all legal tribunals—not only the PTAB, but also federal and state courts—adoption of a privilege only for the PTAB would be a valuable first step toward this goal.
The USPTO agrees with these views and believes the proposed rule reflects them. As a policy matter, open and frank discussions between practitioners and clients promotes effective legal representation before the Office.
Taking into consideration comments from the public and insight gained from practice, the Office proposes to amend 37 CFR 42 to add new section 42.57 that clarifies which patent practitioners are eligible for assertions of attorney-client privilege.
The term “patent practitioner” is used to conform with existing terminology and avoid confusion with other terms used around the world, such as “IP Advisor” or “Patent Advisor.” It fits with practice elsewhere in Title 37, which refers to domestic “patent practitioners,”
The rule would provide that the privilege only applies where the practitioner performs legal work authorized by the jurisdiction in which the practitioner practices. For instance, communications between clients and U.S. patent agents relating to patent application matters would be protected as privileged under the rule, but communications between these parties regarding litigation strategies would not be protected. The proposed rule also does not recognize privilege as applying to advice given by lay persons in jurisdictions that do not impose professional qualifications as a requirement to practice. However, the proposed rule can apply to communications from an in-house counsel who performs the functions of a patent attorney under appropriate circumstances, even though some civil law jurisdictions may not grant in-house counsel the privilege-type protections given to attorneys.
The Office invites the public to provide any comments on the proposed rule to inform further action.
This proposed rule revises the rules of practice before PTAB to recognize that
Accordingly, prior notice and opportunity for public comment are not required pursuant to 5 U.S.C. 553(b) or (c), or any other law.
For the reasons set forth herein, the Deputy General Counsel for General Law of the USPTO has certified to the Chief Counsel for Advocacy of the Small Business Administration that this proposed rule will not have a significant economic impact on a substantial number of small entities.
The changes proposed in this rule are to revise the rules of practice before PTAB to explicitly recognize that communications between non-attorney or foreign patent practitioners and their clients that pertain to authorized practice before the USPTO or foreign patent offices are privileged and to define those persons who may avail themselves of this privilege. These proposed changes are expected to create no additional burden to those practicing before the Board as this rule merely clarifies rights and protections for the practitioner and client and does not impose a change in practice or requirements. In fact, this rule may produce a small benefit from a reduction in uncertainty and mitigation of discovery costs. For the foregoing reasons, the changes proposed in this rule will not have a significant economic impact on a substantial number of small entities.
This rulemaking has been determined to be not significant for purposes of Executive Order 12866 (Sept. 30, 1993).
The Office has complied with Executive Order 13563. Specifically, the Office has, to the extent feasible and applicable: (1) Made a reasoned determination that the benefits justify the costs of the rule; (2) tailored the rule to impose the least burden on society consistent with obtaining the regulatory objectives; (3) selected a regulatory approach that maximizes net benefits; (4) specified performance objectives; (5) identified and assessed available alternatives; (6) involved the public in an open exchange of information and perspectives among experts in relevant disciplines, affected stakeholders in the private sector and the public as a whole, and provided on-line access to the rulemaking docket; (7) attempted to promote coordination, simplification, and harmonization across government agencies and identified goals designed to promote innovation; (8) considered approaches that reduce burdens and maintain flexibility and freedom of choice for the public; and (9) ensured the objectivity of scientific and technological information and processes.
This rulemaking does not contain policies with federalism implications sufficient to warrant preparation of a Federalism Assessment under Executive Order 13132 (Aug. 4, 1999).
This rulemaking will not: (1) Have substantial direct effects on one or more Indian tribes; (2) impose substantial direct compliance costs on Indian tribal governments; or (3) preempt tribal law. Therefore, a tribal summary impact statement is not required under Executive Order 13175 (Nov. 6, 2000).
This rulemaking is not a significant energy action under Executive Order 13211 because this rulemaking is not likely to have a significant adverse effect on the supply, distribution, or use of energy. Therefore, a Statement of Energy Effects is not required under Executive Order 13211 (May 18, 2001).
This rulemaking meets applicable standards to minimize litigation, eliminate ambiguity, and reduce burden as set forth in sections 3(a) and 3(b)(2) of Executive Order 12988 (Feb. 5, 1996).
This rulemaking does not concern an environmental risk to health or safety that may disproportionately affect children under Executive Order 13045 (Apr. 21, 1997).
This rulemaking will not affect a taking of private property or otherwise have taking implications under Executive Order 12630 (Mar. 15, 1988).
Under the Congressional Review Act provisions of the Small Business Regulatory Enforcement Fairness Act of 1996 (5 U.S.C. 801
The changes set forth in this rulemaking do not involve a Federal intergovernmental mandate that will result in the expenditure by State, local, and tribal governments, in the aggregate, of 100 million dollars (as adjusted) or more in any one year, or a Federal private sector mandate that will result in the expenditure by the private sector of 100 million dollars (as adjusted) or more in any one year, and will not significantly or uniquely affect small governments. Therefore, no actions are necessary under the provisions of the
This rulemaking will not have any effect on the quality of the environment and is thus categorically excluded from review under the National Environmental Policy Act of 1969.
The requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) are not applicable because this rulemaking does not contain provisions which involve the use of technical standards.
The Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3549) requires that the Office consider the impact of paperwork and other information collection burdens imposed on the public. This proposed rule not does not involve any new information collection requirements that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3549). Any information collections associated with this rule have been previously approved under OMB control number 0651-0069.
Notwithstanding any other provision of law, no person is required to respond to, nor shall any person be subject to, a penalty for failure to comply with a collection of information subject to the requirements of the Paperwork Reduction Act unless that collection of information displays a currently valid OMB control number.
Administrative practice and procedure, inventions and patents.
For the reasons set forth in the preamble, 37 CFR part 42 is proposed to be amended as follows:
35 U.S.C. 2(b)(2), 6, 21, 23, 41, 135, 311, 312, 316, 321-326; Pub. L. 112-29, 125 Stat. 284; and Pub. L. 112-274, 126 Stat. 2456.
(a)
(b)
Copyright Royalty Board, Library of Congress.
Proposed rule; extension of comment period for reply comments.
The Copyright Royalty Judges announce that they will accept reply comments in response to comments they received about a proposed rule regarding rates and terms applicable during the upcoming rate period for the section 115 statutory license for making and distributing phonorecords of nondramatic musical works.
Reply comments for the proposed rule published July 25, 2016 (81 FR 48371) are due no later than November 17, 2016.
The proposed rule and the comments filed in response to it are posted on the agency's Web site (
Kimberly Whittle, Attorney Advisor, by telephone at (202) 707-7658, or by email at
On July 25, 2016, the Judges published a proposed rule and requested comments. 81 FR 48371. The proposed rule was based upon a partial settlement
On or before August 24, 2016, the Judges received two timely comments, one from the American Association of Independent Music (A2IM) that supported it and one from Sony Music Entertainment (“Sony”) that supported it in part and opposed it in part.
On August 30, 2016, the National Music Publishers' Association and the Nashville Songwriters Association International filed a joint
The reply comments, if any, must be submitted no later than November 17, 2016.
Interested members of the public must submit reply comments to only
Department of Veterans Affairs.
Proposed rule.
The Department of Veterans Affairs (VA) proposes to amend its regulations governing the Veterans' Mortgage Life Insurance (VMLI) program in order to provide VMLI-eligible individuals the option to lower their premiums by purchasing less than the minimum coverage amount required under current VA regulations. The proposed rule would also amend current VA regulations to reflect that the statutory maximum amount of coverage available under the VMLI program was previously increased to $200,000, to define the term “eligible individual,” and to clarify that eligibility for VMLI coverage has been extended to include servicemembers as well as veterans. These additional amendments are necessary to conform the existing regulations to current statutory provisions.
Comments must be received on or before December 19, 2016.
Written comments may be submitted through
Jeanne King, Attorney-Advisor, Insurance Service, Department of Veterans Affairs (310/290B), 5000 Wissahickon Avenue, P.O. Box 8079, Philadelphia, PA 19101, (215) 842-2000, ext. 4839. (This is not a toll-free number.)
The Veterans' Mortgage Life Insurance (VMLI) program was established in 1971 to provide mortgage protection insurance to service-disabled veterans who receive Specially Adapted Housing Grants from VA. Under 38 U.S.C. 2106(g), the amount of VMLI coverage for a veteran is the amount necessary to pay the veteran's mortgage indebtedness in full, except as limited by section 2106(b) or “regulations prescribed by the Secretary under this section.” Section 2106(b) currently limits the amount of VMLI available to $200,000. Therefore, currently, a veteran who has a mortgage indebtedness that is greater than $200,000 and seeks VMLI must be covered in the amount of $200,000 and pay the corresponding premiums for such coverage. VA has concluded that requiring this level of coverage in such circumstance may cause some individuals to forego VMLI protection because they cannot afford the premiums. To address this specific problem and to allow veterans to pay lower premiums regardless of their mortgage indebtedness, VA proposes to exercise its explicit statutory authority set forth in section 2106(g) and amend its regulations to permit program participants to lower their premiums by carrying VMLI in an amount less than both the $200,000 statutory maximum and the amount necessary to pay the covered mortgage indebtedness in full.
As noted, paying the premiums on the level of coverage required under current regulations can present a financial hardship to individuals insured under the program. We realize that allowing eligible individuals to carry an amount of VMLI lower than the amount outstanding on the mortgage loan may result in circumstances where an insured dies with a balance on the loan that exceeds the amount of VMLI in effect, which currently occurs when an individual's mortgage balance exceeds the statutory maximum level of coverage. In such a situation, the individual's survivors may have to assume payment on the mortgage. However, VA believes that it is preferable for individuals to participate in the VMLI program to the extent they can financially, rather than foregoing coverage entirely because they cannot afford it. If an eligible individual opts out of the program, and then dies with an outstanding balance on the loan, his or her survivors could ultimately be forced to assume an even greater indebtedness than if the individual had carried partial VMLI coverage.
Individuals often seek to lower their VMLI premiums by requesting an amount of coverage less than both the statutory limit and the amount necessary to pay the mortgage indebtedness in full. For example, from January 1, 2005, to December 31, 2010, when the statutory coverage limit was $90,000, VA received 231 requests to terminate existing VMLI coverage. VA reviewed approximately 100 requests to determine if financial hardship was a factor in individuals' decisions to terminate coverage. Thirty percent of veterans who terminated their coverage during that period stated that the premium charged for their coverage was the main factor motivating their requests.
Effective October 1, 2011, the Veterans' Benefits Act of 2010 raised the statutory maximum coverage for VMLI from $90,000 to $150,000, and to $200,000 after January 1, 2012. See Public Law 111-275, Title IV, § 407, 124 Stat. 2864, 2880. Depending on a veteran's age and mortgage balance, this statutory change could cause an individual's monthly premiums to increase by almost $400.00—from less than $460.00 to more than $850.00 per month. As such, VA has concluded that, because premiums for the new statutory maximum amount of $200,000 are considerably higher than premiums for the former maximum amount, an increasing number of individuals may terminate their VMLI coverage or decline coverage entirely unless VA offers options to buy a lesser amount of VMLI.
To promptly address this problem, VA adopted an interim policy allowing
In establishing the VMLI program, Congress intended to provide seriously disabled veterans with a reasonable level of mortgage protection insurance. If individuals decline coverage because they cannot afford the premiums, the purpose of the program is undermined. Therefore, VA proposes to amend its Part 8a regulations to reflect the new statutory maximum and provide program participants the option to select a more affordable level of coverage that is lower than both the statutory maximum and their outstanding mortgage balance. VA believes this change would benefit all VMLI-eligible individuals because it would provide needed flexibility in the program and empower veterans to decide what level of coverage they can afford. As explained above, VA has concluded that it is preferable for individuals to make their own financial decisions as to what level of VMLI they can afford, rather than foregoing coverage because they cannot afford a higher amount mandated by statute. Absent VA's proposed amendment, current regulations would likely prompt some veterans to decline VMLI coverage because they cannot afford the required premiums, ultimately forcing more survivors into greater mortgage debt than if partial VMLI coverage were available.
We interpret 38 U.S.C. 2106 as authorizing VA to prescribe regulations permitting VMLI coverage in amounts less than the statutory maximum and the outstanding mortgage indebtedness. Section 2106(g) requires that VMLI participants carry the amount of insurance necessary to pay their mortgage indebtedness in full, but explicitly authorizes the Secretary to prescribe an exception to this requirement. Moreover, section 2106(b) imposes a cap of $200,000 in coverage but does not mandate that VMLI participants carry the maximum amount of coverage available. Therefore, VA's proposed amendments to its regulations are implicitly authorized by 38 U.S.C. 2106.
The proposed amendment would exercise this authority by amending 38 CFR 8a.1(c) and 38 CFR 8a.2(a) to provide insureds with the option to select a more affordable level of coverage. We propose to revise the term “initial amount of insurance” in § 8a.1(c) to mean “the amount of insurance selected by the insured, which may be less than the statutory maximum of $200,000 and less than the amount necessary to pay the mortgage indebtedness in full.” This change would make clear that VMLI-eligible individuals are authorized to carry such VMLI coverage as they select, up to the lesser of the $200,000 statutory maximum or the amount necessary to pay their mortgage indebtedness in full. We would also amend § 8a.2(a) and (b)(1) and § 8a.4(b) and (c) to reflect that the current statutory maximum of VMLI coverage, as previously increased, is $200,000.
The proposed amendments to 38 CFR 8a.4(b)-(c) removing “available to” and adding in its place “selected by” are designed to ensure conformity with this change by making clear that the amount of insurance on the life of the eligible individual may be a reduced amount selected by the eligible individual, up to the lesser of the $200,000 statutory maximum or the amount necessary to pay their mortgage indebtedness in full. For the reasons discussed above, these amendments would benefit veterans and their beneficiaries by adding needed flexibility to the program and empowering individuals to make financial decisions based on the level of VMLI coverage they can afford. While such decisions require veterans and their families to consider the financial risk of choosing a lower amount of VMLI that may not cover their mortgage indebtedness in full, we feel that such personal financial decisions are best left to veterans and their families. Accordingly, VA's proposed amendments seek to provide veterans with the flexibility to choose the level of VMLI coverage that meets their financial needs. In doing so, we seek to minimize the number of eligible individuals who opt out of the program for financial reasons, and reduce instances where a veteran's survivors must assume greater indebtedness than if the veteran had carried at least partial VMLI coverage. In short, VA has concluded that veterans should enjoy the option to obtain VMLI coverage tailored to their specific needs.
We also propose a number of technical changes to 38 CFR part 8a to ensure consistency with current statutory authority. In the Housing and Economic Recovery Act of 2008, Congress extended eligibility for VMLI coverage to servicemembers in addition to veterans. See Public Law 110-289, section 2602, 122 Stat. 2654, 2858-2860. We propose to add a new definition of “eligible individual” at § 8a.1(f) to reflect this extension of eligibility for VMLI coverage and replace the term veteran with individual wherever appropriate in §§ 8a.1 through 8a.4. These substitutions would not cause any substantive change other than that brought about by Public Law 110-289.
Additionally, we propose one technical change to 38 CFR 8a.2(b)(8), which currently prescribes, “[a]ll claims, arising out of the deaths of insured veterans occurring prior to (date of final publication), shall be subject to the provisions of paragraph (a) of this section then in effect which limited the amount of VMLI coverage to a lifetime maximum per eligible veteran.” The parenthetical “(date of final publication)” appears to have been erroneously maintained in the Code of Federal Regulations, rather than being replaced by the appropriate date. We are correcting this error by striking “(date of final publication)” and inserting “December 24, 1987,” which is the effective date of the final rule that codified that regulation. See 52 FR 26356-01 (July 14, 1987) (proposed); 52 FR 48681-02 (Dec. 24, 1987) (final). No substantive change is intended.
We would also revise the authority citations at the end of § 8a.2 and § 8a.4 and add authority citations at the end of § 8a.1 and § 8a.3 to cite to 38 U.S.C. 501, 2101, 2101A, and 2106.
The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in an expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any one year. This proposed rule would have no such effect on State, local, and tribal governments or on the private sector.
This proposed rule contains no provisions constituting a collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521).
Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, and other advantages; distributive impacts; and equity). Executive Order 13563 (Improving
The economic, interagency, budgetary, legal, and policy implications of this regulatory action have been examined, and it has been determined not to be a significant regulatory action under Executive Order 12866. VA's impact analysis can be found as a supporting document at
The Secretary of Veterans Affairs hereby certifies that this proposed rule would not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601-612. This proposed rule would directly affect only individuals and would not directly affect any small entities. Therefore, pursuant to 5 U.S.C. 605(b), this rulemaking is exempt from the initial and final regulatory flexibility analysis requirements of sections 603 and 604.
The Catalog of Federal Domestic Assistance number and title for the program affected by this document is 64.103, Life Insurance for Veterans.
The Secretary of Veterans Affairs, or designee, approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. Gina S. Farrisee, Deputy Chief of Staff, Department of Veterans Affairs, approved this document on October 7, 2016, for publication.
Life insurance, Mortgage insurance, Veterans.
For the reasons stated in the preamble, VA proposes to amend 38 CFR part 8a as set forth below:
38 U.S.C. 501, and 2101 through 2106, unless otherwise noted.
The revision and additions read as follows:
(c) The term
(f) The term
The revision reads as follows:
The addition reads as follows:
The revision reads as follows:
Environmental Protection Agency (EPA).
Proposed rule.
On December 1, 2015, the Environmental Protection Agency (EPA) finalized amendments to the National Emission Standards for Hazardous Air Pollutants (NESHAP) Refinery Maximum Achievable Control Technology (MACT) 1 and Refinery MACT 2 regulations and the New Source Performance Standards (NSPS) for petroleum refineries. Subsequently, the EPA received three petitions for reconsideration of the final rules. The EPA is announcing reconsideration and request for public comment on five issues raised in the petitions for reconsideration where petitioners claim that the public was not afforded an opportunity to comment. Additionally, the EPA is proposing amendments to the final rule to clarify a compliance issue raised by stakeholders subject to the final rule and to correct a referencing error. The EPA is seeking comment only on the five identified petition issues and on the proposed compliance issue clarification and referencing error amendments. The EPA will not respond to comments addressing any other issues or any other provisions of the final rule.
Comments must be received on or before December 2, 2016.
Submit your comments, identified by Docket ID No. EPA-HQ-OAR-2010-0682, at
The
Please note that any updates made to any aspect of the hearing, including whether or not a hearing will be held, will be posted online at
For questions about this proposed action, contact Ms. Brenda Shine, Sector Policies and Programs Division, Refining and Chemicals Group (E143-01), Office of Air Quality Planning and Standards, U.S. Environmental Protection Agency, Research Triangle Park, North Carolina, 27711; telephone number: (919) 541-3608; fax number: (919) 541-0246; and email address:
The statutory authority for this action is provided by sections 112 and 307(d)(7)(B) of the Clean Air Act (CAA)(42 U.S.C. 7412 and 7607(d)(7)(B)).
Table 1 of this preamble is not intended to be exhaustive, but rather to provide a guide for readers regarding entities likely to be affected by this action for the source categories listed. To determine whether your facility is affected, you should examine the applicability criteria in the appropriate NESHAP. If you have any questions regarding the applicability of any aspect of these NESHAP, please contact the appropriate person listed in the preceding
In addition to being available in the docket, an electronic copy of this proposal will also be available on the
On June 30, 2014, the EPA published a proposed rule in the
Following promulgation, the EPA received three separate petitions for reconsideration: Two jointly from API and the American Fuel and Petrochemical Manufacturers (AFPM) and one from Earthjustice (submitted on behalf of Air Alliance Houston, California Communities Against Toxics, Clean Air Council, Coalition for a Safe Environment, Del Amo Action Committee, Environmental Integrity Project, Sierra Club, Texas Environmental Justice Advocacy Services and Utah Physicians for a Healthy Environment). The petitions are available for review in the rulemaking docket (see Docket ID No. EPA-HQ-OAR-2010-0682).
On January 19, 2016, API and AFPM requested an administrative reconsideration under section 307(d)(7)(B) of the CAA of certain provisions of Refinery MACT 1 and 2, as promulgated in the December 2015 final rule. Specifically, API and AFPM requested that the EPA reconsider the maintenance vent provisions in Refinery MACT 1 for sources constructed on or before June 30, 2014; the alternate startup, shutdown, or hot standby standards for fluid catalytic cracking units (FCCU) constructed on or before June 30, 2014, in Refinery MACT 2; the alternate startup and shutdown for sulfur recovery units (SRU) constructed on or before June 30, 2014, in Refinery MACT 2; and the new catalytic reforming units (CRU) purging limitations in Refinery MACT 2. The request pertained to providing and/or clarifying the compliance time for these sources. In response to this request and additional information received relative to providing additional compliance time for these provisions, the EPA issued a proposal on February 9, 2016 (81 FR 6814). A final rule was published on July 13, 2016 (81 FR 45232, July 13, 2016), fully responding to the January 19, 2016, initial petition for reconsideration submitted by API and AFPM.
On February 1, 2016, Earthjustice filed a petition for reconsideration of several aspects of the December 1, 2015, final rule, and on that same day API and AFPM submitted a supplemental petition for reconsideration, identifying additional issues on which they sought reconsideration. In these petitions, both Earthjustice and API/AFPM requested that the EPA reconsider certain aspects of the December 2015 revisions to Refinery MACT 1 and 2, noting that CAA section 307(d)(7)(B) authorizes the EPA to reconsider a rule where it is impracticable to raise an objection during the period for public comment (but within the time specified for judicial review) or if the grounds for such an objection arose after the close of the public comment period. In particular, Earthjustice claimed that several aspects of the revisions to Refinery MACT 1 were not proposed, and, thus they were precluded from commenting on them during the public comment period: (1) Work practice standards for PRDs and flares; (2) alternative water overflow provisions for delayed coking units (DCU); (3) reduced monitoring provisions for fenceline monitoring; and (4) adjustments to the risk assessment to account for these new work practice standards. The API/AFPM petition outlined a number of specific issues related to the work practice standards for PRDs and flares, and the alternative water overflow provisions for DCUs, as well as a number of other specific issues on other aspects of the rule. On June 16, 2016, the EPA granted the petitions for reconsideration from Earthjustice and API/AFPM on the petitioners' claims as they relate to the following aspects of the December 2015 revisions to the final rule to provide an opportunity for public notice and comment: (1) The work practice standards for PRDs; (2) the work practice standards for emergency flaring events; (3) the assessment of risk as modified based on implementation of these PRD and emergency flaring work practice standards; (4) the alternative work practice standards for DCUs employing the water overflow design; and (5) the provision allowing refineries to reduce the frequency of fenceline monitoring at sampling stations that consistently record benzene concentrations below 0.9 micrograms per cubic meter.
After reviewing the two February 1, 2016, petitions for reconsideration as described above, we granted reconsideration to provide the public an opportunity to comment on selected provisions of the December 2015 amendments and the assessment of risk as modified to account for the implementation of the PRD and emergency flaring work practice standards included in the December 2015 final rule. To ensure public participation in its final decisions, the Agency is requesting public comment on these issues as described below. The EPA is seeking comment only on these five specific issues. The EPA will not respond to any comments addressing any other provisions of the December 1, 2015, final Refinery Sector Rule or any other rule or issues.
In the proposed rule (79 FR 36970, June 30, 2014), EPA proposed to revise Refinery MACT 1 to establish operating and pressure release requirements that apply to all PRDs and to prohibit atmospheric releases of hazardous air pollutants (HAP) from PRDs. To ensure compliance, we proposed to require that sources monitor PRDs using a system that is capable of recording the time and duration of each pressure release and notifying operators that a pressure release has occurred. Many commenters suggested that a prohibition on atmospheric PRD releases was not
Based on these comments, we evaluated the two California district rules and determined that 8 percent (or 12 refineries) are subject to these requirements, which was a sufficient number of subject refineries to establish work practice standards that represent the emissions limitation achieved in practice by the best performers. The two rules are similar in that they both establish comprehensive regulatory programs to address the group or system of PRDs at refineries by requiring monitoring, root cause analysis, and corrective action, and by focusing on PRDs with the greatest emissions potential through a combination of applicability thresholds (albeit with differing thresholds between the two rules). In addition, both rules exclude emissions from certain types of PRDs—typically lower-release potential PRDs, liquid-type PRDs, or in the case of SCAAMD PRDs resulting from events outside of the refinery's control. We considered the two rules as the basis for determining the best performers for establishing the work practice standard that is included in the December 2015 final Refinery Sector Rule (see 40 CFR 63.648(j)(3)). In doing so, similar to these two rules, we established a work practice standard that is a comprehensive set of requirements that apply to the group of PRDs at refineries, and that focuses on reducing the size and frequency of atmospheric releases of HAP from PRDs, with an emphasis on prevention, monitoring, correction, and limitations on the frequency of release events. For further details on our analysis of the SCAQMD and BAAQMD rules and our use of those rules to establish a comprehensive work practice standard for PRDs that are representative of the best performing refineries, refer to the December 1, 2015, notice at 80 FR 75216 and the memorandum in the docket titled, “Pressure Relief Device Control Option Impacts for Final Refinery Sector Rule, July 30, 2015 (Docket ID No. EPA-HQ-OAR-2010-0682-0750).
In the final rule, we established a four-part work practice standard in place of the prohibition on release to the atmosphere based on what was achieved by the best performers, as represented by the two California rules. Consistent with the proposed rule, the first component of the work practice standard requires that owners or operators monitor PRDs using a system that is capable of recording the time and duration of each pressure release and notifying operators that a pressure release has occurred. Second, the work practice standard requires refinery owners or operators to establish preventative measures for each affected PRD to prevent direct release of HAP to the atmosphere as a result of pressure release events. Third, in the event of an atmospheric release, the work practice standard requires refinery owners or operators to conduct a root cause analysis to determine the cause of a PRD release event. If the root cause was due to operator error or negligence, then the release would be a violation of the work practice standard. A second release due to the same root cause for the same equipment in a 3-year period would be a violation of the work practice standard. A third release in a 3-year period would be a violation of the work practice standard, regardless of the root cause.
We excluded the following PRDs that have very low potential to emit (PTE) based on their type of service, size and pressure from the work practice standard: PRDs that only release material that is liquid at standard temperature and pressure (STP) and that are hard-piped to a controlled drain system, PRDs that do not have a PTE of 72 pounds per day (lbs/day) or more of volatile organic compounds (VOC), PRDs with design release pressure of less than 2.5 pounds per square inch gauge (psig), PRDs on mobile equipment, PRDs in heavy liquid service, and PRDs that are designed solely to release due to liquid thermal expansion. Although these PRDs are excluded from the work practice standard, they are subject to the operating and pressure relief requirements in 40 CFR 63.648(j)(1) and (2), which apply to all PRDs.
We request public comments on the work practice standard for PRDs as provided in 40 CFR 63.648(j)(3) and (5) through (7), including the number and type of release/event allowances; the type of PRDs covered by the work practice standard; and the definition of “
In the June 2014 proposed rule, the EPA proposed to amend the operating and monitoring requirements for petroleum refinery flares. As discussed in the proposal at 79 FR 36904, we determined that the requirements for flares in the General Provisions at 40 CFR 63.18 were not adequate to ensure compliance with the Refinery MACT standards. In general, flares used as air pollution control devices are expected to achieve a 98-percent HAP destruction efficiency. However, because flows of waste gases to the flares had diminished based on reductions achieved by the increased use of flare gas recovery systems, there were times when the waste gas to the flare contained insufficient heat content to adequately combust and, thus, a 98-percent HAP destruction efficiency was not being achieved. In addition, the practice of applying assist media to the flare (particularly steam to prevent smoking of the flare tip) had led to a decrease in the combustion efficiency of flares.
To ensure that a 98-percent HAP destruction efficiency was being met, as contemplated at the time the MACT standard was promulgated, we proposed revisions to Refinery MACT 1 that required flares to operate with a continuously-lit pilot flame at all times when gases are sent to the flare, with no visible emissions except for periods not to exceed 5 minutes during any 2 consecutive hours, and to meet flare tip velocity limits and combustion zone operating limits at all times when gases are flared.
During the comment period on the proposed rule, we received comments that the concern over insufficient heat content of the waste gas or over-assisting are less problematic in attaining a high level of destruction efficiency at the flare in emergency situations, where the flow in the flare
In the final rule, we determined that it was appropriate to set different standards for when a flare is operating below its smokeless capacity and when it is operating above its smokeless capacity. We finalized the proposed requirements (with minor revisions) to apply when a flare is operating below its smokeless capacity.
We established a separate work practice standard that applies when a flare exceeds its smokeless capacity. As with flares operating below the smokeless capacity, the work practice standard requires the refinery to have a continuously-lit pilot flame and meet combustion zone operating limits (
If the root cause analysis indicates that the exceedance of the flare tip velocity and/or the visible emissions limit is caused by operator error or poor maintenance, the exceedance is a violation of the work practice standard. A second event causing an exceedance of either the flare tip velocity or the visible emissions limit within a rolling 3-year period from the same root cause on the same equipment is a violation of the standard. A third exceedance of the velocity or visible emissions limit occurring from the same flare in a rolling 3-year period is a violation of the work practice standard, regardless of the cause. However,
In reviewing the regulatory text for this proposed action, we determined that 40 CFR 63.670(o)(1)(ii)(B) contains an incorrect reference to pressure relief devices for which preventative measures must be implemented. The correct reference is paragraph 40 CFR 63.648(j)(3)(ii) not 40 CFR 63.648(j)(5). We are proposing to correct this referencing error.
We request public comments on the above smokeless capacity work practice standard in 40 CFR 63.670(o), including the requirements to maintain records of prevention measures in 40 CFR 63.670(o)(1)(ii)(B) and (o)(1)(vi); the requirement to establish a single smokeless design capacity in 40 CFR 63.670(o)(1)(iii)(B); the number and type of releases/events that constitute a violation; the phrase “. . . and the flare vent gas flow rate is less than the smokeless design capacity of the flare” in 40 CFR 63.670(c) and (d)”; the proposed correction to paragraph 40 CFR 63.670(o)(1)(ii)(B); and other provisions in 40 CFR 63.670(o)(3) through (7). We also request public comments on the recordkeeping and reporting requirements associated with these work practice standards in 40 CFR 63.655(g)(11)(iv) and (i)(9)(x) through (xii).
The results of our residual risk review for the Petroleum Refinery source categories were published in the June 30, 2014, proposal (79 FR 36934 through 36942), and included assessment of chronic and acute inhalation risk, as well as multipathway and environmental risk, to inform our decisions regarding acceptability and ample margin of safety. The results indicated that the cancer risk to the individual most exposed (maximum individual risk or “MIR”) based on allowable HAP emissions is no greater than approximately 100-in-1 million, which is the presumptive limit of acceptability, and that the MIR based on actual HAP emissions is no greater than approximately 60-in-1 million but may be closer to 40-in-1 million. In addition, the maximum chronic non-cancer target organ-specific hazard index (TOSHI) due to inhalation exposures was less than 1. The evaluation of acute non-cancer risks, which was conservative, showed acute risks below a level of concern. Based on the results of a refined site-specific multipathway analysis portion of the risk review, we also concluded that the cancer risk to the individual most exposed through ingestion is considerably less than 100-in-1 million.
In the final Refinery MACT 1 rule, we established work practice standards for PRD releases and emergency flaring events, which under the proposed rule would not have been allowed. Thus, because we did not consider such non-routine emissions under our risk assessment for the proposed rule, we performed a screening assessment of risk associated with these emissions for the final rule as discussed in detail in “Final Residual Risk Assessment for the Petroleum Refining Source Sector” in Docket ID No. EPA-HQ-OAR-2010-0682. Our analysis showed that these HAP emissions could increase the MIR based on actual emissions by as much as 2-in-1 million, which results in essentially the same level of risk as was estimated at proposal. We also estimated that chronic non-cancer TOSHIs attributable to the additional exposures from non-routine flaring and PRD HAP emissions are well below 1. When adding the additional chronic noncancer TOSHI risks from the screening analysis with the analysis in the proposal, chronic noncancer TOSHI risks still remain below 1. Further, our screening analysis also projected that maximum acute exposure to non-routine PRD and flare emissions would result in a maximum hazard quotient (HQ) of 14 from benzene emissions based on a reference exposure level (REL). Based on risk analysis performed for the proposed rule and the screening assessment to consider how conclusions from that analysis would be affected by the additional non-routine flare and PRD emissions allowed under the final rule, we determined that the risk posed after implementation of the revisions to the MACT standards is acceptable.
We request public comments on the screening analysis and the conclusions reached based on that analysis in conjunction with the risk analysis performed for the proposed rule.
In Refinery MACT 1, we finalized MACT standards for DCU decoking
We request public comments on the alternative work practice standard for delayed coking units employing a water overflow design provided in 40 CFR 63.657(e).
In the December 2015 final rule, we revised Refinery MACT 1 to establish a work practice standard requiring refinery owners to monitor benzene concentrations around the fenceline or perimeter of the refinery. We promulgated new EPA Methods 325A and B which specify monitor siting and quantitative sample analysis procedures. The work practice is designed to improve the management of fugitive emissions at petroleum refineries through the use of passive monitors by requiring sources to implement corrective measures if the benzene concentration in air attributable to emissions from the refinery exceeds a fenceline benzene concentration action level. The work practice requires refinery owners to reduce fenceline levels that exceed the concentration action level to at or below that level. In the final rule, we included provisions that were not proposed that would allow for reduced monitoring frequency (after 2 years of continual monitoring) at monitoring locations with consistently low fenceline concentrations.
We request public comments on the provision allowing refineries to reduce the frequency of fenceline monitoring at monitoring sites that consistently record benzene concentrations below 0.9 micrograms per cubic meter, as provided in 40 CFR 63.658(e)(3).
In this action, the EPA is proposing to amend provisions related to how to address overlapping requirements for equipment leaks that are contained in Refinery MACT 1 and in the Refinery Equipment Leak NSPS (40 CFR part 60, subpart GGGa). The Refinery MACT 1 provision at 40 CFR 63.640(p)(2) currently states that equipment leaks that are subject to the provisions in the Refinery Equipment Leak NSPS (40 CFR part 60 subpart GGGa) are only required to comply with the provisions in the Refinery Equipment Leak NSPS. However, the Refinery Equipment Leak NSPS does not include the new work practice standards finalized in the final Refinery MACT 1 at 40 CFR 63.648(j) which apply to releases from PRD. Certain provisions of 40 CFR 63.648(j) detail a work practice standard for the management of releases from PRD. We intended that these new work practice standards would be applicable to all PRD at refineries, including those PRD subject to the requirements in the Refinery Equipment Leaks NSPS. In order to provide clarity and assure that stakeholders subject to these provisions fully understand their compliance obligations, we are proposing that equipment components that are also subject to the provisions of the Refinery Equipment Leak NSPS, are required to comply with the provisions specified in the Refinery Equipment Leaks NSPS, except for PRDs in organic HAP service, which must only comply with the requirements in Refinery MACT 1 at 40 CFR 63.648(j) for PRDs. We are also amending the introductory text in 40 CFR 63.648(j) to reference Refinery Equipment Leaks NSPS at 40 CFR 60.482-4a and amending paragraphs (j)(2)(i) through (iii) of Refinery MACT 1 to correct the existing reference to 40 CFR 60.485(b), which should refer to 40 CFR 60.485(c) and 40 CFR 60.485a(c).
Additional information about these statues and Executive Orders can be found at
This action is not a significant regulatory action and was, therefore, not submitted to the Office of Management and Budget (OMB) for review.
This action does not impose any new information collection burden under the PRA. OMB has previously approved the information collection activities contained in the existing regulations at 40 CFR part 63, subpart CC and has assigned OMB control number 2060-0340. The proposed amendments are the result of a clarification that does not affect the estimated burden of the existing rule. Specifically, we are proposing amendments clarifying that facilities using the equipment leak overlap provisions must also comply with the PRD work practice standard in 40 CFR part 63, subpart CC. In our burden estimates for the December 1, 2015, final rule, we assumed that all major source refineries would have to comply with the PRD work practice standards. Consequently, the burden estimates provided with the December 1, 2015, final rule are consistent with the proposed clarifying amendment. Therefore, we have not revised the information collection request for the existing rule.
I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. In making this determination, the impact of concern is any significant adverse economic impact on small entities. An agency may certify that a rule will not have a significant economic impact on a substantial number of small entities if the rule relieves regulatory burden, has no net burden, or otherwise has a positive economic effect on the small entities subject to the rule. The proposed rule consists of a clarification which does not change the expected economic impact analysis performed for the existing rule. We have, therefore, concluded that this action will have no net regulatory burden for all directly regulated small entities.
This action does not contain an unfunded mandate of $100 million or more as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The action imposes no enforceable duty on any state, local, or tribal governments or the private sector.
This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.
This action does not have tribal implications as specified in Executive Order 13175. It will not have substantial direct effect on tribal governments, 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, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this action.
This action is not subject to Executive Order 13045 because it is not economically significant as defined in Executive Order 12866, and because the EPA does not believe the environmental health or safety risks addressed by this action present a disproportionate risk to children. This action requests comment on a risk assessment that is described in section III. C. of this preamble.
This action is not subject to Executive Order 13211 because it is not a significant energy action under Executive Order 12866.
This rulemaking does not involve technical standards.
The EPA believes that this action does not have disproportionately high and adverse human health or environmental effects on minority populations, low-income populations, and/or indigenous peoples, as specified in Executive Order 12898 (59 FR 7629, February 16, 1994). The proposed amendments serve to clarify one aspect of the rule. They do not relax the control measures on regulated sources, and, therefore, do not change the level of environmental protection.
Environmental protection, Administrative practice and procedures, Air pollution control, Hazardous substances, Intergovernmental relations, Reporting and recordkeeping requirements.
For the reasons stated in the preamble, title 40, chapter I, of the Code of Federal Regulations is proposed to be amended as follows:
42 U.S.C. 7401
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(2) Equipment leaks that are also subject to the provisions of 40 CFR part 60, subpart GGGa, are required to comply only with the provisions specified in 40 CFR part 60, subpart GGGa, except that pressure relief devices in organic HAP service must only comply with the requirements in § 63.648(j).
(j) Except as specified in paragraph (j)(4) of this section, the owner or operator must comply with the requirements specified in paragraphs (j)(1) and (2) of this section for pressure relief devices, such as relief valves or rupture disks, in organic HAP gas or vapor service instead of the pressure relief device requirements of § 60.482-4 of this chapter, § 60.482-4a of this chapter, or § 63.165, as applicable. Except as specified in paragraphs (j)(4) and (5) of this section, the owner or operator must also comply with the requirements specified in paragraph (j)(3) of this section for all pressure relief devices.
(2) * * *
(i) If the pressure relief device does not consist of or include a rupture disk, conduct instrument monitoring, as specified in § 60.485(c) of this chapter, § 60.485a(c) of this chapter, or § 63.180(c), as applicable, no later than 5 calendar days after the pressure relief device returns to organic HAP gas or vapor service following a pressure release to verify that the pressure relief device is operating with an instrument reading of less than 500 ppm.
(ii) If the pressure relief device includes a rupture disk, either comply with the requirements in paragraph (j)(2)(i) of this section (not replacing the rupture disk) or install a replacement disk as soon as practicable after a pressure release, but no later than 5 calendar days after the pressure release. The owner or operator must conduct instrument monitoring, as specified in § 60.485(c) of this chapter, § 60.485a(c) of this chapter, or § 63.180(c), as applicable, no later than 5 calendar days after the pressure relief device returns to organic HAP gas or vapor service following a pressure release to verify that the pressure relief device is operating with an instrument reading of less than 500 ppm.
(iii) If the pressure relief device consists only of a rupture disk, install a replacement disk as soon as practicable after a pressure release, but no later than 5 calendar days after the pressure release. The owner or operator may not initiate startup of the equipment served by the rupture disk until the rupture disc is replaced. The owner or operator must conduct instrument monitoring, as specified in § 60.485(c) of this chapter, § 60.485a(c) of this chapter, or § 63.180(c), as applicable, no later than 5 calendar days after the pressure relief device returns to organic HAP gas or vapor service following a pressure release to verify that the pressure relief device is operating with an instrument reading of less than 500 ppm.
(o) * * *
(1) * * *
(ii) * * *
(B) Implementation of prevention measures listed for pressure relief devices in § 63.648(j)(3)(ii) for each pressure relief valve that can discharge to the flare.
Environmental Protection Agency (EPA).
Notice of filing of petitions and request for comment.
This document announces the Agency's receipt of several initial filings of pesticide petitions requesting the establishment or modification of regulations for residues of pesticide chemicals in or on various commodities.
Comments must be received on or before November 17, 2016.
Submit your comments, identified by docket identification (ID) number and the pesticide petition number (PP) of interest as shown in the body of this document, by one of the following methods:
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Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at
Michael L. Goodis, Registration Division (RD) (7505P), 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).
If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under
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EPA is announcing its receipt of several pesticide petitions filed under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, requesting the establishment or modification of regulations in 40 CFR part 180 for residues of pesticide chemicals in or on various food commodities. The Agency is taking public comment on the requests before responding to the petitioners. EPA is not proposing any particular action at this time. EPA has determined that the pesticide petitions described in this document contain the data or information prescribed in FFDCA section 408(d)(2), 21 U.S.C. 346a(d)(2); however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the pesticide petitions. After considering the public comments, EPA intends to evaluate whether and what action may be warranted. Additional data may be needed before EPA can make a final determination on these pesticide petitions.
Pursuant to 40 CFR 180.7(f), a summary of each of the petitions that are the subject of this document, prepared by the petitioner, is included in a docket EPA has created for each rulemaking. The docket for each of the petitions is available at
As specified in FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), EPA is publishing notice of the petition so that the public has an opportunity to comment on this request for the establishment or modification of regulations for residues of pesticides in or on food commodities. Further information on the petition may be obtained through the petition summary referenced in this unit.
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21 U.S.C. 346a.
Fish and Wildlife Service, Interior.
Proposed rule; reopening of comment period.
We, the U.S. Fish and Wildlife Service (Service), notify the public that we are reopening the comment period on our February 4, 2013, proposed rule to list the distinct population segment of wolverine (
In order to fully consider and incorporate public comment, the Service requests submittal of comments by close of business November 17, 2016. Comments submitted electronically using the Federal eRulemaking Portal (see
(1)
(2)
We request that you send comments only by the methods described above. We will post all comments on
Jodi Bush, Field Supervisor, U.S. Fish and Wildlife Service, Montana Ecological Services Office, 585 Shepard Way, Helena, MT 59601, by telephone (406) 449-5225). Persons who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 800-877-8339.
Please refer to the February 4, 2013, proposed listing rule at 78 FR 7864 for information about the wolverine's taxonomy; life history; requirements for habitat, space, and food; densities; status in Canada and Alaska; geographic range delineation complexities; distribution; and habitat relationships and distribution. Please also refer to our December 14, 2010, 12-month petition finding (75 FR 78030) and our February 4, 2013, proposed rule to list the North American wolverine (78 FR 7864) for a detailed evaluation of the wolverine under our distinct population segment (DPS) policy, which published in the
Please refer to the proposed listing rule for the wolverine (78 FR 7864; February 4, 2013) for a detailed description of previous Federal actions concerning the wolverine prior to 2013. On February 4, 2013, we published a proposed rule to list the DPS of wolverine occurring in the contiguous United States as threatened, under the Act, with a proposed rule under section 4(d) of the Act that outlines the prohibitions necessary and advisable for the conservation of the wolverine (78 FR 7864). We also published a February 4, 2013, proposed rule to establish a nonessential experimental population (NEP) area for the North American wolverine in the Southern Rocky Mountains of Colorado, northern New Mexico, and southern Wyoming (78 FR 7890). On October 31, 2013, we reopened the comment period on the proposed listing rule for an additional 30 days (78 FR 65248).
Following publication of the 2013 proposed rules, there was scientific disagreement and debate about the interpretation of the habitat requirements for wolverines and the available climate change information used to determine the extent of threats to the DPS. Based on this substantial disagreement regarding the sufficiency or accuracy of the available data relevant to the proposed listing, on February 5, 2014 (79 FR 6874), we announced a 6-month extension of the final determination of whether to list the wolverine DPS as a threatened species. We also reopened the comment period on the proposed rule to list the contiguous U.S. DPS of the North American wolverine for 90 days.
On August 13, 2014, we withdrew the proposed rule to list the DPS of the North American wolverine as a threatened species under the Act (79 FR 47522). This withdrawal was based on our conclusion that the factors affecting the DPS as identified in the proposed rule were not as significant as believed at the time of the proposed rule's publication in 2013. As a result, we also withdrew our associated proposed rule under section 4(d) of the Act contained in the proposed listing rule and withdrew the proposed NEP designation under section 10(j) of the Act for the southern Rocky Mountains.
In October 2014, three complaints were filed in the District Court for the District of Montana by Defenders of Wildlife, WildEarth Guardians, Center for Biological Diversity, and other organizations challenging the withdrawal of the proposal to list the North American wolverine DPS.
In effect, the court's action returns the process to the proposed rule stage, and the status of the wolverine under the Act has effectively reverted to that of a proposed species for the purposes of consultation under section 7 of the Act. Therefore, this document notifies the public that we are reopening the comment period on the February 4, 2013, proposed rule to list the DPS of wolverine occurring in the contiguous United States as threatened, under the Act (78 FR 7864). We also announce that we will be initiating an entirely new status review of the North American wolverine, to determine whether this DPS meets the definition of an endangered or threatened species under the Act, or whether the species is not warranted for listing. Any listing determination we make must be made based on the best available information. We invite the public to comment on the proposed rule, and we request new information regarding the North American wolverine that has become available since the publication of the proposed rule to inform this status review.
We will accept written comments and information during this reopened comment period on our proposed rule to list the DPS of wolverine occurring in the contiguous United States as threatened that was published in the
(1) Biological, commercial trade, or other relevant data concerning any threats (or lack thereof) to this species and regulations that may be addressing those threats.
(2) Additional information concerning the historical and current status, range, distribution, and population size of this species, including the locations of any additional populations of this species.
(3) Any information on the biological or ecological requirements of the species, and ongoing conservation measures or efforts for the species and its habitat.
(4) Current or planned activities in the areas occupied by the species and possible impacts of these activities on this species.
(5) The reasons why we should or should not designate habitat as “critical habitat” under section 4 of the Act (16 U.S.C. 1531
(6) Specific information on the amount and distribution of wolverine habitat, including den sites.
(7) Specific information on the impacts of small population size and genetic diversity on the wolverine.
(8) Information on the projected and reasonably likely impacts of climate change on the wolverine and its habitat, including the loss of snowpack and impacts to wolverine denning habitat.
(9) Additional provisions the Service may wish to consider to conserve, recover, and manage the proposed DPS of the North American wolverine occurring in the contiguous United States.
If you submitted comments or information on the proposed rule (78 FR 7864) during the initial comment periods from February 4, 2013, to May 6, 2013, from October 31, 2013 to December 2, 2013, or from February 4, 2014, to May 6, 2014, please do not resubmit them. Any such comments are incorporated as part of the public record of this rulemaking proceeding, and we will fully consider them in the preparation of our final determination. Our final determination will take into consideration all written comments and any additional information we receive during all comment periods. The final decision may differ from the proposed rule, based on our review of all information received during this rulemaking proceeding. If we receive significant new scientific information, we may need to reopen the public comment period so that the public can comment on the new information.
You may submit your comments and materials concerning the proposed rule by one of the methods listed in
If you submit a comment via
Comments and materials we receive will be available for public inspection on
The primary authors of this notice are the staff members of the Mountain Prairie Regional Office, U.S. Fish and Wildlife Service.
The authority for this action is the Endangered Species Act of 1973, as amended (16 U.S.C. 1531
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Proposed rule; request for comments.
NMFS is amending the 2006 Consolidated Atlantic Highly Migratory Species (HMS) Fishery Management Plan (FMP) based on the results of the 2016 stock assessment update for Atlantic dusky sharks. Based on this assessment, NMFS determined that the dusky shark stock remains overfished and is experiencing overfishing. Consistent with the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), NMFS is proposing management measures that would reduce fishing mortality on dusky sharks and rebuild the dusky shark population consistent with legal requirements. The proposed measures could affect U.S. commercial and recreational fishermen who harvest sharks in the Atlantic Ocean, including the Gulf of Mexico and Caribbean Sea.
Written comments must be received by December 22, 2016. NMFS will hold six public hearings on Draft Amendment 5b and this implementing proposed rule on November 9, November 15, November 16, November 21, and November 28, 2016. NMFS will also hold an operator-assisted public hearing via conference call and webinar for this proposed rule on December 12, 2016, from 2:00 p.m. to 4:00 p.m. EST. For specific locations, dates and times see the
You may submit comments on this document, identified by NOAA-NMFS-2013-0070, by any one of the following methods:
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NMFS will hold 6 public hearings and 1 conference call on this proposed rule. NMFS will hold public hearings in Manalapan, NJ; Newport, RI; Belle Chasse, LA; Houston, TX; Melbourne, FL; and Manteo, NC; and via a public conference call. For specific locations, dates and times see the
Copies of the supporting documents—including the draft environmental impact statement (DEIS), Regulatory Impact Review (RIR), Initial Regulatory Flexibility Analysis (IRFA), and the 2006 Consolidated Atlantic HMS FMP are available from the HMS Web site at
Tobey Curtis at 978-281-9273 or Karyl Brewster-Geisz at 301-427-8503.
The Atlantic commercial shark fisheries are managed primarily under the authority of the Magnuson-Stevens Act. The 2006 Consolidated HMS FMP and its amendments are implemented by regulations at 50 CFR part 635. A brief summary of the background of this proposed rule is provided below. Additional information regarding Atlantic HMS management can be found in the Draft Environmental Impact Statement (DEIS) for Amendment 5b to the 2006 Consolidated HMS FMP (Amendment 5b), the 2006 Consolidated HMS FMP and its amendments, the annual HMS Stock Assessment and Fishery Evaluation (SAFE) Reports, and online at
NMFS has prohibited the retention of dusky sharks in commercial and recreational fisheries since 2000. In 2008, in response to a 2006 stock assessment declaring dusky sharks to be overfished with overfishing occurring despite this complete prohibition, NMFS adopted a rebuilding plan for the stock. This rebuilding plan, set out in Amendment 2 to the Consolidated HMS FMP, undertook a suite of measures to address dusky shark overfishing, focusing primarily on bycatch of the species in other shark fisheries. Major components of this plan—which are unchanged by this action—include a continued prohibition on retention of dusky sharks (§§ 635.22(c)(4) and 635.24(a)(5)), time/area closures (§ 635.21(d)), and the prohibition of landing sandbar sharks (the historic target species for the large coastal shark fishery) outside of the shark research fishery along with significant retention limit reductions in the bottom longline fishery where interactions were commonly occurring (§§ 635.24(a)(1), (2), and (3)). The terminal year for rebuilding was set at 2108, consistent with the assessment, which concluded that the stock could rebuild within 100 to 400 years. In 2011, three years into this 100-year rebuilding plan, a benchmark stock assessment for dusky sharks was completed through the Southeast Data, Assessment, and Review (SEDAR) 21 process (76 FR 62331, October 7, 2011), the first assessment for dusky sharks conducted within the SEDAR process. The 2011 stock assessment provided an update to a 2006 dusky shark stock assessment and concluded that the stock remained overfished with overfishing occurring.
On October 7, 2011 (76 FR 62331), NMFS made stock status determinations for several shark species based on the results of the SEDAR 21 process. NMFS determined in the notice that dusky sharks, a prohibited species, were still overfished and still experiencing overfishing (
NMFS considered alternatives to rebuild several overfished Atlantic shark species, including dusky sharks, in Draft Amendment 5 (77 FR 70552, November 26, 2012). The proposed measures were designed to reduce fishing mortality and effort, while ensuring that a limited sustainable shark fishery for certain species could be maintained consistent with legal obligations and the 2006 Consolidated HMS FMP. NMFS received substantial public comment disputing the basis for the proposed dusky shark measures, and NMFS decided further analysis was necessary on those measures in a separate FMP amendment, EIS, and proposed rule. NMFS finalized management measures for the other Atlantic shark species included in Draft Amendment 5 in the Final Amendment 5a and associated final rule (78 FR 40318, July 3, 2013), while announcing that dusky shark management measures would be included in an upcoming, separate rulemaking known as Amendment 5b (
NMFS prepared a Predraft for Amendment 5b in March 2014 that considered the feedback received on Draft Amendment 5, solicited additional public input, and consulted with its Advisory Panel at the Spring 2014 meeting. The Predraft considered alternatives that were not included in Draft Amendment 5, as well as new information.
Following the Predraft for Amendment 5b, additional information regarding dusky sharks became available that was not available at the time of the SEDAR 21 stock assessment. NMFS, in response to two petitions from environmental groups regarding listing dusky sharks under the Endangered Species Act (ESA), conducted an ESA Status Review for the Northwest Atlantic population of dusky sharks, which was completed in October 2014. That status review included an updated analysis of three fishery-independent surveys, the Northeast Fisheries Science Center (NEFSC) Coastal Shark Bottom Longline Survey (NELL), the Virginia Institute of Marine Science Shark Longline Survey (VIMS LL), and the University of North Carolina Shark Longline Survey (UNC LL), using the same methodology as the SEDAR 21 Data Workshop (McCandless et al., 2014). The updated analysis included data from 2010—2012 and showed an increasing trend in dusky shark indices of abundance for all three surveys since 2009, the terminal year of data used for dusky sharks in the SEDAR 21 stock assessment. The ESA Status Review Team concluded that, based on the most recent stock assessment, abundance projections, updated analyses, and the potential threats and risks to population extinction, the dusky shark population in the Northwest Atlantic and Gulf of Mexico has a low risk of extinction currently and in the foreseeable future. On December 16, 2014, NMFS announced a 12-month finding that determined that the Northwest Atlantic and Gulf of Mexico population of dusky sharks did not warrant listing under the ESA at that time (79 FR 74954).
NMFS applied additional restrictions in the shark research fishery to reduce dusky shark mortality in 2013 (refer to the Amendment 5b DEIS; see
By Fall 2015, as described in an HMS staff presentation to its Advisory Panel, the reductions in dusky shark mortality since 2009, and the increasing population trends from fishery-independent surveys, had indicated that management actions may have already reduced dusky shark mortality to levels prescribed by the SEDAR 21 stock assessment (
On October 27, 2015, the environmental advocacy organization Oceana filed a complaint against NMFS in Federal district court alleging violations of the Magnuson-Stevens Act and Administrative Procedure Act with respect to delays in taking action to rebuild and end overfishing of dusky sharks. A settlement agreement was reached between NMFS and the Plaintiffs on May 18, 2016, regarding the timing of the pending agency action. This settlement acknowledged that NMFS was in the process of developing an action to address overfishing and rebuilding of dusky sharks and that an assessment update was ongoing and stipulated that, based upon the results of the assessment update, NMFS would submit a proposed rule to the
A draft of the SEDAR 21 stock assessment update for dusky sharks became available in July 2016 and underwent internal NMFS peer review in August 2016. The assessment update added 2010-2015 data inputs from the same data sources vetted and approved in SEDAR 21 (fishery-dependent and -independent data, relative effort series, etc.) to the accepted models in order to update the status of the stock using the most recent data. Five model scenarios were run, all of which were considered to be plausible states of nature according to SEDAR 21 (
Despite including much of the same data as those used in the 2014 ESA Dusky Shark Status Review Report (McCandless et al., 2014), which suggested mostly positive trends in dusky shark relative abundance, the 2016 assessment update concluded that the stock is still overfished and experiencing overfishing, although the level of overfishing has decreased compared to previous assessments and is low. Specifically, Spawning Stock Fecundity (SSF) relative to SSF
The rebuilding year was also updated according to the new model projections. The target rebuilding year was calculated as the amount of time needed for the stock to reach the target (SSF
In order to achieve rebuilding by 2107 with a 50% probability, the final models projected that F on the stock would have to be reduced 24-80% (median = 35%) from 2015 levels. The assessment update states that the stock can sustain small amounts of fishing mortality during its rebuilding. When developing measures to address overfishing or rebuilding in HMS fisheries, NMFS' general approach is that measures should have at least a 50-percent probability of success in achieving those goals. For Atlantic highly migratory sharks, however, NMFS has, since 1999, typically used a 70-percent probability for sharks, in light of their late age to maturity, reproduction, population growth rate, and other considerations. Given particular issues specific to the 2016 SEDAR 21 dusky shark assessment update (explained below), NMFS used the F reduction associated with the 50-percent probability to develop Draft Amendment 5b.
While peer reviewers did not identify any issues with how the 2016 assessment update was conducted, SEDAR 21 and the 2016 update noted a high level of uncertainty in the input observations, as well as the model outputs, beyond that of many other Atlantic shark stock assessments. Data on dusky sharks is limited, given the retention prohibition and fact that interactions with prohibited sharks are rare events, and dusky shark sharks are often misidentified. Data input to the models came from different types of fishing vessels/gears and time series collected by different entities, including the Atlantic Shark Bottom Longline Observer Program, Shark Bottom Longline Research Fishery, the Atlantic Pelagic Observer Program, the recreational Large Pelagics Survey, the Northeast Fisheries Science Center's Bottom Longline Survey, and the Virginia Institute of Marine Science's Bottom Longline Survey. Based on these data, the five plausible model scenarios in the 2016 assessment update produced a very wide range of estimates (overfishing and overfished status) and outcomes (F reductions, rebuilding timelines, etc.). In light of the range of estimates and outcomes, NMFS used the median of the five scenarios in its development of measures in Draft Amendment 5b to address overfishing and rebuilding of dusky sharks. Given the range of plausible scenarios from the assessment update, using the median of multiple scenarios is an acceptable method because it is an objective approach for reconciling a range of management options. It is also consistent with the management approach to similar situations in other fisheries (
Because of the above issues, NMFS decided it was appropriate from a scientific, technical perspective to use the F reduction associated with the 50-percent probability when developing Draft Amendment 5b. While NMFS typically uses a 70-percent probability for Atlantic highly migratory shark species, the 2016 update has a higher level of uncertainty than other shark assessments and presents a more pessimistic view of stock status than was expected based on our preliminary review of the same information and other available information. Such information includes the information reviewed in the ESA Status Review, reductions in U.S. fleet fishing effort due to management actions, and updated age and growth information indicating that dusky sharks are more productive than previously thought (Natanson et al. 2014). This information could not be used in the 2016 assessment update, because assessment updates only incorporate data inputs (
Therefore, based on the 2016 assessment update, NMFS needs to reduce dusky shark fishing mortality by approximately 35% relative to 2015 levels to rebuild the stock by the year 2107. NMFS also needs to address overfishing, but the level of overfishing is not high (median F
The Magnuson-Stevens Act requires that each FMP establish a mechanism for specifying ACLs at a level such that overfishing does not occur, including measures to ensure accountability (AMs) (16 U.S.C. 1853(a)(15)). In 2010, NMFS addressed these requirements for Atlantic highly migratory shark stocks in Amendment 3 to the 2006 Consolidated HMS FMP (Amendment 3) (NMFS 2010), including sharks in the prohibited shark complex, which includes dusky sharks. Draft Amendment 5b clarifies that the ACL for the 19 species of sharks in the prohibited shark complex is zero. NMFS believes that an ACL of zero is appropriate and, along with existing and proposed conservation and management measures, will prevent overfishing.
In its proposed revisions to the NS 1 guidelines (80 FR 2786; January 20, 2015), NMFS explains in § 600.310(g)(3) that if an ACL is set equal to zero and the AM for the fishery is a closure that prohibits fishing for a stock, additional AMs are not required if only small amounts of catch (including bycatch) occur, and the catch is unlikely to result in overfishing. According to the available analyses, prohibited shark species—basking sharks (Campana 2008), night sharks (Carlson et al. 2008), sand tiger sharks (Carlson et al., 2009), white sharks (Curtis et al. 2014), and bigeye thresher sharks (Young et al. 2016)—are not experiencing overfishing. While such analyses have not been completed for all other prohibited shark species, there is no information suggesting that overfishing is occurring on other members of this complex. In addition, commercial and recreational retention of prohibited sharks is prohibited, and there is only a small
NMFS acknowledges that, in addition to the small amount of bycatch, there is also information on a small amount of occasional prohibited shark landings. Based on observer and other data and input from the HMS AP, NMFS believes that these landings most likely are due to misidentification issues and lack of awareness of shark fishing regulations, which would be addressed through this action. Even though dusky sharks are experiencing overfishing, NMFS believes that an ACL of zero is still appropriate for the prohibited shark complex. The estimated level of overfishing for dusky sharks is not high (median F
NMFS is proposing additional measures in Draft Amendment 5b and this proposed rule to prevent overfishing of dusky sharks (see “Proposed Measures” below). These measures are in addition to previously-adopted shark management measures. NMFS considers these and other management measures for dusky sharks (
Additionally, Amendment 7 to the 2006 Consolidated HMS FMP in 2015 effected management measures in the pelagic longline fishery by implementing measures to control bluefin tuna bycatch in that fishery. As a result, pelagic longline fishery management and monitoring has changed significantly and, at least in the initial years of management under these controls, effort has decreased.
The time series NMFS used to evaluate the impact of conservation and management measures and fishing mortality on the prohibited shark complex begins in 2008 to coincide with the implementation of Amendment 2 and ends in 2015, the most recent year for which data are available. Bycatch data are not available in as timely a manner as data on landed catch, and interactions with prohibited sharks are rare events, which can be highly variable from year to year. Thus, three-year rolling averages were used to smooth interannual variability in the observed catches.
On an annual basis, NMFS will continue to monitor the prohibited shark complex, based on a comparison of the most recent three-year average mortality to previous three-year averages to evaluate the impact of conservation and management measures, and evaluate fishing mortality on the prohibited shark complex. NMFS anticipates that bycatch of dusky and other prohibited sharks will continue to occur; in other words, the three-year averages will be higher than zero. However, small amounts of bycatch are permissible where the ACL is set to zero and the bycatch is small and does not lead to overfishing. For the reasons discussed above, NMFS does not believe that further AMs are needed to prevent overfishing. If significant changes in the three-year average mortality occur, NMFS would evaluate trends in relative abundance data from species within the prohibited shark complex and evaluate current fisheries practices and look for patterns in bycatch mortality of species within the complex to determine if additional measures are needed to address overfishing.
NMFS solicits public comment on its approach to the ACL/AMs for the prohibited shark complex and whether other approaches might address the scientific and management concerns noted above.
The objectives of Draft Amendment 5b are to end overfishing and rebuild the dusky shark stock. This section summarizes NMFS' proposed, preferred measures. NMFS expects that these measures will prevent overfishing and achieve at least a 35% mortality reduction for dusky sharks to ensure stock rebuilding with at least 50%
A number of alternatives that were considered and/or commented on during the development of this action are not preferred alternatives at this time, because they are not needed to meet the objectives of the amendment and would result in negative economic impacts, would not meet the objectives of the amendment, would not be logistically/administratively feasible, are not scientifically supportable, and/or they would result in other unnecessary, negative impacts, as described in the DEIS (see
As explained in this proposed rule and the DEIS, NMFS has already taken significant actions that reduce fishing effort and mortality. After extensive review of available management measures, NMFS has determined that the proposed measures will prevent overfishing and rebuild dusky sharks. However, we specifically request comment from the public on other potential management measures and any scientific, policy, or other support for them. In response to public comment, NMFS may make changes in Final Amendment 5b and the final rule by modifying the proposed measures or adopting different or additional measures, which are not currently preferred.
The two proposed recreational measures address permitting (Alternative A2) and gear use (Alternative A6a). The first proposed measure would require HMS permit holders that recreationally fish for, retain, possess, or land sharks to obtain a “shark endorsement,” which would require completing an online shark identification and fishing regulation training course, before they will be permitted to fish for, retain, possess, or land sharks. This would include HMS Angling and Charter/Headboat permit holders, as well as General category and Swordfish General Commercial permit holders when participating in a registered HMS fishing tournament. Obtaining the shark endorsement would be included in the annual HMS Angling, Charter/Headboat, Atlantic tunas General category, and Swordfish General Commercial permit application or annual renewal process and would not result in any additional fees beyond the cost of the permit itself. NMFS requests public input on how to most effectively implement the requirement through this process, including the appropriate effective date and implementation strategy. Unlike changing permit categories (which can only be done within 45 calendar days of the date of issuance of the permit), vessel owners could obtain a shark endorsement, which would be added to their relevant permit, throughout the year. An online quiz, administered during the application or renewal process, would be required in order to obtain the shark endorsement. This online quiz would focus on identification of prohibited species (
The second proposed measure would require HMS permit holders that recreationally fish for, retain, possess, or land sharks (the same permit holders as those described above) to use circle hooks when fishing for, retaining, possessing, or landing sharks. Any shark caught on a hook other than a circle hook would have to be released. This requirement is intended to apply across the recreational shark fishery. To ensure that the measure encompasses all shark fishing activity, we also specify that a person on board an HMS-permitted vessel fishing with natural baits and using wire or heavy (200 lb test or greater) monofilament or fluorocarbon leaders (
By requiring circle hooks across the recreational shark fishery, dusky shark mortality is expected to decrease. Most evidence suggests that circle hooks reduce shark at-vessel and post-release mortality rates without significantly reducing catchability compared to J-hooks, although it varies by species, gear configuration, bait, and other factors. Willey et al. (2016) found that 3% of sharks caught recreationally with circle hooks were deep hooked while 6% caught on J-hooks were deep hooked. Campana et al. (2009) observed that 96% of sharks that were deep hooked were severely injured or dead while 97% of sharks that were hooked superficially (mouth or jaw) were released healthy and with no apparent trauma. As deep hooked sharks are more likely to die, Willey et al.'s (2016) results indicate circle hooks could reduce mortality of sharks deep-hooked by J-hooks by approximately 48 percent (
Under these recreational measures combined, HMS permitted recreational vessels without a shark endorsement and/or not fishing with circle hooks would be prohibited from retaining any sharks.
In total, the DEIS considers nine main commercial alternatives that cover education, outreach, gear, and time/area measures for pelagic longline, bottom longline, and shark gillnet fisheries. The four commercial fishery measures that are proposed would address dusky shark post-release mortality (Alternatives B3 and B9), avoidance (Alternative B6), and outreach and education (Alternatives B5 and B6) and thus would decrease fishing mortality of dusky sharks in the commercial fisheries. The first proposed measure would require that all pelagic longline fishermen release all sharks that are not being boarded or retained by using a dehooker, or by cutting the gangion no more than three feet from the hook. This alternative would reduce post-release mortality on dusky sharks because using a dehooker or cutting the gangion no more than three feet from the hook would reduce the amount of trailing gear attached to released dusky sharks. A study on recreationally caught thresher sharks (Sepulveda et al. 2015), suggested that thresher sharks that had ~2 m of trailing gear had 88% higher mortality rates than those without. While this study focuses on thresher sharks and not dusky sharks, its conclusion regarding the effects of trailing gear on post-release mortality rates of sharks can be presumed to be generally applicable to other sharks, although further research would be needed to better quantify the percent mortality reductions that could be expected under different species and gear combinations. NMFS Tech Memo OPR-29 on marine turtle mortality indicates that reducing gear left on sea turtles reduces post-interaction mortality of mouth-hooked turtles by 25-33%, further supporting the approach that reducing trailing gear on animals generally improves post-release survival. Because it would apply to all sharks that are not being retained, it would also reduce misidentification problems that occur in identifying dusky sharks from other shark species, because fishermen would have to cut the gangion closer to the shark, allowing a better view for identification purposes. Therefore, implementing this measure is anticipated to have direct short- and long-term minor, beneficial ecological impacts.
The second proposed measure would require additional training on shark identification and safe handling for HMS permitted pelagic longline, bottom longline, and shark gillnet vessels. The course would be taught in conjunction with current Protected Species Safe Handling, Release, and Identification workshops that these vessel owners and operators are already required to attend. The training course would provide information regarding shark identification and regulations, as well as best practices to avoid interacting with dusky sharks and how to minimize mortality of dusky sharks and other prohibited species caught as bycatch. This training course requirement provides outreach to those who are likely to interact with dusky sharks, and should decrease interactions and post-release mortality of dusky sharks. Implementing this measure could result in direct, moderate, beneficial ecological impacts after these vessel owners and operators complete the training course.
In the third proposed measure, NMFS would develop additional outreach materials for commercial fisheries regarding shark identification, and require that all HMS permitted pelagic longline, bottom longline, and shark gillnet vessels abide by a dusky shark fleet communication and relocation protocol. The protocol would require vessels to report the location of dusky shark interactions over the radio to other vessels in the area and that subsequent fishing sets on that fishing trip could be no closer than 1 nautical mile from where the encounter took place. Providing the fleet with more information regarding dusky shark locations and avoiding areas and conditions where dusky sharks are located should reduce dusky shark bycatch. This additional awareness from enhanced outreach methods and the fleet communication and relocation protocol would have direct short- and long-term minor beneficial ecological impacts as it would help reduce bycatch of dusky sharks.
The fourth proposed measure would require the use of circle hooks by HMS directed limited access shark permit holders fishing with bottom longline gear. Circle hooks are already required in the pelagic longline fishery, and this would extend that requirement to the bottom longline fishery to help reduce dusky shark mortality. Currently, approximately 25% of bottom longline vessels do not solely use circle hooks, so this measure would result in additional reductions in dusky shark post-release mortality on those vessels that switch to circle hooks. As in the recreational fishery circle hook measure described above, implementing a circle hook requirement would reduce post-release mortality rates and have direct moderate beneficial impacts in both the short- and long-term for dusky sharks.
NMFS is requesting comments on the alternatives and analyses described in this proposed rule and contained in Draft Amendment 5b and its DEIS, IRFA and RIR. Comments may be submitted via
Comments on this proposed rule may be submitted via
The public is reminded that NMFS expects participants at the public hearings to conduct themselves appropriately. At the beginning of each public hearing, a representative of NMFS will explain the ground rules (
Pursuant to the Magnuson-Stevens Act, the NMFS Assistant Administrator has determined that the proposed rule is consistent with the 2006 Consolidated HMS FMP and its amendments, other provisions of the Magnuson-Stevens Act, ATCA, and other applicable law, subject to further consideration after public comment.
This proposed rule has been determined to be not significant for purposes of Executive Order 12866.
NMFS prepared a DEIS for this proposed rule that discusses the impact on the environment that would result from this rule. A copy of the DEIS is available from NMFS (see
This proposed rule would require HMS-permitted recreational fishermen to obtain a shark endorsement in order to fish for, retain, possess, or land sharks. Public comment is sought regarding: whether this proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; the accuracy of the burden estimate; 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, including through the use of automated collection techniques or other forms of information technology. Send comments on these or any other aspects of the collection of information to (enter office name) at the
Notwithstanding any other provision of the law, no person is required to respond to, nor shall any 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.
An initial regulatory flexibility analysis (IRFA) was prepared, as required by section 603 of the Regulatory Flexibility Act (RFA). The IRFA describes the economic impact this proposed rule, if adopted, would have on small entities. A summary of the analysis follows. A copy of this analysis is available from NMFS (see
As described in the preamble of this rule and in the Draft Amendment 5b DEIS (see
The objectives of, and legal basis for, this proposed rule are summarized in the preamble of this rule and in the Draft Amendment 5b DEIS (see
This proposed rule is expected to directly affect commercial pelagic longline, bottom longline, shark gillnet, and recreational shark fishing vessels that possess HMS permits. To fish for Atlantic HMS, pelagic longline vessels must possess an Atlantic shark limited access permit, an Atlantic swordfish limited access permit, and an Atlantic Tunas Longline category permit. For the recreational management measures, the proposed management measures would only directly apply to small entities that are Charter/Headboat permit holders that provide for-hire trips that target sharks. Other HMS recreational fishing permit holders are considered individuals, not small entities.
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 its affiliates), and has combined annual receipts not in excess of $11 million for all its affiliated operations worldwide. The Small Business Administration (SBA) has established size standards for all other major industry sectors in the U.S., including the scenic and sightseeing transportation (water) sector (NAICS code 487210, for-hire), which includes charter/party boat entities. The Small Business Administration (SBA) has defined a small charter/party boat entity as one with average annual receipts (revenue) of less than $7.5 million.
Regarding those entities that would be directly affected by the recreational management measures, HMS Angling (Recreational) category permits are typically obtained by individuals who are not considered businesses or small entities for purposes of the RFA. Additionally, while Atlantic Tunas General category and Swordfish General commercial permit holders hold commercial permits and are usually considered small entities, because the proposed management measures would only affect them when they are fishing under the recreational regulations for sharks during a registered tournament, NMFS is not considering them small entities for this rule. However, because vessels with the HMS Charter/Headboat category permit are for-hire vessels, these permit holders can be regarded as small entities for RFA purposes. At this time, NMFS is unaware of any charter/headboat businesses that could exceed the SBA receipt/revenue thresholds for small entities. Overall, the recreational alternatives would impact a portion of the 3,596 HMS Charter/Headboat permit holders interested in shark fishing.
Regarding those entities that would be directly affected by the commercial management measures, the average annual revenue per active pelagic longline vessel is estimated to be $187,000 based on the 170 active vessels between 2006 and 2012 that produced an estimated $31.8 million in revenue annually. The maximum annual revenue for any pelagic longline vessel between 2006 and 2015 was less than $1.9 million, well below the NMFS small business size standard for commercial fishing businesses of $11 million. Other non-longline HMS commercial fishing vessels typically generally earn less revenue than pelagic longline vessels. Therefore, NMFS considers all Atlantic HMS commercial permit holders to be small entities. The preferred commercial alternatives would apply to the 280 Atlantic tunas Longline category permit holders and 224 directed shark permit holders. Of these 280 permit holders, only 136 have Individual Bluefin Quotas (IBQ) shares required to go commercial pelagic longline fishing.
NMFS has determined that the preferred alternatives would not likely directly affect any small organizations or small government jurisdictions defined under RFA. More information regarding the description of the fisheries affected, and the categories and number of permit holders, can be found in Chapter 3 of the Draft Amendment 5b DEIS (see
Several of the preferred alternatives in Draft Amendment 5b would result in reporting, record-keeping, and compliance requirements that may require new Paperwork Reduction Act (PRA) filings and some of the preferred alternatives would modify existing reporting and record-keeping requirements, and add compliance requirements. NMFS estimates that the number of small entities that would be subject to these requirements would include the Atlantic tuna Longline category (280), Directed and Incidental Shark Limited Access (224 and 275, respectively), and HMS Charter/Headboat category (3,596) permit holders.
The preferred recreational alternative, A2, would require recreational fishermen fishing for, retaining, possessing, or landing sharks to obtain a shark endorsement in addition to other existing permit requirements. Obtaining the shark endorsement would be included in the online HMS permit application and renewal processes and would require the applicant to learn about prohibited shark species identification, regulations, and safe handling guidelines, and then complete a short quiz focusing on shark species identification. The applicant would simply need to indicate the desire to obtain the shark endorsement, after which he or she would be directed to a short online quiz that would take minimal time to complete. Adding the endorsement to the permit and requiring applicants to take the online quiz to obtain the endorsement will require a modification to the existing PRA for the permits.
Alternative B5, a preferred alternative, would require completion of shark identification and fishing regulation training as a new part of all Safe Handling and Release Workshops for HMS pelagic longline (PLL), BLL, and shark gillnet vessel owners and operators. The training course would provide information regarding shark identification and regulations, as well as best practices to avoid interacting with dusky sharks and how to minimize mortality of dusky sharks caught as bycatch. Compliance with this course requirement would be mandatory and be a condition for permit renewal. A certificate would be issued to all commercial pelagic longline vessel owners indicating compliance with this requirement and the certificate would be required for permit renewal.
Alternative B6, a preferred alternative, would require that all vessels with an Atlantic shark commercial permit and fishing with pelagic longline, bottom longline, or shark gillnet gear abide by a dusky shark fleet communication and relocation protocol. The protocol would require vessels to report the location of
The proposed rule would not conflict with any relevant regulations, Federal or otherwise. Description of Any Significant Alternatives to the Proposed Rule That Accomplish the Stated Objectives of the Applicable Statutes and That Minimize Any Significant Economic Impact of the Proposed Rule on Small Entities
The RFA (5 U.S.C. 603 (c) (1)-(4)) lists four general categories of “significant” alternatives that would assist an agency in the development of significant alternatives. These categories of alternatives are:
1. Establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities;
2. Clarification, consolidation, or simplification of compliance and reporting requirements under the rule for such small entities;
3. Use of performance rather than design standards; and,
4. Exemptions from coverage of the rule for small entities.
In order to meet the objectives of this proposed rule, consistent with all legal requirements, NMFS cannot exempt small entities or change the reporting requirements only for small entities because all the entities affected are considered small entities. Thus, there are no alternatives discussed that fall under the first and fourth categories described above. Under the third category, “use of performance rather than design standards,” NMFS considers Alternative B5, which would provide additional training for pelagic longline, bottom longline, and shark gillnet fishermen, to be a performance standard rather than a design standard. Alternative B5's training requirement will apply to all commercial vessels and take place in conjunction with other currently required training workshops. As described below, NMFS analyzed several different alternatives in this proposed rulemaking and provides the rationale for identifying the preferred alternative to achieve the desired objective.
In this rulemaking, NMFS considers two different categories of alternatives. The first category, recreational alternatives, covers seven main alternatives that address various strategies of reducing dusky shark mortality in the recreational fishery. The second category of alternatives, commercial measures, considers eight main alternatives that address various strategies of reducing dusky shark mortality in the commercial fishery.
The potential impacts these alternatives may have on small entities have been analyzed and are discussed in the following sections. The preferred alternatives include: Alternative A2, Alternative A6a, Alternative B3, Alternative B5, Alternative B6, and Alternative B9. The economic impacts that would occur under these preferred alternatives were compared with the other alternatives to determine if economic impacts to small entities could be minimized while still accomplishing the stated objectives of this rule.
Alternative A1, the no action alternative, would not implement any management measures in the recreational shark fishery to decrease mortality of dusky sharks, likely resulting in direct, short- and long-term neutral economic impacts. Since there would be no changes to the fishing requirements, there would be no economic impacts on small entities. If more restrictive measures are required in the long-term under MSA or other statutes such as the Endangered Species Act, moderate adverse economic impacts may occur. NMFS does not prefer this alternative at this time, given that the purpose of this action is to address overfishing and rebuilding.
Under Alternative A2, a preferred alternative, HMS Angling and Charter/Headboat permit holders would be required to obtain a shark endorsement, which requires completion of an online shark identification and fishing regulation training course and quiz in order to fish for, retain, possess, or land sharks. Obtaining the shark endorsement would be included in the online HMS permit application and renewal processes and would require the applicant to complete a training course focusing on shark species identification, fishing regulations, and safe handling. This alternative would likely result in no economic impacts since there would be no additional cost to the applicant and only a small additional investment in time. Obtaining the shark endorsement would be a part of the normal HMS permit application or renewal. The applicant would simply need to indicate the desire to obtain the shark endorsement, after which he or she would be directed to an online training course and quiz. The goal of the training course is to help prevent anglers from landing prohibited or undersized sharks, and thus, help rebuild stocks. Furthermore, the list of shark endorsement holders would allow for more targeted surveys and outreach, likely increasing the reliability of recreational shark catch estimates. This preferred alternative helps achieve the objectives of this proposed rule while minimizing any significant economic impacts on small entities.
Alternative A3 would require participants in the recreational shark fishery (Angling and Charter/Headboat permit holders) to carry an approved shark identification placard on board the vessel when fishing for sharks. This alternative would likely result in short- and long-term minor economic impacts. The cost of obtaining a placard, which would be provided by NMFS, whether by obtaining a pre-printed one or self-printing, would be modest. To comply with the requirement of this alternative, the angler would need to keep the placard on board the vessel when fishing for sharks and, since carrying other documents such as permits and boat registration is already required, this is unlikely to be a large inconvenience. This alternative would have slightly more economic impacts than Alternative A2 on small entities and would likely be less effective than the training course in Alternative A2.
Under Alternative A4, NMFS would extend the existing prohibition on the retention of certain ridgeback sharks (bignose, Caribbean reef, dusky, Galapagos, night, sandbar, and silky sharks) to include the rest of the ridgeback sharks, namely oceanic whitetip, tiger sharks, and smoothhound sharks, which currently may be retained by recreational shark fishermen (HMS Angling and Charter/Headboat permit holders) under certain circumstances. This alternative would simplify compliance with the ridgeback prohibition, which includes dusky sharks, for the majority of fishermen targeting sharks. Dusky shark mortality in the recreational fishery is in part due to misidentification of dusky sharks (which are prohibited) as one the retainable species. This alternative, however, could also potentially have adverse economic impacts for a small subset of fishermen that target oceanic whitetip, tiger, and smoothhound
Under Alternative A5, the minimum recreational size limit for authorized shark species, except for Atlantic sharpnose, bonnethead, and hammerhead (great, scalloped, and smooth) sharks, would increase from 54 to 89 inches fork length, which is the approximate length at maturity for dusky sharks. Under this alternative, increasing the recreational size limit would likely result in both direct short- and long-term, moderate adverse economic impacts for recreational fishermen, charter/headboat operators, and tournament operators. Because many shark species have a maximum size below an 89 inch size limit, there could be reduced incentive to fish recreationally for sharks due to the decreased potential to legally land these fish. Increasing the minimum size for retention would also impact the way that tournaments and charter vessels operate. While the impacts of an 89 inch fork length minimum size on tournaments awarding points for pelagic sharks may be lessened because these tournament participants target larger sharks, such as shortfin mako, blue, and thresher, that grow to larger than 89 inches fork length, this may not be the case for tournaments targeting smaller sharks. Tournaments that target smaller sharks, especially those that target shark species that do not reach sizes exceeding 89 inches fork length such as blacktip sharks, may be heavily impacted by this alternative. Reduced participation in such tournaments could potentially decrease the amount of monetary prizes offered to winners. Thus, implementation of this management measure could significantly alter the way some tournaments and charter vessels operate, or reduce both opportunities to fish for sharks and thus drastically reduce general interest and demand for recreational shark fishing, which could create adverse economic impacts. While this alternative may result in minor beneficial ecological impacts for dusky sharks, for the aforementioned reasons, NMFS does not prefer this alternative at this time.
Sub-alternative A6a is a preferred alternative and would require all persons on board vessels with Atlantic HMS permits participating in fishing tournaments that bestow points, prizes, or awards for sharks to use circle hooks when fishing for or retaining sharks, and require the use of circle hooks by all HMS recreational permit holders when fishing for or retaining sharks outside of a tournament. Any sharks caught on non-circle hooks would have to be released. It would be presumed that an operator is recreationally fishing for sharks if it is fishing with natural bait and using wire or heavy (200 pound test or greater) monofilament or fluorocarbon leader. Relative to the total cost of gear and tackle for a typical fishing trip, the cost associated with switching from J-hooks to circle hooks is negligible. Thus, the immediate cost in switching hook type is likely minimal. However, there is conflicting indication that the use of circle hooks may reduce or increase catch per unit effort (CPUE) resulting in lower catch of target species. In the event that CPUE is reduced, some recreational fishermen may choose not to fish for sharks or to enter tournaments that offer awards for sharks. These missed fishing opportunities could result in minor adverse economic impacts in the short- and long-term. However, since the economic impacts are minor and circle hooks would likely reduce fishing mortality for dusky sharks, NMFS prefers this alternative at this time.
Sub-Alternative Ab6 is similar to A6a, but instead of requiring circle hooks when fishing for sharks defined by deploying natural bait while using a wire or heavy (200 pound test or greater) monofilament or fluorocarbon leader, it instead requires circle hooks when fishing for sharks defined by deploying a 5/0 or greater size hook to fish with natural bait outside of a fishing tournament. This use of the hook size standard to determine if the trip could be targeting sharks may result in more recreational trips requiring circle hooks than under alterative A6a, but many of those trips might actually not be targeting sharks, but instead other large pelagic fish. The use of a heavy leader is probably more correlated with angling activity that is targeting sharks.
Sub-Alternative A6c is similar to A6a and A6b, but restricted to requiring the use of circle hooks by all HMS permit holders participating in fishing tournaments that bestow points, prizes, or awards for sharks. This alternative impacts a smaller universe of recreational fishermen, so the adverse impacts are smaller. However, given the limited scope of this requirement, the benefits to reducing dusky shark mortality via the use of circle hooks are also more limited.
Alternative A7 would prohibit any HMS permit holders from retaining any shark species in the recreational fishery. Recreational fishermen may still fish for and target authorized shark species for catch and release. The large number of fishermen who already practice catch and release and the catch and release shark fishing tournaments currently operating would not be impacted. As this alternative would help eliminate accidental landings of already-prohibited dusky sharks, it would have minor beneficial ecological impacts. However, prohibiting retention of sharks could have major impacts on fishing behaviors and activity of other recreational shark fishermen and reduce their demand for charter/headboat trips. Only allowing catch and release of authorized sharks in the recreational fishery could impact some fishermen that retain sharks recreationally and tournaments that award points for landing sharks. Thus, prohibiting retention of Atlantic sharks in the recreational shark fisheries could drastically alter the nature of recreational shark fishing and reduce incentives to fish for sharks. Additionally, the reduced incentive to fish for sharks could negatively impact profits for the HMS Charter/Headboat industry. Because there could be major impacts to the recreational shark fisheries from this management measure, Alternative A7 would likely have direct short- and long-term, moderate adverse economic impacts on small business entities.
Under Alternative B1, the no action alternative, NMFS would not implement any measures to reduce dusky shark mortality in the commercial shark or HMS fisheries. Since no management measures would be implemented under this alternative, NMFS would expect fishing practices to remain the same and economic impacts to be neutral in the short-term. Dusky sharks are a prohibited species and fishermen are not allowed to harvest this species. Thus, there would not be any economic impacts on the fishery in the short-term. If more restrictive measures are required in the long-term under MSA or other statutes such as the Endangered Species Act, moderate adverse economic impacts may occur. NMFS does not prefer this alternative at this time, given that the purpose of this action is to address overfishing and rebuilding.
Under Alternative B2, HMS commercial fishermen would be limited to 750 hooks per pelagic longline set with no more than 800 assembled gangions onboard the vessel at any time. Based on average number of hooks per pelagic longline set data, the hook restriction in this alternative could have neutral economic impacts on fishermen targeting bigeye tuna, mixed tuna species, and mixed HMS species, because the average number of hooks used on pelagic longline sets targeting these species is slightly above or below the limit considered in this alternative. This alternative would likely have adverse economic impacts on pelagic longline fishermen who target dolphin fish, because these fishermen on average use 1,066 hooks per set. If NMFS implemented this alternative, fishermen targeting dolphin fish with pelagic longline gear would have to reduce their number of hooks by approximately 30 percent per set, which may result in a similar percent reduction in set revenue or could result in increased operating costs if fishermen decide to offset the limited number of hooks with more fishing sets. While this alternative would have minor beneficial ecological impacts, overall, Alternative B2 would be expected to have short- and long-term minor adverse economic impacts on the pelagic longline fishery.
Under Alternative B3, a preferred alternative, HMS commercial fishermen must release all sharks that are not being boarded or retained by using a dehooker, or by cutting the gangion no more than three feet from the hook. This alternative would have neutral to adverse economic impacts on commercial shark fishermen using pelagic longline gear. Currently, fishermen are required to use a dehooking device if a protected species is caught. This alternative would require this procedure to be used on all sharks that would not be retained, or fishermen would have to cut the gangion to release the shark. Currently, it is common practice in the pelagic longline fishery to release sharks that are not going to be retained (especially larger sharks) by cutting the gangion, but they usually do not cut the gangion so only 3 feet remain, so there might be a slight learning curve. Using a dehooker to release sharks in the pelagic longline fishery is a less common practice; therefore, there may be more of a learning curve that would make using this technique more time consuming and would make fishing operations temporarily less efficient while fishermen become used to this technique. NMFS expects that these inefficiencies would be minimal and that fishermen would become adept in using a dehooker to release sharks over time given they are all practiced at using a dehooker to release protected species. Thus, Alternative B3 would be expected to have short- and long-term neutral economic impacts on the pelagic longline fishery.
Under Alternative B4, NMFS considered various dusky shark hotspot closures for vessels fishing with pelagic longline gear. The hotspot closures considered are the same areas that were analyzed in Draft Amendment 5 and the A5b Predraft. These hotspot closure alternatives are located where increased levels of pelagic longline interactions with dusky sharks had been identified based on HMS Logbook data. During the months that hotspot closures are effective, Atlantic shark commercial permit holders (directed or incidental) would not be able to fish with pelagic longline gear in these areas. While these closures would result in minor ecological benefits, NMFS does not prefer them at this time because the preferred alternatives would address overfishing and rebuilding without the adverse social and economic impacts associated with these closures.
This alternative would define a rectangular area in a portion of the existing Charleston Bump time/area closure area, and prohibit the use of pelagic longline gear by all vessels during the month of May in that area. This alternative is expected to have moderate short and long-term direct adverse economic impacts on 46 vessels that have historically fished in this Charleston Bump area during the month of May. This closure would result in the loss of approximately $15,250 in gross revenues per year per vessel assuming no redistribution of effort outside of the closed area.
However, it is likely that some of the vessels that would be impacted by this hotspot closure would redistribute their effort to other fishing areas. Based on natural breaks in the percentage of sets vessels made inside and outside of this alternative's hotspot closure area, NMFS estimated that if a vessel historically made less than 40 percent of its sets in the hotspot closure area, it would likely redistribute all of its effort. If a vessel made more than 40 percent but less than 75 percent of its sets in the hotspot closure area, it would likely redistribute 50 percent of its effort impacted by the hotspot closure area to other areas. Finally, if a vessel made more than 75 percent of its sets solely within the hotspot closure area, NMFS assumed the vessel would not likely shift its effort to other areas. Based on these individually calculated redistribution rates, the percentage of fishing in other areas during the gear restriction time period, the percentage of fishing in other areas during the hotspot closure time period, and the catch per unit effort for each vessel in each statistical area, NMFS estimated the potential landings associated with redistributed effort associated with fishing sets displaced by the hotspot closure area. The net loss in fishing revenues as a result of the Charleston Bump Hotspot May closure after considering likely redistribution of effort is estimated to be $8,300 per vessel per year. Alternative B4a would result in moderate short- and long-term adverse economic impacts as a result of restricting pelagic longline vessels from fishing in the Charleston Bump Hotspot May area, thus causing decreased revenues and increased costs associated with fishing in potentially more distant waters if vessel operators redistribute their effort.
This alternative would prohibit the use of pelagic longline gear in the vicinity of the “Hatteras Shelf” area of the Cape Hatteras Special Research Area during the month of May where elevated levels of dusky shark interactions have been reported. This alternative is expected to have moderate
This alternative would prohibit the use of pelagic longline gear in the vicinity of the “Hatteras Shelf” area of the Cape Hatteras Special Research Area during the month of June where elevated levels of dusky shark interactions have been reported. This alternative is expected to have moderate short and long-term direct adverse economic impacts on 37 vessels that have historically fished in this Hatteras Shelf Hotspot area during the month of June. The average annual revenue from 2008 through 2014 from all fishing sets made in this hotspot closure area has been approximately $7,640 per vessel during the month of June, assuming that fishing effort does not move to other areas. However, it is likely that some of the vessels that would be impacted by this hotspot closure would redistribute their effort to other fishing areas. The net impact of the Hatteras Shelf Hotspot June closure on fishing revenues after considering likely redistribution of effort is estimated to be $4,010 per vessel per year. Alternative B4c would result in moderate adverse economic impacts as a result of restricting pelagic longline vessels from fishing in the Hatteras Shelf Hotspot June area, thus causing decreased revenues and increased costs associated with fishing in potentially more distant waters if vessel operators redistribute their effort.
This alternative would prohibit the use of pelagic longline gear in the vicinity of the “Hatteras Shelf” area of the Cape Hatteras Special Research Area during the month of November where elevated levels of dusky shark interactions have been reported. This alternative is expected to have minor short and long-term direct adverse economic impacts on 23 vessels that have historically fished in this Hatteras Shelf Hotspot area during the month of November. The average annual revenue from 2008 through 2014 from all fishing sets made in this hotspot closure area has been approximately $5,230 per vessel during the month of November, assuming that fishing effort does not move to other areas. However, it is likely that some of the vessels that would be impacted by this hotspot closure would redistribute their effort to other fishing areas. The net impact of the Hatteras Shelf Hotspot November closure on fishing revenues after considering likely redistribution of effort is estimated to be $3,540 per vessel per year. Alternative B4d would result in minor adverse economic impacts as a result of restricting pelagic longline vessels from fishing in the Hatteras Shelf Hotspot November area, thus causing decreased revenues and increased costs associated with fishing in potentially more distant waters if vessel operators redistribute their effort.
This alternative would prohibit the use of pelagic longline gear by all U.S. flagged-vessels permitted to fish for HMS in the three distinct closures in the vicinity of the Mid-Atlantic Canyons during the month of October where elevated levels of dusky shark interactions have been reported. This alternative is expected to have moderate short and long-term direct adverse economic impacts on 64 vessels that have historically fished in this Canyons Hotspot October area. The average annual revenue from 2008 through 2014 from all fishing sets made in this hotspot closure area has been approximately $9,950 per vessel during the month of October, assuming that fishing effort does not move to other areas. However, it is likely that some of the vessels that would be impacted by this hotspot closure would redistribute their effort to other fishing areas. The net impact of the Canyons Hotspot October closure on fishing revenues after considering likely redistribution of effort is estimated to be $3,720 per vessel per year. Alternative B4e would result in moderate adverse economic impacts as a result of restricting pelagic longline vessels from fishing in the Canyons Hotspot October area, thus causing decreased revenues and increased costs associated with fishing in potentially more distant waters if vessel operators redistribute their effort.
This alternative would prohibit the use of pelagic longline gear by all U.S. flagged-vessels permitted to fish for HMS in July in an area adjacent to the existing Northeastern U.S. closure which is currently effective for the month of June, where elevated levels of dusky shark interactions have been reported. This alternative is expected to have moderate short- and long-term direct adverse economic impacts on 35 vessels that have historically fished in this Southern Georges Banks Hotspot area during the month of July. The average annual revenue from 2008 through 2014 from all fishing sets made in this hotspot closure area has been approximately $14,230 per vessel during the month of July, assuming that fishing effort does not move to other areas. However, it is likely that some of the vessels that would be impacted by this hotspot closure would redistribute their effort to other fishing areas. The net impact of the Southern Georges Banks Hotspot July closure on fishing revenues after considering likely redistribution of effort is estimated to be $8,290 per vessel per year. Alternative B4f would result in moderate adverse economic impacts as a result of restricting longline vessels from fishing in the Southern Georges Banks Hotspot July area, thus causing decreased revenues and increased costs associated with fishing in potentially more distant waters if vessel operators redistribute their effort.
This alternative would prohibit the use of pelagic longline gear by all U.S. flagged-vessels permitted to fish for HMS in August in an area adjacent to the existing Northeastern U.S. closure, which is currently effective for the month of June, where elevated levels of dusky shark interactions have been reported. This alternative is expected to have moderate short and long-term direct adverse economic impacts on 35 vessels that have historically fished in this Southern Georges Banks Hotspot area during the month of August. The average annual revenue from 2008 through 2014 from all fishing sets made
This alternative would prohibit the use of pelagic longline gear by all U.S. flagged-vessels permitted to fish for HMS in a portion of the existing Charleston Bump time/area closure during the month of November where elevated levels of dusky shark interactions have been reported. This alternative is expected to have minor short and long-term direct adverse economic impacts on 32 vessels that have historically fished in this Charleston Bump Hotspot area during the month of November. The average annual revenue from 2008 through 2014 from all fishing sets made in this hotspot closure area has been approximately $7,030 per vessel during the month of November, assuming that fishing effort does not move to other areas. However, it is likely that some of the vessels that would be impacted by this hotspot closure would redistribute their effort to other fishing areas. The net impact of the Charleston Bump Hotspot November closure on fishing revenues after considering likely redistribution of effort is estimated to be $2,720 per vessel per year. Alternative B4h would result in minor adverse social and economic impacts as a result of restricting pelagic longline vessels from fishing in the Charleston Bump Hotspot November area, thus causing decreased revenues and increased costs associated with fishing in potentially more distant waters if vessel operators redistribute their effort.
This alternative would allow PLL vessels that have demonstrated an ability to avoid dusky sharks and comply with dusky shark regulations to fish within any dusky hotspot closure adopted. This approach would address the fact that, according to HMS logbook data, relatively few vessels have consistently accounted for the majority of the dusky shark interactions and also address requests from PLL participants to increase individual accountability within the fishery. Depending on the metrics selected and fishery participant behavior, this alternative could have adverse socioeconomic effects on certain vessels that are both poor avoiders of dusky sharks and are non-compliant with the regulations. This alternative would require an annual determination of which vessels would qualify for conditional access based on dusky shark interactions. NMFS would analyzed the socioeconomic impact by using similar fishing effort redistribution proposed in Draft Amendment 7 and described in Alternative B5. This alternative would have neutral to beneficial effects for vessels that are still authorized to fish in a hotspot closure(s), and would reduce adverse socioeconomic effects of a closure(s). As explained above, NMFS is not preferring any hotspot closure alternative and thus is not preferring this alternative, which would work in conjunction with a closure.
This alternative would implement bycatch caps on dusky shark interactions over a three-year period in hotspot areas. Under this alternative, NMFS would allow pelagic longline vessels limited access to high dusky shark interaction areas with an observer onboard while limiting the number of dusky shark interactions that could occur in these areas. Once the dusky shark bycatch cap for an area is reached, that area would close until the end of the three-year bycatch cap period. This alternative could lead to adverse economic impacts by reducing annual revenue from fishing in the various hot spot areas depending on the number of hotspots where bycatch cap limits are reached, the timing of those potential closures during the year, and the amount of effort redistribution that occurs after the closures. In addition to direct impacts to vessels owners, operators, and crew members, this alternative would have moderate, adverse indirect impacts in the short and long-term on fish dealers, processors, bait/gear suppliers, and other shore-based businesses impacted by reduced fishing opportunities for pelagic longline vessel owners that would have fished in the hotspot area. As explained above, NMFS is not preferring any hotspot closure alternative and thus is not preferring this alternative, which would work in conjunction with a closure.
Alternative B5, a preferred alternative, would provide additional training to pelagic longline, bottom longline, and shark gillnet vessel owners and operators as a new part of all currently required Safe Handling and Release Workshops. The training course would provide information regarding shark identification and regulations, as well as best practices to avoid interacting with dusky sharks and how to minimize mortality of dusky sharks caught as bycatch. This training course requirement provides targeted outreach to those who continue to interact with dusky sharks, which should decrease interactions with dusky sharks. This alternative would have minor adverse economic impacts since the fishermen would be required to attend a workshop, incur some travel costs, and would not be fishing while taking attending the workshop. Given the minor economic impacts and this alternative's potential to decrease dusky interactions and mortality, NMFS prefers this alternative.
The economic impacts associated with Alternative B6, a preferred alternative, which would increase dusky shark outreach and awareness through development of additional commercial fishery outreach materials and establish a communication and fishing set relocation protocol for HMS commercial fishermen following interactions with dusky sharks and increase outreach, are anticipated to be neutral. These requirements would not cause a substantial change to current fishing operations, but have the potential to help fishermen become more adept in avoiding dusky sharks. If fishermen become better at avoiding dusky sharks, there is the possibility that target catch could increase. On the other hand, the requirement to move the subsequent fishing set one nautical mile from where a previous dusky shark interaction occurred could move fishermen away from areas where they would prefer to fish and it could increase fuel usage and fuel costs. Given the low economic impacts of this alternative and its potential to decrease dusky shark interactions, NMFS prefers this alternative.
NMFS would seek, through collaboration with the affected states
Under Alternative B8, NMFS would remove pelagic longline gear as an authorized gear for Atlantic HMS. All commercial fishing with pelagic longline gear for HMS in the Atlantic, Gulf of Mexico, and Caribbean would be prohibited, which would have beneficial ecological impacts. However, this would greatly reduce fishing opportunities for pelagic longline fishing vessel owners. Prohibiting the use of pelagic longline fishing gear would result in direct and indirect, major adverse economic impacts in the short and long-term for pelagic longline vessel owners, operators, and crew.
Between 2008 and 2014, 168 different vessels reported using pelagic longline fishing gear in Atlantic HMS Logbooks. Average annual revenues were estimated to be approximately $34,322,983 per year based on HMS logbook records, bluefin tuna dealer reports, and the eDealer database. In 2014, there were 110 active pelagic longline vessels which produced approximately $33,293,118 in revenues. The 2014 landings value is in line with the 2008 to 2014 average. Therefore, NMFS expects future revenues forgone revenue on a per vessel basis to be approximately $309,000 per year based on 110 vessels generating an estimated $34 million in revenues per year. This displacement of fishery revenues would likely cause business closures for a majority of these pelagic longline vessel owners. Given the magnitude of the economic impact of this alternative, it is not a preferred alternative.
Under Alternative B9, a preferred alternative, NMFS would require the use of circle hooks by all HMS directed shark permit holders in the bottom longline fishery. This requirement would likely reduce the mortality associated with dusky shark bycatch in the bottom longline fishery. There is negligible cost associated with switch from J-hooks to circle hooks. However, it is possible that circle hooks may reduce catch per unit effort (CPUE) resulting in lower catch of target species. To the extent that CPUE is reduced, some commercial fishermen using BLL gear may experience reduced landings and associated revenue with the use of circle hooks. This alternative would require the 224 vessels that hold a shark directed limited access permit as of 2015 to use circle hooks. However, 104 of the 224 vessels have an Atlantic tunas longline permit, which requires fishermen to use circle hooks with pelagic longline gear. Thus, those vessels would already possess and use circle hooks. The remaining 120 permit holders would be required to use circle hooks when using bottom longline gear. Given the low switching costs from J-hooks to circle hooks and the potential to reduce dusky shark mortality, NMFS prefers this alternative.
Under this alternative, NMFS would annually allocate individual dusky shark bycatch quota (IDQ) to each individual shark directed or incidental limited access permit holder in the HMS pelagic and bottom longline fisheries for assignment to permitted vessels. These allocations would be transferable between permit holders. When each vessel's IDQ is reached, the vessel would no longer be authorized to fish for HMS for the remainder of the year. The concept of this alternative is similar to the Individual Bluefin Tuna Quota (IBQ) Program implemented in Amendment 7 to the 2006 Consolidated HMS FMP (79 FR 71510; December 2, 2014), which established individual quotas for bluefin tuna bycatch in the pelagic longline fishery and authorized retention and sale of such bycatch. Under this alternative, however, NMFS would continue to prohibit retention and sale of dusky sharks. The goal of individual quotas generally is to provide strong individual incentives to reduce interactions while providing flexibility for vessels to continue to operate in the fishery; however, several unique issues associated with dusky sharks would make these goals difficult to achieve.
In order to achieve the mortality reductions based upon the 2016 SEDAR 21 dusky shark assessment update, the number of dusky shark interactions may need to be substantially reduced. NMFS expects the allocations to each vessel may be extremely low and highly inaccurate/uncertain. As stated above, there is significant uncertainty in estimating dusky shark catches and calculating the appropriate level of catch for this alternative to be feasible. It is not clear that an IDQ system without an appropriate scientific basis would actually reduce interactions with dusky sharks. To the extent that any reduction actually occurred, some vessels would be constrained by the amount of individual quota they are allocated and this could reduce their annual revenue. If a pelagic longline vessel interacts with dusky sharks early in the year and uses their full IDQ allocation, they may be unable to continue fishing with pelagic longline or bottom longline gear for the rest of the year if they are unable to lease quota from other IDQ holders. This would result in reduced revenues and potential cash flow issues for these small businesses.
If vessel owners are only allocated a very low amount of IDQs, it is very unlikely that an active trading market for IDQs will emerge. The initial allocations could be insufficient for many vessels to maintain their current levels of fishing activity and they may not be able to find IDQs to lease or have insufficient capital to lease a sufficient amount of IDQs. Some vessel owners may view the risk of exceeding their IDQ allocations and the associated costs of acquiring additional quota to outweigh the potential profit from fishing, so they may opt to not continue participating in the fishery. The annual transaction costs associated with matching lessor and lessees, the costs associated with drafting agreements, and the uncertainty vessel owners would face regarding quota availability would reduce some of the economic benefits associated with leasing quota and fishing. There would also be increased costs associated with bottom longline vessels obtaining and installing EM and VMS units. Some bottom longline vessel owners might have to consider obtaining new vessels if their current vessels cannot be equipped with EM and VMS. There would be increased costs associated with VMS reporting of dusky interactions. Some fishermen would also need to ship EM hard drives
NMFS is not preferring this alternative, as it does not further the objectives of this action. Given the challenges in properly identifying dusky sharks, every shark would need to be brought on board the vessel and ensure an accurate picture of identifying features was taken by the EM cameras. Such handling would likely increase dusky shark and other shark species mortality, and this action is supposed to reduce mortality. In addition, this alternative is also unlikely to minimize the economic impact of this rule as compared to the preferred alternatives given the potential for reduced fishing revenues, monitoring equipment costs, and transaction costs.
Fisheries, Fishing, Fishing vessels, Foreign relations, Imports, Penalties, Reporting and recordkeeping requirements, Treaties.
For reasons set out in the preamble, 50 CFR part 635 is proposed to be amended as follows:
16 U.S.C. 971
(b) * * *
(1) The owner of a charter boat or headboat used to fish for, retain, possess, or land any Atlantic HMS must obtain an HMS Charter/Headboat permit. In order to fish for, retain, possess, or land Atlantic sharks, the owner must have a valid shark endorsement issued by NMFS, and persons on board must use circle hooks as specified at § 635.21(f) and (k). A vessel issued an HMS Charter/Headboat permit for a fishing year shall not be issued an HMS Angling permit, a Swordfish General Commercial permit, or an Atlantic Tunas permit in any category for that same fishing year, regardless of a change in the vessel's ownership.
(c) * * *
(1) The owner of any vessel used to fish recreationally for Atlantic HMS or on which Atlantic HMS are retained or possessed recreationally, must obtain an HMS Angling permit, except as provided in § 635.4(c)(2). In order to fish for, retain, possess, or land Atlantic sharks, the owner must have a valid shark endorsement issued by NMFS, and persons on board must use circle hooks as specified at § 635.21(f) and (k). Atlantic HMS caught, retained, possessed, or landed by persons on board vessels with an HMS Angling permit may not be sold or transferred to any person for a commercial purpose. A vessel issued an HMS Angling permit for a fishing year shall not be issued an HMS Charter/Headboat permit, a Swordfish General Commercial permit, or an Atlantic Tunas permit in any category for that same fishing year, regardless of a change in the vessel's ownership.
(2) A vessel with a valid Atlantic Tunas General category permit issued under paragraph (d) of this section or with a valid Swordfish General Commercial permit issued under paragraph (f) of this section may fish in a recreational HMS fishing tournament if the vessel has registered for, paid an entry fee to, and is fishing under the rules of a tournament that has registered with NMFS' HMS Management Division as required under § 635.5(d). When a vessel issued a valid Atlantic Tunas General category permit or a valid Swordfish General Commercial permit is fishing in such a tournament, such vessel must comply with HMS Angling category regulations, except as provided in paragraphs (c)(3) and (c)(4) and in addition to paragraph (c)(5) of this section.
(5) In order to fish for, retain, possess, or land sharks, the owner of a vessel fishing in a registered recreational HMS fishing tournament and issued either an Atlantic Tunas General category or Swordfish General Commercial permit must have a shark endorsement, and persons on board must use circle hooks as specified at § 635.21(f) and (k).
(j) * * *
(4) In order to obtain a shark endorsement to fish for, retain, or land sharks, a vessel owner with a vessel fishing in a registered recreational HMS fishing tournament and issued or required to be issued either an Atlantic Tunas General category or Swordfish General Commercial permit or a vessel owner of a vessel issued or required to be issued an HMS Angling or HMS Charter/Headboat permit must take a shark endorsement online quiz. After completion of the quiz, NMFS will issue the vessel owner a new or revised permit with the shark endorsement for the vessel. The vessel owner can take the quiz at any time during the fishing year, but his or her vessel may not leave the dock on a trip during which sharks will be fished for, retained, or landed unless a new or revised permit with a shark endorsement has been issued by NMFS for the vessel. The addition of a shark endorsement to the permit does not constitute a permit category change and does not change the timing considerations for permit category changes specified in paragraph (j)(3) of this section.
(a) Safe handling release, disentanglement, and identification workshops. (1) Both the owner and operator of a vessel that fishes with longline or gillnet gear must be certified by NMFS, or its designee, as having completed a safe handling, release, and identification workshop before a shark or swordfish limited access vessel permit, pursuant to § 635.4(e) and (f), is renewed. For the purposes of this section, it is a rebuttable presumption
(2) NMFS, or its designee, will issue a safe handling, release, and identification workshop certificate to any person who completes a safe handling, release, and identification workshop. If an owner owns multiple vessels, NMFS will issue a certificate for each vessel that the owner owns upon successful completion of one workshop. An owner who is also an operator will be issued multiple certificates, one as the owner of the vessel and one as the operator.
(3) The owner of a vessel that fishes with longline or gillnet gear, as specified in paragraph (a)(1) of this section, is required to possess on board the vessel a valid safe handling, release, and identification workshop certificate issued to that vessel owner. A copy of a valid safe handling, release, and identification workshop certificate issued to the vessel owner for a vessel that fishes with longline or gillnet gear must be included in the application package to renew or obtain a shark or swordfish limited access permit.
(4) An operator that fishes with longline or gillnet gear as specified in paragraph (a)(1) of this section must possess on board the vessel a valid safe handling, release, and identification workshop certificate issued to that operator, in addition to a certificate issued to the vessel owner.
(c) * * *
(2) If a vessel fishes with longline or gillnet gear as described in paragraph (a) of this section, the vessel owner may not renew a shark or swordfish limited access permit, issued pursuant to § 635.4(e) or (f), without submitting a valid safe handling, release, and identification workshop certificate with the permit renewal application.
(3) A vessel that fishes with longline or gillnet gear as described in paragraph (a) of this section and that has been, or should be, issued a valid limited access permit pursuant to § 635.4(e) or (f), may not fish unless a valid safe handling, release, and identification workshop certificate has been issued to both the owner and operator of that vessel.
(5) A vessel owner, operator, shark dealer, proxy for a shark dealer, or participant who is issued either a safe handling, release, and identification workshop certificate or an Atlantic shark identification workshop certificate may not transfer that certificate to another person.
(6) Vessel owners issued a valid safe handling, release, and identification workshop certificate may request, in the application for permit transfer per § 635.4(l)(2), additional safe handling, release, and identification workshop certificates for additional vessels that they own. Shark dealers may request from NMFS additional Atlantic shark identification workshop certificates for additional places of business authorized to receive sharks that they own as long as they, and not a proxy, were issued the certificate. All certificates must be renewed prior to the date of expiration on the certificate.
(7) To receive the safe handling, release, and identification workshop certificate or Atlantic shark identification workshop certificate, persons required to attend the workshop must first show a copy of their HMS permit, as well as proof of identification to NMFS or NMFS' designee at the workshop. If a permit holder is a corporation, partnership, association, or any other entity, the individual attending on behalf of the permit holder must show proof that he or she is the permit holder's agent and provide a copy of the HMS permit to NMFS or NMFS' designee at the workshop. For proxies attending on behalf of a shark dealer, the proxy must have documentation from the shark dealer acknowledging that the proxy is attending the workshop on behalf of the Atlantic shark dealer and must show a copy of the Atlantic shark dealer permit to NMFS or NMFS' designee at the workshop.
(d)
(2) No person issued a Federal Atlantic commercial shark permit under § 635.4 may possess a shark taken by any gear other than rod and reel, handline, bandit gear, longline, or gillnet, except that smoothhound sharks may be retained incidentally while fishing with trawl gear subject to the restrictions specified in § 635.24(a)(7).
(3) No person issued an HMS Commercial Caribbean Small Boat permit may possess a shark taken from the U.S. Caribbean, as defined at § 622.2 of this chapter, by any gear other than with rod and reel, handline or bandit gear.
(4) Persons on a vessel issued a permit with a shark endorsement under § 635.4 may possess a shark only if the shark was taken by rod and reel or handline, except that persons on a vessel issued both an HMS Charter/Headboat permit (with or without a shark endorsement) and a Federal Atlantic commercial shark permit may possess sharks taken by rod and reel, handline, bandit gear, longline, or gillnet if the vessel is engaged in a non for-hire fishing trip and the commercial shark fishery is open pursuant to § 635.28(b).
The additions and revisions read as follows:
(c) * * *
(6) The owner or operator of a vessel permitted or required to be permitted under this part and that has pelagic longline gear on board must undertake the following shark bycatch mitigation measures:
(i) Handling and release requirements. Any hooked or entangled sharks that are not being retained must be released using dehookers or line clippers or cutters. If using a line clipper or cutter, the gangion must be cut so that less than three feet (91.4 cm) of line remains attached to the hook.
(ii)
(d) * * *
(2) The operator of a vessel required to be permitted under this part and that has bottom longline gear on board must undertake the following bycatch mitigation measures:
(iii)
(4) Vessels that have bottom longline gear on board and that have been issued, or are required to have been issued, a directed shark limited access permit under § 635.4(e) must have only circle hooks as defined at § 635.2 on board.
(f)
(2) A person on board a vessel that has been issued or is required to be issued a permit with a shark endorsement under this part and who is participating in an HMS registered tournament that bestows points, prizes, or awards for Atlantic sharks must deploy only circle hooks when fishing for, retaining, possessing, or landing sharks. For the purposes of this requirement, an owner or operator is fishing for sharks if they are using natural bait and wire or heavy (200 pound test or greater) monofilament or fluorocarbon leaders.
(3) A person on board a vessel that has been issued or is required to be issued an HMS Angling permit with a shark endorsement or an HMS Charter/Headboat permit with a shark endorsement must deploy only circle hooks when fishing for, retaining, possessing, or landing sharks. Any shark caught on non-circle hooks must be released. For the purposes of this requirement, an owner or operator is fishing for sharks if they are using natural bait and wire or heavy (200 pound test or greater) monofilament or fluorocarbon leaders.
(g) * * *
(5)
(k)
(2) A person on board a vessel that has been issued or is required to be issued an HMS Angling permit with a shark endorsement or a person on board a vessel with an HMS Charter/Headboat permit with a shark endorsement must deploy only circle hooks when fishing for, retaining, possessing, or landing sharks. Any shark caught on non-circle hooks must be released. For the purposes of this requirement, an owner or operator is fishing for sharks if they are using natural bait and wire or heavy (200 pound test or greater) monofilament or fluorocarbon leaders.
(c) * * *
(1) The recreational retention limit for sharks applies to any person who fishes in any manner, except to persons aboard a vessel that has been issued a Federal Atlantic commercial shark vessel permit under § 635.4. The retention limit can change depending on the species being caught and the size limit under which they are being caught as specified under § 635.20(e). If a commercial Atlantic shark quota is closed under § 635.28, the recreational retention limit for sharks and no sale provision in paragraph (a) of this section may be applied to persons aboard a vessel issued a Federal Atlantic commercial shark vessel permit under § 635.4, only if that vessel has also been issued an HMS Charter/Headboat permit with a shark endorsement under § 635.4 and is engaged in a for-hire fishing trip. A person on board a vessel that has been issued or is required to be issued a permit with a shark endorsement under § 635.4 must use circle hooks as specified in § 635.21(f) and (k) in order to retain sharks per the retention limits specified in this section.
(a) * * *
(50) Fish without being certified for completion of a NMFS safe handling, release, and identification workshop, as required in § 635.8.
(51) Fish without having a valid safe handling, release, and identification workshop certificate issued to the vessel owner and operator on board the vessel as required in § 635.8.
(52) Falsify a NMFS safe handling, release, and identification workshop certificate or a NMFS Atlantic shark identification workshop certificate as specified at § 635.8.
(d) * * *
(21) Fish for, retain, possess, or land sharks without a shark endorsement when issued an Atlantic HMS Angling permit, HMS Charter/Headboat permit, an Atlantic Tunas General Category permit, or a Swordfish General Commercial permit, as specified in § 635.4(c).
(22) Fish for, retain, possess, or land sharks without deploying circle hooks when fishing at a registered HMS fishing tournament that has awards or prizes for sharks, as specified in § 635.21(f) and (k) and § 635.22(c)(1).
(23) Fish for, retain, possess, or land sharks without deploying circle hooks when issued an Atlantic HMS Angling permit or HMS Charter/Headboat permit with a shark endorsement, as specified in in § 635.21(f) and (k) and § 635.22(c)(1).
(24) Release sharks with more than 3 feet (91.4 cm) of trailing gear, as specified in § 635.21(c)(6).
(25) Fail to follow the fleet communication and relocation protocol for dusky sharks as specified at § 635.21(c)(6), (d)(2), and (g)(5).
(26) Deploy bottom longline gear without circle hooks, or have on board both bottom longline gear and non-circle hooks, as specified at § 635.21(d)(4).
Natural Resources Conservation Service (NRCS).
Notice of availability of proposed changes in the NRCS Wisconsin Field Office Technical Guides for review and comment.
NRCS is proposing to revise Section I of the Wisconsin Field Office Technical Guide to include “Wisconsin Wetland Determination Methods” which will replace the existing “Wisconsin Wetland Mapping Conventions issued May 1, 1998” (commonly referred as State Wetland Mapping Conventions). The Wisconsin Wetland Determination Methods will be used as part of the technical documents and procedures to conduct wetland determinations on agriculture land as part of the Food Security Act of 1985 (as amended).
Comments should be submitted, identified by Docket Number NRCS-2016-0010, using any of the following methods:
•
•
• NRCS will post all comments on
Jimmy Bramblett, Wisconsin State Conservationist. Phone: 608-662-4422, by email at
Guidance for Wisconsin Wetland Determination Methods will be used as part of the technical documents and procedures to conduct wetland determinations on agricultural land as required by 16 U.S.C. 3822. NRCS is required by 16 U.S.C. 3862 to make available for public review and comment all proposed revisions to standards and procedures used to carry out highly erodible land and wetland provisions of the law.
All comments will be considered. If no comments are received, Guidance for Wisconsin Wetland Determination Methods will be considered final.
Electronic copies of the proposed Guidance for Wisconsin Wetland Determination Methods are available through
Rural Business-Cooperative Service, USDA.
Notice.
The Rural Business-Cooperative Service (the Agency) announces the acceptance of applications under the Rural Energy for America Program (REAP) which is designed to help agricultural producers and rural small businesses reduce energy costs and consumption and help meet the Nation's critical energy needs. REAP have two types of funding assistance: (1) Renewable Energy Systems and Energy Efficiency Improvements Assistance, and (2) Energy Audit and Renewable Energy Development Assistance Grants.
The Renewable Energy Systems and Energy Efficiency Improvement Assistance provides grants and guaranteed loans to agricultural producers and rural small businesses to purchase and install renewable energy systems and make energy efficiency improvements to their operations. Eligible renewable energy systems for REAP provide energy from: Wind, solar, renewable biomass (including anaerobic digesters), small hydro-electric, ocean, geothermal, or hydrogen derived from these renewable resources.
The Energy Audit and Renewable Energy Development Assistance Grant is available to a unit of State, Tribal, or local government; instrumentality of a State, Tribal, or local government; institution of higher education; rural electric cooperative; a public power entity; or a council, as defined in 16 U.S.C. 3451. The recipient of grant funds, grantee, will establish a program to assist agricultural producers and rural small businesses with evaluating the energy efficiency and the potential to incorporate renewable energy technologies into their operations.
See under
The applicable USDA Rural Development Energy Coordinator for your respective State, as identified via the following
For information about this Notice, please contact Maureen Hessel, Business Loan and Grant Analyst, USDA Rural Development, Energy Division, 1400 Independence Avenue SW., Stop 3225, Room 6870, Washington, DC 20250. Telephone: (202) 401-0142. Email:
The Rural Energy for America Program (REAP) helps agricultural producers and rural small businesses reduce energy costs and consumption and helps meet the Nation's critical energy needs. REAP has two types of funding assistance: (1) Renewable Energy Systems and Energy Efficiency Improvements Assistance and (2) Energy Audit and Renewable Energy Development Assistance Grants.
The Renewable Energy Systems and Energy Efficiency Improvements Assistance provides grants and guaranteed loans to agricultural producers and rural small businesses for renewable energy systems and energy efficiency improvements. Eligible renewable energy systems for REAP provide energy from: Wind, solar, renewable biomass (including anaerobic digesters), small hydro-electric, ocean, geothermal, or hydrogen derived from these renewable resources.
The Energy Audit and Renewable Energy Development Assistance Grant is available to a unit of State, Tribal, or local government; instrumentality of a State, Tribal, or local government; institution of higher education; rural electric cooperative; a public power entity; or a council, as defined in 16 U.S.C. 3451. The recipient of grant funds, (grantee), will establish a program to assist agricultural producers and rural small businesses with evaluating the energy efficiency and the potential to incorporate renewable energy technologies into their operations.
A.
The administrative requirements in effect at the time the application window closes for a competition will be applicable to each type of funding available under REAP and are described in 7 CFR part 4280, subpart B. In addition to the other provisions of this Notice:
(1) The provisions specified in 7 CFR 4280.101 through 4280.111 apply to each funding type described in this Notice.
(2) The requirements specified in 7 CFR 4280.112 through 4280.124 apply to renewable energy system and energy efficiency improvements project grants.
(3) The requirements specified in 7 CFR 4280.125 through 4280.152 apply to guaranteed loans for renewable energy system and energy efficiency improvements projects. For Federal FY 2017, the guarantee fee amount is one percent of the guaranteed portion of the loan, and the annual renewal fee is one-quarter of 1 percent (0.250 percent) of the guaranteed portion of the loan.
(4) The requirements specified in 7 CFR 4280.165 apply to a combined grant and guaranteed loan for renewable energy system and energy efficiency improvements projects.
(5) The requirements specified in 7 CFR 4280.186 through 4280.196 apply to energy audit and renewable energy development assistance grants.
A.
B.
C.
To ensure that small projects have a fair opportunity to compete for the funding and are consistent with the priorities set forth in the statute, the Agency will set-aside 20 percent of the Federal FY 2017 funds until June 30, 2017, to fund grants of $20,000 or less.
(1)
(2)
(3)
(4)
D.
E.
The eligibility requirements for the applicant, borrower, lender, and project (as applicable) are clarified in 7 CFR part 4280 subpart B, and are summarized in this Notice. Failure to
A.
B.
C.
D.
(1)
(2)
E.
A.
B.
(1)
(a) Information for the required content of a grant application to be considered complete is found in 7 CFR part 4280, subpart B.
(i) Grant applications for renewable energy systems and energy efficiency improvements projects with total project costs of $80,000 or less must provide information required by 7 CFR 4280.119.
(ii) Grant applications for renewable energy systems and energy efficiency improvements projects with total project costs of $200,000 or less, but more than $80,000, must provide information required by 7 CFR 4280.118.
(iii) Grant applications for renewable energy systems and energy efficiency improvements projects with total project costs of greater than $200,000 must provide information required by 7 CFR 4280.117.
(iv) Grant applications for energy audits or renewable energy development assistance grant applications must provide information required by 7 CFR 4280.190.
(b) All grant applications must be submitted either as hard copy to the appropriate Rural Development Energy Coordinator in the State in which the applicant's proposed project is located, or electronically using the Government-wide
(i) Applicants submitting a grant application as a hard copy must submit one original to the appropriate Rural Development Energy Coordinator in the State in which the applicant's proposed project is located. A list of USDA Rural Development Energy Coordinators is available via the following link:
(ii) Applicants submitting a grant application to the Agency via
(c) After successful applicants are notified of the intent to make a Federal award, applicants must meet the requirements of 7 CFR 4280.122 (a) through (h) for the grant agreement to be executed.
(2)
(a) Information for the content required for a guaranteed loan application to be considered complete is found in 7 CFR 4280.137.
(b) All guaranteed loan applications must be submitted as a hard copy to the appropriate Rural Development Energy Coordinator in the State in which the applicant's proposed project is located. A list of USDA Rural Development Energy Coordinators is available via the following link:
(c) After successful applicants are notified of the intent to make a Federal
(3)
(a) Information for the content required for a combined guaranteed loan and grant application to be considered complete is found in 7 CFR 4280.165(c).
(b) All combined guaranteed loan and grant application applications must be submitted as hard copy to the appropriate Rural Development Energy Coordinator in the State in which the applicant's proposed project is located. A list of USDA Rural Development Energy Coordinators is available via the following link:
(c) After successful applicants are notified of the intent to make a Federal award, applicants must meet the requirements, including the requisite forms and certifications, specified in 7 CFR 4280.117, 4280.118, 4280.119, and 4280.137, as applicable, for the issuance of a grant agreement and loan note guarantee.
(4)
(a) Grant applications for energy audits or renewable energy development assistance must provide the information required by 7 CFR 4280.190 to be considered a complete application.
(b) All energy audits or renewable development assistance grant applications must be submitted either as hard copy to the appropriate Rural Development Energy Coordinator in the State in which the applicant's proposed project is located, or electronically using the Government-wide
(c) After successful applicants are notified of the intent to make a Federal award, applicants must meet the requirements of 7 CFR 4280.195 for the grant agreement to be executed.
5.
(a) Be registered in SAM prior to submitting an application; which can be obtained at no cost via a toll-free request line at (866) 705-5711 or online at
(b) Provide a valid DUNS number in its application.
(c) Continue to maintain an active SAM registration with current information at all times during which it has an active Federal award or an application under consideration by the Agency.
(d) If an applicant has not fully complied with the requirements of IV.C. (1) through (3) at the time the Agency is ready to make an award, the Agency may determine the applicant is not eligible to receive the award.
C.
(1)
(a) For applicants requesting $20,000 or less that wish to have their application compete for the “Grants of $20,000 or less set aside,” complete applications must be received no later than:
(i) 4:30 p.m. local time on October 31, 2016, or
(ii) 4:30 p.m. local time on March 31, 2017.
(b) For applicants requesting grant funds of over $20,000 (unrestricted) or funding for a combination grant and guaranteed loan, complete applications must be received no later than 4:30 p.m. local time on March 31, 2017.
(2)
(3)
D.
E.
(1)
(a) Applicants can be awarded only one renewable energy system project and one energy efficiency improvement grant in Federal FY 2017.
(b) For renewable energy system grants, the minimum grant is $2,500 and the maximum is $500,000. For energy efficiency improvements grants, the minimum grant is $1,500 and the maximum grant is $250,000.
(c) For renewable energy system and energy efficiency improvements loan guarantees, the minimum REAP guaranteed loan amount is $5,000 and the maximum amount of a guaranteed loan to be provided to a borrower is $25 million.
(d) Renewable energy system and energy efficiency improvements guaranteed loan and grant combination applications. Paragraphs IV.E.(1)(b) and (c) of this Notice contain the applicable maximum amounts and minimum amounts for grants and guaranteed loans. Requests for guaranteed loan and combined grant and guaranteed loan will not exceed 75 percent of eligible project costs, with any Federal grant portion not to exceed 25 percent of the total eligible project costs, whether the grant is part of a combination request or is a grant-only.
(2)
(a) Applicants may submit only one energy audit grant application and one renewable energy development assistance grant application for Federal FY 2017 funds.
(b) The maximum aggregate amount of energy audit and renewable energy development assistance grants awarded to any one recipient under this Notice cannot exceed $100,000 for Federal FY 2017.
(c) The 2014 Farm Bill mandates that the recipient of a grant that conducts an energy audit for an agricultural producer or a rural small business must require the agricultural producer or rural small business to pay at least 25 percent of the cost of the energy audit, which shall be retained by the eligible entity for the cost of the audit.
(3)
F.
(1)
(2)
(3)
(4)
(5)
A.
(1)
(a) Complete renewable energy systems and energy efficiency improvements grant applications requesting $20,000 or less are eligible to compete in up to five competitions as described in 7 CFR 4280.121(b).
(b) Complete renewable energy systems and energy efficiency improvements grant applications, regardless of the amount of funding requested are eligible to compete in two competitions each Federal FY—a State competition and a national competition as described in 7 CFR 4280.121(a).
(2)
(3)
(4)
B.
(1)
(a) Funds for renewable energy system and energy efficiency improvements grants of $20,000 or less will be allocated to the States. Eligible applications must be submitted by October 31, 2016, or May 1, 2017, in order to be considered for these set-aside funds. Approximately 50 percent of these funds will be made available for those complete applications the Agency receives by October 31, 2016, and approximately 50 percent of the funds for those complete applications the Agency receives by May 1, 2017. All unused State allocated funds for grants of $20,000 or less will be pooled to the National Office.
(b) Eligible applications received by May 1, 2017, for renewable energy system and energy efficiency improvements grants of $20,000 or less, that are not funded by State allocations can be submitted to the National Office to compete against grant applications of $20,000 or less from other States at a national competition. Obligations of these funds will take place prior to June 30, 2017.
(c) Eligible applications for renewable energy system and energy efficiency improvements, regardless of the amount of the funding request, received by May 1, 2017, can compete for unrestricted grant funds. Unrestricted grant funds will be allocated to the States. All unused State allocated unrestricted grant funds will be pooled to the National Office.
(d) National unrestricted grant funds for all eligible renewable energy system and energy efficiency improvements grant applications received by May 1, 2017, which include grants of $20,000 or less, that are not funded by State allocations can be submitted to the National Office to compete against grant applications from other States at a final national competition.
(2)
(3)
(4)
C.
(1) 7 CFR 4280.120(g)(3) may allow for applicants who are members of unserved or under-served populations to receive additional points if one of the following criteria are met:
(a) Owned by a veteran, including but not limited to individuals as sole proprietors, members, partners, stockholders, etc., of not less than 20 percent. In order to receive points, applicants must provide a statement in their applications to indicate that owners of the project have veteran status; or
(b) Owned by a member of a socially-disadvantaged group, which are groups whose members have been subjected to racial, ethnic, or gender prejudice because of their identity as members of a group without regard to their individual qualities. In order to receive points, the application must include a statement to indicate that the owners of the project are members of a socially-disadvantaged group.
(2) 7 CFR 4280.120(g)(4) may allow for applications that further a Presidential initiative, or a Secretary of Agriculture priority to receive additional points including:
(a) Located in rural areas with the lowest incomes where, according to the most recent 5-year American Community Survey, show that at least 20 percent of the population is living in poverty. Or a project is located in a community (village, town, city, or Census Designated Place) with a median household income of 60 percent or less of the State's non-metropolitan median household income. This will support Secretary of Agriculture's priority of providing 20 percent of its funding to these areas of need; and
(b) Located in designated Strike Force or Promise Zone areas, which is a Secretary of Agriculture's priority.
D.
(1)
(a) For State allocated funds:
(i) The applicant must be notified that they may accept the remaining funds or submit the total request for National Office reserve funds available after pooling. If the applicant agrees to lower its grant request, the applicant must certify that the purposes of the project will be met and provide the remaining total funds needed to complete the project.
(ii) If two or more grant or combination applications have the same score and remaining funds in the State allocation are insufficient to fully award them, the Agency will notify the applicants that they may either accept the proportional amount of funds or submit their total request for National Office reserve funds available after pooling. If the applicant agrees to lower its grant request, the applicant must certify that the purposes of the project will be met and provide the remaining total funds needed to complete the project.
(b) The applicant notification for national funds will depend on size of the grant request.
(i) For an application requesting a grant of $20,000 or less in which this is the fifth and final competition or for those applications requesting grants of over $20,000 and combined grant and guaranteed loan application, the applicant must be notified that they may accept the remaining funds or their grant application will be withdrawn. If the applicant agrees to lower the grant request, the applicant must certify that the purposes of the project will be met and provide the remaining total funds needed to complete the project.
(ii) For an application requesting a grant of $20,000 or less which is eligible to compete in one or more additional competitions after the national competition, the applicant must be notified that they may accept the remaining funds or have their request considered in subsequent competitions. If the applicant agrees to lower its grant request, the applicant must certify that the purposes of the project will be met and provide the remaining total funds needed to complete the project.
(iii) If two or more grant or combination applications have the same score and remaining funds are insufficient to fully award them, the Agency will notify the applicants that they may either accept the proportional amount of funds or be notified in accordance with V.D.(1)(b)(i) or (ii), as applicable.
(iv) At its discretion, the Agency may instead allow the remaining funds to be carried over to the next Federal FY rather than selecting a lower scoring application(s) or distributing funds on a pro-rata basis.
(2)
(3)
A.
B.
(1)
(2)
(3)
(4)
(5)
(a) Renewable energy system and energy efficiency improvements grants that are awarded are required to fulfill the reporting requirements as specified in 7 CFR 4280.123.
(b) Guaranteed loan applications that are awarded are required to fulfill the reporting requirements as specified in 7 CFR 4280.143.
(c) Combined guaranteed loan and grant applications that are awarded are required to fulfill the reporting requirements as specified in 7 CFR 4280.165(f).
(d) Energy audit and renewable energy development assistance grants grant applications that are awarded are required to fulfill the reporting requirements as specified in 7 CFR 4280.196.
For further information contact the applicable USDA Rural Development Energy Coordinator for your respective State, as identified via the following link:
For information about this Notice, please contact Maureen Hessel, Business Loan and Grant Analyst, USDA Rural Development, Energy Division, 1400 Independence Avenue SW., Stop 3225, Room 6866,
In accordance with the Paperwork Reduction Act of 1995, the information collection requirements associated with renewable energy system and energy efficiency improvements grants and guaranteed loans, as covered in this Notice, have been approved by the Office of Management and Budget (OMB) under OMB Control Number 0570-0050. The information collection requirements associated with energy audit and renewable energy development assistance grants have also been approved by OMB under OMB Control Number 0570-0059.
The U.S. Department of Agriculture (USDA) prohibits discrimination against its customers, employees, and applicants for employment on the basis of race, color, national origin, age, disability, sex, gender identity, reprisal and where applicable, political beliefs, marital status, familial or parental status, religion, sexual orientation, or all or part of an individual's income is derived from any public assistance program, or protected genetic information in employment or in any program or activity conducted or funded by the Department. (Not all prohibited bases will apply to all programs and/or employment activities.)
If you wish to file a Civil Rights program complaint of discrimination, complete the USDA Program Discrimination Complaint Form (PDF), found online at
Individuals who are deaf, hard of hearing or have speech disabilities and wish to file either an EEO or program complaint, please contact USDA through the Federal Relay Service at (800) 877-8339 or (800) 845-6136 (in Spanish).
Persons with disabilities, who wish to file a program complaint, please see information above on how to contact us directly by mail or by email. If you require alternative means of communication for program information (
Rural Utilities Service, USDA.
Notice of Intent to Prepare an Environmental Impact Statement and Hold Public Scoping Meetings.
The Rural Utilities Service (RUS) intends to prepare an Environmental Impact Statement (EIS) and hold public scoping meetings in connection with possible impacts related to the Cardinal-Hickory Creek Transmission Line Project proposed by Dairyland Power Cooperative (DPC). Other utilities participating in the Project are American Transmission Company LLC, by its corporate manager ATC Management Inc. and ITC Midwest LLC.
The proposal consists of the construction of a 345-kilovolt (kV) transmission line and associated infrastructure connecting the Hickory Creek Substation in Dubuque County, Iowa, with the Cardinal Substation in the Town of Middleton, Wisconsin (near Madison, Wisconsin). The Project also includes a new intermediate 345/138-kV substation near the Village of Montfort in either Grant County or Iowa County, Wisconsin. The total length of the 345-kV transmission lines associated with the proposed project will be approximately 125 miles. DPC and the other project participants have identified proposed and alternate segments and locations for transmission lines and associated facilities and for the intermediate substation. Dairyland Power Cooperative is requesting RUS to provide financing for its portion of the proposed project.
RUS will conduct four public scoping meetings in an open-house format at the following locations:
To send comments or for further information, contact Dennis Rankin, Environmental Protection Specialist, U.S. Department of Agriculture, Rural Utilities Service, 1400 Independence Avenue SW., Room 2244, Stop 1571, Washington, DC 20250-1571 Email:
An Alternative Evaluation Study (AES) and Macro Corridor Study (MCS), prepared by Dairyland Power Cooperative, will be presented at the public scoping meetings. The reports are available for public review at the RUS address provided in this notice and at Dairyland Power Cooperative, 3251 East Avenue, South, La Crosse, WI 54602. In addition, the reports will be available at RUS' Web site,
Preliminary proposed transmission line corridors, the siting area for the intermediate substation, and the two existing end-point substations have been identified. The EIS will address the construction, operation, and
Total length of the transmission lines for the proposed project will be approximately 125 miles. The project study area includes part or all of the following counties in Iowa: Clayton and Dubuque. In Wisconsin, the project area includes parts of the following counties: Dane, Grant, Iowa, and Lafayette.
Among the alternatives RUS will address in the EIS is the No Action alternative, under which the project would not be undertaken. In the EIS, the effects of the proposed project will be compared to the existing conditions in the area affected. Alternative transmission line corridors and the intermediate substation location will be refined as part of the EIS scoping process and will be addressed in the Draft EIS. RUS will carefully study public health and safety, environmental impacts, and engineering aspects of the proposed project and all related facilities.
The U.S. Army Corps of Engineers (USACE) and the U.S. Fish and Wildlife Service (USFWS) are participating in the environmental review process as cooperating agencies, with RUS as the lead Federal agency.
RUS will use input provided by government agencies, private organizations, and the public in the preparation of the Draft EIS. The Draft EIS will be available for review and comment for 45 days. A Final EIS that considers all comments received will subsequently be prepared. The Final EIS will be available for review and comment for 30 days. Following the 30- day comment period, RUS will prepare a Record of Decision (ROD). Notices announcing the availability of the Draft EIS, the Final EIS, and the ROD will be published in the
Any final action by RUS related to the proposed project will be subject to, and contingent upon, compliance with all relevant federal, state, and local environmental laws and regulations and completion of the environmental review requirements as prescribed in the RUS Environmental Policies and Procedures (7 CFR part 1970).
Bureau of Industry and Security, Commere.
Notice.
The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, has discontinued Information Collection 0694-0009, “Triangular Transactions Covered by a U.S. Import Certificate.” Although this collection has been discontinued, the Triangular Transactions “Stamp” is still valid and has been added to collection 0694-0017 as a supplemental document.
Requests for additional information should be directed to Mark Crace, BIS ICB Liaison, (202)482-8093 or
Enforcement and Compliance, International Trade Administration, Department of Commerce.
Effective October 11, 2016.
Emily Halle at (202) 482-0176 (Japan); Jun Jack Zhao at (202) 482-1396 (Taiwan); and Myrna Lobo at (202) 482-2371 (Republic of Turkey), AD/CVD Operations, Enforcement and Compliance, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230.
On September 20, 2016, the Department of Commerce (the Department) received antidumping duty (AD) petitions concerning imports of steel concrete reinforcing bar (rebar) from Japan, Taiwan, and the Republic of Turkey (Turkey), filed in proper form on behalf of the Rebar Trade Action Coalition and its individual members (Petitioners).
On September 23 and 30, 2016, the Department requested additional information and clarification of certain areas of the Petitions.
In accordance with section 732(b) of the Tariff Act of 1930, as amended (the Act), Petitioners allege that imports of rebar from Japan, Taiwan, and Turkey are being, or are likely to be, sold in the United States at less-than-fair value within the meaning of section 731 of the Act, and that such imports are materially injuring, or threatening material injury to, an industry in the United States. Also, consistent with section 732(b)(1) of the Act, Petitioners state that the Petitions are accompanied by information reasonably available to Petitioners supporting their allegations.
The Department finds that Petitioners filed these Petitions on behalf of the domestic industry because Petitioners are interested parties as defined in sections 771(9)(C) and (E) of the Act. The Department also finds that Petitioners demonstrated sufficient industry support with respect to the initiation of the AD investigations that Petitioners are requesting.
Because the Petitions were filed on September 20, 2016, the period of investigation (POI) for each investigation is, pursuant to 19 CFR 351.204(b)(1), July 1, 2015, through June 30, 2016.
The product covered by these investigations is rebar from Japan, Taiwan, and Turkey. For a full description of the scope of these investigations,
During our review of the Petitions, the Department issued questions to, and received responses from, Petitioners pertaining to the proposed scope to ensure that the scope language in the Petitions would be an accurate reflection of the products for which the domestic industry is seeking relief.
As discussed in the preamble to the Department's regulations, we are setting aside a period for interested parties to raise issues regarding product coverage (scope). The Department will consider all comments received from parties and, if necessary, will consult with parties prior to the issuance of the preliminary determinations. If scope comments include factual information (
The Department requests that any factual information the parties consider relevant to the scope of the investigations be submitted during this time period. However, if a party subsequently finds that additional factual information pertaining to the scope of the investigations may be relevant, the party may contact the Department and request permission to submit the additional information. As stated above, all such comments must be filed on the records of each of the concurrent AD and CVD investigations.
All submissions to the Department must be filed electronically using Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS).
The Department will be giving interested parties an opportunity to provide comments on the appropriate physical characteristics of rebar to be reported in response to the Department's AD questionnaires. This information will be used to identify the key physical characteristics of the merchandise under consideration in order to report the relevant costs of
Interested parties may provide any information or comments that they feel are relevant to the development of an accurate list of physical characteristics. Specifically, they may provide comments as to which characteristics are appropriate to use as: (1) General product characteristics and (2) product-comparison criteria. We note that it is not always appropriate to use all product characteristics as product-comparison criteria. We base product-comparison criteria on meaningful commercial differences among products. In other words, although there may be some physical product characteristics utilized by manufacturers to describe rebar, it may be that only a select few product characteristics take into account commercially meaningful physical characteristics. In addition, interested parties may comment on the order in which the physical characteristics should be used in matching products. Generally, the Department attempts to list the most important physical characteristics first and the least important characteristics last.
In order to consider the suggestions of interested parties in developing and issuing the AD questionnaires, all product characteristics comments must be filed by 5:00 p.m. EDT on October 31, 2016, which is 20 calendar days from the signature date of this notice. Any rebuttal comments must be filed by 5:00 p.m. EST on November 10, 2016. All comments and submissions to the Department must be filed electronically using ACCESS, as explained above, on the records of each of the concurrent AD investigations.
Section 732(b)(1) of the Act requires that a petition be filed on behalf of the domestic industry. Section 732(c)(4)(A) of the Act provides that a petition meets this requirement if the domestic producers or workers who support the petition account for: (i) At least 25 percent of the total production of the domestic like product; and (ii) more than 50 percent of the production of the domestic like product produced by that portion of the industry expressing support for, or opposition to, the petition. Moreover, section 732(c)(4)(D) of the Act provides that, if the petition does not establish support of domestic producers or workers accounting for more than 50 percent of the total production of the domestic like product, the Department shall: (i) Poll the industry or rely on other information in order to determine if there is support for the petition, as required by subparagraph (A); or (ii) determine industry support using a statistically valid sampling method to poll the “industry.”
Section 771(4)(A) of the Act defines the “industry” as the producers as a whole of a domestic like product. Thus, to determine whether a petition has the requisite industry support, the statute directs the Department to look to producers and workers who produce the domestic like product. The International Trade Commission (ITC), which is responsible for determining whether “the domestic industry” has been injured, must also determine what constitutes a domestic like product in order to define the industry. While both the Department and the ITC must apply the same statutory definition regarding the domestic like product,
Section 771(10) of the Act defines the domestic like product as “a product which is like, or in the absence of like, most similar in characteristics and uses with, the article subject to an investigation under this title.” Thus, the reference point from which the domestic like product analysis begins is “the article subject to an investigation” (
With regard to the domestic like product, Petitioners do not offer a definition of the domestic like product distinct from the scope of the investigations. Based on our analysis of the information submitted on the record, we have determined that rebar, as defined in the scope, constitutes a single domestic like product and we have analyzed industry support in terms of that domestic like product.
In determining whether Petitioners have standing under section 732(c)(4)(A) of the Act, we considered the industry support data contained in the Petitions with reference to the domestic like product as defined in the “Scope of the Investigations,” in Appendix I of this notice. To establish industry support, Petitioners provided their 2015 shipments of the domestic like product, and compared their shipments to estimated total shipments of the domestic like product for the entire domestic industry.
Our review of the data provided in the Petitions, General Issues Supplement, and other information readily available to the Department indicates that Petitioners have established industry support.
The Department finds that Petitioners filed the Petitions on behalf of the domestic industry because they are interested parties as defined in sections 771(9)(C) and (E) of the Act and they have demonstrated sufficient industry support with respect to the AD investigations that they are requesting the Department initiate.
Petitioners allege that the U.S. industry producing the domestic like product is being materially injured, or is threatened with material injury, by reason of the imports of the subject merchandise sold at less than normal value (NV). In addition, Petitioners allege that subject imports exceed the negligibility threshold provided for under section 771(24)(A) of the Act.
Petitioners contend that the industry's injured condition is illustrated by reduced market share; underselling and price suppression or depression; lost sales and revenues; declines in production, capacity utilization, and U.S. shipments; negative impact on employment variables; and decline in financial performance.
The following is a description of the allegations of sales at less-than-fair value upon which the Department based its decision to initiate investigations of imports of rebar from Japan, Taiwan, and Turkey. The sources of data for the deductions and adjustments relating to U.S. price and NV are discussed in greater detail in the country-specific initiation checklists.
For Japan, Petitioners based export price (EP) on quoted sales offers or transactions to customers in the United States for rebar produced in, and exported from, Japan.
For Taiwan, and Turkey, Petitioners based EP on transaction-specific average unit values (AUVs) for shipments of rebar identified from each of these countries entered under the relevant Harmonized Tariff Schedule of the United States (HTSUS) subheading for one month during the POI into a specific port.
For Japan, Taiwan, and Turkey, Petitioners were unable to obtain information regarding home market prices and, therefore, calculated NV based on constructed value (CV).
Based on the data provided by Petitioners, there is reason to believe that imports of rebar from Japan, Taiwan, and Turkey, are being, or are likely to be, sold in the United States at less-than-fair value. Based on comparisons of EP to NV in accordance
Based upon the examination of the AD Petitions on rebar from Japan, Taiwan, and Turkey, we find that the Petitions meet the requirements of section 732 of the Act. Therefore, we are initiating AD investigations to determine whether imports of rebar for Japan, Taiwan, and Turkey, are being, or are likely to be, sold in the United States at less-than-fair value. In accordance with section 733(b)(1)(A) of the Act and 19 CFR 351.205(b)(1), unless postponed, we will make our preliminary determinations no later than 140 days after the date of this initiation.
On June 29, 2015, the President of the United States signed into law the Trade Preferences Extension Act of 2015, which made numerous amendments to the AD and CVD law.
Based on information from an independent source and other open source research, Petitioners identified 20 companies in Japan, 8 companies in Taiwan, and 35 companies in Turkey, as producers/exporters of rebar.
Comments for the above-referenced investigations must be filed electronically using ACCESS. An electronically-filed document must be received successfully in its entirety by the Department's electronic records system, ACCESS, by 5:00 p.m. ET by the dates noted above. We intend to finalize our decision regarding respondent selection within 20 days of publication of this notice.
In accordance with section 732(b)(3)(A) of the Act and 19 CFR 351.202(f), copies of the public version of the Petitions have been provided to the governments of Japan, Taiwan, and Turkey via ACCESS. To the extent practicable, we will attempt to provide a copy of the public version of the Petitions to each exporter named in the Petitions, as provided under 19 CFR 351.203(c)(2).
We will notify the ITC of our initiation, as required by section 732(d) of the Act.
The ITC will preliminarily determine, within 45 days after the date on which the Petitions were filed, whether there is a reasonable indication that imports of rebar from Japan, Taiwan, and/or Turkey are materially injuring or threatening material injury to a U.S. industry.
Factual information is defined in 19 CFR 351.102(b)(21) as: (i) Evidence submitted in response to questionnaires; (ii) evidence submitted in support of allegations; (iii) publicly available information to value factors under 19 CFR 351.408(c) or to measure the adequacy of remuneration under 19 CFR 351.511(a)(2); (iv) evidence placed on the record by the Department; and (v) evidence other than factual information described in (i)-(iv). Any party, when submitting factual information, must specify under which subsection of 19 CFR 351.102(b)(21) the information is being submitted and, if the information is submitted to rebut, clarify, or correct factual information already on the record, to provide an explanation identifying the information already on the record that the factual information seeks to rebut, clarify, or correct. Time limits for the submission of factual information are addressed in 19 CFR 351.301, which provides specific time limits based on the type of factual information being submitted. Please review the regulations prior to submitting factual information in these investigations.
Parties may request an extension of time limits before the expiration of a time limit established under Part 351, or as otherwise specified by the Secretary. In general, an extension request will be considered untimely if it is filed after the expiration of the time limit established under Part 351 expires. For submissions that are due from multiple parties simultaneously, an extension request will be considered untimely if it is filed after 10:00 a.m. on the due date. Under certain circumstances, we may elect to specify a different time limit by which extension requests will be considered untimely for submissions which are due from multiple parties simultaneously. In such a case, we will inform parties in the letter or memorandum setting forth the deadline (including a specified time) by which extension requests must be filed to be considered timely. An extension request must be made in a separate, stand-alone submission; under limited circumstances we will grant untimely-filed requests for the extension of time limits. Review
Any party submitting factual information in an AD or CVD proceeding must certify to the accuracy and completeness of that information.
Interested parties must submit applications for disclosure under APO in accordance with 19 CFR 351.305. On January 22, 2008, the Department published
This notice is issued and published pursuant to section 777(i) of the Act and 19 CFR 351.203(c).
The merchandise subject to these investigations is steel concrete reinforcing bar imported in either straight length or coil form (rebar) regardless of metallurgy, length, diameter, or grade or lack thereof. Subject merchandise includes deformed steel wire with bar markings (
The subject merchandise includes rebar that has been further processed in the subject country or a third country, including but not limited to cutting, grinding, galvanizing, painting, coating, 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 rebar.
Specifically excluded are plain rounds (
At the time of the filing of the petition, there was an existing countervailing duty order on steel reinforcing bar from the Republic of Turkey.
The subject merchandise is classifiable in the Harmonized Tariff Schedule of the United States (HTSUS) primarily under item numbers 7213.10.0000, 7214.20.0000, and 7228.30.8010. The subject merchandise may also enter under other HTSUS numbers including 7215.90.1000, 7215.90.5000, 7221.00.0017, 7221.00.0018, 7221.00.0030, 7221.00.0045, 7222.11.0001, 7222.11.0057, 7222.11.0059, 7222.30.0001, 7227.20.0080, 7227.90.6030, 7227.90.6035, 7227.90.6040, 7228.20.1000, and 7228.60.6000.
HTSUS numbers are provided for convenience and customs purposes; however, the written description of the scope remains dispositive.
Pursuant to Section 6(c) of the Educational, Scientific and Cultural Materials Importation Act of 1966 (Pub. L. 89-651, as amended by Pub. L. 106-36; 80 Stat. 897; 15 CFR part 301), we invite comments on the question of whether instruments of equivalent scientific value, for the purposes for which the instruments shown below are intended to be used, are being manufactured in the United States.
Comments must comply with 15 CFR 301.5(a)(3) and (4) of the regulations and be postmarked on or before November 7, 2016. Address written comments to Statutory Import Programs Staff, Room 3720, U.S. Department of Commerce, Washington, DC 20230. Applications may be examined between 8:30 a.m. and 5:00 p.m. at the U.S. Department of Commerce in Room 3720.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (the “Department”) preliminarily determines that The Navigator
Effective October 18, 2016.
Carrie Bethea, AD/CVD Operations, Office V, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-1491.
The Department published the antidumping duty order for certain uncoated paper from Portugal in the
The merchandise covered by this order includes uncoated paper in sheet form; weighing at least 40 grams per square meter but not more than 150 grams per square meter; that either is a white paper with a GE brightness level
Certain Uncoated Paper includes (a) uncoated free sheet paper that meets this scope definition; (b) uncoated ground wood paper produced from bleached chemi-thermo-mechanical pulp (BCTMP) that meets this scope definition; and (c) any other uncoated paper that meets this scope definition regardless of the type of pulp used to produce the paper.
Specifically excluded from the scope are (1) paper printed with final content of printed text or graphics and (2) lined paper products, typically school supplies, composed of paper that incorporates straight horizontal and/or vertical lines that would make the paper unsuitable for copying or printing purposes. For purposes of this scope definition, paper shall be considered “printed with final content” where at least one side of the sheet has printed text and/or graphics that cover at least five percent of the surface area of the entire sheet.
The product is currently classified under Harmonized Tariff Schedule of the United States (HTSUS) categories 4802.56.1000, 4802.56.2000, 4802.56.3000, 4802.56.4000, 4802.56.6000, 4802.56.7020, 4802.56.7040, 4802.57.1000, 4802.57.2000, 4802.57.3000, and 4802.57.4000. Some imports of subject merchandise may also be classified under 4802.62.1000, 4802.62.2000, 4802.62.3000, 4802.62.5000, 4802.62.6020, 4802.62.6040, 4802.69.1000, 4802.69.2000, 4802.69.3000, 4811.90.8050 and 4811.90.9080. While HTSUS subheadings are provided for convenience and customs purposes, the written description of the scope of the investigation is dispositive.
Pursuant to section 751(b)(1) of the Tariff Act of 1930, as amended (“the Act”) and 19 CFR 351.216(c)-(d), the Department will only conduct a changed circumstances review less than 24 months after the date of publication of the final determination with good cause and upon receipt of information concerning, or a request from an interested party for a review of, an antidumping duty finding which shows changed circumstances sufficient to warrant a review of the order.
Navigator has shown that good cause exists to conduct a changed circumstance review because the name change will affect its import documentation before U.S. Customs and Border Protection (“CBP”), thus affecting CBP's treatment of its entries. The information submitted by Navigator claiming that Navigator is the successor-in-interest to Portucel also demonstrates changed circumstances sufficient to warrant a review. Therefore, in accordance with section 751(b)(1) of the Act and 19 CFR 351.216(c)-(d), the Department is initiating a changed circumstances review to determine whether Navigator is the successor-in-interest to Portucel.
The Department may issue the notice of initiation of the review and the preliminary results concurrently when it concludes that expedited action is warranted.
In determining whether one company is the successor to another for purposes of applying the antidumping duty (“AD”) law, the Department examines a number of factors including, but not limited to, changes in (1) management, (2) production facilities, (3) suppliers, and (4) customer base.
In its August 26, 2016 submission, Navigator provided documentation demonstrating that Navigator is the successor in interest to Portucel in that no major changes occurred with respect to management, production process, customer base, or suppliers.
According to the information provided, no material changes in management,
Should our final results remain the same as these preliminary results, effective the date of publication of the final results, we will instruct U.S. Customs and Border Protection to assign entries of subject merchandise exported by Navigator the antidumping duty cash-deposit rate applicable to Portucel.
Interested parties are invited to comment on these preliminary results. Case briefs or other written comments may be submitted to the Assistant Secretary for Enforcement and Compliance no later than 14 days after the date of publication of this notice, and 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 must submit a written request to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce. All documents must be filed electronically using ACCESS. An electronically-filed request must be received successfully in its entirety by ACCESS by 5:00 p.m. Eastern Standard Time, within 14 days after the date of publication of this notice.
Consistent with 19 CFR 351.216(e), we will issue the final results of this changed circumstances review no later than 270 days after the date on which this review was initiated or within 45 days of publication of these preliminary results if all parties agree to our preliminary finding.
We are issuing and publishing this initiation and preliminary results notice in accordance with sections 751(b)(1) and 777(i)(1) of the Act and 19 CFR 351.216 and 351.221(c)(3).
Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce.
Effective October 11, 2016.
Kaitlin M. Wojnar at (202) 482-3857, AD/CVD Operations, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230.
On September 20, 2016, the Department of Commerce (the Department) received a countervailing duty (CVD) petition concerning imports of steel concrete reinforcing bar (rebar) from the Republic of Turkey (Turkey),
On September 22 and 23, 2016, the Department requested additional information and clarification of certain aspects of the Petition.
In accordance with section 702(b)(1) of the Tariff Act of 1930, as amended (the Act), Petitioners allege that the Government of Turkey (the GOT) is providing countervailable subsidies, within the meaning of sections 701 and 771(5) of the Act, to manufacturers, producers, or exporters of rebar from Turkey and that imports of such rebar are materially injuring, or threatening material injury to, an industry in the United States. Additionally, consistent with section 702(b)(1) of the Act, the Petition is accompanied by information reasonably available to Petitioners supporting their allegations of programs in Turkey on which we are initiating a CVD investigation.
The Department finds that Petitioners filed the Petition on behalf of the domestic industry because Petitioners are interested parties, as defined by section 771(9)(C) of the Act. As discussed in the “Determination of Industry Support for the Petition” section, below, the Department also finds that Petitioners demonstrated sufficient industry support with respect to initiation of the requested CVD investigation.
The period of investigation is January 1, 2015, through December 31, 2015.
The product covered by this investigation is rebar from Turkey. For a full description of the scope of this investigation, see the Appendix to this notice.
During our review of the Petition, the Department issued questions to, and received responses from, Petitioners pertaining to the proposed scope to ensure that the scope language in the Petition accurately reflected the products for which the domestic industry is seeking relief.
As discussed in the preamble to the Department's regulations,
The Department requests that any factual information parties consider relevant to the scope of the investigations be submitted during this time period. However, if a party subsequently finds that additional factual information pertaining to the scope may be relevant, the party may contact the Department and request permission to submit the additional information. All such comments and information must be filed on the record of this CVD investigation, as well as the record of each of the concurrent AD investigations.
All submissions to the Department must be filed electronically using Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS).
Pursuant to section 702(b)(4)(A) of the Act, the Department notified representatives of the GOT of its receipt of the Petition and provided them with the opportunity for consultations regarding the CVD allegations.
Section 702(b)(1) of the Act requires that a petition be filed on behalf of the domestic industry. Section 702(c)(4)(A) of the Act provides that a petition meets this requirement if the domestic producers or workers who support the petition account for: (i) At least 25 percent of the total production of the domestic like product and (ii) more than 50 percent of the production of the domestic like product produced by that portion of the industry expressing support for, or opposition to, the petition. Moreover, section 702(c)(4)(D) of the Act provides that, if the petition does not establish support of domestic producers or workers accounting for more than 50 percent of the total production of the domestic like product, the Department shall: (i) Poll the industry or rely on other information in order to determine if there is support for the petition, as required by subparagraph (A), or (ii) determine industry support using a statistically valid sampling method to poll the “industry.”
Section 771(4)(A) of the Act defines the “industry” as the producers, as a whole, of a domestic like product. Thus, to determine whether a petition has the requisite industry support, the statute directs the Department to look to
Section 771(10) of the Act defines the domestic like product as “a product which is like, or in the absence of like, most similar in characteristics and uses with, the article subject to an investigation under this title.” Thus, the reference point from which the domestic like product analysis begins is “the article subject to an investigation” (
With regard to the domestic like product, Petitioners do not offer a definition of the domestic like product distinct from the scope of the investigation. Based on our analysis of the information submitted on the record, we have determined that rebar, as defined in the scope, constitutes a single domestic like product, and we have analyzed industry support in terms of that domestic like product.
In determining whether Petitioners have standing under section 702(c)(4)(A) of the Act, we considered the industry support data contained in the Petition with reference to the domestic like product as defined in the “Scope of the Investigation,” in the Appendix to this notice. To establish industry support, Petitioners provided their 2015 shipments of the domestic like product, and compared their shipments to estimated total shipments of the domestic like product for the entire domestic industry.
Our review of the data provided in the Petition, General Issues Supplement, and other information readily available to the Department indicates that Petitioners have established industry support.
The Department finds that Petitioners filed the Petition on behalf of the domestic industry because they are interested parties, as defined in sections 771(9)(C) and (F) of the Act, and they have demonstrated sufficient industry support with respect to the CVD investigation that they are requesting the Department initiate.
Because Turkey is a “Subsidies Agreement Country” within the meaning of section 701(b) of the Act, section 701(a)(2) of the Act applies to this investigation. Accordingly, the ITC must determine whether imports of the subject merchandise from Turkey materially injure, or threaten material injury to, a U.S. industry.
Petitioners allege that imports of the subject merchandise are benefitting from countervailable subsidies and that such imports are causing, or threaten to cause, material injury to the U.S. industry producing the domestic like product. In addition, Petitioners allege that subject imports exceed the negligibility threshold provided for under section 771(24)(A) of the Act.
Petitioners contend that the industry's injured condition is illustrated by reduced market share; underselling and price suppression or depression; lost sales and revenues; declines in production, capacity utilization, and U.S. shipments; negative impact on employment variables; and decline in financial performance.
Section 702(b)(1) of the Act requires the Department to initiate a CVD investigation whenever an interested party files a CVD petition on behalf of an industry that (1) alleges the elements necessary for the imposition of a duty under section 701(a) of the Act and (2) is accompanied by information
Petitioners allege that exporters/producers of rebar in Turkey benefited from countervailable subsidies bestowed by the GOT. The Department examined the Petition and finds that it complies with the requirements of section 702(b)(1) of the Act. Therefore, in accordance with section 702(b)(1) of the Act, we are initiating a CVD investigation to determine whether manufacturers, producers, and/or exporters of rebar from Turkey not covered by an existing CVD order on rebar from Turkey receive countervailable subsidies from the GOT.
On June 29, 2015, the President of the United States signed the Trade Preferences Extension Act of 2015 (TPEA) into law, which made numerous amendments to the Act.
Based on our review of the Petition, we find that there is sufficient information to initiate a CVD investigation on 21 of 23 alleged programs. For a full discussion of the basis for our decision to initiate or not initiate on each program,
In accordance with section 703(b)(1) of the Act and 19 CFR 351.205(b)(1), unless postponed, we will make our preliminary determination in this investigation no later than 65 days after the date of initiation.
Petitioners named one company as an exporter/producer of rebar from Turkey that is not currently subject to an existing CVD order on imports of rebar from Turkey.
Interested parties must submit applications for disclosure under APO in accordance with 19 CFR 351.305(b). Instructions for filing such applications may be found on the Department's Web site at
In accordance with section 702(b)(4)(A)(i) of the Act and 19 CFR 351.202(f), a copy of the public version of the Petition has been provided to the GOT via ACCESS. To the extent practicable, we will attempt to provide a copy of the public version of the Petition to each known exporter/producer, as named in the Petition,
We will notify the ITC of our initiation, as required by section 702(d) of the Act.
Within 45 days of the date on which the Petition was filed, the ITC will preliminarily determine whether there is a reasonable indication that imports of rebar from Turkey are materially injuring, or threatening material injury to, a U.S. industry.
Factual information is defined in 19 CFR 351.102(b)(21) as: (i) Evidence submitted in response to questionnaires; (ii) evidence submitted in support of allegations; (iii) publicly available information to value factors under 19 CFR 351.408(c) or to measure the adequacy of remuneration under 19 CFR 351.511(a)(2); (iv) evidence placed on the record by the Department; and (v) evidence other than factual information described in (i) through (iv). The regulation requires any party, when submitting factual information, to specify under which subsection of 19 CFR 351.102(b)(21) the information is being submitted and, if the information is submitted to rebut, clarify, or correct factual information already on the record, to provide an explanation identifying the information already on the record that the factual information seeks to rebut, clarify, or correct. Specific time limits for submission of factual information, based on the type of factual information being submitted, are provided at 19 CFR 351.301. Parties should review the regulations prior to submitting factual information in this investigation.
Parties may request the extension of a time limit established under 19 CFR 351.301, or as otherwise specified by the Secretary, before the applicable time limit has expired. In general, an extension request will be considered untimely if it is filed after the expiration of the time limit. For submissions that are due from multiple parties simultaneously, an extension request will be considered untimely if it is filed after 10:00 a.m. ET on the due date. Under certain circumstances, we may elect to specify a different deadline after which extension requests will be considered untimely for submissions that are due from multiple parties simultaneously. In such a case, we will inform parties in the letter or memorandum establishing the applicable time limit. An extension request must be made in a separate, stand-alone submission. In limited circumstances, we will grant untimely-filed extension requests.
Any party submitting factual information in an AD or CVD proceeding must certify the accuracy and completeness of that information.
Interested parties must submit applications for disclosure under APO in accordance with 19 CFR 351.305. On January 22, 2008, the Department published
This notice is issued and published pursuant to sections 702 and 777(i) of the Act.
The merchandise subject to this investigation is steel concrete reinforcing bar imported in either straight length or coil form (rebar) regardless of metallurgy, length, diameter, or grade or lack thereof. Subject merchandise includes deformed steel wire with bar markings (
The subject merchandise includes rebar that has been further processed in the subject country or a third country, including but not limited to cutting, grinding, galvanizing, painting, coating, or any other processing that would not otherwise remove the merchandise from the scope of the investigation if performed in the country of manufacture of the rebar.
Specifically excluded are plain rounds (
At the time of the filing of the petition, there was an existing countervailing duty order on steel reinforcing bar from the Republic of Turkey.
The subject merchandise is classifiable in the Harmonized Tariff Schedule of the United States (HTSUS) primarily under item numbers 7213.10.0000, 7214.20.0000, and 7228.30.8010. The subject merchandise may also enter under other HTSUS numbers including 7215.90.1000, 7215.90.5000, 7221.00.0017, 7221.00.0018, 7221.00.0030, 7221.00.0045, 7222.11.0001, 7222.11.0057, 7222.11.0059, 7222.30.0001, 7227.20.0080, 7227.90.6030, 7227.90.6035, 7227.90.6040, 7228.20.1000, and 7228.60.6000.
HTSUS numbers are provided for convenience and customs purposes; however, the written description of the scope remains dispositive.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; receipt of application for Letters of Authorization; request for comments and information.
NMFS' Office of Protected Resources has received a request from the NMFS Alaska Fisheries Science Center (AFSC) for authorization to take small numbers of marine mammals incidental to conducting fisheries research, over the course of five years from the date of issuance. Pursuant to regulations implementing the Marine Mammal Protection Act (MMPA), NMFS is announcing receipt of the AFSC's request for the development and implementation of regulations governing the incidental taking of marine mammals. NMFS invites the public to provide information, suggestions, and comments on the AFSC's application and request.
Comments and information must be received no later than November 17, 2016.
Comments on the applications should be addressed to Jolie Harrison, Chief, Permits and Conservation Division, Office of Protected Resources, National Marine Fisheries Service. Physical comments should be sent to 1315 East-West Highway, Silver Spring, MD 20910 and electronic comments should be sent to
Ben Laws, Office of Protected Resources, NMFS, (301) 427-8401.
An electronic copy of the AFSC's application may be obtained online at:
Section 101(a)(5)(A) of the MMPA (16 U.S.C. 1361
Incidental taking shall be allowed if NMFS finds that the taking will have a negligible impact on the species or stock(s) affected and will not have an unmitigable adverse impact on the availability of the species or stock(s) for taking for subsistence uses, and if the permissible methods of taking and requirements pertaining to the
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.”
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).”
On June 28, 2016, NMFS received an adequate and complete application from the AFSC requesting authorization for take of marine mammals incidental to fisheries research conducted by the AFSC. The requested regulations would be valid for five years from the date of issuance. The AFSC plans to conduct fisheries research surveys in multiple geographic regions, including the Gulf of Alaska, Bering Sea, and Arctic Ocean. It is possible that marine mammals may interact with fishing gear (
The Federal Government has a responsibility to conserve and protect living marine resources in U.S. federal waters and has also entered into a number of international agreements and treaties related to the management of living marine resources in international waters outside the United States. NOAA has the primary responsibility for managing marine fin and shellfish species and their habitats, with that responsibility delegated within NOAA to NMFS.
In order to direct and coordinate the collection of scientific information needed to make informed management decisions, Congress created six Regional Fisheries Science Centers, each a distinct organizational entity and the scientific focal point within NMFS for region-based, Federal fisheries-related research. This research is aimed at monitoring fish stock recruitment, abundance, survival and biological rates, geographic distribution of species and stocks, ecosystem process changes, and marine ecological research. The AFSC is the research arm of NMFS in U.S. waters off of Alaska.
Research is aimed at monitoring fish stock recruitment, survival and biological rates, abundance and geographic distribution of species and stocks, and providing other scientific information needed to improve our understanding of complex marine ecological processes. The AFSC proposes to administer and conduct these survey programs over the five-year period.
Interested persons may submit information, suggestions, and comments concerning the AFSC's request (see
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of a public meeting.
The Mid-Atlantic Fishery Management Council's (MAFMC's)
The meeting will begin at 1 p.m. on Wednesday, November 9, 2016, and end at 3 p.m. on Thursday, November 10, 2016, to view the agenda see
The meeting will be held at the Admiral Fell Inn, 888 S. Broadway, Baltimore, MD 21231; telephone: (410) 522-7377.
Christopher M. Moore, Ph.D., Executive Director, Mid-Atlantic Fishery Management Council, telephone: (302) 526-5255.
The Mid-Atlantic Fishery Management Council's
These meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aid should be directed to M. Jan Saunders, (302) 526-5251, at least 5 days prior to the meeting date.
16 U.S.C. 1801
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; request for comments.
The Assistant Regional Administrator for Sustainable Fisheries, Greater Atlantic Region, NMFS, has made a preliminary determination that an Exempted Fishing Permit application from the Commercial Fisheries Research Foundation and Rhode Island Department of Environmental Management contains all of the required information and warrants further consideration. This Exempted Fishing Permit would allow seven commercial fishing vessels and one party/charter vessel to collect black sea bass catch data while on routine fishing trips and retain a limited amount of black sea bass for laboratory analysis. Regulations under the Magnuson-Stevens Fishery Conservation and Management Act require publication of this notice to provide interested parties the opportunity to comment on applications for proposed Exempted Fishing Permits.
Comments must be received on or before November 2, 2016.
You may submit written comments by any of the following methods:
•
•
Reid Lichwell, Fisheries Management Specialist, 978-281-9112.
The Commercial Fisheries Research Foundation (CFRF) and Rhode Island Department of Environmental Management (RI DEM) submitted a complete application for an EFP on September 9, 2016, to develop a research fleet that would collect fishery-dependent information on black sea bass for eight months, November 2016 through July 2017. The EFP would authorize seven commercial fishing vessels and one party/charter vessel to collect data on black sea bass catch, and retain a limited amount of black sea bass for a laboratory study conducted by RI DEM. This EFP would exempt the participating vessels from the following Federal regulations:
1. Recreational possession limits specified at 50 CFR 648.145;
2. Commercial and party/charter minimum size limits for black sea bass specified at 50 CFR 648.147(a) and (b) respectively;
The research fleet would be comprised of vessels fishing with different gear types including trawls, lobster pots, gillnets, and hook and line. All gear deployments would be typical of the routine fishing practices associated with the fishery being targeted. All vessels fishing under this research would have either a black sea bass moratorium or charter/party federal permit allowing them to legally land black sea bass. There will be no increase in fishing effort associated with this project.
Each vessel would be randomly selected to conduct sampling events during three trips per month within Southern New England and the Mid-Atlantic Bight. During each sampling event, up to 50 black sea bass would be temporarily held to record their length and sex. Some may be retained for shoreside analysis. Each vessel would be allowed to retain 100 black sea bass per month, not to exceed a cumulative total of 6,400 individual fish or 10,880 lb (4,935 kg) of black sea bass catch over the course of the project.
All legal sized black sea bass retained for sampling by commercial vessels would be reported through a dealer as “research” landings and attributed to the state of Rhode Island's allocated commercial black sea bass quota. Undersize black sea bass retained for sampling would be weighed and recorded as bycatch on all appropriate fishing logs. The participating vessels would be able to sell their additional catch as they typically would under the permits they possess. Catch not retained for sale or sampling will be returned to the sea as soon as practicable. The participating vessels would be issued the appropriate state exemptions to all applicable state regulations. If the Federal commercial coastwide quota for black sea bass is reached and leads to a Federal black sea bass closure, then no retention of black sea bass would occur under this EFP until the fishery reopens.
Vessels fishing under this research permit would be exempt from the commercial and party/charter minimum size limits for black sea bass, to allow for the retention of both adult and undersized juvenile black sea bass. The party/charter vessel would be exempt from the possession limits found at § 648.145 to retain black sea bass for sampling above the designated possession limit; there are no federal commercial possession limits for black sea bass.
If approved, CFRF and RI DEM may request minor modifications and extensions to the EFP throughout the study period. EFP modifications and extensions may be granted without further notice if they are deemed essential to facilitate completion of the proposed research and have minimal impacts that do not change the scope or impact of the initially approved EFP request. Any fishing activity conducted outside the scope of the exempted fishing activity would be prohibited.
16 U.S.C. 1801
Defense Acquisition Regulations System, Department of Defense (DoD).
Notice and request for comments regarding a proposed revision of an approved information collection requirement.
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35), DoD announces the proposed revision of a public information collection requirement and seeks public comment on the provisions thereof.
DoD will consider all comments received by December 19, 2016.
You may submit comments, identified by OMB Control Number
Comments received generally will be posted without change to
Ms. Carrie Moore, at 571-372-6093. The information collection requirements addressed in this notice are available on the World Wide Web at:
DFARS 204.404-70(a) prescribes use of DFARS Clause 252.204-7000, Disclosure of Information, in contracts that require the contractor to access or generate unclassified information that may be sensitive and inappropriate for release to the public. The clause requires the contractor to obtain approval of the contracting officer before release of any unclassified contract-related information outside the contractor's organization, unless the information is already in the public domain. In requesting this approval, the contractor must identify the specific information to be released, the medium to be used, and the purpose for the release.
Department of Defense (DoD).
Notice of availability.
DoD announces the availability of the Inventory of Contracted Services for Fiscal Year 2015 pursuant to section 2330a of title 10, United States Code. The inventory is available to the public.
Office of the Director, Defense Procurement and Acquisition Policy, ATTN: OUSD(AT&L)DPAP/CPIC, 3060 Defense Pentagon, Washington, DC 20301-3060. Mr. Jeff Grover may be contacted by email at
In accordance with section 2330a of title 10 United States Code, the Office of the Deputy Director, Defense Procurement and Acquisition Policy, Contract Policy and International Contracting (DPAP/CPIC) will make available to the public the annual inventory of contracted services. The inventory is posted to the Defense Procurement and Acquisition Policy Web site at:
Federal Student Aid (FSA), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 3501
Interested persons are invited to submit comments on or before November 17, 2016.
To access and review all the documents related to the information collection listed in this notice, please use
For specific questions related to collection activities, please contact Beth Grebeldinger, 202-377-4018.
The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that
Department of Energy (DOE).
Notice of open meeting.
This notice announces a meeting of the Environmental Management Site-Specific Advisory Board (EM SSAB), Portsmouth. The Federal Advisory Committee Act (Pub. L. 92-463, 86 Stat. 770) requires that public notice of this meeting be announced in the
Thursday, November 3, 2016 6:00 p.m.
Ohio State University, Endeavor Center, 1862 Shyville Road, Piketon, Ohio 45661.
Greg Simonton, Alternate Deputy Designated Federal Officer, Department of Energy Portsmouth/Paducah Project Office, Post Office Box 700, Piketon, Ohio 45661, (740) 897-3737,
U.S. Department of Energy.
Submission for Office of Management and Budget (OMB) review; comment request.
The Department of Energy (DOE) has submitted an information collection request to the OMB for extension under the provisions of the Paperwork Reduction Act of 1995. The information collection requests a three-year extension of its Financial Assistance Information Collection, OMB Control Number 1910-0400. This information collection request covers information necessary to administer and manage DOE's financial assistance programs.
Comments regarding this collection must be received on or before November 17, 2016. If you anticipate difficulty in submitting comments within that period or if you want access to the collection of information, without charge, contact the OMB Desk Officer for DOE listed below as soon as possible.
Written comments should be sent to the following:
Richard Bonnell by email at
This information collection request contains:
Federal Grant and Cooperative Agreement Act, 31 U.S.C. 6301-6308. Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 (Pub. L. 104-13).
Office of Electricity Delivery and Energy Reliability, DOE.
Notice of application.
Tenaska Power Services Co. (Applicant or TPS) has applied for authority to transmit electric energy from the United States to Mexico pursuant to section 202(e) of the Federal Power Act.
Comments, protests, or motions to intervene must be submitted on or before November 17, 2016.
Comments, protests, motions to intervene, or requests for more information should be addressed to: Office of Electricity Delivery and Energy Reliability, Mail Code: OE-20, U.S. Department of Energy, 1000 Independence Avenue SW., Washington, DC 20585-0350. Because of delays in handling conventional mail, it is recommended that documents be transmitted by overnight mail, by electronic mail to
Exports of electricity from the United States to a foreign country are regulated by the Department of Energy (DOE) pursuant to sections 301(b) and 402(f) of the Department of Energy Organization Act (42 U.S.C. 151(b), 7172(f)) and require authorization under section 202(e) of the Federal Power Act (16 U.S.C. 824a(e)).
On September 28, 2016, DOE received an application from TPS for authority to transmit electric energy from the United States to Mexico as a power marketer for a five-year term using existing international transmission facilities.
In its application, TPS states that it does not own or control any electric generation or transmission facilities, and it does not have a franchised service area. The electric energy that TPS proposes to export to Mexico would be surplus energy purchased from third parties such as electric utilities and Federal power marketing agencies pursuant to voluntary agreements. The existing international transmission facilities to be utilized by the Applicant have previously been authorized by Presidential Permits issued pursuant to Executive Order 10485, as amended, and are appropriate for open access transmission by third parties.
Comments and other filings concerning TPS's application to export electric energy to Mexico should be clearly marked with OE Docket No. EA-431. An additional copy is to be provided to both Norma Rosner Iacovo, Tenaska Power Services Co., 1701 E. Lamar Blvd., Suite 100, Arlington, TX 76006, and Neil L. Levy, KING & SPALDING LLP, 1700 Pennsylvania Ave. NW., Washington, DC 20006.
A final decision will be made on this application after the environmental impacts have been evaluated pursuant to DOE's National Environmental Policy Act Implementing Procedures (10 CFR part 1021) and after a determination is made by DOE that the proposed action will not have an adverse impact on the sufficiency of supply or reliability of the U.S. electric power supply system.
Copies of this application will be made available, upon request, for public inspection and copying at the address provided above, by accessing the program Web site at
This is a supplemental notice in the above-referenced proceeding of DifWind Farms LTD VI's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is October 31, 2016.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission,
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email
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 Commission received the following electric corporate filings:
Description: Application of Luning Energy LLC, et al. for Authorization Under Section 203 of the Federal Power Act and Request for Waivers and Expedited Action.
Take notice that the Commission received the following electric rate filings:
Take notice that the Commission received the following electric securities filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
On October 7, 2016, the Commission issued an order in Docket No. EL16-119-000, pursuant to section 206 of the Federal Power Act (FPA), 16 U.S.C. 824e (2012), instituting an investigation into the justness and reasonableness of Illinois Power Generating Company's proposed rate reduction.
The refund effective date in Docket No. EL16-119-000, established pursuant to section 206(b) of the FPA, will be the date of publication of this notice in the
Any interested person desiring to be heard in Docket No. EL16-119-000 must file a notice of intervention or motion to intervene, as appropriate, with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rule 214 of the Commission's Rules of Practice and Procedure, 18 CFR 385.214 (2016), within 21 days of the date of issuance of the order.
The following notice of meeting is published pursuant to section 3(a) of the government in the Sunshine Act (Pub. L. 94-409), 5 U.S.C. 552b:
Federal Energy Regulatory Commission.
October 20, 2016, 10:00 a.m.
Room 2C, 888 First Street NE., Washington, DC 20426.
Open.
Agenda.
* NOTE—Items listed on the agenda may be deleted without further notice.
Kimberly D. Bose, Secretary, Telephone (202) 502-8400.
For a recorded message listing items struck from or added to the meeting, call (202) 502-8627.
This is a list of matters to be considered by the Commission. It does not include a listing of all documents relevant to the items on the agenda. All public documents, however, may be viewed on line at the Commission's Web site at
A free webcast of this event is available through
Immediately following the conclusion of the Commission Meeting, a press briefing will be held in the Commission Meeting Room. Members of the public may view this briefing in the designated overflow room. This statement is intended to notify the public that the press briefings that follow Commission meetings may now be viewed remotely at Commission headquarters, but will not be telecast through the Capitol Connection service.
This is a supplemental notice in the above-referenced proceeding of Terra-Gen Mojave Windfarms, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is October 31, 2016.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email
Take notice that the Commission received the following electric corporate filings:
Accession Number: 20161007-5222.
Take notice that the Commission received the following electric rate filings:
Take notice that the Commission received the following public utility holding company filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR § 385.211 and § 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
This is a supplemental notice in the above-referenced proceeding of Portal Ridge Solar B, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is October 31, 2016.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email
Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
This is a supplemental notice in the above-referenced proceeding of Portal Ridge Solar C, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is October 31, 2016.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email
Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:
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.
Any person desiring to protest in any of the above proceedings must file in accordance with Rule 211 of the Commission's Regulations (18 CFR 385.211) on or before 5:00 p.m. Eastern time on the specified comment date.
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Environmental Protection Agency (EPA).
Notice.
EPA is announcing its receipt of information submitted pursuant to a test rule issued by EPA under the Toxic Substances Control Act (TSCA). As required by TSCA, this document
Information about the following chemical substance and/or mixture is provided in Unit IV.:
Section 4(d) of TSCA (15 U.S.C. 2603(d)) requires EPA to publish a notice in the
A docket, identified by the docket identification (ID) number EPA-HQ-OPPT-2013-0677, has been established for this
The docket for this
This unit contains the information required by TSCA section 4(d) for the information received by EPA about
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15 U.S.C. 2601
Environmental Protection Agency (EPA).
Notice.
EPA has received applications to add new food uses on previously registered pesticide products. Pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA is hereby providing notice of receipt and opportunity to comment on these applications.
Comments must be received on or before November 17, 2016.
Submit your comments, identified by the docket identification (ID) number of interest as shown in the body of this document, by one of the following methods:
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Michael L. Goodis, P.E., 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).
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EPA has received applications to add new food uses on previously registered pesticide products. Pursuant to the provisions of FIFRA section 3(c)(4) (7 U.S.C. 136a(c)(4)), EPA is hereby providing notice of receipt and opportunity to comment on these applications. Notice of receipt of these applications does not imply a decision by the Agency on these applications.
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7 U.S.C. 136
Environmental Protection Agency (EPA).
Notice.
EPA has authorized its contractor, Abt Associates of Bethesda, MD, and Versar, Inc., of Springfield, VA to access information which has been submitted to EPA under all sections of the Toxic Substances Control Act (TSCA). Some of the information may be claimed or determined to be Confidential Business Information (CBI).
Access to the confidential data occurred on or about July 26, 2016.
This action is directed to the public in general. This action may, however, be of interest to all who manufacture, process, or distribute industrial chemicals. Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action.
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPPT-2003-0004, is available at
Under EPA contract number EP-W-16-009, contractor Abt Associates of 4800 Montgomery Lane, Bethesda, MD and 55 Wheeler Street, Cambridge, MA; and Versar, Inc., of 6850 Versar Center, Springfield, VA, are assisting the Office of Pollution Prevention and Toxics (OPPT) by supporting scientific and engineering assessments of chemicals. For chemicals identified by the Agency, they are assisting in preparing evaluations of the following: physical/chemical properties, hazards, and functions; production/processing/use methods; occupational exposure, environmental release, fate, transport, and other human and environmental exposure risks; life-cycle environmental impacts; methods to prevent or control waste generation, releases or exposure; and comparison of substitute chemicals or technologies. They will also assist in developing methods for chemical ranking by hazard and other factors and for assessing exposure and release.
In accordance with 40 CFR 2.306(j), EPA has determined that under EPA contract number EP-W-16-009, Abt Associates and Versar were given access to CBI submitted to EPA under all section(s) of TSCA to perform successfully the duties specified under the contract. Abt Associates and Versar personnel were given access to information submitted to EPA under all section(s) of TSCA. Some of the information may be claimed or determined to be CBI.
EPA is issuing this notice to inform all submitters of information under all sections of TSCA that EPA has provided Abt Associates and Versar access to these CBI materials on a need-to-know basis only. All access to TSCA CBI under this contract is taking place at EPA Headquarters and Abt Associates' sites located in Bethesda, MD and Cambridge, MA, in accordance with EPA's
Access to TSCA data, including CBI, will continue until March 30, 2021. If the contract is extended, this access will also continue for the duration of the extended contract without further notice.
Abt Associates and Versar personnel have signed nondisclosure agreements and were briefed on appropriate security procedures before they were permitted access to TSCA CBI.
15 U.S.C. 2601
Environmental Protection Agency (EPA).
Notice; request for public comment.
In accordance with the Prospective Purchaser Agreement, notice is hereby given of a proposed administrative settlement concerning the Willow Run Powertrain Site in Ypsilanti, Michigan with the following settling parties: Willow Run Arsenal of Democracy Landholdings Limited Partnership and the American Center for Mobility. The settlement requires the Settling Parties to, if necessary, execute and record a Declaration of Restrictive Covenant; provide access to the Site and exercise due care with respect to existing contamination. The settlement includes a covenant not to sue the Settling Parties pursuant to the Comprehensive Environmental Response, Compensation, and Liability Act or the Resource Conservation and Recovery Act with respect to the Existing Contamination. Existing Contamination is defined as any hazardous substances, pollutants, or contaminants or Waste Material present or existing on or under the Property as of the Effective Date of the Settlement Agreement; any hazardous substances, pollutants, or contaminants or Waste Material that migrated from the Property prior to the Effective Date; and any hazardous substances, pollutants, or contaminants or Waste Material presently at the Site that migrates onto, on, under, or from the Property after the Effective Date.
For thirty (30) days following the date of publication of this notice, the Agency will receive written comments relating to the settlement. The Agency will consider all comments received and may modify or withdraw its consent to the settlement if comments received disclose facts or considerations which indicate that the settlement is inappropriate, improper, or inadequate. The Agency's response to any comments received will be available for public inspection at the EPA, Region 5, Records Center, 77 W. Jackson Blvd., 7th Fl., Chicago, Illinois 60604. Commenters may request an opportunity for a public hearing in the affected area, in accordance with Section 7003(d) of RCRA.
Comments must be submitted on or before 30 days after publication in the
The proposed settlement is available for public inspection at the EPA, Region 5, Records Center, 77 W. Jackson Blvd., 7th Fl., Chicago, Illinois 60604. A copy of the proposed settlement may be obtained from Peter Felitti, Assoc. Regional Counsel, EPA, Office of Regional Counsel, Region 5, 77 W. Jackson Blvd., Mail Code: C-14J, Chicago, Illinois 60604. Comments should reference the Willow Run Powertrain Site, Ypsilanti, Michigan and should be addressed to Peter Felitti, Assoc. Regional Counsel, EPA, Office of Regional Counsel, Region 5, 77 W. Jackson Blvd., Mail Code: C-14J, Chicago, Illinois 60604.
Peter Felitti, Assoc. Regional Counsel, EPA, Office of Regional Counsel, Region 5, 77 W. Jackson Blvd., Mail Code: C-14J, Chicago, Illinois 60604.
The Settling Parties propose to acquire ownership of the former General Motors Corporation North American operation, at 2930 Ecorse Road in Ypsilanti, Michigan. The Site is one of the 89 sites that were placed into an Environmental Response Trust (the “Trust”) as a result of the resolution of the 2009 GM bankruptcy. The Trust is administrated by Revitalizing Auto Communities Environmental Response.
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Written PRA comments should be submitted on or before December 19, 2016. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.
Direct all PRA comments to Cathy Williams, FCC, via email
For additional information about the information collection, contact Cathy Williams at (202) 418-2918.
The information collections contained in these rule sections require manufacturers of certain emergency radio beacons to include supplemental information with their equipment certification application which are due to the I formation collection requirements which were adopted by the Federal Communications Commission in FCC 16-119 on August 30, 2016. Manufacturers of Automatic Identification System Search and Rescue Transmitters (AIS-SARTS), 406 MHz Emergency Position Indicating RadioBeacons (EPRIBs) and Maritime Survivor Locating Device (MSLD) must provide a copy of letter from the U.S. Coast Guard stating their devices satisfies technical requirements specified in the IEC 61097-17 technical standard for AIS-SARTs, or Radio Technical Commission for Maritime Services (RTCM) Standard 11000 for 406 MHz EPIRBs, or that RTCM Standard 11901 for MSLDs. They must also provide a copy or the technical test data, and the instruction manual(s). For 406 MHz PLBs manufacturers must include documentation from COSPAS/SARSAT recognized test facility that the PLB satisfies the technical requirements specified in COSPAS-SARSAT Standard C/S T.001 and COSPAS-SARSAT Standard C/S T.007 standards and documentation from an independent test facility stating that the PLB complies RTCM Standard 11010.2. The information is used by Telecommunications Certification Bodies (TCBs) to determine if the devices meets the necessary international technical standards and insure compliance with applicable rules. If this information were not available, operation of marine safety equipment could be hindered threatening the ability of rescue personnel to locate vessels in distress.
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid OMB control
Written PRA comments should be submitted on or before December 19, 2016. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.
Direct all PRA comments to Cathy Williams, FCC, via email
For additional information about the information collection, contact Cathy Williams at (202) 418-2918.
In AM radio, the tower itself functions as the antenna. Consequently, a nearby tower may become an unintended part of the AM antenna system, reradiating the AM signal and distorting the authorized AM radiation pattern. Our old rules contained several sections concerning tower construction near AM antennas that were intended to protect AM stations from the effects of such tower construction, specifically, Sections 73.1692, 22.371, and 27.63. These old rule sections imposed differing requirements on the broadcast and wireless entities, although the issue is the same regardless of the types of antennas mounted on a tower. Other rule parts, such as Part 90 and Part 24, entirely lacked provisions for protecting AM stations from possible effects of nearby tower construction. In the Third Report and Order the Commission adopted a uniform set of rules applicable to all services, thus establishing a single protection scheme regarding tower construction near AM tower arrays. The Third Report and Order also designates “moment method” computer modeling as the principal means of determining whether a nearby tower affects an AM radiation pattern. This serves to replace time-consuming direct measurement procedures with a more efficient computer modeling methodology that is reflective of current industry practice.
47 CFR 1.30002(b) requires a proponent of construction or modification of a tower within a specified distance of a directional AM station, and also exceeding a specified height, to notify the AM station at least 30 days in advance of the commencement of construction. If the tower construction or modification would distort the AM pattern, the proponent shall be responsible for the installation and maintenance of detuning equipment.
47 CFR 1.30002(c) states that proponents of tower construction or alteration near an AM station shall use moment method modeling, described in § 73.151(c), to determine the effect of the construction or alteration on an AM radiation pattern.
47 CFR 1.30002(f) states that, with respect to an AM station that was authorized pursuant to a directional proof of performance based on field strength measurements, the proponent of the tower construction or modification may, in lieu of the study described in § 1.30002 (c), demonstrate through measurements taken before and after construction that field strength values at the monitoring points do not exceed the licensed values. In the event that the pre-construction monitoring point values exceed the licensed values, the proponent may demonstrate that post-construction monitoring point values do not exceed the pre-construction values. Alternatively, the AM station may file for authority to increase the relevant monitoring point value after performing a partial proof of performance in accordance with § 73.154 to establish that the licensed radiation limit on the applicable radial is not exceeded.
47 CFR 1.30002(g) states that tower construction or modification that falls outside the criteria described in paragraphs § 1.30002(a) and (b) is presumed to have no significant effect on an AM station. In some instances, however, an AM station may be affected by tower construction notwithstanding the criteria set forth in paragraphs § 1.30002(a) and (b). In such cases, an AM station may submit a showing that its operation has been affected by tower construction or alteration. Such showing shall consist of either a moment method analysis or field strength measurements. The showing shall be provided to (i) the tower proponent if the showing relates to a tower that has not yet been constructed or modified and otherwise to the current tower owner, and (ii) to the Commission, within two years after the date of completion of the tower construction or modification. If necessary, the Commission shall direct the tower proponent to install and maintain any detuning apparatus necessary to restore proper operation of the AM antenna.
47 CFR 1.30002(h) states that an AM station may submit a showing that its operation has been affected by tower construction or modification commenced or completed prior to or on the effective date of the rules adopted in this Part pursuant to MM Docket No. 93-177. Such a showing shall consist of either a moment method analysis or of field strength measurements. The showing shall be provided to the current owner and the Commission within one year of the effective date of the rules adopted in this Part. If necessary, the Commission shall direct the tower
47 CFR 1.30002(i) states that a Commission applicant may not propose, and a Commission licensee or permittee may not locate, an antenna on any tower or support structure, whether constructed before or after the effective date of these rules, that is causing a disturbance to the radiation pattern of the AM station, as defined in paragraphs § 1.30002(a) and (b), unless the applicant, licensee, or tower owner completes the new study and notification process and takes appropriate ameliorative action to correct any disturbance, such as detuning the tower, either prior to construction or at any other time prior to the proposal or antenna location.
47 CFR 1.30003(a) states that when antennas are installed on a nondirectional AM tower the AM station shall determine operating power by the indirect method (see § 73.51). Upon the completion of the installation, antenna impedance measurements on the AM antenna shall be made. If the resistance of the AM antenna changes, an application on FCC Form 302-AM (including a tower sketch of the installation) shall be filed with the Commission for the AM station to return to direct power measurement. The Form 302-AM shall be filed before or simultaneously with any license application associated with the installation.
47 CFR 1.30003(b) requires that, before antennas are installed on a tower in a directional AM array, the proponent shall notify the AM station so that, if necessary, the AM station may determine operating power by the indirect method (see § 73.51) and request special temporary authority pursuant to § 73.1635 to operate with parameters at variance. For AM stations licensed via field strength measurements (see § 73.151(a)), a partial proof of performance (as defined by § 73.154) shall be conducted both before and after construction to establish that the AM array will not be and has not been adversely affected. For AM stations licensed via a moment method proof (see § 73.151(c)), the proof procedures set forth in § 73.151(c) shall be repeated. The results of either the partial proof of performance or the moment method proof shall be filed with the Commission on Form 302-AM before or simultaneously with any license application associated with the installation.
47 CFR 1.30004(a) requires proponents of proposed tower construction or modification to an existing tower near an AM station that are subject to the notification requirement in §§ 1.30002-1.30003 to provide notice of the proposed tower construction or modification to the AM station at least 30 days prior to commencement of the planned tower construction or modification. Notification to an AM station and any responses may be oral or written. If such notification and/or response is oral, the party providing such notification or response must supply written documentation of the communication and written documentation of the date of communication upon request of the other party to the communication or the Commission. Notification must include the relevant technical details of the proposed tower construction or modification, and, at a minimum, also include the following: proponent's name and address; coordinates of the tower to be constructed or modified; physical description of the planned structure; and results of the analysis showing the predicted effect on the AM pattern, if performed.
47 CFR 1.30004(b) requires that a response to a notification indicating a potential disturbance of the AM radiation pattern must specify the technical details and must be provided to the proponent within 30 days.
47 CFR 1.30004(d) states that if an expedited notification period (less than 30 days) is requested by the proponent, the notification shall be identified as “expedited,” and the requested response date shall be clearly indicated.
47 CFR 1.30004(e) states that in the event of an emergency situation, if the proponent erects a temporary new tower or makes a temporary significant modification to an existing tower without prior notice, the proponent must provide written notice to potentially affected AM stations within five days of the construction or modification of the tower and cooperate with such AM stations to remedy any pattern distortions that arise as a consequence of such construction.
47 CFR 73.875(c) requires an LPFM applicant to submit an exhibit demonstrating compliance with § 1.30003 or § 1.30002, as applicable, with any modification of license application filed solely pursuant to paragraphs (c)(1) and (c)(2) of this section, where the installation is on or near an AM tower, as defined in § 1.30002.
47 CFR 73.1675(c)(1) states that where an FM, TV, or Class A TV licensee or permittee proposes to mount an auxiliary facility on an AM tower, it must also demonstrate compliance with § 1.30003 in the license application.
47 CFR 73.1690(c) requires FM, TV, or Class A TV station applicants to submit an exhibit demonstrating compliance with § 1.30003 or § 1.30002, as applicable, with a modification of license application, except for applications solely filed pursuant to paragraphs (c)(6) or (c)(9) of this section, where the installation is located on or near an AM tower, as defined in § 1.30002.
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with
Written comments should be submitted on or before November 17, 2016. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contacts below as soon as possible.
Direct all PRA comments to Nicholas A. Fraser, OMB, via email
For additional information or copies of the information collection, contact Nicole Ongele at (202) 418-2991. To view a copy of this information collection request (ICR) submitted to OMB: (1) Go to the Web page
The Commission will submit this information collection to OMB during this comment period to obtain the full three-year clearance from them. The purpose of this information is to ensure that schools and libraries that are eligible to receive discounted Internet Access services (Category One), and Broadband Internal Connections, Managed Internal Broadband Services, and Basic Maintenance of Broadband Internal Connections (Basic Maintenance) (known together as Category Two Services) have in place Internet safety policies. Schools and libraries receiving these services must certify, by completing FCC Form 486 (Receipt of Service Confirmation and Certification of Compliance with the Children's Internet Protection Act), that respondents are enforcing a policy of Internet safety and enforcing the operation of a technology prevention measure. Also, respondents who received a Funding Commitment Decision Letter indicating services eligible for universal service funding must file FCC Form 486 to indicate their service start date and to start the payment process. In addition, all members of a consortium must submit signed certifications to the Billed Entity of their consortium using FCC Form 479; Certification by Administrative Authority to Billed Entity of Compliance with Children's Internet Protection Act, in language consistent with the certifications adopted for the FCC Form 486. Consortia must, in turn, certify collection of the FCC Forms 479 on the FCC Form 486. FCC Form 500 is used by E-rate participants to make adjustments to previously filed forms, such as changing the contract expiration date filed with the FCC Form 471, changing the funding year service start date filed with the FCC Form 486, cancelling or reducing the amount of funding commitments, requesting extensions of the deadline for non-recurring services, and notifying USAC of equipment transfers. All of the requirements contained herein are necessary to implement the congressional mandate for universal service.
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning:
The FCC may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Written PRA comments should be submitted on or before December 19, 2016. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.
Direct all PRA comments to Cathy Williams, FCC, via email
For additional information about the information collection, contact Cathy Williams at (202) 418-2918.
The third party disclosure coordination and information exchange requirements are necessary to ensure that licensees do not cause interference to each other.
Notice is hereby given that the Federal Deposit Insurance Corporation (“FDIC”) as Receiver for Mountain Heritage Bank, Clayton, Georgia (“the Receiver”) intends to terminate its receivership for said institution. The FDIC was appointed receiver of Mountain Heritage Bank on June 24, 2011. The liquidation of the receivership assets 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 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.
Federal Deposit Insurance Corporation.
Board of Governors of the Federal Reserve System.
Notice for comment regarding the Federal Reserve proposal to extend without revision the clearance under the Paperwork Reduction Act for the following information collection activity.
The Board of Governors of the Federal Reserve System (Board or Federal Reserve) invites comment on a proposal to extend for three years, without revision, the following reporting and recordkeeping requirements related to amendments made by the Gramm-Leach-Bliley Act, to the Bank Holding Company Act, the Federal Reserve Act, and related regulations:
• The mandatory Declarations to Become a Financial Holding Company (FHC) (FR 4010);
• The voluntary Requests for Determinations and Interpretations Regarding Activities Financial in Nature (FR 4011);
• The mandatory Notices of Failure to Meet Capital or Management Requirements (FR 4012);
• The mandatory Notices by State Member Banks to Invest in Financial Subsidiaries (FR 4017);
• The mandatory Regulatory Relief Requests Associated with Merchant Banking Activities (FR 4019); and
• The mandatory Recordkeeping Requirements Associated with Merchant Banking Activities (FR 4023).
These collections of information are event-generated and as such, there are no formal reporting forms associated with them. In each case, the type of information required to be filed is described in the Board's regulations.
On June 15, 1984, the Office of Management and Budget (OMB) delegated to the Board authority under the Paperwork Reduction Act (PRA) to approve of and assign OMB control numbers to collection of information requests and requirements conducted or sponsored by the Board. In exercising this delegated authority, the Board is directed to take every reasonable step to solicit comment. In determining whether to approve a collection of information, the Board will consider all comments received from the public and other agencies.
Comments must be submitted on or before December 19, 2016.
You may submit comments, identified by
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All public comments are available from the Board's Web site at
Additionally, commenters may send a copy of their comments to the OMB Desk Officer—Shagufta Ahmed—Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Room 10235 725 17th Street NW., Washington, DC 20503 or by fax to (202) 395-6974.
A copy of the PRA OMB submission, including the proposed reporting form and instructions, supporting statement, and other documentation will be placed into OMB's public docket files, once approved. These documents will also be made available on the Federal Reserve Board's public Web site at:
Federal Reserve Board Clearance Officer—Nuha Elmaghrabi—Office of the Chief Data Officer, Board of Governors of the Federal Reserve System, Washington, DC 20551 (202) 452-3829. Telecommunications Device for the Deaf (TDD) users may contact (202) 263-4869, Board of Governors of the Federal Reserve System, Washington, DC 20551.
The Board invites public comment on the following information collection, which is being reviewed under authority delegated by the OMB under the PRA. Comments are invited on the following:
a. Whether the proposed collection of information is necessary for the proper performance of the Federal Reserve's functions; including whether the information has practical utility;
b. The accuracy of the Federal Reserve's estimate of the burden of the proposed information collection, including the validity of the methodology and assumptions used;
c. Ways to enhance the quality, utility, and clarity of the information to be collected;
d. Ways to minimize the burden of information collection on respondents, including through the use of automated collection techniques or other forms of information technology; and
e. Estimates of capital or startup costs and costs of operation, maintenance, and purchase of services to provide information.
At the end of the comment period, the comments and recommendations received will be analyzed to determine the extent to which the Federal Reserve should modify the proposed revisions prior to giving final approval.
The BHC Act, and Regulations Y and LL specify the information to be included in a declaration.
An FHC declaration filed by a U.S. BHC must state that the BHC elects to become an FHC, must be signed by an authorized official or representative, and must provide the following information:
• The name and head office address of the BHC and of each depository institution controlled by the BHC (multi-tiered filers may file a single declaration, provided the name and head office address of each tiered company is listed.)
• a certification that the BHC and all depository institutions controlled by the BHC are well capitalized and well managed as of the declaration date
• the capital ratios (as of the close of the previous quarter for all relevant capital measures) for each depository institution the BHC controls
An FHC declaration filed by a U.S. SLHC must state that the SLHC elects to be treated as an FHC, must be signed by an authorized official or representative,
• The name and head office address of the SLHC and of each depository institution controlled by the SLHC (Multi-tiered filers may file a single declaration, provided the name and head office address of each tiered company is listed.)
• a certification that the SLHC and all depository institutions controlled by the SLHC are well capitalized and well managed as of the declaration date
• the capital ratios (as of the close of the previous quarter for all relevant capital measures) for each depository institution the SLHC controls
An FHC declaration filed by an FBO must state that the FBO elects to be treated as an FHC, must be signed by an authorized official or representative, and must provide the following information:
• With respect to each foreign bank controlled by the FBO, the bank's risk-based capital ratios, amount of tier 1 capital, and total assets, as of the close of the most recent quarter and as of the close of the most recent audited reporting period
• a certification that each foreign bank controlled by the FBO is well-capitalized and well-managed
• a certification that all U.S. depository institutions controlled by the FBO are well capitalized and well managed as of the declaration date
• the capital ratios (as of the close of the previous quarter for all relevant capital measures) for each U.S. depository institution controlled by the FBO
Regulation Y specifies the information to be collected in connection with each type of request.
• Identify, define, and describe the activity and explain how the activity would be conducted,
• explain why the activity should be considered financial in nature or incidental to a financial activity; and
• include information supporting the request and any other information required by the Board.
A request for an advisory opinion that a specific activity is within the scope of activities previously determined to be financial in nature, or incidental to a financial activity, must be in writing and:
• Identify and describe the proposed activity or the proposed product or service,
• offer support for the desired interpretation, and
• include any other information requested by the Board.
An applicant seeking prior approval to engage in an activity that the applicant believes is complementary to a financial activity must submit a written request that:
• Identifies, defines, and describes the activity and explains how the activity would be conducted;
• identifies the financial activity to which the proposed activity would be complementary and provides information sufficient to support a finding that the proposed activity is complementary to the financial activity;
• describes the scope and relative size of the proposed activity, measured by the percentage of the FHC's projected revenues expected to be derived from, and assets associated with, the activity;
• discusses the risks the activity may reasonably be expected to pose to the safety and soundness of the FHC's depository institutions and to the financial system generally;
• describes the potential adverse effects, including potential conflicts of interest, decreased or unfair competition, or other risks, that the activity could cause, and the measures the FHC proposes to take to address those potential effects;
• describes the potential benefits to the public, such as greater convenience, increased competition, or gains in efficiency, the proposal may be reasonably expected to produce; and
• provides information about the FHC's financial and managerial resources and any other information requested by the Board.
Regulation Y provides that the notice must identify the noncompliant banking entity and the area of noncompliance. Regulation Y does not prescribe a format for such notices, however, they typically take the form of a letter.
• An explanation of the specific actions the FHC will take to correct all areas of noncompliance
• a schedule within which each action will be taken
• any other information the Board may require
Regulation H requires FR 4017 notices to be in the form of a letter with enclosures and to:
• Describe the proposed transaction by which the bank would acquire the stake in the financial subsidiary;
• provide the name and head office address of the subsidiary;
• describe each current and proposed activity of the financial subsidiary and the legal authority for each activity;
• provide the capital ratios, as of the end of the most recent calendar quarter, for the bank and each of its depository institution affiliates;
• certify that the bank and each of its depository institution affiliates were well-capitalized at the close of the previous calendar quarter and as of the notice date;
• certify that the bank and each of its depository institution affiliates are well-managed as of the notice date;
• certify that the bank meets any applicable debt rating or alternative requirements and complies both before and after the transaction with the limit on the aggregate amount of assets held by the bank's financial subsidiaries; and
• describe the insurance activities, if the financial subsidiary will engage in insurance activities, to be conducted and identify each state in which the company holds an insurance license and the state insurance authority that issued the license.
Regulation Y requires requests for extension of the holding period for a merchant bank investment to include the following information:
• The reasons for the request, including information addressing the factors the Board must consider in acting on such a request (including the costs and risks to the FHC of disposing of the investment, market conditions, the extent and history of the FHC's involvement in managing or operating the portfolio company, and the FHC's average holding period for its merchant banking investments)
• an explanation of the FHC's plan for divesting the investment
A notice of extended routine management or operation of a portfolio company can be in the form of a brief letter and must identify the portfolio company, the date on which the FHC first became involved in the routine management or operation of the portfolio company, the reasons for the FHC's involvement, the actions taken by the FHC to address the circumstances
The general policies and procedures that an FHC must establish with respect to merchant banking must be reasonably designed to:
• Monitor, with respect to each investment and the entire portfolio, carrying and market values and performance;
• identify and manage market, credit, and other risks of such investments;
• identify and monitor terms and risks of transactions of companies in which the FHC has merchant banking investments;
• ensure the corporate separateness of the FHC and the companies in which it has merchant banking investments;
• ensure compliance with sections 23A and 23B of the FRA, anti-tying statutes, Regulation Y, and any other applicable provisions of law.
• FR 4010 is authorized by section 4(
• FR 4011 is authorized by section 4(j) and (k) of the BHC Act (12 U.S.C. 1843(j)-(k)), and sections 225.88 and 225.89 of the Board's Regulation Y (12 CFR 225.88, 225.89).
• FR 4012 is authorized by section 4(
• FR 4017 is authorized by section 9 of the FRA (12 U.S.C. 335), and section 208.76 of the Board's Regulation H (12 CFR 208.76).
• FR 4019 is authorized by section 4(k)(7) of the BHC Act (12 U.S.C. 1843(k)(7)); sections 225.171(e)(3), 225.172(b)(4); and section 225.173(c)(2) of the Board's Regulation Y (12 CFR 225.171(e)(3), 225.172(b)(4), 225.173(c)(2)).
• FR 4023 is authorized by section 4(k)(7) of the BHC Act (12 U.S.C. 1843(k)(7)), and sections 225.171(e)(4) and 225.175 of the Board's Regulation Y (12 CFR 225.171(e)(4), 225.175).
The obligation to respond to the FR 4011 is voluntary (for requests to determine that an activity is financial in nature or to issue an advisory opinion that an activity is within the scope of an activity previously determined to be financial in nature) and required to obtain or retain benefits (for approvals to engage in an activity that is complementary to a financial activity). The obligation to respond to the FR 4010, FR 4017, and FR 4019 is required to obtain or retain benefits. The obligation to respond to FR 4012 and the obligation to comply with the recordkeeping requirements of the FR 4023 is mandatory.
The information collected on the FR 4010, FR 4011, FR 4017, and FR 4019 and information related to a failure to meet capital requirements on the FR 4012 is not generally considered confidential. Nevertheless, a respondent may request confidential treatment of information contained in these information collections in accordance with section (b)(4) or (b)(6) of the Freedom of Information Act (FOIA) (5 U.S.C. 552(b)(4), (b)(6)). Any request for confidential treatment of information must be accompanied by a detailed justification for confidentiality. Information related to a failure to meet management requirements on the FR 4012 is considered confidential and exempt from disclosure under section (b)(4), because the release of this information would cause substantial harm to the competitive position of the entity, and section (b)(8), if the information is related to examination, operating, or condition reports prepared by, on behalf of, or for the use of an agency responsible for the regulation or supervision of financial institutions (5 U.S.C. 552(b)(4), (b)(8)).
Additionally, the records kept in accordance with the Recordkeeping Requirements Associated with Merchant Banking Activities are retained by the respondent itself and the FOIA would only be implicated if the Board's examiners retained a copy of the records as part of an examination or supervision of a banking institution. In this case, the records would likely be exempt from disclosure under exemption (b)(8), for examination material. 5 U.S.C. 552(b)(8). In addition, the records may also be exempt under (b)(4) and (b)(6).
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 extension of a previously approved information collection requirement concerning debarment and suspension. This request also incorporated two other related information collection requirements (“Information Regarding Responsibility Matters” and “Prohibition on Contracting with Inverted Domestic Corporations—Representation and Notification”), which will be cancelled upon approval of this clearance. A notice was published in the
Submit comments on or before November 17, 2016.
Submit comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: Office of Information and Regulatory Affairs of OMB, Attention: Desk Office for GSA, Room 10236, NEOB, Washington, DC 20503. Additionally, submit a copy to GSA by any of the following methods:
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Submit comments via the Federal eRulemaking portal by searching the OMB control number. Select the link “Submit a Comment” that corresponds
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Ms. Cecelia L. Davis, Procurement Analyst, Office of Acquisition Policy, at 202-219-0202 or via email at
The FAR requires contracts to be awarded to only those contractors determined to be responsible. Instances where a firm, its principals, or subcontractors, have been indicted, convicted, suspended, proposed for debarment, debarred, or had a contract terminated for default are critical factors to be considered by a Government contracting officer in making a responsibility determination. FAR 52.209-5 and 52.212-3(h), Certification Regarding Responsibility Matters, and FAR 52.209-6, Protecting the Government's Interest when Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment, require the disclosure of this and other information relating to responsibility.
The Federal Awardee Performance and Integrity Information System (FAPIIS) was developed to meet the statutory requirement to develop and maintain an information system that contains specific information on the integrity and performance of covered Federal agency contractors and grantees. FAPIIS provides users access to integrity and performance information from the FAPIIS reporting module in the Contractor Performance Assessment Reporting System (CPARS), as well as proceedings information and suspension/debarment information from the Central Contractor Registration (CCR) and the Excluded Parties List System (EPLS) functions in the System for Award Management (SAM).
The prescription at FAR 9.104-7(b) requires contracting officers to insert the provision at 52.209-7, Information Regarding Responsibility Matters, in solicitations where the resultant contract value is expected to exceed $550,000. This provision contains a check box to be completed by the offeror indicating whether or not it has current active Federal contracts and grants with total value greater than $10,000,000. If the offeror indicated that it has current active Federal contracts and grants with total value greater than $10,000,000, then the offeror must enter certain responsibility information into FAPIIS.
FAR 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters, requires each contractor that checked in the provision at 52.209-7 that it has current active Federal contracts and grants with total value greater than $10,000,000, to update responsibility information in FAPIIS on a semiannual basis, throughout the life of the contract.
FAR 52.209-2 and 52.212-3(n), Prohibition on Contracting with Inverted Domestic Corporations—Representation, is prescribed at 9.108-5(a) for use in each solicitation for the acquisition of products and services (including construction). The provision requires each offeror to represent whether it is, or is not, an inverted domestic corporation or a subsidiary of an inverted domestic corporation.
FAR 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations, is prescribed for use at FAR 9.108-5(b) for use in ach solicitation and contract for the acquisition of products and services (including construction). This clause requires the contractor to promptly notify the contracting officer in the event the contractor becomes an inverted domestic corporation or a subsidiary of an inverted domestic corporation.
The analysis of the public comment is summarized as follows:
One response was received. The commenter supports the efforts to contract with only responsible parties and to assure contracting officers engage in appropriate due diligence to support this effort.
FAR 52.209-5 implements policy guidance on debarment, suspension and ineligibility. FAR 52.209-5 is a certification that is placed in all solicitations when the contract value is expected to exceed the simplified acquisition threshold and covers 3 years. FAR 52.209-7 goes in solicitations expected to exceed $550,000 and covers 5 years and requires that the information be placed into FAPIIS (as required by statute).
Public comments are particularly invited on: Whether this collection of information is necessary; whether it will have practical utility; whether our 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 in which we can minimize the burden of the collection of information on those who are to respond, through the use of appropriate technological collection techniques or other forms of information technology.
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Notice with comment period.
Under the National Childhood Vaccine Injury Act (NCVIA) (42 U.S.C. 300aa-26), the Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) develops vaccine information materials that all health care providers are required to give to patients/parents prior to administration of specific vaccines. HHS/CDC seeks written comment on the proposed updated vaccine information statements for MMR (measles, mumps, and rubella) and MMRV (measles, mumps, rubella, and varicella) vaccines.
Written comments must be received on or before December 19, 2016.
You may submit comments, identified by Docket No. CDC-2016-0094, by any of the following methods:
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Skip Wolfe, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Mailstop A-19, 1600 Clifton Road NE., Atlanta, Georgia 30329, email:
The National Childhood Vaccine Injury Act of 1986 (Pub. L. 99-660), as amended by section 708 of Public Law 103-183, added section 2126 to the Public Health Service Act. Section 2126, codified at 42 U.S.C. 300aa-26, requires the Secretary of Health and Human Services to develop and disseminate vaccine information materials for distribution by all health care providers in the United States to any patient (or to the parent or legal representative in the case of a child) receiving vaccines covered under the National Vaccine Injury Compensation Program (VICP).
Development and revision of the vaccine information materials, also known as Vaccine Information Statements (VIS), have been delegated by the Secretary to the Centers for Disease Control and Prevention (CDC). Section 2126 requires that the materials be developed, or revised, after notice to the public, with a 60-day comment period, and in consultation with the Advisory Commission on Childhood Vaccines, appropriate health care provider and parent organizations, and
(1) A concise description of the benefits of the vaccine,
(2) A concise description of the risks associated with the vaccine,
(3) A statement of the availability of the National Vaccine Injury Compensation Program, and
(4) Such other relevant information as may be determined by the Secretary.
The vaccines initially covered under the National Vaccine Injury Compensation Program were diphtheria, tetanus, pertussis, measles, mumps, rubella and poliomyelitis vaccines. Since April 15, 1992, any health care provider in the United States who intends to administer one of these covered vaccines is required to provide copies of the relevant vaccine information materials prior to administration of any of these vaccines. Since then, the following vaccines have been added to the National Vaccine Injury Compensation Program, requiring use of vaccine information materials for them as well: Hepatitis B,
HHS/CDC is proposing updated versions of the MMR (measles, mumps, and rubella) and MMRV (measles, mumps, rubella, and varicella) vaccine information statements.
The vaccine information materials referenced in this notice are being developed in consultation with the Advisory Commission on Childhood Vaccines, the Food and Drug Administration, and parent and health care provider groups.
We invite written comment on the proposed revised vaccine information materials entitled “MMR Vaccine (Measles, Mumps, and Rubella): What You Need to Know” and “MMRV Vaccine (Measles, Mumps, Rubella, and Varicella): What You Need to Know.” Copies of the proposed vaccine information materials are available at
The PPR will continue to be administered to all active grantees of the CED program. Grantees will be required to use this reporting tool for their semi-annual reports to be submitted twice a year. The current PPR replaced both the annual questionnaire and other semi-annual reporting formats, which resulted in an overall reduction in burden for the grantees while significantly improving the quality of the data collected by OCS. OCS seeks to renew this PPR to continue to collect quality data from grantees. To ensure the burden on grantees is not increased, but that the information collected demonstrates the full impact of the program, OCS has conducted an in-depth review to remove indicators that are not being used; add indicators that will allow OCS to better demonstrate the impact of the program; and clarify language of some indicators to reduce grantee confusion. Based on this review, proposed changes to the CED PPR are minimal and focused on clarifying language, removing outdated indicators, and gathering minimal additional data that will not increase the burden on grantees. These measures will result in a stronger and streamlined CED PPR that will allow for the following:
A summary of all proposed changes can be provided upon request.
In compliance with the requirements of the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. Chap 35), the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 330 C Street SW., Washington DC 20201. Attn: ACF Reports Clearance Officer. Email address:
The Department specifically requests comments 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 of the proposed collection of information; (c) 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. Consideration will be given to comments and suggestions submitted within 60 days of this publication.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research (CDER) is proposing to withdraw approval of an abbreviated new drug application (ANDA) for methylphenidate hydrochloride (HCl) extended-release (ER) tablets and is announcing an opportunity for the holder of the ANDA to request a hearing on this proposal.
Mallinckrodt Pharmaceuticals may submit a request for a hearing by November 17, 2016. Submit all data, information, and analyses upon which the request for a hearing relies by December 19, 2016. Submit written or electronic comments by December 19, 2016.
The request for a hearing may be submitted by Mallinckrodt Pharmaceuticals by either of the following methods:
Submit electronic comments in the following way:
•
Submit written/paper submissions as follows:
•
• Because your request for a hearing will be made public, you are solely responsible for ensuring that your request does not include any confidential information that you may not wish to be publicly posted, such as confidential business information,
Mallinckrodt Pharmaceuticals may submit all data and analysis upon which the request for a hearing relies in the same manner as the request for a hearing except as follows:
•
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Maryll W. Toufanian, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1716, Silver Spring, MD 20993-0002, 240-402-7944.
CONCERTA (methylphenidate HCl) ER tablet is the subject of new drug application (NDA) 021121, held by Janssen Pharmaceuticals, Inc., and was approved on August 1, 2000. CONCERTA is a central nervous system stimulant intended for the treatment of attention deficit hyperactivity disorder in children 6 years of age and older, adolescents, and adults up to the age of 65. CONCERTA is a multiphasic modified-release product that is formulated to release a bolus of methylphenidate, resulting in an initial rapid rise in plasma concentration comparable to the effect of an immediate-release (IR) methylphenidate formulation, followed by sustained delivery later in the day, thereby allowing for once daily dosing. The relative bioavailability of CONCERTA in adults is comparable to IR methylphenidate administered three times daily, but the CONCERTA formulation minimizes the fluctuations between peak and trough concentrations associated with IR methylphenidate administered three times daily. CONCERTA is approved for the following strengths: 18 milligrams (mg), 27 mg, 36 mg, and 54 mg. CONCERTA was approved based on, among other things, safety studies and adequate and well-controlled clinical efficacy studies showing that the product is safe for its intended uses and has the effects claimed for it.
FDA's Office of Generic Drugs (OGD) approved ANDA 202608, held by Mallinckrodt Pharmaceuticals (Mallinckrodt), for a generic version of CONCERTA under the requirements of section 505(j) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(j)) and FDA's implementing regulations. OGD approved ANDA 202608 on December 28, 2012, for the 27-mg, 36-mg, and 54-mg strengths.
At the time of approval, FDA determined that the ANDA included data sufficient to demonstrate the bioequivalence of the Mallinckrodt product to CONCERTA. The bioequivalence (BE) testing and data submitted in the ANDA conformed to recommendations provided in a draft guidance for industry on “Methylphenidate hydrochloride.” The draft guidance was issued on September 14, 2012 (77 FR 56851), and provided information and recommendations for establishing bioequivalence to CONCERTA that reflected FDA's understanding, at that time, of how to evaluate the pharmacokinetic (PK) properties of CONCERTA to support a demonstration of bioequivalence. The demonstration of bioequivalence was necessary to the approval of Mallinckrodt's product. Unlike CONCERTA, Mallinckrodt was not required to submit clinical studies to demonstrate the safety and effectiveness of its product. Instead, Mallinckrodt's ANDA was approved based on a finding that the product was bioequivalent to CONCERTA and met the other requirements for ANDA approval in section 505(j) of the FD&C Act.
Mallinckrodt began marketing its generic version of CONCERTA in March 2013. OGD routinely monitors all newly approved ANDA products for safety and efficacy concerns as they penetrate the marketplace, including the monitoring of adverse events reported to the Agency. In May 2013, the FDA Adverse Event Reporting System (FAERS) began receiving reports that described insufficient therapeutic effect of the Mallinckrodt product, particularly reports describing insufficient effect later in the day.
a.
The initial meeting of the TSI Committee occurred in December 2013.
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•
•
•
The TSI was concluded in June 2014. Based on the information considered, the TSI Committee determined that the Mallinckrodt product may deliver methylphenidate into the body at a slower rate than CONCERTA during the time period of 7 to 12 hours post-dosing, and therefore, the product may not be bioequivalent or therapeutically equivalent to CONCERTA. Following the TSI Committee's investigation, CDER concluded that the therapeutic equivalence (TE) rating for the Mallinckrodt product in FDA's “Approved Drug Products with Therapeutic Equivalence Evaluations” (commonly referred to as the “Orange Book”) should be changed from AB to BX to indicate that the data are insufficient to determine that the Mallinckrodt product is therapeutically equivalent to CONCERTA.
On November 6, 2014 (79 FR 65978), CDER issued a revised draft guidance for industry on “Bioequivalence Recommendations for CONCERTA (Methylphenidate Hydrochloride) Extended-Release Tablets” (revised draft BE guidance) (Ref. 2), with recommendations for establishing bioequivalence to CONCERTA that reflect CDER's refined understanding of the relationship between the PK profile of CONCERTA and its therapeutic effect. The revised draft BE guidance is available on FDA's Web site and will be placed in Docket No. FDA-2016-N-3118.
On November 12, 2014, representatives from OGD and other CDER offices notified Mallinckrodt by telephone of CDER's concerns regarding its generic product. OGD explained that the TE rating for the product would be changed from AB to BX immediately. OGD requested that Mallinckrodt: (1) Voluntarily withdraw its product from the market under 21 CFR 314.150(d) and request that FDA withdraw approval of the ANDA or (2) confirm bioequivalence of its product within 6 months, consistent with the recommendations in the revised draft BE guidance issued on November 6, 2014. Mallinckrodt declined to voluntarily withdraw its product from the market, and it has not submitted data or information that confirms bioequivalence of its product to CONCERTA.
b.
In addition to the reanalysis described above, FDA performed further clinical trial simulations based on the BE data originally submitted in the ANDA to assess the potential clinical significance of the difference in PK profile,
Along with a reanalysis of data submitted in the original ANDA, in March 2015, CDER sponsored its own study to evaluate bioequivalence of the 27-mg Mallinckrodt product as compared to CONCERTA. The CDER-sponsored study was a single-dose, 4-treatment, fully replicated, crossover, randomized BE study (consistent with the study design recommended in the revised draft BE guidance) in healthy subjects under fasting conditions. The study compared: (1) The test product—Mallinckrodt's methylphenidate HCl ER tablets, 27 mg; and (2) the reference product—CONCERTA ER tablets, 27 mg. A total of 28 subjects were enrolled in the study, and 24 subjects completed all 4 periods. Plasma samples were collected for up to 24 hours following each treatment. The mean methylphenidate plasma concentration profiles for both the test and reference products exhibited PK properties consistent with those observed in the 54-mg fasting BE study submitted by Mallinckrodt in its ANDA. In particular, decreased plasma concentrations were observed with administration of the Mallinckrodt product as compared to CONCERTA after 6 to 7 hours. The 90 percent CI of the geometric mean test-to-reference ratio for AUC
Finally, FDA analyzed FAERS reports from February 2014 to May 2015. The types and quality of reports received by FDA during that time period were very similar to the reports received before FDA changed the TE rating. The reports continued to contain specific complaints describing the failure of therapeutic effect during the latter part of the day.
The applicant has not submitted data that confirms bioequivalence of its product to CONCERTA. A memorandum describing in detail the information considered following the TSI and explaining CDER's determination will be placed in Docket No. FDA-2016-N-3118 (Ref. 6).
An NDA (or reference listed drug) applicant must submit “full reports of investigations” to show that the drug for which the applicant is seeking approval is safe and effective. In other words, reference listed drugs must meet the safety and substantial evidence of effectiveness standard (see section 505(b)(1) and (2), (c), and (d) of the FD&C Act). A reference listed drug applicant can meet the standard by conducting its own clinical studies (stand-alone application) or relying, in part, on the Agency's previous finding of safety and/or effectiveness or literature (a 505(b)(2) application). An ANDA applicant does not submit independent clinical studies to demonstrate safety and effectiveness. Rather, an ANDA applicant relies on the Agency's previous finding of safety and effectiveness for the reference listed drug and is required to meet other requirements such as demonstrating bioequivalence to the reference listed drug to support approval. In the absence of information showing bioequivalence between the generic drug at issue and the reference listed drug, there is no basis for concluding that the Agency's finding of safety and efficacy (or substantial evidence of effectiveness) supporting approval of the reference listed drug likewise supports approval of the generic drug.
Therefore, based on all available data and information, notice is given to Mallinckrodt and to all other interested persons that the Director of CDER proposes to issue an order, under section 505(e)(3) of the FD&C Act and § 314.150(a)(2)(iii), withdrawing approval of ANDA 202608 and all amendments and supplements to it on the grounds that, on the basis of new information, evaluated together with the evidence available when the application was approved, there is a lack of substantial evidence that the drug will have the effect it is represented to have under the conditions of use prescribed, recommended, or suggested in its labeling.
In accordance with section 505(e) of the FD&C Act, the applicant is hereby provided an opportunity to request a hearing to show why approval of ANDA 202608 should not be withdrawn and an opportunity to raise, for administrative determination, all issues relating to the legal status of the drug product covered by this application.
An applicant who decides to seek a hearing must file the following: (1) A written notice of participation and request for hearing (see
The failure of an applicant to file a timely written notice of participation and request for a hearing, as required by § 314.200, constitutes an election by that applicant not to avail itself of the opportunity for a hearing concerning CDER's proposal to withdraw approval of the application and constitutes a waiver of any contentions concerning the legal status of the drug product. FDA will then withdraw approval of the application, and the drug product may not thereafter be lawfully introduced or delivered for introduction into interstate commerce. Any new drug product introduced or delivered for introduction into interstate commerce without an approved application is subject to regulatory action at any time.
A request for a hearing may not rest upon mere allegations or denials, but must present specific facts showing that there is a genuine and substantial issue of fact that requires a hearing. If a request for a hearing is not complete or is not supported, the Commissioner of Food and Drugs will enter summary
All submissions under this notice of opportunity for a hearing must be filed in two copies. Except for data and information prohibited from public disclosure under 21 U.S.C. 331(j) or 18 U.S.C. 1905, the submissions may be seen in the Division of Dockets Management (see
This notice is issued under section 505(e) of the FD&C Act and under the authority delegated to the Director of CDER by the Commissioner of Food and Drugs.
The following references are on display in the Division of Dockets Management (see
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research (CDER) is proposing to withdraw approval of an abbreviated new drug application (ANDA) for methylphenidate hydrochloride (HCl) extended-release (ER) tablets and is announcing an opportunity for the holder of the ANDA to request a hearing on this proposal.
Kremers Urban Pharmaceuticals Inc., may submit a request for a hearing by November 17, 2016. Submit all data, information, and analyses upon which the request for a hearing relies by December 19, 2016. Submit written or electronic comments by December 19, 2016.
The request for a hearing may be submitted by Kremers Urban Pharmaceuticals Inc., by either of the following methods:
Submit electronic comments in the following way:
•
Submit written/paper submissions as follows:
•
Because your request for a hearing will be made public, you are solely responsible for ensuring that your request does not include any confidential information that you may not wish to be publicly posted, such as confidential business information,
Kremers Urban Pharmaceutical Inc., may submit all data and analysis upon which the request for a hearing relies in the same manner as the request for a hearing except as follows:
• Confidential Submissions—To submit any data and analyses with confidential information that you do not wish to be made publicly available, submit your data and analyses only as a written/paper submission. You should submit two copies total of all data and analysis. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of any decisions on this matter. The second copy, which will have the claimed information redacted/blacked out, will be available for public viewing and posted on
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Maryll W. Toufanian, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1716, Silver Spring, MD 20993-0002, 240-402-7944.
CONCERTA (methylphenidate HCl) ER tablet is the subject of new drug application (NDA) 021121, held by Janssen Pharmaceuticals, Inc., and was approved on August 1, 2000. CONCERTA is a central nervous system stimulant intended for the treatment of attention deficit hyperactivity disorder in children 6 years of age and older, adolescents, and adults up to the age of 65. CONCERTA is a multiphasic modified-release product that is formulated to release a bolus of methylphenidate, resulting in an initial rapid rise in plasma concentration comparable to the effect of an immediate-release (IR) methylphenidate formulation, followed by sustained delivery later in the day, thereby allowing for once daily dosing. The relative bioavailability of CONCERTA in adults is comparable to IR methylphenidate administered three times daily, but the CONCERTA formulation minimizes the fluctuations between peak and trough concentrations associated with IR methylphenidate administered three times daily. CONCERTA is approved for the following strengths: 18 milligrams (mg), 27 mg, 36 mg, and 54 mg. CONCERTA was approved based on, among other things, safety studies and adequate and well-controlled clinical efficacy studies showing that the product is safe for its intended uses and has the effects claimed for it.
FDA's Office of Generic Drugs (OGD) approved ANDA 091695, held by Kremers Urban Pharmaceuticals Inc. (Kremers),
At the time of approval, FDA determined that the ANDA included data sufficient to demonstrate the bioequivalence of the Kremers product to CONCERTA. The bioequivalence (BE) testing and data submitted in the ANDA conformed to recommendations provided in a draft guidance for industry on “Methylphenidate hydrochloride.” The draft guidance was issued on September 14, 2012 (77 FR 56851), and provided information and recommendations for establishing bioequivalence to CONCERTA that reflected FDA's understanding, at that time, of how to evaluate the pharmacokinetic (PK) properties of CONCERTA to support a demonstration of bioequivalence. The demonstration of bioequivalence was necessary to the approval of Kremers' product. Unlike CONCERTA, Kremers was not required to submit clinical studies to demonstrate the safety and effectiveness of its product. Instead, Kremers' ANDA was approved based on a finding that the product was bioequivalent to CONCERTA and met the other requirements for ANDA approval in section 505(j) of the FD&C Act.
Kremers began marketing the 18-mg and 27-mg strengths of its generic version of CONCERTA in August 2013 and began marketing the 36-mg and 54-mg strengths in October 2013. OGD routinely monitors all newly approved ANDA products for safety and efficacy concerns as they penetrate the marketplace, including the monitoring of adverse events reported to the Agency. Beginning in September 2013, the FDA Adverse Event Reporting System (FAERS) received reports describing insufficient therapeutic effect of the Kremers product, particularly reports of insufficient effect later in the day.
a.
The initial meeting of the TSI Committee occurred in December 2013. The TSI Committee was composed of CDER physicians, pharmacists, and chemists, as well as other CDER scientists and experts, who carefully reviewed all of the data and information related to the Kremers product. Key information reviewed and discussed by the TSI Committee is summarized as follows.
•
•
•
The TSI was concluded in June 2014. Based on the information considered, the TSI Committee determined that the Kremers product may deliver methylphenidate into the body at a slower rate than CONCERTA during the time period of 7 to 12 hours post-dosing, and therefore, the product may not be bioequivalent or therapeutically equivalent to CONCERTA. Following the TSI Committee's investigation, CDER concluded that the therapeutic equivalence (TE) rating for the Kremers product in FDA's “Approved Drug Products With Therapeutic Equivalence Evaluations” (commonly referred to as the “Orange Book”) should be changed from AB to BX to indicate that the data are insufficient to determine that the Kremers product is therapeutically equivalent to CONCERTA.
On November 6, 2014 (79 FR 65978), CDER issued a revised draft guidance for industry on “Bioequivalence Recommendations for CONCERTA (Methylphenidate Hydrochloride) Extended-Release Tablets” (revised draft BE guidance) (Ref. 1)), with recommendations for establishing bioequivalence to CONCERTA that reflect CDER's refined understanding of the relationship between the PK profile of CONCERTA and its therapeutic effect. The revised draft BE guidance is available on FDA's Web site and will be placed in Docket No. FDA-2016-N-3120.
On November 12, 2014, representatives from OGD and other CDER offices notified Kremers by telephone of CDER's concerns regarding its generic product. OGD explained that
b.
In light of the close relationship between the PK profile and therapeutic effect of methylphenidate products (Refs. 4 and 5), FDA performed a clinical trial simulation based on the BE data submitted in the ANDA to predict the potential clinical significance of the difference in PK profile,
In addition to a reanalysis of data submitted in the original ANDA, FDA also reviewed BE data submitted by Kremers in June 2015. Kremers conducted fully replicated BE studies under fasting and fed conditions using the 54-mg strength product, in accordance with the recommendations in the revised draft BE guidance. FDA independently analyzed the data submitted and found that Kremers' product failed to meet the criteria for bioequivalence under fed conditions because it did not provide the same extent of methylphenidate exposure as CONCERTA during the 8- to 12-hour time period after administration.
Finally, FDA analyzed FAERS reports from February 2014 to May 2015. The types and quality of reports received by FDA during that time period were very similar to the FAERS reports received before the change in TE rating. The reports continued to contain specific complaints describing the lack of therapeutic effect during the latter part of the day.
A memorandum describing in detail the information considered following the TSI and explaining CDER's determination will be placed in Docket No. FDA-2016-N-3120 (Ref. 6).
An NDA (or reference listed drug) applicant must submit “full reports of investigations” to show that the drug for which the applicant is seeking approval is safe and effective. In other words, reference listed drugs must meet the safety and substantial evidence of effectiveness standard (see section 505(b)(1), (b)(2), (c), and (d) of the FD&C Act). A reference listed drug applicant can meet the standard by conducting its own clinical studies (stand-alone application) or relying, in part, on the Agency's previous finding of safety and/or effectiveness or literature (a 505(b)(2) application). An ANDA applicant does not submit independent clinical studies to demonstrate safety and effectiveness. Rather, an ANDA applicant relies on the Agency's previous finding of safety and effectiveness for the reference listed drug and is required to meet other requirements, such as demonstrating bioequivalence to the reference listed drug to support approval. In the absence of information showing bioequivalence between the generic drug at issue and the reference listed drug, there is no basis for concluding that the Agency's finding of safety and efficacy (or substantial evidence of effectiveness) supporting approval of the reference listed drug likewise supports approval of the generic drug.
Therefore, based on all available data and information, notice is given to Kremers and to all other interested persons that the Director of CDER proposes to issue an order, under section 505(e)(3) of the FD&C Act and § 314.150(a)(2)(iii), withdrawing approval of ANDA 091695 and all amendments and supplements to it on the grounds that, on the basis of new information, evaluated together with the evidence available when the application was approved, there is a lack of substantial evidence that the drug will have the effect it is represented to have under the conditions of use prescribed, recommended, or suggested in its labeling.
In accordance with section 505(e) of the FD&C Act, the applicant is hereby provided an opportunity to request a hearing to show why approval of ANDA 091695 should not be withdrawn and an opportunity to raise, for administrative determination, all issues relating to the legal status of the drug product covered by this application.
An applicant who decides to seek a hearing must file the following: (1) A written notice of participation and request for hearing (see
The failure of an applicant to file a timely written notice of participation and request for a hearing, as required by § 314.200, constitutes an election by that applicant not to avail itself of the opportunity for a hearing concerning CDER's proposal to withdraw approval of the application and constitutes a waiver of any contentions concerning the legal status of the drug product. FDA will then withdraw approval of the application, and the drug product may not thereafter be lawfully introduced or delivered for introduction into interstate commerce. Any new drug product introduced or delivered for introduction into interstate commerce without an approved application is subject to regulatory action at any time.
A request for a hearing may not rest upon mere allegations or denials, but must present specific facts showing that there is a genuine and substantial issue of fact that requires a hearing. If a request for a hearing is not complete or is not supported, the Commissioner of Food and Drugs will enter summary judgment against the person who requests the hearing, making findings and conclusions, and denying a hearing.
All submissions under this notice of opportunity for a hearing must be filed in two copies. Except for data and information prohibited from public disclosure under 21 U.S.C. 331(j) or 18 U.S.C. 1905, the submissions may be seen in the Division of Dockets Management (see
This notice is issued under section 505(e) of the FD&C Act and under the authority delegated to the Director of CDER by the Commissioner of Food and Drugs.
The following references are on display in the Division of Dockets Management (see
Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS).
Notice.
In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.
Comments on this ICR must be received no later than November 17, 2016.
Submit your comments, including the ICR Title, to the desk officer for HRSA, either by email to
To request a copy of the clearance requests submitted to OMB for review, email the HRSA Information Collection Clearance Officer at
NPDB began operation on September 1, 1990. The statutory authorities establishing and governing the NPDB are Title IV of Public Law (Pub. L.) 99-660, the Health Care Quality Improvement Act of 1986, as amended, Section 5 of the Medicare and Medicaid Patient and Program Protection Act of 1987, Public Law 100-93, codified as Section 1921 of the Social Security Act, and Section 221(a) of the Health Insurance Portability and Accountability Act of 1996, Public Law 104-191, codified as Section 1128E of
NPDB acts primarily as a flagging system; its principal purpose is to facilitate comprehensive review of practitioners' professional credentials and background. Information on medical malpractice payments, health-related civil judgments, adverse licensure actions, adverse clinical privileging actions, adverse professional society actions, and Medicare/Medicaid exclusions is collected from, and disseminated to, eligible entities such as licensing boards, hospitals, and certain other health care entities. It is intended that NPDB information should be considered with other relevant information in evaluating a practitioner's credentials.
NPDB outlines specific reporting requirements for hospitals, medical malpractice payers, health plans, and certain other health care entities per 45 CFR 60.7, 60.12, 60.14, 60.15, and 60.16. These reporting requirements are further explained in Chapter E of the NPDB e-Guidebook, which can be found at:
Through a process called Attestation, hospitals, medical malpractice payers, health plans, and certain other health care entities will be required to attest that they understand and have met their responsibility to submit all required reports to the NPDB. The Attestation process will be completely automated through the secure NPDB system (
Although the Attestation process and forms are new, the secure NPDB system currently used by hospitals, medical malpractice payers, health plans, and certain other health care entities to conduct reporting and querying will not change, ensuring that these entities are familiar with the interface needed to complete the Attestation process. NPDB will ask these entities to attest their reporting compliance every 2 years. If the organization is responsible for privileging or credentialing individuals who provide services for other sites, those sites will be included in the Attestation process.
The Attestation forms will collect the following information: information regarding sub-sites and entity relationships; contact information for the Attesting Official; and a statement attesting whether or not all required reports have been submitted.
Title 5, U.S.C. 4314(c) (4) of the Civil Service Reform Act of 1978, Public Law 95-454, requires that the appointment of Performance Review Members be published in the
The following persons may be named to serve on the Performance Review Boards or Panels, which oversee the evaluation of performance appraisals of Senior Executive Service members of
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), 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.
Notice is hereby given of a change in the meeting of the National Science Advisory Board for Biosecurity, November 04, 2016, 12:00 p.m. to November 04, 2016, 03:00 p.m., National Institutes of Health, 6705 Rockledge Drive, Suite 750, Bethesda, MD 20892 which was published in the
The call-in number has changed to 1 (866) 939-3921. The meeting date, time and location remains the same. The meeting is open to the public.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App), 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.
Notice of Federal advisory committee meeting.
The Navigation Safety Advisory Council will meet in Tampa, Florida to discuss matters relating to maritime collisions, rammings, and groundings, Inland Rules of the Road, International Rules of the Road, navigation regulations and equipment, routing measures, marine information, diving safety, and aids to navigation systems. These meetings will be open to the public.
The Navigation Safety Advisory Council will meet on Wednesday, November 2, 2016, from 8 a.m. to 5:30 p.m., and on Thursday, November 3, 2016, from 8 a.m. to 5:30 p.m. Please note these meetings may close early if the Council has completed its business.
The meeting will be held at Hilton Saint Petersburg Bayfront, 333 1st Street S., Saint Petersburg, Florida 33701-4342. The hotel Web site
For information on facilities or services for individuals with disabilities or to request special assistance at the meeting, contact Mr. Lahn listed in
If you have questions about these meetings, please contact Mr. George Detweiler, the Navigation Safety Advisory Council Alternate Designated Federal Officer, Commandant (CG-NAV-2), U.S. Coast Guard, 2703 Martin Luther King Jr. Avenue SE., Stop 7418, Washington, DC 20593, telephone 202-372-1566 or email
Notice of this meeting is in compliance with the Federal Advisory Committee Act, Title 5 United States Code, Appendix.
The Navigation Safety Advisory Council is an advisory committee authorized in 33 U.S.C. 2073 and chartered under the provisions of the Federal Advisory Committee Act. The Navigation Safety Advisory Council provides advice and recommendations to the Secretary, through the Commandant of the U.S. Coast Guard, on matters relating to prevention of maritime collisions, rammings, and groundings, Inland and International Rules of the Road, navigation regulations and equipment, routing measures, marine information, diving safety, and aids to navigation systems.
(1) The Vessel Traffic Service Study conducted by the National Transportation Safety Board; and
(2) The Atlantic and Gulf Coast Seacoast Waterways and Analysis Management System Study being conducted by the Coast Guard.
Following the above presentations, the Designated Federal Officer will form subcommittees to continue discussions on the following task statements:
(1) Navigation Safety Advisory Council Task 16-01 Review the navigation safety consequences of ships using Ultra Low Sulphur Fuel Oil and recommend measures to mitigate those consequences; and
(2) Navigation Safety Advisory Council Task 16-02 Develop criteria for reporting “near miss” incidents.
Public comments or questions will be taken during the meeting as the Council discusses each issue and prior to the Council formulating recommendations on each issue. There will also be a public comment period at the end of the meeting.
(1) Subcommittee discussions continued from Wednesday, November 2, 2016;
(2) Subcommittee reports presented to the Council;
(3) New Business; and
a. Summary of Navigation Safety Advisory Council action items.
b. Schedule next meeting date—Summer, 2017.
c. Council discussions and acceptance of new tasks.
A public comment period will be held after the discussion of new tasks. Speakers are requested to limit their comments to 10 minutes each. Public comments or questions will be taken at the discretion of the Designated Federal Officer during the discussion and recommendations, and new business portion of the meeting. Please contact Mr. Lahn, listed in the
U.S. Citizenship and Immigration Services, Department of Homeland Security.
30-Day notice.
The Department of Homeland Security (DHS), U.S. Citizenship and Immigration Services (USCIS) will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995. The information collection notice was previously published in the
The purpose of this notice is to allow an additional 30 days for public comments. Comments are encouraged and will be accepted until November 17, 2016. This process is conducted in accordance with 5 CFR 1320.10.
Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, must be directed to the OMB USCIS Desk Officer via email at
You may wish to consider limiting the amount of personal information that you provide in any voluntary submission you make. For additional information please read the Privacy Act notice that is available via the link in the footer of
USCIS, Office of Policy and Strategy, Regulatory Coordination Division, Samantha Deshommes, Chief, 20 Massachusetts Avenue NW., Washington, DC 20529-2140, Telephone number (202) 272-8377 (comments are not accepted via telephone message). Please note contact information provided here is solely for questions regarding this notice. It is not for individual case status inquiries. Applicants seeking information about the status of their individual cases can check Case Status Online, available at the USCIS Web site at
You may access the information collection instrument with instructions, or additional information by visiting the Federal eRulemaking Portal site at:
(1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
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U.S. Citizenship and Immigration Services, Department of Homeland Security.
30-Day Notice.
The Department of Homeland Security (DHS), U.S. Citizenship and Immigration Services (USCIS) will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995. The information collection notice was previously published in the
The purpose of this notice is to allow an additional 30 days for public comments. Comments are encouraged and will be accepted until November 17, 2016. This process is conducted in accordance with 5 CFR 1320.10.
Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, must be directed to the OMB USCIS Desk Officer via email at
You may wish to consider limiting the amount of personal information that you provide in any voluntary submission you make. For additional information please read the Privacy Act notice that is available via the link in the footer of
USCIS, Office of Policy and Strategy, Regulatory Coordination Division, Samantha Deshommes, Chief, 20 Massachusetts Avenue NW., Washington, DC 20529-2140, Telephone number (202) 272-8377 (comments are not accepted via telephone message). Please note contact information provided here is solely for questions regarding this notice. It is not for individual case status inquiries. Applicants seeking information about the status of their individual cases can check Case Status Online, available at the USCIS Web site at
You may access the information collection instrument with instructions, or additional information by visiting the Federal eRulemaking Portal site at:
(1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
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Office of Housing, HUD.
Notice Amendment.
The Department is publishing a notice advising of a system of records amendment for system of records: Computerized Homes Underwriting Management System—Development of New System of Records, Loan Application Management System, published in the
Helen Goff Foster, Chief Privacy Officer/Senior Agency Official for Privacy, 451 Seventh Street SW., Room 10139, Washington, DC 20410, telephone number 202-402-6836 (this is not a toll-free number). Individuals who are hearing- and speech-impaired may access this number via TTY by calling the Federal Relay Service at 800-877-8339 (this is a toll-free number).
Amendments to this notice: HUD published in the
• Mortgagors (Borrowers): name, address, Social Security number (SSN) or other identification number, racial/ethnic background (if disclosed), date of birth, credit scores (often referred to as FICO® Scores), marital status, and details about the mortgage loan, including loan application documentation. This information is supplied by lenders during the mortgage application and underwriting process.
• Non-Borrowing Spouses: name, SSN or other identification number, date of birth, and details about the mortgage loan, including loan application documentation. This information is supplied by lenders during the mortgage application and underwriting process on specific loan types to acknowledge in writing that the non-borrowing spouse has protections under the law to remain in the home after the death of their borrowing spouse or an indication that the non-borrowing spouse is not a borrower and not required to sign the loan contract and the property does not serve as their primary residence.
• Appraisers and Inspectors: name, address, SSN or other identification number, territory, workload, and minority data including racial/ethnic background, Minority Business Enterprise (MBE) Code, and sex, for statistical tracking purposes. Mortgagee (Lender) Staff Appraisers and Underwriters, 203k Consultants, and HECM Counselors: SSN or other identification number, territory and workload of the individuals.
• HUD Employees: name and SSN or other identifying number of employees involved in the single family underwriting process. This includes, but is not limited to: Homeownership Center managers, staff appraisers, architectural employees, receiving clerks, assignment clerks, commitment clerks, records clerks, and closing clerks.
• Individuals registering to access the HUD Housing Counselor Certification Examination: legal first and last name, mailing address, telephone number, email address, fax number (if applicable), SSN, and employer's HUD Housing Counseling System (HCS) number (if registrant's employer is a housing counseling agency participating in HUD's Housing Counseling Program). Registrants have the option of providing demographic information: race, ethnicity, gender and languages in which counseling services are offered. HUD is collecting information on languages to assess the number of examinees that might benefit from certification examination training materials being available in other languages. Information for fee payment will be collected by a third party vendor and will include credit card number, expiration date, and security code.
• Individuals registering for HUD Certified Housing Counselor status or for Agency Application Coordinator for FHA Connection: legal first and last name, mailing address, telephone number, email address, fax number (if applicable), SSN, HUD Housing Counselor Certification System ID number, mother's maiden name, and employer's HUD Housing Counseling System (HCS) ID number, and verification of employing agency's name.
• Examination Information: scores from housing counselor certification examination list of all test-takers who pass the certification examination.
• Client Certificate of Housing Counseling: legal first and last name and address of the housing counseling client receiving counseling services from an agency participating in HUD's Housing Counseling Program; legal first and last name and the Counselor ID number of the counselor completing the client certificate of housing counseling; name, address, telephone number, Employer Identification Number (EIN), and HCS ID number of the agency participating in HUD's Housing Counseling Program; date and type of counseling service received; fees collected or waived; and whether counseling or education occurred in-person or remotely (telephone or Internet).
• NOTE: Certain records contained in this system which pertain to individuals contain principally proprietary information concerning sole proprietorships that may also reflect personal information, however, only the records reflecting personal information are subject to the Privacy Act.
According to GRS 1.2 DAA-GRS-2013-0008-0001, records collected and stored for HUD Certified Housing Counselor Certification and/or Client Housing Counseling Certificates that reside in the systems will be kept for a minimum 10 years after the final action is taken on the file, document, and/or transaction. Longer retention is authorized if required for business use (Reference: GRS 1.2 DAA-GRS-2013-0008-0001).
After the record retention requirements have been met (a minimum of 10 years), the data and records can be purged or deleted from the system. If paper records are generated from the system, they can be archived at the local Federal Records Center after the final action or transaction has taken place.
Pursuant to the Privacy Act and the Office of Management and Budget (OMB) guidelines, the amended notices meets threshold requirements for having to transmit a report to OMB, the Senate Committee on Homeland Security and Governmental Affairs, and the House Committee on Oversight and Government Reform, as instructed by paragraph 4c of Appendix l to OMB Circular No. A-130, “Federal Agencies Responsibilities for Maintaining Records About Individuals,” November 28, 2000.
5 U.S.C. 552a; 88 Stat. 1896; 42 U.S.C. 3535(d).
HSNG.SF/HUP.02.
Computerized Homes Underwriting Management System (CHUMS) F17/Loan Application Management System (LAMS) P292)).
The CHUMS and LAMS system is hosted at the Hewlett Packard (HP) Facility at 2020 Union Carbide Drive, South Charleston, West Virginia 25303-2734. HP is the designated records management facility for LAMS and the Atlanta Federal Records Center at 4712 Southpark Boulevard, Ellenwood, GA 30294 is the records management facility for CHUMS until LAMS is fully implemented. Additionally, staff in HUD Headquarters and throughout the country access CHUMS and LAMS through HUD's standard telecommunications network from desktop work stations, and access by both HUD employees and business partners is granted via secure HTTP through the HUD FHA Connection portal. Internal and external HUD hosted locations are as follows: HUD headquarters building, 451 Seventh Street, SW., Washington, DC 20410; the HUD owned and operated Home Ownership Centers, located in Atlanta, GA; Denver, CO; Philadelphia, PA; and Santa Ana, CA; and the sixty-one (61) HUD owned and operated Field Offices
Individuals who have applied for a mortgage insured under HUD/FHA's single-family mortgage insurance programs, including any non-borrowing spouses associated with the transaction. Also, HUD business partners (appraisers, inspectors, mortgagee staff underwriters), HUD employees (appraisers, mortgage credit examiners, architectural employees, receiving clerks, assignment clerks, commitment clerks, records clerks, and closing clerks) involved in the HUD/FHA single-family underwriting process; individuals who pass the HUD Certified Housing Counselor examination whether or not they become certified, individuals seeking HUD certified housing counselor certification, or housing counseling clients receiving housing counseling from an agency participating in HUD's Housing Counseling Program.
Automated files contain the following categories of records:
• Mortgagors (Borrowers): name, address, Social Security number (SSN) or other identification number, racial/ethnic background (if disclosed), date of birth, credit scores (often referred to as FICO® Scores), marital status, and details about the mortgage loan, including loan application documentation. This information is supplied by lenders during the mortgage application and underwriting process.
• Non-Borrowing Spouses: name, SSN or other identification number, date of birth, and details about the mortgage loan, including loan application documentation. This information is supplied by lenders during the mortgage application and underwriting process on specific loan types to acknowledge in writing that the non-borrowing spouse has protections under the law to remain in the home after the death of their borrowing spouse or an indication that the non-borrowing spouse is not a borrower and not required to sign the loan contract and the property does not serve as their primary residence.
• Appraisers and Inspectors: name, address, SSN or other identification number, territory, workload, and minority data including racial/ethnic background, minority business enterprise (MBE) Code, and sex, for statistical tracking purposes.
• Mortgagee (Lender) Staff Appraisers and Underwriters: SSN or other identification number, territory and workload of the individuals.
• HUD Employees: name, SSN or other identifying number of employees involved in the single family underwriting process. This includes, but is not limited to: Homeownership Center managers, staff appraisers, architectural employees, receiving clerks, assignment clerks, commitment clerks, records clerks, and closing clerks.
• Individuals registering to access the HUD Housing Counselor Certification Examination: Legal first and last name, mailing address, telephone number, email address, fax number (if applicable), SSN, and employer's HUD Housing Counseling System (HCS) number (if registrant's employer is a housing counseling agency participating in HUD's Housing Counseling Program). Registrants have the option of providing demographic information: Race, ethnicity, gender and languages in which counseling services are offered. HUD is collecting information on languages to assess the number of examinees that might benefit from certification examination training materials being available in other languages. Information for fee payment will be collected by a third party vendor and will include credit card number, expiration date, and security code.
• Individuals registering for HUD Certified Housing Counselor status or for Agency Application Coordinator for FHA Connection: Legal first and last name, mailing address, telephone number, email address, fax number (if applicable), SSN, HUD Housing Counselor Certification System ID number, mother's maiden name, and employer's HUD Housing Counseling System (HCS) ID number, and verification of employing agency's name.
• Examination Information: Scores from housing counselor certification examination list of all test-takers who pass the certification examination.
• Client Certificate of Housing Counseling: Legal first and last name and address of the housing counseling client receiving counseling services from an agency participating in HUD's Housing Counseling Program, legal first and last name and the Counselor ID number of the counselor completing the client certificate of housing counseling, name, address, telephone number,
Certain records contained in this system which pertain to individuals contain principally proprietary information concerning sole proprietorships may also reflect personal information, however, only the records reflecting personal information are subject to the Privacy Act.
Section 203, National Housing Act, Public Law 73-479, enables HUD/FHA to process applications for HUD mortgage insurance and respond to inquiries regarding applications and insured mortgages; The Housing and Community Development Act of 1987, 42 U.S.C. 3543, authorizes HUD to collect SSNs Social Security numbers for FHA Connect users are collected to ensure mortgagee eligibility requirements are met, 12 U.S.C. § 1708(d)); Subtitle D of title XIV of the Dodd-Frank Wall Street Reform and Consumer Protection Act, Public Law 111-203, 124 Stat. 1376 (July 21, 2010); Section 106 of the Housing and Urban Development Act of 1968, 12 U.S.C. 1701x.
The Loan Application Management System (LAMS) is developed to better assist FHA with its automated processing, analysis, and screening of the appraisal documentation. CHUMS is developed to support lenders and HUD staff in the processing of insurance applications for single-family mortgages, from the initial loan application all the way through endorsement. Various mortgage loan types are processed through CHUMS, including loans for First Time Homebuyers, Home Equity Conversion Mortgages (HECM), Section 184 Indian Home Loan Guarantee, and 203K rehabilitation loans. CHUMS provides HUD field office staff functionality for tracking and processing cases, and allows monitoring of workloads by field office management. CHUMS also contains the FHA TOTAL (Technology Open to Approved Lenders) Scorecard, which evaluates the overall creditworthiness of mortgage loan applications submitted through Automated Underwriting Systems based on a number of credit variables, and determines the associated level of risk for loans submitted for FHA insurance.
The new LAMS tool is being created to become the eventual replacement system for CHUMS. The existing functionality in CHUMS will be moved into LAMS in stages over the next five years. In its initial release, LAMS will enable HUD to start collecting case binder data into an industry-wide electronic format that is acceptable to Mortgage Industry Standard Maintenance Organization (MISMO) data standards. The improved enhancements will allow HUD to screen out errors in the appraisal and endorsement process more proficiently. In the past, HUD has identified far too late in the appraisal and endorsement process when a loan was at risk or in danger of fraud. Implementing the new LAMS tool and new evaluation process will allow HUD to better evaluate errors in the appraisal and endorsement process, and avoid endorsing unqualified loans. FHA believes that having the mortgage insurance documentation evaluated earlier on in the process will over time have a tremendous impact on the performance of HUD's mortgage insurance programs. The existing HUD data collected on applications for single-family mortgage insurance endorsements, includes electronic copies of mortgage documentation, along with the results of automated risk scoring and fraud validations, electronic copies of the lender submitted mortgage insurance appraisal records, the underlying data and metadata of documentation obtained in the application, underwriting, insuring and closing stages of the mortgage loan transaction will be used for risk management evaluation studies of the abovementioned mortgage insurance portfolios. The purpose for collecting the new records that will be maintained by this system is to verify the participating agency's compliance with HUD's Housing Counseling Program requirements. Other statutory changes to improve the effectiveness of housing counseling include increasing the breadth of counseling services so that they are comprehensive with respect to homeownership and rental counseling and issuing client Certificates of Housing Counseling to verify counseling requirements for FHA and other Federal, State, and local programs, as applicable. HUD's Housing Counseling Program currently provides comprehensive homeownership and rental counseling. As noted in the proposed rule published on September 13, 2013, an individual counselor, in contrast to multiple counseling agencies, will have to show competency (through passage of an examination) in identifying and understanding the breadth of homeownership and rental counseling services. Currently, a potential homebuyer or homeowner is likely to seek a housing counseling agency that specializes in a specific area and receive comprehensive counseling by a counselor in that specific area. As a result of increasing the breadth of counseling service knowledge, a housing counselor providing counseling on a specific area requested by the client would also be trained to identify cross-cutting issues that a client may not have identified when seeking out a specific counselor or during the intake process by the housing counseling agency. In addition, certifying individual counselors may further enhance the high regard of agencies and counselors participating in HUD's Housing Counseling Program.
In addition to those disclosures generally permitted under 5 U.S.C. Section 552a (b) of the Privacy Act, all or a portion of the records or information contained in this system may be disclosed outside HUD as a routine use pursuant to 5 U.S.C. 552a (b) (3) as follows:
1. To appropriate agencies, entities, and persons to the extent such disclosures are compatible with the purpose for which the records in this system were collected, as set forth by Appendix I—HUD's Routine Use Inventory Notice,
2. To appropriate agencies, entities, and persons when:
a. HUD suspects or has confirmed that the security or confidentiality of information in a system of records has been compromised;
b. HUD has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of systems or programs (whether maintained by HUD or another agency or entity) that rely upon the compromised information;
c. HUD determines that the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with HUD's efforts to respond to the suspected or confirmed compromise of security.
3. To a congressional office from the record of an individual in response to
4. To the Federal Bureau of Investigations for investigations of possible fraud revealed in FHA underwriting, insuring or monitoring process for mortgage insurance.
5. To the Department of Justice for prosecutions of fraud revealed in FHA underwriting, insuring or monitoring process for mortgage insurance.
6. To the General Accounting Office (GAO) for audit purposes.
7. To financial institutions (including Government Sponsored Enterprises), computer software companies and other Federal agencies (including the Federal Reserve) to enhance program operations and performance through automated underwriting, credit scoring and risk management.
8. To other federal agencies (including the Federal Reserve) for purposes of research not involving personally identifiable information, to evaluate program effectiveness in meeting HUD's/FHA's mission, or to inform policy makers on changes to effect program improvements.
9. To the Department's Office of Policy Development Research and its researchers for mortgage credit evaluations and statistical analysis.
10. To contractors, grantees, experts, consultants, and the agents thereof, and others performing or working on a contract, service, grant, cooperative agreement with HUD, when necessary to accomplish an agency function related to these system of records, limited to only those data elements considered relevant to accomplishing an agency function. Individuals provided information under this routine use is subject to the same Privacy Act requirements and limitations on disclosure as are applicable to HUD officers and employees. To contractors, experts, consultants with whom HUD has a contract, service agreement or other assignment of the Department, when necessary to utilize relevant data for purposes of testing new technology and systems designed to enhance program operations and performance.
11. To third party fee collection service when needed for payment of certified housing counselor examination fees. Only legal name, address for credit card billing, and telephone number will be released.
12. To the general public to verify if a certified housing counselor identification number is valid. Only certified housing counselor first and last name and housing counseling agency(ies) that employ this counselor will be released under this be routine use for valid certified housing counselor identification numbers. The information will be released to any interested person only through a specific Web page on either
Records in this system are stored on magnetic tape/disc/drum. If paper records are generated, they will be stored from unauthorized use and stored at the Federal Records facility.
Electronic/paper records are retrieved by case number, name, social security number housing counselor ID number, or other identification number. Office of Housing Counseling Staff will be able to retrieve counselor employment history for specific time periods. The general public will be able to verify if a counselor is currently certified by HUD through a public access Web page on HUD.gov or HUD Exchange. The public search will identify the name of the housing counselor and agency(ies) the counselor is employed by. Full access to HUD Certified Housing Counselor Database information in CHUMS will be limited to a few individuals on an as-needed basis for compliance purposes.
Electronic records are maintained in secure areas, and access is limited to authorized personnel.
Current Procedures: Data is retained online for 13 months after the date of endorsement, or 13-18 months for non-endorsed cases, and then archived. The archived data can be retrieved upon request. In archive data, CHUMS retains case data indefinitely. The Records Retention Schedule for CHUMS/F17 is listed in the HUD Records Disposition Schedules Handbook (2225.6), Schedule 20,
Processes are being put in place to align all practices where information will be retained, archived, then destroyed in accordance with HUD approved Records Disposition Schedule Handbook (2225.6), Schedule 20. According to Records Management Office and Schedule 20 of HUD's Record Retention Schedule, records will be retained, archived, and destroyed a minimum of 6 years after the term of the mortgage. In some cases, this may be up to 36 years, at which time the information should be transferred to NARA. The transfer of the data would eliminate the concern of not having access to the information if needed in the future. The records collected and stored for HUD Certified Housing Counselor Certification and/or Client Housing Counseling Certificates that reside in the systems will be kept for a minimum 10 years after the final action is taken on the file, document, and/or transaction. Longer retention is authorized if required for business use (Reference: GRS 1.2 DAA-GRS-2013-0008-0001). After the record retention requirements have been met (a minimum of 10 years), the data and records can be purged or deleted from the system. Backup and Recovery digital media will be destroyed or otherwise rendered irrecoverable per NIST SP 800-88 “Guidelines for Media Sanitization” (September 2006). This complies with all Federal regulations.
Director, Office of Single Family Program Development, Department of Housing and Urban Development, 451 Seventh Street SW., Washington, DC 20410.
For Information, assistance, or inquiries about the existence of records, contact Helen Goff Foster, Chief Privacy Officer/Senior Agency Official for Privacy, 451 Seventh Street SW., Room 10139, Washington, DC 20410, telephone number 202-402-6836 (this is not a toll-free number). When seeking records about yourself from this system of records or any other HUD system of records, your request must conform with the Privacy Act regulations set forth in 24 CFR part 16 “Procedures for Inquiries”. You must first verify your identity by providing your full name, current address, and date and place of birth. You must sign your request, and your signature must either be notarized or submitted under 28 U.S.C. 1746, a law that permits statements to be made under penalty of perjury as a substitute for notarization. In addition, your request should:
(1) Explain why you believe HUD would have information on you.
(2) Identify which HUD office you believe has the records about you.
(3) Specify when you believe the records would have been created.
(4) Provide any other information that will help the FOIA staff determine
If you are seeking records pertaining to another living individual, you must obtain a statement from that individual certifying their agreement for you to access their records. Without the above information, the HUD Office may not be able to conduct an effective search, and your request may be denied due to lack of specificity or lack of compliance with applicable regulations.
The Department's rules for contesting contents of records and appealing initial denials appear in 24 CFR part 16, “Procedures for Inquiries.” Additional assistance may be obtained by contacting Helen Goff Foster, Chief Privacy Officer/Senior Agency Official for Privacy, 451 Seventh Street SW., Room 10139, Washington, DC 20410, or the HUD Departmental Privacy Appeals Officer, Office of General Counsel, Department of Housing and Urban Development, 451 Seventh Street SW., Room 10110, Washington, DC 20410.
Records in the system are obtained from: Mortgagors, appraisers, inspectors, mortgagee staff appraisers, mortgagee staff underwriters, housing counselors, individuals that pass the HUD Certified Housing Counselor examination, HUD Housing Counseling Program clients that receive education and counseling from a HUD participating housing counseling agency, and HUD employees.
None.
Office of the Chief Information Officer, HUD.
Notice.
HUD is seeking approval from the Office of Management and Budget (OMB) for renewal of the information collection described below. In accordance with the Paperwork Reduction Act, HUD is requesting comment from all interested parties on the proposed collection of information. The purpose of this notice is to allow for 60 days of public comment.
Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB Control Number and should be sent to: Anna P. Guido, Reports Management Officer, QDAM, Department of Housing and Urban Development, 451 7th Street SW., Room 4176, Washington, DC 20410-5000; telephone 202-402-5535 (this is not a toll-free number) or email at
Anna P. Guido, Reports Management Officer, QDAM, Department of Housing and Urban Development, 451 7th Street SW., Washington, DC 20410; email Anna P. Guido at
Copies of available documents submitted to OMB may be obtained from Ms. Guido.
This notice informs the public that HUD is seeking approval from OMB for renewal of the information collection described in Section A.
The
Management reports required in conjunction with the Annual Performance Report (§ 92.509) are used by HUD Field Offices to assess the effectiveness of locally designed programs in meeting specific statutory requirements and by Headquarters in preparing the Annual Report to Congress. Specifically, these reports permit HUD to determine compliance with the requirement that PJs provide a 25 percent match for HOME funds expended during the Federal fiscal year (Section 220 of the Act) and that program income be used for HOME eligible activities (Section 219 of the Act), as well as the Women and Minority Business Enterprise requirements (§ 92.351(b)).
Financial, project, tenant and owner documentation is used to determine compliance with HOME Program cost limits (Section 212(e) of the Act), eligible activities (§ 92.205), and eligible costs (§ 92.206), as well as to determine whether program participants are achieving the income targeting and affordability requirements of the Act (Sections 214 and 215). Other information collected under Subpart H (Other Federal Requirements) is primarily intended for local program management and is only viewed by HUD during routine monitoring visits. The written agreement with the owner for long-term obligation (§ 92.504) and tenant protections (§ 92.253) are required to ensure that the property owner complies with these important elements of the HOME Program and are also reviewed by HUD during monitoring visits. HUD reviews all other data collection requirements during monitoring to assure compliance with the requirements of the Act and other related laws and authorities.
HUD tracks PJ performance and compliance with the requirements of 24 CFR parts 91 and 92. PJs use the required information in the execution of
This notice is soliciting comments from members of the public and affected parties concerning the collection of information described in Section A on the following:
(1) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) The accuracy of the agency's estimate of the burden of the proposed collection of information;
(3) Ways to enhance the quality, utility, and clarity of the information to be collected; and
(4) Ways to minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology,
Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. Chapter 35.
Fish and Wildlife Service, Interior.
Notice; request for comments.
We (U.S. Fish and Wildlife Service) have sent an Information Collection Request (ICR) to OMB for review and approval. We summarize the ICR below and describe the nature of the collection and the estimated burden and cost. We 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.
You must submit comments on or before November 17, 2016.
Send your comments and suggestions on this information collection to the Desk Officer for the Department of the Interior at OMB-OIRA at (202) 395-5806 (fax) or
To request additional information about this ICR, contact Tina Campbell at
On May 19, 2016, we published in the
We again invite comments concerning this information collection on:
• Whether or not the collection of information is necessary, including whether or not the information will have practical utility;
• The accuracy of our estimate of the burden for this collection of information;
• 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 respondents.
Comments that you submit in response to this notice are a matter of public record. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment, including your personal identifying information, may be made publicly available at any time. While you can ask OMB and us in your comment to withhold your personal identifying information from public review, we cannot guarantee that it will be done.
Bureau of Land Management, Interior.
Notice.
The plats of survey of the following described lands are scheduled to be officially filed in the Bureau of Land Management, Oregon State Office, Portland, Oregon, 30 days from the date of this publication.
A copy of the plats may be obtained from the Public Room at the Bureau of Land Management, Oregon State Office, 1220 SW. 3rd Avenue, Portland, Oregon 97204, upon required payment.
Kyle Hensley, (503) 808-6124, Branch of Geographic Sciences, Bureau of Land Management, 1220 SW. 3rd Avenue, Portland, Oregon 97204. Persons who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 to contact the above individual during normal business hours. The FIRS is available 24 hours a day, 7 days a week, to leave a message or question with the above individual. You will receive a reply during normal business hours.
A person or party who wishes to protest against this survey must file a written notice with the Oregon State Director, Bureau of Land Management, stating that they wish to protest. A statement of reasons for a protest may be filed with the notice of protest and must be filed with the Oregon State Director within thirty days after the protest is filed. If a protest against the survey is received prior to the date of official filing, the filing will be stayed pending consideration of the protest. A plat will not be officially filed until the day after all protests have been dismissed or otherwise resolved. Before including your address, phone number, email address, or other personally 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 us in your comment to withhold your personally identifying information from public review, we cannot guarantee that we will be able to do so.
Bureau of Land Management, U.S. Department of the Interior.
Notice of public meeting.
In accordance with the Federal Land Policy and Management Act (FLPMA) and the Federal Advisory Committee Act of 1972 (FACA), the U.S. Department of the Interior, Bureau of Land Management (BLM) Boise District Resource Advisory Council (RAC), will hold a meeting as indicated below.
The meeting will be held November 9, 2016, at the Boise District Office, 3948 Development Avenue, Boise, Idaho 83705 beginning at 9:00 a.m. and adjourning by 4:00 p.m. Members of the public are invited to attend. A public comment period will be held from 11:00 a.m. to 11:10 a.m.
Seth Flanigan, Public Affairs Specialist and RAC Coordinator, BLM Boise District, 3948 Development Ave., Boise, Idaho 83705, telephone (208) 384-3393.
The 15-member Council advises the Secretary of the Interior, through the BLM, on a variety of planning and management issues associated with public land management in southwestern Idaho. During the November meeting the Boise District RAC will receive updates on
The public may present written or oral comments to members of the Council. At each full RAC meeting, time is provided in the agenda for hearing public comments. Depending on the number of persons wishing to comment and time available, the time for individual oral comments may be limited. Individuals who plan to attend and need special assistance should contact the BLM Coordinator as provided above. Persons who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 to contact Mr. Flanigan. The FIRS is available 24 hours a day, 7 days a week, to leave a message or question with Mr. Flanigan. You will receive a reply during normal business hours.
National Park Service, Interior.
Notification of boundary revision.
The boundary of Big Thicket National Preserve is modified to include ten tracts totaling 822.48 acres of land. These lands are located in Hardin County, Liberty County, Orange County and Tyler County, Texas, immediately adjacent to the boundary of the preserve. Subsequent to the publication of this notice, the United States will acquire fee title to those tracts of land by donation from several nonprofit conservation organizations and an individual donor.
The effective date of this boundary revision is October 18, 2016.
The map depicting this boundary revision is available for inspection at the following locations: National Park Service, Land Resources Program Center, Intermountain Region, 12795 West Alameda Parkway, Denver, Colorado 80228 and National Park Service, Department of the Interior, 1849 C Street NW., Washington, DC 20240.
Chief Realty Officer Steve Muyskens, National Park Service, Land Resources Program Center, Intermountain Region, 12795 West Alameda Parkway, Denver, Colorado 80228, telephone (303) 969-2610.
Notice is hereby given that, pursuant to section 1 of the Act of October 11, 1974 (Pub. L. 93-439, 88 Stat. 1254), codified as amended at 16 U.S.C. 698, the boundary of Big Thicket National Preserve is modified to include ten tracts of lands listed as follows: Tract 127-10 (1.72 acres); Tract 134-07 (114.45 acres); Tract 172-10 (18 acres); Tract 215-04 (.57-acre); Tract 219-17 (11.60 acres); Tract 219-18 (360.97 acres); Tract 219-19 (29.03 acres); Tract 222-08 (1 acre); Tract 223-14 (118.65 acres) and Tract 229-06 (166.49 acres) for a total of 822.48 acres. The boundary revision is depicted on Map No. 175/120,858 dated April 18, 2016.
16 U.S.C. 698 provides that, after notifying the House Committee on Natural Resources and the Senate Committee on Energy and Natural Resources, the Secretary of the Interior is authorized to make this boundary revision upon publication of notice in the
National Park Service, Interior.
Notice.
The U.S. Department of the Interior, Bureau of Land Management (BLM), Nevada State Office, has completed an inventory of human remains and associated funerary objects recovered from Spirit Cave, NV, in consultation with the appropriate Indian tribes or Native Hawaiian organizations, and has determined that there is no cultural affiliation between the human remains and associated funerary objects and present-day Indian tribes or Native Hawaiian organizations. Representatives of any Indian tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of the human remains and associated funerary objects should submit a written request to the BLM. If no additional requestors come forward, transfer of control of the human remains and associated funerary objects from Spirit Cave may proceed.
Representatives of any Indian tribe or Native Hawaiian organization that wish to request transfer of control of the human remains and associated funerary objects from Spirit Cave should submit a written request with information in support of the request to the BLM Nevada State Office, at the address in this notice by November 17, 2016.
John Ruhs, State Director, Bureau of Land Management, Nevada State Office, 1340 Financial Boulevard, Reno, NV 89502-7147, telephone (775) 861-6590, email
Notice is here given in accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), 25 U.S.C. 3003, of the completion of an inventory of human remains and associated funerary objects under the control of the BLM Nevada State Office, Reno, NV. The human remains and associated funerary objects were removed from Spirit Cave in Churchill County, NV.
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA, 25 U.S.C. 3003(d)(3). The determinations in this notice are the sole responsibility of the museum, institution, or Federal agency that has control of the Native American human remains and associated funerary objects. The National Park Service is not responsible for the determinations in this notice.
A detailed assessment of the human remains and associated funerary objects was made by the BLM Nevada State Office professional staff in consultation with representatives of the Comanche Nation, Oklahoma; Confederated Tribes of the Goshute Reservation, Nevada and Utah; Duckwater Shoshone Tribe of the
In 1940, human remains representing, at minimum, four individuals and 10 associated funerary objects were removed from Spirit Cave in Churchill County, NV, on lands then owned by the United States and now administered by the BLM Nevada State Office. Sydney and Georgia Wheeler located Spirit Cave during salvage excavations conducted by the Nevada State Parks Commission in and around the Lahontan Basin of western Nevada and made collections from the site. This “Spirit Cave Assemblage” was then curated at the Nevada State Museum in Carson City, NV. The human remains consist of one intact, well-preserved mummified skeleton of an adult male, aged 40-44 years (Spirit Cave Burial #2; NSM Catalog # Ahur 2064; commonly referred to as the “Spirit Cave mummy”); one cremation burial (NSM Catalog #'s Ahur 752 and Ahur 773); one adult female, aged 30-35 years (NSM # Ahur 770); and a subadult male, aged approximately 15 years (NSM # Ahur 748). No known individuals were identified. The 10 associated funerary objects are one outer mat, one inner mat, two leather moccasins, one rabbit skin blanket, three woven bags, and two mat fragments. Radiocarbon dating estimates the age of the human remains to be between 5,400 to 10,600 years ago.
DNA analysis illustrates that the human remains in the Spirit Cave Assemblage are effectively more closely related to Native Americans than they are to any other population. The associated funerary objects contained within the Spirit Cave Assemblage manifest characteristics of Native American ancestry, including a rabbit skin blanket, moccasins, and woven mats. These cultural items are consistent with the raw materials used and the general types of items manufactured throughout the prehistory of the Great Basin. Therefore, the BLM Nevada State Office has determined that the human remains are Native American.
While there are similarities in material culture between items buried with the individuals that are part of the Spirit Cave Assemblage and the Northern Paiute peoples, such as the rabbit skin blanket, these similarities are at a general Numic pattern within the Great Basin that includes many tribes (“Numic pattern” refers to items or objects similarly made by multiple tribes of Paiute, Shoshone, Ute, and Goshute peoples who all share a common language group). The manufacturing of rabbit skin blankets, woven mats, and moccasins are all material items made by multiple tribes across the Great Basin, both past and present. Oral tradition suggests that while the Northern Paiute tribes originated in the region from which Spirit Cave is located, at least one other non-Paiute tribe once occupied the region as well. The available archeological and material culture evidence suggests that the Northern Paiute peoples and their associated modern tribes may have occupied the central Great Basin by 3,000 years ago, although there is no similar evidence which places them in the western Great Basin at this time. The DNA results also do not provide evidence that the Spirit Cave individuals were a distinct biological group from other groups of that age. Additionally, the age and small sample size of the Spirit Cave Assemblage does not provide sufficient evidence from which BLM can determine that the Spirit Cave individuals were part of a an identifiable earlier cultural group, pursuant to NAGPRA 43 CFR 10.14(c)(2). BLM cannot determine cultural affiliation of the Spirit Cave Assemblage.
Officials of the BLM Nevada State Office have determined that:
• Pursuant to 25 U.S.C. 3001(9), the human remains described in this notice are Native American.
• Pursuant to 25 U.S.C. 3001(9), the human remains described in this notice represent the physical remains of four individuals of Native American ancestry.
• Pursuant to 25 U.S.C. 3001(3)(A), the 10 objects described in this notice are reasonably believed to have been placed with or near individual human remains at the time of death or later as part of the death rite or ceremony.
• Pursuant to 25 U.S.C. 3001(2), a relationship of shared group identity cannot be reasonably traced between the Native American human remains and associated funerary objects and any present-day Indian tribe.
• According to final judgements of the Indian Claims Commission, the land from which the Native American human remains and associated funerary objects were removed is the aboriginal land of the Northern Paiute, represented by the Fort McDermitt Paiute and Shoshone Tribes of the Fort McDermitt Indian Reservation, Nevada and Oregon; Lovelock Paiute Tribe of the Lovelock Indian Colony, Nevada; Paiute-Shoshone Tribe of the Fallon Reservation and Colony, Nevada; Pyramid Lake Paiute Tribe of the Pyramid Lake Reservation, Nevada; Reno-Sparks Indian Colony, Nevada; Summit Lake Paiute Tribe of Nevada; Walker River Paiute Tribe of the Walker River Reservation, Nevada; Winnemucca Indian Colony of Nevada; and Yerington Paiute Tribe of the Yerington Colony & Campbell Ranch, Nevada.
• Pursuant to 43 CFR 10.11(c)(1), the disposition of the human remains and associated funerary objects may be to the Fort McDermitt Paiute and Shoshone Tribes of the Fort McDermitt Indian Reservation, Nevada and Oregon; Lovelock Paiute Tribe of the Lovelock Indian Colony, Nevada; Paiute-Shoshone Tribe of the Fallon Reservation and Colony, Nevada; Pyramid Lake Paiute Tribe of the Pyramid Lake Reservation, Nevada; Reno-Sparks Indian Colony, Nevada; Summit Lake Paiute Tribe of Nevada; Walker River Paiute Tribe of the Walker River Reservation, Nevada; Winnemucca Indian Colony of Nevada; and Yerington Paiute Tribe of the Yerington Colony & Campbell Ranch, Nevada.
• Pursuant to 43 CFR 10.11(d), transfer of the human remains and associated funerary objects to the Paiute-Shoshone Tribe of the Fallon Reservation and Colony, Nevada, may proceed.
Representatives of the Indian tribes that wish to request transfer of control of these human remains and associated funerary objects should submit a written request with information in support of the request to John Ruhs, State Director, Bureau of Land Management, Nevada State Office, 1340 Financial Boulevard, Reno, NV 89502-7147, telephone (775) 861-6590, email
The BLM Nevada State Office is responsible for notifying the Fort McDermitt Paiute and Shoshone Tribes of the Fort McDermitt Indian Reservation, Nevada and Oregon; Lovelock Paiute Tribe of the Lovelock Indian Colony, Nevada; Paiute-Shoshone Tribe of the Fallon Reservation and Colony, Nevada; Pyramid Lake Paiute Tribe of the Pyramid Lake Reservation, Nevada; Reno-Sparks Indian Colony, Nevada; Summit Lake Paiute Tribe of Nevada; Walker River Paiute Tribe of the Walker River Reservation, Nevada; Winnemucca Indian Colony of Nevada; and Yerington Paiute Tribe of the Yerington Colony & Campbell Ranch, Nevada that this notice has been published.
National Park Service, Interior.
Notice of availability.
The National Park Service (NPS) announces the availability of the Abbreviated Final General Management Plan/Environmental Impact Statement (Abbreviated Final GMP/EIS) for Fire Island National Seashore, New York. The focus of this plan is to guide and direct NPS management strategies for the next 15 to 20 years that support the protection of important natural resources and processes; significant recreation resources; cultural resources of national, state, and local significance; and unique residential communities. The Abbreviated Final GMP/EIS also includes revisions to the Draft Wilderness Stewardship Plan and Backcountry Camping Policy for the Otis Pike Fire Island High Dune Wilderness (WSP) which will guide decisions regarding the future use and protection of the congressionally designated Otis Pike Fire Island High Dune Wilderness and areas adjacent to the wilderness that are designated backcountry camping areas.
October 18, 2016.
The Abbreviated Final GMP/EIS and WSP are available electronically at
Kaetlyn Jackson, Fire Island National Seashore, 631-687-4770,
Fire Island National Seashore (the Seashore), a unit of the national park system, is located along the south shore of Long Island in Suffolk County, New York. The Seashore is composed of two distinct units: A 26-mile stretch of Fire Island, the 32-mile-long barrier island that runs parallel to the south shore of Long Island; and the William Floyd Estate, situated on the south shore of Long Island near the east end of Fire Island. The Fire Island unit encompasses 19,579 acres of upland, tidal, and submerged lands, including an extensive system of dunes, centuries-old maritime forests, solitary beaches, nearly 1,400 acres of federally designated wilderness, and the historic Fire Island Lighthouse. The William Floyd Estate is a 613-acre property that was the home of one of New York's signers of the
Pursuant to the National Environmental Policy Act of 1969 (42 U.S.C. 4321
Comments received on the Draft GMP/EIS resulted in minor changes to the text but did not significantly alter the alternatives or the impact analysis; thus, the National Park Service has prepared an Abbreviated Final General Management Plan/Environmental Impact Statement (Abbreviated Final GMP/EIS). The Abbreviated Final GMP/EIS discusses the public and agency comments received on the Draft GMP/EIS and provides NPS responses. The Abbreviated Final GMP/EIS contains errata sheets that show factual corrections to the text of the Draft GMP/EIS or where the text has been revised to reflect minor additions or changes suggested by commenters.
As in the Draft GMP/EIS, the Abbreviated Final GMP/EIS identifies the NPS Preferred Alternative as the combination of Management Alternative 3 for Fire Island & Park-wide with Management Alternative B for the William Floyd Estate because together they best meet the Seashore's management goals and convey the greatest number of significant beneficial results, relative to their potential impacts, in comparison with the other alternatives. Management Alternative 3 in combination with Management Alternative B would do the most to ensure the cooperative stewardship of Fire Island National Seashore's dynamic coastal environment and its cultural and natural systems while recognizing its larger ecological, social, economic, and cultural context and meeting the specific needs and management goals of the William Floyd Estate.
Circulated with the Draft GMP/EIS for public review was the Draft Wilderness Stewardship Plan and Backcountry Camping Policy for the Otis Pike Fire Island High Dune Wilderness (WSP). The purpose of the WSP is to guide decisions regarding the future use and protection of the congressionally designated Otis Pike Fire Island High Dune Wilderness and adjacent areas that are designated backcountry camping areas. It identifies the core qualities of wilderness character and outlines the framework through which the wilderness can be preserved, consistent with law, policy, and the specific legislative history applicable to this wilderness. The Abbreviated Final GMP/EIS contains errata sheets that show changes and clarifications to the Draft WSP. Some of the changes are a result of public comments while others are editorial in nature. When finalized, the WSP will replace the 1983
National Park Service, Interior.
Notice.
The Stearns History Museum, in consultation with the appropriate Indian tribes or Native Hawaiian organizations, has determined that the cultural items listed in this notice meet the definition of sacred objects. Lineal descendants or representatives of any Indian tribe or Native Hawaiian organization not identified in this notice that wish to claim these cultural items should submit a written request to the Stearns History Museum. If no additional claimants come forward, transfer of control of the cultural items to the lineal descendants, Indian tribes, or Native Hawaiian organizations stated in this notice may proceed.
Lineal descendants or representatives of any Indian tribe or Native Hawaiian organization not identified in this notice that wish to claim these cultural items should submit a written request with information in support of the claim to the Stearns History Museum at the address in this notice by November 17, 2016.
Adam Smith, Stearns History Museum, 235 South 33rd Avenue, Saint Cloud, MN 56301, telephone (320) 253-8424, email
Notice is here given in accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), 25 U.S.C. 3005, of the intent to repatriate cultural items under the control of the Stearns History Museum, Saint Cloud, MN that meet the definition of sacred objects under 25 U.S.C. 3001.
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA, 25 U.S.C. 3003(d)(3). The determinations in this notice are the sole responsibility of the museum, institution, or Federal agency that has control of the Native American cultural items. The National Park Service is not responsible for the determinations in this notice.
On an unknown date in 1902, two cultural items were removed from the White Earth Band of the Minnesota Chippewa Tribe in Mahnomen, Clearwater and Becker Counties, MN. In 1902, William Wynkoop Smith collected the cultural items during his visit to the White Earth Band of the Minnesota Chippewa Tribe. The items remained in the Smith home in Saint Cloud, MN and later Cold Spring, MN. In 1982, Smith donated the items to the museum. The two sacred objects are ceremonial clubs. When the items were donated to the museum in 1982, the Curator identified them as Anishinaabe. Further research into beadwork and design confirm the items are of Anishinaabe origin.
At an unknown date between 1930 and 1982, three cultural items were removed from the White Earth Band of the Minnesota Chippewa Tribe in Mahnomen, Clearwater and Becker Counties, MN. The three sacred objects are one drum, one rattle and one headband. The drum was owned by Charlotte Fineday Broker, a member of the White Earth Band of the Minnesota Chippewa Tribe who lived with the White Earth Band of the Minnesota Chippewa Tribe her entire life. Broker died in 1951 and her daughter-in-law Martha Aspinwall Broker, also a member of the White Earth Band of the Minnesota Chippewa Tribe, acquired the item. Martha married Charlotte's son Robert in 1918, moved to Royalton, MN by 1930 and St. Cloud, MN by 1943. It is unclear when, between 1930 and 1982, the three sacred objects left the White Earth Band of the Minnesota Chippewa Tribe. In 1982, Martha Broker donated all three items to the museum.
Officials of the Stearns History Museum have determined that:
• Pursuant to 25 U.S.C. 3001(3)(C), the 5 cultural items described above are specific ceremonial objects needed by traditional Native American religious leaders for the practice of traditional Native American religions by their present-day adherents.
• Pursuant to 25 U.S.C. 3001(2), there is a relationship of shared group identity that can be reasonably traced between the sacred objects and White Earth Band of the Minnesota Chippewa Tribe.
Lineal descendants or representatives of any Indian tribe or Native Hawaiian organization not identified in this notice that wish to claim these cultural items should submit a written request with information in support of the claim to Adam Smith, Stearns History Museum, 235 South 33rd Avenue, Saint Cloud, MN 56301, telephone (320) 253-8424, email
The Stearns History Museum is responsible for notifying the White Earth Band of the Minnesota Chippewa Tribe that this notice has been published.
United States International Trade Commission.
October 26, 2016 at 10:00 a.m.
Room 101, 500 E Street SW., Washington, DC 20436, Telephone: (202) 205-2000.
Open to the public.
1. Agendas for future meetings: None.
2. Minutes.
3. Ratification List.
4. Vote in Inv. Nos. 731-TA-1082 and 1083 (Second Review) (Chlorinated Isocyanurates from China and Spain). The Commission is currently scheduled to complete and file its determinations and views of the Commission on November 16, 2016.
5. Outstanding action jackets: None.
In accordance with Commission policy, subject matter listed above, not disposed of at the scheduled meeting, may be carried over to the agenda of the following meeting.
By order of the Commission.
U.S. International Trade Commission.
Notice.
Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on September 12, 2016, under section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, on behalf of R2 Semiconductor, Inc. of Sunnyvale, California. The complaint alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain integrated circuits with voltage regulators and products containing the same by reason of infringement of certain claims of U.S. Patent No. 8,233,250 (“the '250 patent”). The complaint further alleges that an industry in the United States exists as required by subsection (a)(2) of section 337.
The complainant requests that the Commission institute an investigation and, after the investigation, issue a limited exclusion order and cease and desist orders.
The complaint, except for any confidential information contained therein, is available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street SW., Room 112, Washington, DC 20436, telephone (202) 205-2000. Hearing impaired individuals are advised that information on this matter can be obtained by contacting the Commission's TDD terminal on (202) 205-1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at (202) 205-2000. General information concerning the Commission may also be obtained by accessing its internet server at
The Office of Unfair Import Investigations, U.S. International Trade Commission, telephone (202) 205-2560.
The authority for institution of this investigation is contained in section 337 of the Tariff Act of 1930, as amended, and in section 210.10 of the Commission's Rules of Practice and Procedure, 19 CFR 210.10 (2016).
(1) Pursuant to subsection (b) of section 337 of the Tariff Act of 1930, as amended, an investigation be instituted to determine whether there is a violation of subsection (a)(1)(B) of section 337 in the importation into the United States, the sale for importation, or the sale within the United States after importation of certain integrated circuits with voltage regulators and products containing the same by reason of infringement of one or more of claims 1-4, 7-17, 20-26, 28-29, and 31 of the '250 patent, and whether an industry in the United States exists as required by subsection (a)(2) of section 337;
(2) Pursuant to Commission Rule 210.50(b)(1), 19 CFR 210.50(b)(1), the presiding administrative law judge shall take evidence or other information and hear arguments from the parties and other interested persons with respect to the public interest in this investigation, as appropriate, and provide the Commission with findings of fact and a recommended determination on this issue, which shall be limited to the statutory public interest factors set forth in 19 U.S.C. 1337(d)(1), (f)(1), (g)(1);
(3) For the purpose of the investigation so instituted, the following are hereby named as parties upon which this notice of investigation shall be served:
(a) The complainant is: R2 Semiconductor, Inc., 1196 Borregas Ave., Suite 201, Sunnyvale, CA 94089.
(b) The respondents are the following entities alleged to be in violation of section 337, and are the parties upon which the complaint is to be served:
(c) The Office of Unfair Import Investigations, U.S. International Trade Commission, 500 E Street SW., Suite 401, Washington, DC 20436; and
(4) For the investigation so instituted, the Chief Administrative Law Judge, U.S. International Trade Commission, shall designate the presiding Administrative Law Judge.
Responses to the complaint and the notice of investigation must be submitted by the named respondents in accordance with section 210.13 of the Commission's Rules of Practice and Procedure, 19 CFR 210.13. Pursuant to 19 CFR 201.16(e) and 210.13(a), such responses will be considered by the Commission if received not later than 20 days after the date of service by the Commission of the complaint and the notice of investigation. Extensions of time for submitting responses to the complaint and the notice of investigation will not be granted unless good cause therefor is shown.
Failure of a respondent to file a timely response to each allegation in the complaint and in this notice may be deemed to constitute a waiver of the right to appear and contest the allegations of the complaint and this notice, and to authorize the administrative law judge and the Commission, without further notice to the respondent, to find the facts to be as alleged in the complaint and this notice and to enter an initial determination and a final determination containing such findings, and may result in the issuance of an exclusion order or a cease and desist order or both directed against the respondent.
By order of the Commission.
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has issued a limited exclusion order denying entry of certain computer cables, chargers, adapters, peripheral devices and packaging containing the same. The investigation is terminated.
Amanda Pitcher Fisherow, Esq., Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 205-2737. Copies of non-confidential documents filed in connection with this investigation are or will be available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 205-2000. General information concerning the Commission may also be obtained by accessing its Internet server at
The Commission instituted this investigation on December 17, 2015, based on a complaint filed on behalf of Belkin International, Inc. of Playa Vista, California (“Complainant”). 80 FR 78763-64 (December 17, 2015). The complaint alleges violations of Section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, in the sale for importation, importation, or sale within the United States after importation of certain computer cables, chargers, adapters, peripheral devices and packaging containing the same by reason of infringement of one or more of U.S. Trademark Registration No. 2,339,459; U.S. Trademark Registration No. 2,339,460; U.S. Trademark Registration No. 4,168,379; and U.S. Trademark Registration No. 4,538,212. The Commission's notice of investigation named the following respondents: Dongguan Pinte Electronic Co., Ltd., of Dongguan City, China; and Dongguan Shijie Fresh Electronic Products Factory, of Dongguan City, China (collectively “Respondents”). The Office of Unfair Import Investigations (“OUII”) was named as a party.
On August 8, 2016, the Commission determined not to review an initial determination finding the Respondents in default and requested briefing from the parties and the public on the issues of remedy, the public interest, and bonding. 81 FR 53505-06 (Aug. 12, 2016).
Complainant filed a submission requesting a limited exclusion order (“LEO”) against the Respondents, arguing that none of the public interest factors weigh against granting an LEO. Complainant asserts that there are several competitors in the market and complainant can fulfill any increased demand. No public interest submissions were filed by the public. Complainant requested that Respondents either should not be afforded the opportunity to import during the period of Presidential review, or in the alternative, that the bond be set at 100 percent of entered value in accordance with the Commission practice for defaulting respondents. OUII supported the Complainant's requested relief, including imposition of 100 percent bond.
The Commission finds that the statutory requirements for relief under section 337(g)(1), (19 U.S.C. 1337(g)(1)) are met with respect to the Respondents. In addition, the Commission finds that the public interest factors enumerated in section 337(g)(1) do not preclude issuance of the statutory relief.
The Commission has determined that the appropriate remedy in this investigation is an LEO prohibiting the unlicensed entry of certain computer cables, chargers, adapters, peripheral devices and packaging containing the same that are manufactured abroad by or on behalf of, or imported by or on behalf of, Respondents that infringe one or more of U.S. Trademark Registration Nos. 2,339,459; 2,339,460; 4,168,379; and 4,538,212.
Finally, the Commission has determined that the bond during the period of Presidential review pursuant to 19 U.S.C. 1337(j) shall be in the amount of 100 percent of the entered value of the imported articles that are subject to the LEO. The Commission's orders were delivered to the President and to the United States Trade Representative on the day of their issuance.
The authority for the Commission's determination is contained in section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in part 210 of the Commission's Rules of Practice and Procedure (19 CFR part 210).
By order of the Commission.
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has determined not to review the presiding administrative law judge's (“ALJ”) initial determination (“ID”) (Order No. 10) terminating the investigation on the basis of settlement. The Commission has terminated the investigation.
Amanda Pitcher Fisherow, Esq., Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 205-2737. Copies of non-confidential documents filed in connection with this investigation are or will be available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 205-2000. General information concerning the Commission may also be obtained by accessing its Internet server at
The Commission instituted this investigation on March 4, 2016, based on a complaint and supplements filed on behalf of
On September 2, 2016, the parties filed a joint motion to terminate the investigation based on settlement. The parties provided confidential and non-confidential versions of the settlement agreement and represented that there are no other agreements, written or oral, express or implied, between the Settling Parties concerning the subject matter of this Investigation.
On September 13, 2016, the ALJ granted the joint motion. Order No. 10. The ALJ found that all of the requirements of Commission Rule 210.21(a)-(b), 19 CFR 210.21(a)-(b), had been met and that there were no public interest concerns that would weigh against termination. No petitions for review were filed.
The Commission has determined not to review the subject ID.
The authority for the Commission's determination is contained in section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in Part 210 of the Commission's Rules of Practice and Procedure (19 CFR part 210).
By order of the Commission.
Notice of application.
Registered bulk manufacturers of the affected basic class, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration in accordance with 21 CFR 1301.34(a) on or before November 17, 2016. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before November 17, 2016.
Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 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/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152.
The Attorney General has delegated her 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 Deputy Assistant Administrator of the DEA Office of Diversion Control (“Deputy Assistant Administrator”) pursuant to section 7 of 28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR 1301.34(a), this is notice that on June 10, 2016, Anderson Brecon, Inc., DBA PCI of Illinois, 4545 Assembly Drive, Rockford, Illinois 61109 applied to be registered as an importer of oxycodone (9143), a basic class of controlled substance listed in schedule II.
The company plans to import the listed controlled substances in bulk over-encapsulated tablets for clinical trial only. Approval of permit applications will occur only when the registrant's business activity is consistent with what is authorized under 21 U.S.C. 952(a)(2). Authorization will not extend to the import of FDA approved or non-approved finished dosage forms for commercial sale.
Notice of application.
Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration in accordance with 21 CFR 1301.34(a) on or before November 17, 2016. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before November 17, 2016.
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. Comments and request for hearings on applications to import narcotic raw material are not appropriate. 72 FR 3417, (January 25, 2007).
The Attorney General has delegated her authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to
In accordance with 21 CFR 1301.34(a), this is notice that on September 5, 2016, Johnson Matthey Inc., Pharmaceutical Materials, 2003 Nolte Drive, West Deptford, New Jersey 08066-1742, applied to be registered as an importer of the following basic classes of controlled substances:
The company plans to import Thebaine derivatives and Fentanyl as reference standards. The company plans to import the remaining listed controlled substances as raw materials, to be used in the manufacture of bulk controlled substances, for distribution to its customers.
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 in accordance with 21 CFR 1301.33(a) on or before December 19, 2016.
Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152.
The Attorney General has delegated her 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 Office of Diversion Control (“Assistant Administrator”) pursuant to section 7 of 28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR 1301.33(a), this is notice that on September 5, 2016, Johnson Matthey Inc., Custom Pharmaceuticals Department, 2003 Nolte Drive, West Deptford, New Jersey 08066-1742 applied to be registered as a bulk manufacturer the following basic classes of controlled substances:
The company plans to manufacture the listed controlled substances in bulk for sale to its customers.
In reference to drug codes 7360 (marihuana) and 7370 (THC), the company plans to bulk manufacture these drugs as synthetics. No other activities for these drug codes are authorized for this registration.
Wage and Hour Division, Department of Labor.
Notice.
The Department of Labor (DOL) is soliciting comments concerning a proposed extension of the information collection request (ICR) titled, “Report of Construction Contractor's Wage Rates.” This comment request is part of continuing Departmental efforts to reduce paperwork and respondent burden in accordance with the Paperwork Reduction Act of 1995 (PRA), 44 U.S.C. 3501
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. A copy of the proposed information request can be obtained by contacting the office listed below in the
Written comments must be submitted to the office listed in the
You may submit comments identified by Control Number 1235-0015, by either one of the following methods:
Robert Waterman, Compliance Specialist, Division of Regulations, Legislation, and Interpretation, Wage and Hour Division, U.S. Department of Labor, Room S-3502, 200 Constitution Avenue NW., Washington, DC 20210; telephone: (202) 693-0406 (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) 693-0023 (not a toll-free number). TTY/TTD callers may dial toll-free (877) 889-5627 to obtain information or request materials in alternative formats.
• 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;
• Enhance the quality, utility, and clarity of the information to be collected;
• 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;
• 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,
Notice.
This notice announces the membership of the National Endowment for the Arts (NEA) Senior Executive Service (SES) Performance Review Board (PRB).
Send comments concerning this notice to: National Endowment for the Arts, 400 7th Street SW., Washington, DC 20506.
Craig McCord Sr. by telephone at (202) 682-5473 or by email at
Sections 4314(c)(1) through (5) of Title 5, U.S.C., requires each agency to establish, in accordance with regulations prescribed by the Office of Personnel Management, one or more SES Performance Review Boards. The Board shall review and evaluate the initial appraisal of a senior executive's performance by the supervisor, along with any response by the senior executive, and make recommendations to the appointing authority relative to the performance of the senior executive.
The following persons have been selected to serve on the Performance Review Board of the National Endowment for the Arts (NEA):
National Science Foundation.
Announcement of membership of the National Science Foundation's
This announcement of the membership of the National Science Foundation's Office of Inspector General and National Science Board Office Senior Executive Service Performance Review Board is made in compliance with 5 U.S.C. 4314(c)(4).
Comments should be addressed to Division Director, Division of Human Resource Management, National Science Foundation, Room 315, 4201 Wilson Boulevard, Arlington, VA 22230.
Ms. Dianne Campbell Krieger at the above address or (703) 292-5194.
The membership of the National Science Board's Senior Executive Service Performance Review Board is as follows:
Nuclear Regulatory Commission.
Request for comment.
On June 27, 2016, the U.S. Nuclear Regulatory Commission (NRC) received from LaCrosse
Submit comments by November 17, 2016. Comments received after this date will be considered if it is practical to do so, but the Commission is able to ensure consideration only for comments received on or before this date.
You may submit comments by any of the following methods (unless this document describes a different method for submitting comments on a specific subject):
•
•
For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in the
Marlayna Vaaler, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-3178; email:
Please refer to Docket ID NRC-2015-0279 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:
•
•
•
Please include Docket ID NRC-2015-0279 in in the subject line of your comment submission, in order to ensure that the NRC is able to make your comment submission available to the public in this docket.
The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC posts all comment submissions at
If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment submissions into ADAMS.
The La Crosse Boiling Water Reactor (LACBWR) was an Atomic Energy Commission (AEC) Demonstration Project Reactor that first went critical in 1967, commenced commercial operation in November 1969, and was capable of producing 50 megawatts electric. The reactor is located on the east bank of the Mississippi River in Vernon County, Wisconsin. The Allis-Chalmers Company was the original licensee; the AEC later sold the plant to the Dairyland Power Cooperative (DPC) and granted it Provisional Operating License No. DPR-45 on August 28, 1973.
The reactor permanently ceased operations on April 30, 1987, and reactor defueling was completed on June 11, 1987. In a letter dated August 4, 1987, the NRC terminated DPC's authority to operate LACBWR under Provisional Operating License No. DPR-
The NRC issued an order to authorize decommissioning of LACBWR and approve the licensee's proposed Decommissioning Plan (DP) on August 7, 1991. Because the NRC approved DPC's DP before August 28, 1996, pursuant to 10 CFR 50.82, the DP is considered the Post-Shutdown Decommissioning Activities Report (PSDAR) for LACBWR. The PSDAR public meeting was held on May 13, 1998, and subsequent updates to the LACBWR decommissioning report have combined the DP and PSDAR into the “LACBWR Decommissioning Plan and Post-Shutdown Decommissioning Activities Report” (D-Plan/PSDAR).
The DPC developed an on-site independent spent fuel storage installation (ISFSI) and completed the movement of all 333 spent nuclear fuel elements from the Fuel Element Storage Well to dry cask storage at the ISFSI by September 19, 2012 (ADAMS Accession No. ML12290A027). The remaining associated buildings and structures are ready for dismantlement and decommissioning activities.
By Order dated May 20, 2016 (ADAMS Accession No. ML16123A073), the NRC approved the direct transfer of Possession Only License No. DPR-45 for LACBWR from DPC to LaCrosse
By letter dated June 27, 2016 (ADAMS Accession No. ML16200A095), LS submitted the License Termination Plan (LTP) for LACBWR in accordance with 10 CFR 50.82(a)(9). The LTP includes a site characterization to ensure that final radiation surveys (FRS) cover all areas where contamination existed, remains, or has the potential to exist or remain; identification of remaining dismantlement activities; plans for site remediation; a description of the FRS plan to confirm that LACBWR will meet the release criteria in 10 CFR part 20, subpart E; dose-modeling scenarios that ensure compliance with the radiological criteria for license termination; an estimate of the remaining site-specific decommissioning costs; and a supplement to the Environmental Report describing any new information or significant environmental changes associated with proposed license termination activities. The LACBWR LTP is currently being reviewed by the NRC.
By letter dated June 27, 2016 (ADAMS Accession No. ML16181A068), LS submitted a request for approval to remove portions of the site from the part 50 License, No. DPR-45. Specifically, LS intends to remove and release five radiologically non-impacted portions of the site from its part 50 license in accordance with 10 CFR 50.83(b), “Release of part of a power reactor facility or site for unrestricted use.” This request is the subject of this notice.
For The Nuclear Regulatory Commission.
The ACRS Subcommittee on ESBWR will hold a meeting on October 20, 2016, Room T-2B1, 11545 Rockville Pike, Rockville, Maryland.
The meeting will be open to public attendance.
The agenda for the subject meeting shall be as follows:
Members of the public desiring to provide oral statements and/or written comments should notify the Designated Federal Official (DFO), Girija Shukla (Telephone 301-415-6855 or Email:
Detailed meeting agendas and meeting transcripts are available on the NRC Web site at
If attending this meeting, please enter through the One White Flint North building, 11555 Rockville Pike, Rockville, MD. After registering with security, please contact Mr. Theron Brown (240-888-9835) to be escorted to the meeting room.
On June 30, 2016, New York Stock Exchange LLC (“Exchange” or “NYSE”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act” or “Exchange Act”)
On July 26, 2016, the Exchange filed Amendment No. 1 to the proposed rule change.
This order institutes proceedings under Section 19(b)(2)(B) of the Act
The Exchange states that it does not currently trade any securities on a UTP basis. The Exchange proposes new rules to trade all Tape B and Tape C symbols, on a UTP basis, on its new trading platform, Pillar.
The Exchange represents that the proposed rules for these ETPs are substantially identical (other than with respect to certain non-substantive and technical amendments) to the rules of the NYSE Arca Equities exchange for the qualification, listing, and trading of these ETPs.
According to the Exchange, it will trade securities pursuant to UTP only on its Pillar platform, not on its current trading platform. Further, at this time, the Exchange states that it does not intend to list ETPs pursuant to the proposed rules. The Exchange does not proposing to change any of the current rules of the Exchange pertaining to the listing and trading of ETPs in the NYSE Listed Company Manual or in its other rules.
The Commission is instituting proceedings pursuant to Section 19(b)(2)(B) of the Act
Pursuant to Section 19(b)(2)(B) of the Act,
The Commission requests that interested persons provide written submissions of their views, data, and arguments with respect to the issues identified above, as well as any other concerns they may have with the proposal. In particular, the Commission invites the written views of interested persons concerning whether the proposal is consistent with Section 6(b)(5) or any other provision of the Act, or the rules and regulations thereunder. Although there do not appear to be any issues relevant to approval or disapproval that would be facilitated by an oral presentation of views, data, and arguments, the Commission will consider, pursuant to Rule 19b-4, any request for an opportunity to make an oral presentation.
Interested persons are invited to submit written data, views, and arguments regarding whether the proposal should be approved or disapproved by November 8, 2016. Any person who wishes to file a rebuttal to any other person's submission must file that rebuttal by November 22, 2016. The Commission asks that commenters address the sufficiency of the Exchange's statements in support of the proposal, which are set forth in the Notice,
In particular, the Commission seeks comment on whether the proposed rules regarding ETPs, which would not expressly apply on a continuing basis, are consistent with the Act.
Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
The Exchange proposes to amend the Fees Schedule. The text of the proposed rule change is available on the Exchange's Web site (
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to amend its Fees Schedule, effective October 3, 2016. Specifically, the Exchange proposes to increase the transaction fee for Professional Customers and Voluntary Professionals (“W” origin code) (“Professionals”) for all manual transactions in all penny and non-penny equity, index (excluding Underlying Symbol List A
The Exchange believes the proposed rule change is consistent with the Act and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of Section 6(b) of the Act.
The Exchange believes it is reasonable to increase the transaction fee for Professionals for manual transactions in all penny and non-penny equity, index (excluding Underlying Symbol List A), ETF and ETN options classes to $0.12 per contract because it is lower than the $0.25 fee assessed to Professionals for manual transactions prior to September 1, 2016. Additionally, the proposed fee is consistent with the approximate average transaction fee amount assessed to market-makers for manual transactions. The Exchange believes it is equitable and not unfairly discriminatory to propose to increase the manual transaction fee only for Professionals because it is designed to create a more competitive balance between Professionals (who have trading characteristics akin to broker-dealers) and broker-dealers for open outcry trades. With respect to manual transactions, Professionals often participate on trades in a similar manner as broker-dealers, and therefore the Exchange believes it is reasonable for Professionals to pay a transaction fee for those trades so they can compete on more equal footing for participation on those trades.
The Exchange does not believe the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. The Exchange does not believe the proposed rule change will impose any burden on intramarket competition not necessary or appropriate in furtherance of the purposes of the Act because, while increasing the transaction rate to $0.12 for manual executions in penny and non-penny equity, index (excluding Underlying Symbol List A), ETF and ETN option classes only applies to Professionals, broker-dealers currently pay transaction fees when trading as parties to those executions. The proposed change is designed to create a more competitive balance between Professionals and broker-dealers for open outcry trading. The Exchange does not believe the proposed rule change will impose any burden on intermarket competition that is not necessary or
The Exchange neither solicited nor received comments on the proposed rule change.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A) of the Act
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The proposed rule change consists of modifications to the DTC Rules, By-laws and Organization Certificate (“Rules”)
In its filing with the Commission, the clearing agency included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The clearing agency has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
DTC holds Eligible Securities on behalf of its Participants and reflects the transfer of interests in those securities by computerized book entry. There are two fundamental types of book-entry transfer under the Rules: Delivery and Pledge. A Delivery or a Pledge may be made (i) free of payment, where no funds are transferred through DTC, or (ii) versus payment through DTC net funds settlement in the ordinary course of business. The clarifying amendments in the proposed rule change relate to Pledges.
A Participant may instruct DTC to Deliver Securities from its Account to the Account of another Participant, in which case ownership of the Securities is transferred to the Receiver. Alternatively, a Participant (in this context, a Pledgor) that is granting a
As noted above, the characterization of any Pledge depends on agreements between the Pledgor and the Pledgee made outside of DTC. DTC does not inquire into the terms and conditions of those agreements but affords its Participants the means to Pledge the Securities by book-entry and, thereby, to perfect any properly created security interest with Control.
The Rules around Pledges were originally drafted primarily for bank loan transactions, where the Pledgee at DTC was typically a bank, lending to the counterparty Participant/Pledgor against inventory of the Participant held at DTC. If the Pledgee was also a Participant, it might receive the Pledge Versus Payment and fund the loan through DTC net funds settlement. This is rare, however, and most Pledges are made free of payment, against funding outside of DTC.
However, the Rules were not intended to be limited to this scenario; for instance, the definition of Pledgee prior to this proposed rule change allows for Pledgees that are not only banks.
In recognition of the various types of financing or collateral transactions for which a Pledge may be used, this proposed rule change would delete specific references to banks or loans, clarify that other types of financial institutions may be Pledgees, and make conforming changes to selected provisions relating to these matters.
The proposed rule change would modify Rule 1 (Definitions) and Rule 2 (Participants and Pledgees) to clarify that the Rules do not require (i) an entity to be a bank or to have engaged in a loan transaction with a Participant in order to qualify as a Pledgee, nor do the Rules require (ii) that Securities underlying a Pledge need to be pledged in connection with a loan. In addition, the definition of Pledgee would be updated to expressly include broker-dealers. Although the definition already allows types of entities other than banks to be Pledgees, the change should eliminate any ambiguity for this group of financial institutions that are already a permitted type of Participant pursuant to Rule 3 (Participants Qualifications).
In addition, pursuant to the proposed rule change, the Rules would be revised for other technical and clarifying changes to:
(i) Clarify in Rule 1 that the terms Collateral and Collateral Monitor are used in the context of the obligations of Participants and that the underlying computations and recording of Collateral and Collateral Monitor relate to the applicable Business Day on which they occur;
(ii) Clarify in Rule 1 that the term Collateral Value is used with respect to the Collateral of a Participant and that computations of Collateral Value relate to the applicable Business Day on which they occur;
(iii) Clarify in Rule 1 that an instruction from a Participant or Pledgee to the Corporation with respect to a Release of a Security credited to a Securities Account constitutes an Entitlement Order (in addition to a Delivery, Pledge or Withdrawal constituting Entitlement Orders as is already stated therein);
(iv) Delete a reference in the Rule 1 definition of Free Delivery that a Free Delivery is made as provided in Rule 9(A) (Transactions in Securities and Money Payments) because Free Deliveries by their nature do not involve money payments through DTC's system;
(v) Clarify in the Rule 1 definition of Free Pledge that a Free Pledge is made as provided in Rule 9(B) (in addition to Section 3 of Rule 2 and as specified in the Procedures) since Rule 9(B) applies to instructions to DTC to effect a Delivery, Pledge, Release or Withdrawal of Securities;
(vi) Specify in the Rule 1 definition of Free Release the section number (
(vii) Clarify the definition of Lender in Rule 1 consistent with the Rules generally to include that other lenders in addition to banks may extend credit to DTC for purposes authorized by the Rules;
(viii) Clarify clause (2) of the definition of Pledge in Rule 1 to eliminate any ambiguity as to the scope of clause (2) by adding the words “including for purposes of Rule 4(A)” and the words “or providing for” a security interest, so that there can be no doubt that clause (2) also applies to Rule 4(A) of the DTC Rules and that a “Pledge” on the books of DTC is not limited to the creation of a security interest but may also provide for a security interest consistent with applicable law;
(ix) Clarify the text of the definition of Pledged Security in Rule 1 to (a) simply state that the term Pledged Security means a Deposited Security which is the subject of a Pledge, rather than stating that the term means a Deposited Security which is the subject of a Free Pledge or Pledge Versus Payment, and (b) delete descriptive language relating to Pledges that is redundant to the meaning of the term Pledge as set forth in Rule 1;
(x) Add language to the definition of Limited Participant in Rule 1 in order to eliminate a potential ambiguity and
(xi) Clarify in Section 2 of Rule 2 that a Pledgee (in addition to a Participant) that utilizes the services of DTC for another Person does so as principal so far as the rights of DTC, and other Participants and Pledgees are concerned;
(xii) Clarify text in Section 3 of Rule 2 that a Pledge relates to Deposited Securities rather than Securities in general; and
(xiii) Conform text in Rule 1 and Rule 2 for readability, grammar and usage.
The proposed rule change would become effective upon filing with the Commission.
Section 17A(b)(3)(F)
DTC does not believe that the proposed rule change would have any impact or impose any burden on competition because it merely makes technical and clarifying changes to the Rules that do not impact the rights or obligations of Participants.
DTC has not received or solicited any written comments relating to this proposal. DTC will notify the Commission of any written comments received by DTC.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A)
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On August 12, 2016, NASDAQ PHLX LLC (“Exchange” or “Phlx”) filed with the Securities and Exchange Commission (“SEC” or “Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
Section 19(b)(2) of the Act
Accordingly, the Commission, pursuant to Section 19(b)(2) of the Act,
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Notice is hereby given that pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Rule 0-4 (17 CFR 275.0-4) under the Investment Advisers Act of 1940 (“Act” or “Advisers Act”) (15 U.S.C. 80b-1
The requirements of rule 0-4 are designed to provide Commission staff with the necessary information to assess whether granting the orders of exemption are necessary and appropriate in the public interest and consistent with the protection of investors and the intended purposes of the Act.
Applicants for orders under the Advisers Act can include registered investment advisers, affiliated persons of registered investment advisers, and entities seeking to avoid investment adviser status, among others. Commission staff estimates that it receives up to 3 applications per year submitted under rule 0-4 of the Act seeking relief from various provisions of the Advisers Act and, in addition, up to 9 applications per year submitted under Advisers Act rule 206(4)-5, which addresses certain “pay to play” practices and also provides the Commission the authority to grant applications seeking relief from certain of the rule's restrictions. Although each application typically is submitted on behalf of multiple applicants, the applicants in the vast majority of cases are related entities and are treated as a single respondent for purposes of this analysis. Most of the work of preparing an application is performed by outside counsel and, therefore, imposes no hourly burden on respondents. The cost outside counsel charges applicants depends on the complexity of the issues covered by the application and the time required. Based on conversations with applicants and attorneys, the cost for applications ranges from approximately $12,800 for preparing a well-precedented, routine (or otherwise less involved) application to approximately $200,000 to prepare a complex or novel application. We estimate that the Commission receives 1 of the most time-consuming applications annually, 2 applications of medium difficulty, and 9 of the least difficult applications subject to rule 0-4.
The requirements of this collection of information are required to obtain or retain benefits. Responses will not be kept confidential. 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 public may view the background documentation for this information collection at the following Web site,
Notice is hereby given that pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Section 6 of the Act
The respondents to the collection of information are futures markets.
The Commission estimates that the total annual burden for all respondents to provide ad hoc amendments
Compliance with Rule 6a-4 is mandatory. Information received in response to Rule 6a-4 shall not be kept confidential; the information collected is public information.
Written 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 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. Consideration will be given to comments and suggestions submitted in writing within 60 days of this publication.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information under the PRA unless it displays a currently valid OMB control number.
Please direct your written comments to: Pamela Dyson, Director/Chief Information Officer, Securities and Exchange Commission, c/o Remi Pavlik-Simon, 100 F Street NE., Washington, DC 20549 or send an email to:
On June 30, 2016, Bats BZX Exchange, Inc. (“BZX” or “Exchange”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Commission has received six comment letters on the proposed rule change.
The Exchange proposes to list and trade the Shares under BZX Rule 14.11(e)(4), which governs the listing and trading of Commodity-Based Trust Shares on the Exchange.
According to the Exchange, the Trust will hold only bitcoins as an asset.
The Commission has received six comment letters on the proposed rule change.
One commenter states that the proposal is a timely opportunity for the Exchange and investors, and that the proposal will allow investors to invest in the technology without having to deal with the complexity of holding bitcoins directly.
With respect to security measures to be implemented by the Trust, one commenter recommends that additional steps mandating “proof of control” audits be employed to protect the consumers of this ETP.
Another commenter addressed proof-of-control audits, adding that, unlike with non‐digital assets, an “audit” of assets in bitcoins can be low cost, public, and automated, and that there is no legitimate reason to maintain secrecy of the holdings involved in a trust or exchange.
Another commenter states that, according to the proposed rule change, the Custodian's Cold Storage System utilizes multiple-signature (“Multisig”) technology with an “M-of-N” signing design that requires a signature from more than one (1) Signer (but fewer than the full complement of potential Signers) in order to move the Trust's bitcoins.
A commenter notes that “[b]ecause safety measures cannot prevent thefts from the outside or the inside, [and] because human rationality is inherently bounded,” he does not support the fact that the Trust's bitcoins are not insured.
One commenter states that, despite the advances in Bitcoin development, owning and controlling bitcoins remains a highly specialized task, which includes secure management of private keys and “fairly advanced technological know-how.”
One commenter disagreed with the notion that bitcoins are commodities; rather, the commenter likened bitcoins to be more like “penny stock” or shares of a ponzi scheme.
One commenter expresses concerns regarding the Gemini Exchange Spot Price.
The Commission is instituting proceedings pursuant to Section 19(b)(2)(B) of the Act
Pursuant to Section 19(b)(2)(B) of the Act,
The Commission requests that interested persons provide written submissions of their views, data, and arguments with respect to the issues identified above, as well as any other concerns they may have with the proposal. In particular, the Commission invites the written views of interested persons concerning whether the proposal is consistent with Section 6(b)(5) or any other provision of the Act, or the rules and regulations thereunder. Although there do not appear to be any issues relevant to approval or disapproval that would be facilitated by an oral presentation of views, data, and arguments, the Commission will consider, pursuant to Rule 19b-4, any request for an opportunity to make an oral presentation.
Interested persons are invited to submit written data, views, and arguments regarding whether the proposal should be approved or disapproved by November 8, 2016. Any person who wishes to file a rebuttal to any other person's submission must file that rebuttal by November 22, 2016. The Commission asks that commenters address the sufficiency of the Exchange's statements in support of the proposal, which are set forth in the Notice,
1. The proposed fund, if approved, would be the first exchange-traded product available on U.S. markets to hold a digital asset such as bitcoins, which have neither a physical form (unlike commodities) nor an issuer that is currently registered with any regulatory body (unlike securities, futures, or derivatives), and whose fundamental properties and ownership can, by coordination among a majority of its network processing power, be changed (unlike any of the above). Moreover, as the Exchange acknowledges in its proposal, less than three years ago, the bitcoin exchange then responsible for nearly three-quarters of worldwide bitcoin trading lost a substantial amount of its bitcoin holdings through computer hacking or fraud and failed.
2. According to the Exchange, the Gemini Exchange Spot Price is representative of the accurate price of a bitcoin because of the positive price-discovery attributes of the Gemini Exchange marketplace. What are commenters' views on the manner in which the Trust proposes to value its holdings?
3. According to the Exchange, the Gemini Exchange is a Digital Asset exchange owned and operated by the Custodian and is an affiliate of the Sponsor. What are commenters' views regarding whether any potential conflict of interest or other issue might arise due to the relationship between entities such as the Sponsor, the Custodian, and the Gemini Exchange?
4. According to several commenters, there is a need for the Exchange to provide additional information regarding “proof of control” auditing, multisig protocols, and insurance with respect to the bitcoins held in custody on behalf of the Trust, in the interest of adequate security and investor confidence in bitcoin control. What are commenters' views on these recommendations regarding additional security, control, and insurance measures?
5. A commenter notes that the Gemini Exchange has relatively low liquidity and trading volume in bitcoins and that there is a significant risk that the nominal ETP share price “will be manipulated, by relatively small trades that manipulate the bitcoin price at that exchange.”
6. The Exchange asserts that the widespread availability of information
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.
Notice is hereby given that Northcreek Mezzanine Fund II, L.P., 312 Walnut Street, Suite 2310 Cincinnati, OH 45202, a Federal Licensee under the Small Business Investment Act of 1958, as amended (“the Act”), in connection with the financing of a small concern, has sought an exemption under Section 312 of the Act and Section 107.730, Financings which Constitute Conflicts of Interest of the Small Business Administration (“SBA”) Rules and Regulations (13 CFR 107.730). Northcreek Mezzanine Fund I, L.P. and Northcreek Mezzanine Fund II, L.P. propose to provide debt and equity financing to FBM Holdings LLC, 100 Winners Circle, Brentwood, TN 37027.
The financing is brought within the purview of § 107.730(a)(2) of the Regulations because Northcreek Mezzanine Fund I, L.P. is currently invested in FBM Holdings, LLC and because of its level of ownership, FBM Holdings LLC is an Associate. Northcreek Mezzanine Fund I, L.P. and Northcreek Mezzanine Fund II, L.P. are also Associates and are seeking to co-invest in FBM Holdings, LLC. Therefore this transaction is considered financing an Associate, requiring prior SBA exemption.
Notice is hereby given that any interested person may submit written comments on the transaction, within fifteen days of the date of this publication, to the Associate Administrator for Investment, U.S. Small Business Administration, 409 Third Street SW., Washington, DC 20416.
U.S. Small Business Administration
Notice
This is a notice of an Administrative declaration of a disaster for the State of IOWA dated 10/11/2016.
10/11/2016
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW., Suite 6050, Washington, DC 20416.
Notice is hereby given that as a result of the Administrator's disaster declaration, applications for disaster loans may be filed at the address listed above or other locally announced locations.
The following areas have been determined to be adversely affected by the disaster:
The Interest Rates are:
The number assigned to this disaster for physical damage is 14907 B and for economic injury is 14908 0.
The State which received an EIDL Declaration # is IOWA.
U.S. Small Business Administration.
Notice.
This is a Notice of the Presidential declaration of a major disaster for the State of North Carolina (FEMA-4285-DR), dated 10/10/2016.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW., Suite 6050, Washington, DC 20416.
Notice is hereby given that as a result of the President's major disaster declaration on 10/10/2016, applications for disaster loans may be filed at the address listed above or other locally announced locations.
The following areas have been determined to be adversely affected by the disaster:
The Interest Rates are:
The number assigned to this disaster for physical damage is 149118 and for economic injury is 149120.
U.S. Small Business Administration
Notice.
This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the State of Hawaii (FEMA-4282-DR), dated 10/06/2016.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW., Suite 6050, Washington, DC 20416
Notice is hereby given that as a result of the President's major disaster declaration on 10/06/2016, Private Non-Profit organizations that provide essential services of governmental nature may file disaster loan applications at the address listed above or other locally announced locations.
The following areas have been determined to be adversely affected by the disaster:
The Interest Rates are:
The number assigned to this disaster for physical damage is 14909B and for economic injury is 14910B.
Department of State.
Notice.
Delegates from the United States and Mexican governments, the states of California and Arizona, and the Mexican states of Baja California and Sonora will participate in a regional meeting of the U.S.-Mexico Binational Bridges and Border Crossings Group on Wednesday, October 19, 2016 in San Diego, California. The purpose of this meeting is to discuss operational matters involving existing and proposed international bridges and border crossings and their related infrastructure, and to exchange views on policy as well as technical information. This meeting will include a public session on Wednesday, October 19, 2016, from 8:45 a.m. until 10:45 a.m. This session will allow proponents of proposed bridges and border crossings and related projects to make presentations to the delegations and members of the public.
For further information on the meeting and to attend the public session, please contact the Mexico Desk's Border Affairs Unit, via email at
Federal Aviation Administration (FAA), DOT.
Notice.
This notice contains a summary of a petition seeking relief from specified requirements of Title 14 of the Code of Federal Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, the FAA's exemption process. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.
Comments on this petition must identify the petition docket number and must be received on or before November 7, 2016.
Send comments identified by docket number {FAA-2016-8929} using any of the following methods:
•
•
•
•
Alphonso Pendergrass (202) 267-4713, Office of Rulemaking, Federal Aviation Administration, 800 Independence Avenue SW., Washington, DC 20591.
This notice is published pursuant to 14 CFR 11.85.
Federal Highway Administration (FHWA), DOT.
Notice.
The FHWA is proposing two nationwide waivers from the Buy America requirements for COTS products with steel or iron components and steel tie wire permanently incorporated into precast concrete products.
Specialty steel or iron items, or any steel or iron item that is built to contract specification for a Federal-aid project, would remain subject to FHWA's Buy America requirements. The FHWA is requesting comments on these two proposed nationwide waivers, including the impact this proposal would have on State and local agencies administering Federal-aid projects; contractors; materials suppliers; railroads and utilities performing work related to a Federal-aid highway construction contract; and manufacturers.
Comments must be received on or before December 2, 2016.
Mail or hand deliver comments to Docket Management Facility: U.S. Department of Transportation, 1200 New Jersey Avenue SE., Room W12-140, Washington, DC 20590. You may also submit comments electronically at
Mr. Gerald Yakowenko, FHWA Office of Program Administration, (202) 366-1562,
An electronic copy of this notice may be downloaded from the specific docket page at
The FHWA's Buy America regulation at 23 CFR 635.410 requires a domestic manufacturing process for steel or iron materials that are permanently incorporated into a Federal-aid construction project. The FHWA interprets domestic manufacturing process to include steel manufacturing processes such as melting, rolling, cutting, welding, fabrication, and the process of applying a coating. The regulation is based on the statutory mandate in 23 U.S.C. 313(a).
The statute requires the application of the FHWA Buy America requirements to any project receiving Federal assistance under Title 23; however, the statute provides exceptions if the Secretary finds: (1) The application of the requirement would be inconsistent with the public interest; (2) where materials and products are not produced in the United States in sufficient and reasonably available quantities and of a satisfactory quality; or (3) the inclusion of domestic material will increase the cost of the overall project contract by more than 25 percent. See 23 U.S.C. 313(b).
A request for a waiver may be made for specific projects, for certain materials or products in specific geographic areas, or waivers regarding nationwide public interest or availability issues. See 23 U.S.C. 313(c). Not less than 15 days before waiving any Buy America requirement for Federal-aid highways projects, FHWA is required to notify the public on its intent to issue such a waiver.
(1) If the Secretary of Transportation makes a finding under section 313(b) of Title 23, United States Code, with respect to a project, the Secretary shall:
(A) publish in the
(B) provide notice of such finding and an opportunity for public comment on such finding for a period of not to exceed 60 days.
(2) Nothing in paragraph (1) shall be construed to require the effective date of a finding referred to a in paragraph (1) to be delayed until after the close of the public comment period referred to in paragraph (1)(B).
The FHWA interprets both of these provisions to apply to project-specific waiver requests, not to nationwide waivers, but the Agency is choosing to follow a similar process for nationwide waivers. For nationwide waivers, the Agency will publish a
The FHWA Buy America regulations also contain a regulatory exception for minimal use of foreign iron and steel. See 23 CFR 635.410(b)(4). This exception allows for a small use of foreign iron and steel materials if “the cost of such materials used does not exceed one-tenth of one percent (0.1 percent) of the total contract cost or $2,500, whichever is greater.” The FHWA expects that the contracting agency will maintain a running list of foreign steel or iron material as a project proceeds to be able to confirm compliance with this provision. The intent of this provision was to “eliminate an administrative burden placed on the States for truly minor items.” 48 FR 1946, 1947 (Jan. 17, 1983); 48 FR 53099, 53103 (Nov. 25, 1983).
In its final rule issued on November 25, 1983, FHWA also discussed a nationwide waiver for manufactured products other than steel and cement manufactured products. 48 FR 53099, 53102 (Nov. 25, 1983). In the final rule, FHWA stated that materials and products other than steel, cement, asphalt, and natural materials comprised a small percent of the highway construction program, and it was very difficult to identify the various materials and trace their origin.
As a result of the heightened awareness on projects funded under the American Recovery and Reinvestment Act of 2009 (Recovery Act) (Pub. L. 111-5), project inspectors and auditors spent significant resources examining compliance with FHWA's Buy America requirements for all steel or iron products in highway projects and noted compliance issues with Buy America certifications. In working to address these findings, FHWA realized that there was confusion regarding the application of Buy America requirements to COTS products with steel or iron components, such as sinks, toilets, faucets, traffic controller cabinets, and circuit breaker panels. Some FHWA Divisions were requiring Buy America compliance for steel and iron components and subcomponents of manufactured products. Other Divisions were treating these steel or iron components of manufactured products as excluded from Buy America requirements through the manufactured products waiver. On December 21, 2012, FHWA issued a memorandum intended
On October 12, 2014, the United Steelworkers Union and a group of eight manufacturing corporations filed a lawsuit challenging FHWA's December 21, 2012, Buy America memorandum, claiming that it was a substantive rule that required notice and comment pursuant to the Administrative Procedure Act, 5 U.S.C. 553.
On December 22, 2015, the U.S. District Court for the District of Columbia rendered its decision in the United Steelworkers Union case. The Court found against FHWA and vacated the December 21, 2012, memorandum. The Court also found that the COTS exception was a separate waiver from the manufactured products waiver in the November 25, 1983, rule.
The decision returned matters to pre-2012 memorandum conditions, when there was ambiguity and uncertainty on whether the FHWA Buy America requirements applied to COTS products with steel or iron components. As before December 21, 2012, FHWA Divisions and State DOTs are currently left to interpret the applicability of Buy America in this gray area, creating potential inconsistency in the application of Buy America. In response, FHWA evaluated options to achieve greater nationwide uniformity in the application of its Buy America requirements in a manner consistent with the Court's ruling. The FHWA has also received a number of requests to take action in this regard.
In keeping with the statutory text and the purpose of the Buy America requirements, the following covered materials, among others, have been and continue to be subject to Buy America requirements:
(1) Structural steel (any structural steel shapes used as load-bearing members);
(2) reinforcing steel used in cast-in-place, precast, pre-stressed or post-tensioned concrete products (including reinforcing steel couplers, connectors, wire mesh, steel fibers, pre-stressing or post-tensioning strand, wire rope or cable);
(3) steel or iron materials used in pavements, bridges, tunnels, or other structures: High strength bolts/nuts (any threaded fastening element with a nominal diameter greater than
(4) motor/machinery brakes and other equipment for moveable structures;
(5) guardrail, guardrail posts, offset blocks, guardrail related hardware, transitions, end sections, end treatments, terminals, cable barriers;
(6) steel fencing or steel fabric material, fence posts, fence rails;
(7) steel or iron pipe, casing, conduit, ducting, fire hydrants, manhole covers, rims, risers, drop inlet grates;
(8) mast arms, poles, cross arms, standards, trusses, or supporting structural members for signs, luminaires, or traffic control systems;
(9) incidental steel or iron items that are not explicitly defined in the contract documents but are permanently incorporated. This includes items that are impractical to remove due to design, construction, staging, or other functional requirements. If a steel or iron item is necessary for construction and it is impossible or impractical to remove, then Buy America requirements apply. This category includes, but is not limited to: Corrugated steel stay-in-place forms, sheet piling, steel casing for micropile construction, tie wire, filler metal/green rod for welding operations, etc.;
(10) steel or iron materials that are specified and manufactured for a specific Federal-aid project (for example, a lifting cable that is designed and manufactured for a specific project, or ductile iron pipe fittings built to contractor specifications); and
(11) rails for railroad or transit infrastructure funded under Title 23.
Pursuant to 23 U.S.C. 313(b), however, FHWA finds that the application of the Buy America requirements in certain limited circumstances is inconsistent with the public interest. Accordingly, FHWA is proposing two new nationwide waivers.
The FHWA continues to carry out and require compliance with the Buy America requirements, but it is also cognizant of the practical and administrative issues associated with its implementation. Contracting agencies must document and trace the origin of all steel components for products not waived under the 1983 regulations that are permanently incorporated in a Federal-aid project. If they are not able to document the domestic manufacturing processes for steel components (melted and manufactured in the United States), they must assume the steel is non-domestic and track each component to ensure compliance with the minimal use provisions of 23 CFR 635.410(b)(4) or request a waiver for each product under 23 CFR 635.410(c)(1).
From a practical viewpoint, manufacturers of electrical and mechanical products rely on multiple suppliers, both domestic and foreign, to source steel components for their products. Some steel components may be comprised of subcomponents that originate from different global suppliers with separate manufacturing processes. For many electrical and mechanical products, the Federal-aid highway program represents only a small fraction of the market for that product. For a contracting agency to comply with the Buy America requirements, it would need manufacturers to source and track components separately from its suppliers and provide certifications for all steel components. Only upon issuance of such certifications by manufacturers would contracting agencies be able to properly certify compliance with Buy America requirements. Thus, manufacturers would need to implement new sourcing, inventory, and tracking processes for contracting agencies to fully comply with the Buy America requirements.
Several State DOTs recently informed FHWA that manufacturer's certifications documenting compliance with the Buy America requirements are not available, and as a result, the State DOT must assume that all of the steel components are non-domestic and request a waiver.
The FHWA recognizes that verifying compliance with the Buy America requirements may be burdensome for some materials. For others, it is virtually impossible to trace the processes from the melting of the steel through the manufacturing and coating of the steel or iron materials. The FHWA believes that requiring contracting agencies to document the origin of every amount of steel or iron subcomponent of commercially available off-the-shelf products places an unreasonable burden on recipients and increases their administrative costs without significantly furthering the objectives and policies of Buy America. Therefore, FHWA seeks comments about the administrative costs of documenting the origin of steel or iron used in subcomponents of COTS products.
The first proposed nationwide waiver is for COTS incorporating steel or iron components. The term COTS means any manufactured product incorporating steel or iron components (excluding the covered materials discussed above, vehicles, or tie wire permanently incorporated in precast concrete) that:
(1) Is available and sold to the public in the retail and wholesale market;
(2) is offered to a contracting agency, under a contract or subcontract at any tier, without modification, and in the same form in which it is sold in the retail or wholesale market; and
(3) is broadly used in the construction industry.
The COTS products are limited to manufactured products with steel or iron components, such as sinks, faucets, toilets, door hinges, electrical products, and ITS hardware that are not made specifically for highway projects but are incidental to such projects. By contrast, products produced of steel or iron that are permanent features of a highway project that are specifically manufactured or modified for construction of such projects are excluded from COTS items and must comply with FHWA's Buy America requirements.
The FHWA believes that tracking the country of origin of steel or iron components of COTS places an unreasonable administrative burden on Federal-aid recipients, distributors, and contractors, including small businesses. These entities would likely have to establish costly material inventory tracking systems to ensure that all steel or iron components meet the Buy America requirements. The FHWA believes that manufacturers, distributors, contractors, and Federal-aid recipients would incur significant and unreasonable costs to document and track information regarding manufacturing operations. The FHWA also believes that steel or iron components of COTS constitute a relatively small percentage of the overall steel and iron materials used on Federal-aid projects, and the administrative costs associated with ensuring compliance would be disproportional to the value of the material. The FHWA believes that it may be in the public's interest that related administrative costs are better allocated to other oversight actions that reduce costs or accelerate project delivery. Accordingly, and pursuant to the exception provided under 23 U.S.C. 313(b) when application of the Buy America requirements is inconsistent with the public interest, FHWA proposes to issue this nationwide waiver for COTS with steel or iron components.
The second proposed nationwide waiver is for steel tie wire that is permanently incorporated into precast concrete products. Steel tie wire may be shown or referenced in standard plans, specifications, special provisions, or are standard industry practice. Even when tie wire is permanently incorporated in a precast concrete product, it is considered incidental to the design and construction of the product. Steel tie wire facilitates or allows the final product to be constructed but does not provide a structural function in the final product.
Manufacturers in the precast concrete industry rely extensively on rebar tying guns to tie reinforcing steel. The benefits of using rebar tying guns include the reduction of repetitive stress workplace injuries, such as carpal tunnel syndrome, and an increase in production. These rebar tying guns use tie wire supplied on spools. Although tie wire is domestically produced, patent requirements for the tying guns that are widely used by the precast concrete industry limit the use of tie wire to non-domestic sources. The patented design of these guns requires the use of specific tie wire spools, which are not compatible with the tie wire that is currently produced in the United States. Although there may be companies interested and able to supply Buy America-compliant tie wire, the supply of this product may be limited to specific applications due to its lack of compatibility with the rebar tying guns. The FHWA does not want to discourage innovation or create artificial barriers to continued process improvements in the construction industry. However, the Agency recognizes that more time may be needed to accommodate the demand for Buy America-compliant tie wire (supplied on spools for the proprietary tie wire guns commonly used in the industry) because it may not be domestically produced in sufficient and reasonably available quantities at this time.
The FHWA recognizes the impacts to the precast concrete industry related to the Court's decision to vacate FHWA's December 21, 2012, memorandum, and believes that it is appropriate to issue a 1-year temporary waiver of the Buy America requirements to allow suppliers in the precast industry to provide Buy America compliant tie wire. Accordingly, and pursuant to the exception provided under 23 U.S.C. 313(b) when materials and products are not produced in the United States in sufficient and reasonably available quantities, FHWA proposes to temporarily waive Buy America requirements for tie wire permanently incorporated into precast concrete products for a 1-year period from the date of issuance of the waiver. At the end of the 1-year period, FHWA will assess whether to continue the waiver or apply Buy America requirements to tie wire permanently incorporated into precast concrete products. The FHWA also seeks comments about the domestic availability of tie wire and lifting devices.
The FHWA is considering whether to issue a nationwide waiver for specialized lifting devices incorporated in precast concrete products. Over the years, suppliers in the precast industry have developed many types of specialized steel lifting devices that are designed and used to lift and move different precast concrete products used in highway and infrastructure projects. Many in the precast concrete industry may have come to rely on non-domestic lifting devices. The Court's decision to vacate FHWA's December 21, 2012, memorandum may result in an increase in demand for Buy America compliant
The FHWA requests public comment and input on this proposal for two nationwide waivers for manufactured items. Specifically, FHWA invites public comment on the following issues:
1. Does the COTS definition provide a reasonable description of commercially available off-the-shelf steel or iron items?
2. Are there COTS products that should be on the covered steel or iron materials list? If so, why?
3. Should there be a per-item cost cap for COTS items? If so, what should the cap be?
4. What is the burden, time, and cost associated with enforcing or complying with Buy America requirements for COTS items?
5. Are certifications and/or other documents available to allow owner agencies to trace and verify domestic melting and manufacturing processes for steel or iron products?
6. Does your agency or company track costs associated with the administrative or compliance efforts associated with the Buy America requirements?
7. Is the temporary waiver for tie wire permanently incorporated into precast concrete necessary and appropriate, and if yes, is 1 year the appropriate length?
8. Is domestically produced supply sufficient to meet demand for Buy America compliant lifting devices permanently incorporated into precast concrete?
9. Does your agency or company have concerns regarding the administrative burden, time, and cost associated with enforcing or complying with Buy America requirements on steel or iron products permanently incorporated into precast concrete products?
10. Does your agency or company have concerns regarding the availability of materials and products that comply with Buy America requirements on steel or iron products permanently incorporated into precast concrete products?
11. Does your State DOT have data that document the relative use of steel or iron products incorporated into precast products in comparison with all steel/iron materials used in your highway program?
Federal Transit Administration (FTA), DOT.
Notice of intent to transfer Federally assisted facility.
Section 5334(h) of the Federal Transit Laws, as codified, 49 U.S.C. 5301,
The Port of New Orleans (Port) intends to use the property for administrative purposes to support its activities. The transfer will provide benefits to the Port by providing space for Port personnel to carry out administrative functions. The transfer will support efforts by the Port to expand container terminal capacity to address and capitalize projected growth in container traffic. In addition, Port ownership of the property and building will maintain a position of security in location and afford continuous visibility of the river from Port property. The Port plans to use the property and building for a minimum of 5 years.
Interested parties should notify the Regional Office by writing to Robert C. Patrick, Regional Administrator, Federal Transit Administration, 819 Taylor Street, Room 14A02, Fort Worth, TX 76102.
Eldridge Onco, Regional Counsel, (817) 978-0557.
49 U.S.C. 5334(h) provides guidance on the transfer of capital assets. Specifically, if a recipient of FTA assistance decides an asset acquired under this chapter at least in part with that assistance is no longer needed for the purpose for which it was acquired, the Secretary of Transportation may authorize the recipient to transfer the asset to a local governmental authority to be used for a public purpose with no further obligation to the Government. 49 U.S.C. 5334(h)(1).
The Secretary may authorize a transfer for a public purpose other than mass transportation only if the Secretary decides:
(A) The asset will remain in public use for at least 5 years after the date the asset is transferred;
(B) There is no purpose eligible for assistance under this chapter for which the asset should be used;
(C) The overall benefit of allowing the transfer is greater than the interest of the Government in liquidation and return of the financial interest of the Government in the asset, after considering fair market value and other factors; and
(D) Through an appropriate screening or survey process, that there is no interest in acquiring the asset for Government use if the asset is a facility or land.
This document implements the requirements of 49 U.S.C. 5334(h)(1)(D)
The total property consists of a mostly rectangular shaped 15,029 square foot area parcel, which is currently paved and improved with a one and one-half story concrete ferry terminal building, along with a portion of a pedestrian bridge. The property is located along the west bank of the Mississippi River along Tchoupitoulas Street and Jackson Street Avenue. The property is located in an area surrounded by wharf facilities operated by the Port of New Orleans. The interior and exterior of the building is in need of significant repair. The property is no longer being used to support ferry service.
If no Federal agency is interested in acquiring the property, building, and improvements, FTA will make certain that the other requirements specified in 49 U.S.C. 5334(h)(1)(A) through (C) are met before permitting the asset to be transferred.
National Highway Traffic Safety Administration (NHTSA), U.S. Department of Transportation (DOT).
Notice.
In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Comments must be submitted on or before November 17, 2016.
Send comments, within 30 days, to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street NW., Washington, DC 20503, Attention NHTSA Desk Officer.
Alan Block, Office of Behavioral Safety Research (NPD-310), National Highway Traffic Safety Administration, 1200 New Jersey Avenue SE., W46-499, Washington, DC 20590. Mr. Block's phone number is 202-366-6401 and his email address is
Incorrect selection of a CRS appropriate for the child's height and weight, and premature promotion, are additional factors that increase the risk of injury to a child in the event of a crash. While infants should always ride in rear-facing car seats, NHTSA's 2013 National Survey of the Use of Booster Seats (NSUBS) observed 10 percent of children under age 1 were not in rear-facing car seats; most of these infants were prematurely graduated to forward-facing car seats. Children 1 to 3 years old should ride either in rear-facing or front-facing car seats, but NSUBS found that 9 percent of children 1 to 3 years old were prematurely graduated to booster seats and 3 percent to seat belts. Children ages 4 to 7 should either ride in forward-facing car seats or booster seats. However, 24 percent were observed in seat belts, and 9 percent were unrestrained.
Many information resources are available to aid parents and caregivers with proper CRS selection, installation, and use, including hands-on instruction. Research has shown that hands-on instruction on CRS installation, such as that provided by NHTSA and Safe Kids Worldwide at Child Car Seat Inspection Stations nationwide, is effective in reducing misuse. Unfortunately, this resource seems to be underutilized. Only about one out of ten drivers interviewed for NHTSA's National Child Restraint Use Special Study reported having their CRS inspected at an inspection station. At present, it is unclear what deters and what encourages use of CRS inspection stations and Child Passenger Safety Technicians.
To help increase correct use of CRS and utilization of inspection stations, approval is requested to conduct a national web-based survey to estimate parent and caregiver general knowledge of child passenger safety (CPS) information resources, awareness and use of CRS inspection stations, and barriers to CRS inspection station use. The survey will also examine the relationship between parent and caregiver confidence in installing CRSs, risk perception, and intent to visit an inspection station. The proposed survey is titled, “Awareness & Availability of Child Passenger Safety Information Resources” (AACPSIR).
• 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;
• The accuracy of the agency's estimate of the burden of the proposed information collection;
• 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 respondents, including the use of automated collection techniques or other forms of information technology.
A comment to OMB is most effective if OMB receives it within 30 days of publication.
44 U.S.C. Section 3506(c)(2)(A).
Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT.
Notice of public meeting.
This notice is to inform interested persons that PHMSA will conduct a public meeting on Tuesday, November 15, 2016, in preparation for the 50th session of the United Nations Sub-Committee of Experts on the Transport of Dangerous Goods (UNSCOE TDG) to be held in Geneva, Switzerland from November 28 to December 6, 2016. During this public meeting, PHMSA will be requesting comments relative to potential new work items that may be considered for inclusion in the international agenda.
Tuesday, November 15, 2016; from 9:00 a.m. to 12:00 p.m.
DOT Headquarters, West Building, Oklahoma City Conference Room, 1200 New Jersey Avenue SE., Washington, DC 20590.
Conference call-in and “Skype meeting” capability will be provided. Specific information on such access will be posted when available at
Steven Webb or Aaron Wiener, Office of Hazardous Materials Safety, Department of Transportation, Washington, DC 20590, telephone 202-366-8553.
The primary purpose of this meeting is to prepare for the 50th session of the UNSCOE TDG. This session represents the final meeting scheduled for the 2015-2016 biennium. UNSCOE will consider proposals for the 20th Revised Edition of the
General topics on the agenda for the UNSCOE TDG meeting include:
• Explosives and related matters;
• Listing, classification, and packing;
• Electric storage systems;
• Transport of gases;
• Global harmonization of transport of dangerous goods regulations with the Model Regulations;
• Guiding principles for the Model Regulations;
• Cooperation with the International Atomic Energy Agency (IAEA);
• New proposals for amendments to the Model Regulations;
• Issues relating to the Globally Harmonized System of Classification and Labeling of Chemicals (GHS); and
• Miscellaneous pending issues.
Following the 50th session of the UNSCOE TDG, a copy of the Sub-Committee's report will be available at the United Nations Transport Division's Web site at
Department of the Treasury, Office of the Comptroller of the Currency (OCC).
Notice.
The OCC has determined that the renewal of the charter of the OCC Mutual Savings Association Advisory Committee (MSAAC) is necessary and in the public interest. The OCC hereby gives notice of the renewal of the charter.
The charter of the OCC MSAAC has been renewed for a two-year period that began on September 21, 2016.
Michael R. Brickman, Designated Federal Officer, 202-649-5420, Office of the Comptroller of the Currency, 400 7th Street SW., Washington, DC 20219.
Notice of the renewal of the MSAAC charter is hereby given, with the approval of the
Bureau of Engraving and Printing (BEP), Treasury Department.
Notice of members of Combined Performance Review Board (PRB).
This notice announces the appointment of the members of the Combined Performance Review Board (PRB) for the Bureau of Fiscal Service, the Bureau of Engraving and Printing (BEP), the United States Mint, the Alcohol and Tobacco Tax and Trade Bureau (TTB), and the Financial Crimes Enforcement Network (FinCEN). The Combined PRB reviews the performance appraisals of career senior executives who are below the level of bureau head and principal deputy in the bureaus, except for executives below the Assistant Commissioner/Executive Director level in the Bureau of Fiscal Service. The Combined PRB makes recommendations regarding proposed performance appraisals, ratings, bonuses, pay adjustments, and other appropriate personnel actions.
The membership of the Combined PRB as described in the Notice is effective on October 31, 2016.
Tanya Everett, Human Resources Officer/Office Chief, 14th and C Street SW., Washington, DC 20228, Office: (202) 874-3573.
Pursuant to 5 U.S.C. 4314(c)(4), this Notice announces the appointment of the following primary and alternate members to the Combined PRB:
Bureau of Engraving and Printing elected to not have an alternate.
The Department of the Treasury will submit the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995, Public Law 104-13, on or after the date of publication of this notice.
Comments should be received on or before November 17, 2016 to be assured of consideration.
Send comments regarding the burden estimates, or any other aspect of the information collection, including suggestions for reducing the burden, to (1) Office of Information and Regulatory Affairs, Office of Management and Budget, Attention: Desk Officer for Treasury, New Executive Office Building, Room 10235, Washington, DC 20503, or email at
Copies of the submission may be obtained by emailing
The Department of the Treasury will submit the following information collection requests to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995, Public Law 104-13, on or after the date of publication of this notice.
Comments should be received on or before November 17, 2016 to be assured of consideration.
Send comments regarding the burden estimates, or any other aspect of the information collections, including suggestions for reducing the burden, to (1) Office of Information and Regulatory Affairs, Office of Management and Budget, Attention: Desk Officer for Treasury, New Executive Office Building, Room 10235, Washington, DC 20503, or email at
Copies of the submissions may be obtained by emailing
Notice; correction.
The United States Mint published a notice titled “Request for Citizens Coinage Advisory Committee Membership Applications” in the
In the
Betty Birdsong, Acting United States Mint Liaison to the CCAC; 801 Ninth Street NW., Washington, DC 20220; or call 202-354-7770.
(a) By revising the introductory paragraph by deleting the term “voluntary agencies” and inserting in its place the term “voluntary health and welfare organizations”; and by deleting the term “recipient agencies” and inserting in its place “recipient organizations”.
(b) By revising section 1 of that order to read as follows:
(a) The Director of the Office of Personnel Management shall make arrangements for voluntary health and welfare organizations to solicit contributions from Federal employees and members of the uniformed services at their places of employment or duty. Federal employees and members of the uniformed services can also be solicited to make pledges of volunteer time. These arrangements shall take the form of an annual Combined Federal Campaign in which eligible voluntary health and welfare organizations are authorized to take part.
(b) The Director shall consider permitting annuitants to make contributions to the Combined Federal Campaign through allotments or assignments of amounts from their Federal annuities. The Director may prescribe rules and regulations to govern the solicitation of such contributions and make arrangements to inform annuitants of their ability to make contributions in this manner.”
(c) By revising section 2(a) by deleting the term “voluntary agencies” and inserting in its place the term “voluntary health and welfare organizations”.
(d) By revising the first clause of section 2(b)(1) to delete “and of local communities”.
(e) By revising section 2(b)(2) by deleting the first instance of the word “agencies” and inserting in its place the word “organizations”.
(f) By revising section 2(b)(3) by deleting the term “Agencies” and inserting in its place the term “Organizations”; and by deleting the term “charitable health and welfare agencies” and inserting in its place the term “charitable health and welfare organizations”.
(g) By revising section 2(b)(5) to read as follows:
“(5) Local voluntary, charitable, health and welfare organizations that are not affiliated with a national organization or federation but that satisfy the eligibility criteria set forth in this order and by the Director shall be permitted to participate in the Combined Federal Campaign.”
(h) By revising section 3 by deleting the term “voluntary agencies” and inserting in its place the term “voluntary health and welfare organizations”.
(i) By revising section 5 to read as follows:
(a) outreach coordinators to conduct campaign promotion in a local Combined Federal Campaign; and
(b) central campaign administrators to administer application and pledging systems and to collect and disburse pledged funds.
Such authorizations shall, if made, ensure at a minimum that outreach coordinators and central campaign administrators operate subject to the direction and control of the Director and such local Federal coordinating entities as may be established; and manage the Combined Federal Campaign fairly and equitably. The Director may consult with and consider advice from interested parties and organizations, and shall publish reports on the management and results of the Combined Federal Campaign.”
(j) By revising section 6 to read as follows:
(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.
(d) All rules, regulations, and directives continued or issued under Executive Order 12353, as amended, shall continue in effect until revoked or modified under the provisions of this order.
(b) To ensure accountability for and coordination of research, development, and implementation of activities identified in this order and in the Action Plan, the NSTC shall establish a Space Weather Operations, Research, and Mitigation Subcommittee (Subcommittee). The Subcommittee member agencies shall conduct activities to advance the implementation of this order, to achieve the goals identified in the 2015
(a) The Secretary of Defense shall ensure the timely provision of operational space weather observations, analyses, forecasts, and other products to support the mission of the Department of Defense and coalition partners, including the provision of alerts and warnings for space weather phenomena that may affect weapons systems, military operations, or the defense of the United States.
(b) The Secretary of the Interior shall support the research, development, deployment, and operation of capabilities that enhance the understanding of variations of the Earth's magnetic field associated with solar-terrestrial interactions.
(c) The Secretary of Commerce shall:
(d) The Secretary of Energy shall facilitate the protection and restoration of the reliability of the electrical power grid during a presidentially declared grid security emergency associated with a geomagnetic disturbance pursuant to 16 U.S.C. 824o-1.
(e) The Secretary of Homeland Security shall:
(f) The Administrator of the National Aeronautics and Space Administration (NASA) shall:
(g) The Director of the National Science Foundation (NSF) shall support fundamental research linked to societal needs for space weather information through investments and partnerships, as appropriate.
(h) The Secretary of State, in consultation with the heads of relevant agencies, shall carry out diplomatic and public diplomacy efforts to strengthen global capacity to respond to space weather events.
(i) The Secretaries of Defense, the Interior, Commerce, Transportation, Energy, and Homeland Security, along with the Administrator of NASA and the Director of NSF, shall work together, consistent with their ongoing activities, to develop models, observation systems, technologies, and approaches that inform and enhance national preparedness for the effects of space weather events, including how space weather events may affect critical infrastructure and change the threat landscape with respect to other hazards.
(j) The heads of all agencies that support National Essential Functions, defined by Presidential Policy Directive 40 (PPD-40) of July 15, 2016 (National Continuity Policy), shall ensure that space weather events are adequately addressed in their all-hazards preparedness planning, including mitigation, response, and recovery, as directed by PPD-8 of March 30, 2011 (National Preparedness).
(k) NSTC member agencies shall coordinate through the NSTC to establish roles and responsibilities beyond those identified in section 4 of this order to enhance space weather preparedness, consistent with each agency's legal authority.
(b) Within 120 days of the date of this order, the heads of the sector-specific agencies that oversee the lifeline critical infrastructure functions as defined by the National Infrastructure Protection Plan of 2013—including communications, energy, transportation, and water and wastewater systems—as well as the Nuclear Reactors, Materials, and Waste Sector, shall assess their executive and statutory authority, and limits of that authority, to direct, suspend, or control critical infrastructure operations, functions, and services before, during, and after a space weather event. The heads of each sector-specific agency shall provide a summary of these assessments to the Subcommittee.
(c) Within 90 days of receipt of the assessments ordered in section 5(b) of this order, the Subcommittee shall provide a report on the findings of these assessments with recommendations to the Director of OSTP, the Assistant to the President for Homeland Security and Counterterrorism, and the Director of OMB. The assessments may be used to inform the development and implementation of policy establishing authorities and responsibilities for agencies in response to a space weather event.
(d) Within 60 days of the date of this order, the Secretaries of Defense and Commerce, the Administrator of NASA, and the Director of NSF, in collaboration with other agencies as appropriate, shall identify mechanisms for advancing space weather observations, models, and predictions, and for sustaining and transitioning appropriate capabilities from research to operations and operations to research, collaborating with industry and academia to the extent possible.
(e) Within 120 days of the date of this order, the Secretaries of Defense and Commerce shall make historical data from the GPS constellation and other U.S. Government satellites publicly available, in accordance with Executive Order 13642 of May 9, 2013 (Making Open and Machine Readable
(f) Within 120 days of the date of this order, the Secretary of Homeland Security, through the Administrator of the Federal Emergency Management Agency and in coordination with relevant agencies, shall lead the development of a coordinated Federal operating concept and associated checklist to coordinate Federal assets and activities to respond to notification of, and protect against, impending space weather events. Within 180 days of the publication of the operating concept and checklist, agencies shall develop operational plans documenting their procedures and responsibilities to prepare for, protect against, and mitigate the effects of impending space weather events, in support of the Federal operating concept and compatible with the National Preparedness System described in PPD-8.
(a) “Prepare” and “preparedness” have the same meaning they have in PPD-8. They refer to the actions taken to plan, organize, equip, train, and exercise to build and sustain the capabilities necessary to prevent, protect against, mitigate the effects of, respond to, and recover from those threats that pose the greatest risk to the security of the Nation. This includes the prediction and notification of space weather events.
(b) “Space weather” means variations in the space environment between the Sun and Earth (and throughout the solar system) that can affect technologies in space and on Earth. The primary types of space weather events are solar flares, solar energetic particles, and geomagnetic disturbances.
(c) “Solar flare” means a brief eruption of intense energy on or near the Sun's surface that is typically associated with sunspots.
(d) “Solar energetic particles” means ions and electrons ejected from the Sun that are typically associated with solar eruptions.
(e) “Geomagnetic disturbance” means a temporary disturbance of Earth's magnetic field resulting from solar activity.
(f) “Critical infrastructure” has the meaning provided in section 1016(e) of the USA Patriot Act of 2001 (42 U.S.C. 5195c(e)), namely systems and assets, whether physical or virtual, so vital to the United States that the incapacity or destruction of such systems and assets would have a debilitating impact on security, national economic security, national public health or safety, or any combination of those matters.
(g) “Sector-Specific Agency” means the agencies designated under PPD-21 of February 12, 2013 (Critical Infrastructure Security and Resilience), or any successor directive, to be responsible for providing institutional knowledge and specialized expertise as well as leading, facilitating, or supporting the security and resilience programs and associated activities of its designated critical infrastructure sector in the all-hazards environment.
(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.
Office of Energy Efficiency and Renewable Energy, Department of Energy.
Proposed definition and data availability.
On March 17, 2016, DOE published a notice of proposed rulemaking (NOPR) proposing standards for general service lamps (GSLs) pursuant to the Energy Policy and Conservation Act of 1975 (EPCA), as amended. During the subsequent public meeting and in written comments, stakeholders provided additional data and raised concerns regarding the expansion of scope in the proposed GSL definition and DOE's approach to analyzing the 22 general service incandescent lamp exemptions. In response to several of those comments, DOE collected additional data and is publishing this document to propose a revised definition of GSL; announce the availability of National Electrical Manufacturers Association (NEMA) data and supplemental data collected by DOE; request public comment on proposed definitions and compiled data; and request any additional data that stakeholders may have in support of this evaluation.
The public meeting will be held at the U.S. Department of Energy, Forrestal Building, Room 1E-245, 1000 Independence Avenue SW., Washington, DC 20585. Any foreign national wishing to participate in the meeting should advise DOE as soon as possible by contacting
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4.
No telefacsimilies (faxes) will be accepted. For detailed instructions on submitting comments and additional information on the rulemaking process, see section VI of this document (“Public Participation”).
A link to the docket Web page can be found at:
For further information on how to submit a comment, review other public comments and the docket, or participate in the public meeting, contact the Appliance and Equipment Standards Program Staff at (202) 586-6636 or by email:
DOE intends to incorporate by reference the following industry standards into 10 CFR part 430:
(1) American National Standards Institute C81.61-2016 (“ANSI C81.61-2016”), Electric Lamp Bases—Specifications for Bases (Caps) for Electric Lamps, dated April 20, 2016.
A copy of ANSI C81.61-2016 can be obtained from the American National Standards Institute, 25 W. 43rd Street, 4th Floor, New York, NY 10036, (212) 642-4900, or go to
(2) International Electrotechnical Commission 60061-1:2005 (“IEC 60061-1:2005”), Lamp caps and holders together with gauges for the control of interchangeability and safety—Part 1: Lamp caps, Amendment 35, Edition 3, dated January 27, 2005.
A copy of IEC 60061-1:2005 can be obtained from the American National Standards Institute, 25 W. 43rd Street, 4th Floor, New York, NY 10036, (212) 642-4900, or go to
(3) Underwriter Laboratories 1598C-2014 (“UL 1598C-2014”), Standard for Light-Emitting Diode Retrofit Luminaire Conversion Kits, First Edition, dated January 16, 2014.
A copy of UL 1598C-2014 can be obtained from Comm 2000, 151 Eastern
For a further discussion of these standards, see section V.M.
Title III, Part B of the Energy Policy and Conservation Act of 1975 (EPCA or the Act), Public Law 94-163 (42 U.S.C. 6291-6309, as codified) established the Energy Conservation Program for Consumer Products Other Than Automobiles, a program covering most major household appliances (collectively referred to as “covered products”).
In particular, amendments to EPCA in the Energy Independence and Security Act of 2007 (EISA 2007) directed DOE to conduct two rulemaking cycles to evaluate energy conservation standards for GSLs. (42 U.S.C. 6295(i)(6)(A)-(B)) For the first rulemaking cycle, EPCA, as amended by EISA 2007, directs DOE to initiate a rulemaking no later than January 1, 2014, to evaluate standards for GSLs and determine whether exemptions for certain incandescent lamps should be maintained or discontinued. (42 U.S.C. 6295(i)(6)(A)(i)) The scope of the rulemaking is not limited to incandescent lamp technologies. (42 U.S.C. 6295(i)(6)(A)(ii)) Further, for this first cycle of rulemaking, the EISA 2007 amendments provide that DOE must consider a minimum standard of 45 lumens per watt (lm/W). (42 U.S.C. 6295(i)(6)(A)(ii)) If DOE fails to meet the requirements of 42 U.S.C. 6295(i)(6)(A)(i)-(iv) or the final rule from the first rulemaking cycle does not produce savings greater than or equal to the savings from a minimum efficacy standard of 45 lm/W, the statute provides a “backstop requirement” under which GSLs would be subject to a minimum 45 lm/W standard beginning on January 1, 2020. (42 U.S.C. 6295(i)(6)(A)(v))
In March 2016, DOE published a notice of proposed rulemaking (NOPR) that proposed a revised definition of GSL and energy conservation standards for certain GSLs (hereafter the “March 2016 GSL ECS NOPR”). 81 FR 14528 (March 17, 2016). In conjunction with the NOPR, DOE also published on its Web site the complete technical support document (TSD) for the proposed rule, which described the analyses DOE conducted and included technical documentation for each analysis. The TSD also included the life cycle cost (LCC) spreadsheet, the national impact analysis spreadsheet, and the manufacturer impact analysis (MIA) spreadsheet.
DOE held a public meeting on April 20, 2016, to hear oral comments on and solicit information relevant to the proposed rule. At this meeting, DOE heard concerns from stakeholders regarding the expansion of scope in the proposed GSL definition and DOE's approach to analyzing the 22 exemptions. In addition, DOE received written comments that reiterated these concerns and also provided additional data for DOE's consideration. Specifically, the National Electrical Manufacturers Association (NEMA) provided new data and information on the 22 exempted lamp types to inform DOE's evaluation of whether the exemptions should be maintained or discontinued as required by 42 U.S.C. 6295(i)(6)(A)(i)(II).
Since the publication of the NOPR, DOE has analyzed the data submitted by NEMA and collected additional data where available. DOE is publishing this NOPDDA to: (1) Propose a revised definition of GSL; (2) announce the availability of the NEMA data and supplemental data collected by DOE; (3) request public comment on proposed definitions and compiled data; and (4) request any additional data that stakeholders may have in support of this evaluation. The following sections describe the revised definition and additional data in more detail. After considering the comments received, DOE will publish a final rule.
The term general service lamp (GSL) includes general service incandescent lamps (GSILs), compact fluorescent lamps (CFLs), general service light-emitting diode (LED) and organic light-emitting diode (OLED) lamps, and any other lamps that DOE determines are used to satisfy lighting applications traditionally served by GSILs; however, GSLs do not include any lighting application or bulb shape excluded from the “general service incandescent lamp” definition, or any general service fluorescent lamp or incandescent reflector lamp. (42 U.S.C. 6291(30)(BB))
DOE has the authority to consider additional lamps that it determines are used to satisfy lighting applications traditionally served by GSILs. (42 U.S.C. 6291(30)(BB)(i)(IV)) In the March 2016
More specifically, DOE proposed the following definition for GSL in the March 2016 GSL ECS NOPR:
DOE received some general comments on the proposed definition. General Electric Lighting (GE) asserted that Congress did not give DOE authority to expand the definition of GSL to include all lamps that have any ANSI base, operate at any voltage, and produce general illumination, and that the expanded definition in conjunction with the backstop will eliminate specialty and niche products with no possible substitutes. (GE, No. 70 at pp. 7-8) The International Association of Lighting Designers (IALD) stated that the broadened scope of GSLs was going beyond readily available technology. (IALD, No. 62 at p. 3) Philips Lighting (Philips) also stated it did not support the broadened definition of GSL and referred to detailed comments from NEMA on the matter. (Philips, No. 71 at p. 3) Earthjustice stated that the proposed definition makes it clear what lamp types are covered. (Earthjustice, Public Meeting Transcript, No. 54 at p. 24) However, DOE also received several comments expressing concern that the definition did not clearly specify the scope of lamps that are GSLs.
The California Energy Commission (CEC) stated that many lamp types are not intended for general service applications and should not be included in the GSL definition, but could appear to be under the proposed definition, leading to uncertainty and differences in interpretation between manufacturers. (CEC, No. 69 at p. 18) CEC specifically identified directional lamps less than 2.25 inches in diameter and MR16 lamps as examples in which the coverage of the GSL definition is uncertain. CEC recommended that DOE either state the GSL scope of coverage explicitly by listing specific voltages, wattages, lumen outputs, or similar attributes, or define “general service application” to clarify what applications are general service in nature. (CEC, No. 69 at pp. 18-19) Westinghouse agreed, noting this ambiguity could introduce compliance issues for manufacturers. (Westinghouse, Public Meeting Transcript, No. 54 at p. 39)
GE recommended that DOE define GSLs to be clear in not including specialty incandescent or specialty halogen lamps with specialty bases that operate at other than 120 volts (or MR lamps that operate on a 120 V/12 V transformer) and lamps that have a lumen output of greater than 2,600 lumens. GE also recommended defining specialty base and specialty lamp in a separate definition in order to limit the definition length and improve readability. (GE, No. 70 at p. 10) Further, GE suggested DOE clearly state that products designed or labeled for use in non-general applications should not be included in the definition. (GE, Public Meeting Transcript, No. 54 at pp. 36-37) In contrast, Westinghouse and ASAP voiced concern for the potential loophole that could exist if products could be excluded from scope by simply indicating on their label that they are intended for non-general applications. (Westinghouse, Public Meeting Transcript, No. 54 at p. 39; ASAP, Public Meeting Transcript, No. 54 at p. 43)
NEMA suggested an alternative definition of general service lamp that would modify the proposed definition in the March 2016 GSL ECS NOPR by stating that a general service lamp is used to satisfy a majority of lighting applications and is not a specialty base lamp nor a specialty lamp. Further, NEMA suggested that the definition should specify that general service lamps operate at a rated voltage from 110 to 130 V or 11 to 13 V; have an initial lumen output of 232 lumens or greater for modified spectrum general service incandescent lamps; and have an initial lumen output of 2,600 lumens or less. Additionally, NEMA recommended a definition for “specialty lamp” and “specialty base lamp.” (NEMA, No. 66 at pp. 43-44) NEMA commented that DOE should follow the Federal Trade Commission's (FTC's) approach to labeling specialty lamps. NEMA explained that instead of amending the definition of general service lamp, FTC incrementally categorized certain specialty lamps as “specialty consumer lamps.” (NEMA, No. 66 at p. 19)
The California Investor Owned Utilities (CA IOUs) agreed that a more explicit list of covered lamp types would be helpful but only for informational purposes and not for inclusion in the regulatory text. (CA IOUs, Public Meeting Transcript, No. 54 at pp. 50-51) The Energy Efficiency Advocates (EEAs)
As discussed previously in this section, in the March 2016 GSL ECS NOPR DOE interpreted general service
As stated previously, GSLs include GSILs. (42 U.S.C. 6291(30)(BB)(i)(I)) The definition of “general service incandescent lamp” is as follows:
General service incandescent lamp means a standard incandescent or halogen type lamp that is intended for general service applications; has a medium screw base; has a lumen range of not less than 310 lumens and not more than 2,600 lumens or, in the case of a modified spectrum lamp, not less than 232 lumens and not more than 1,950 lumens; and is capable of being operated at a voltage range at least partially within 110 and 130 volts; however this definition does not apply to the following incandescent lamps—
(1) An appliance lamp;
(2) A black light lamp;
(3) A bug lamp;
(4) A colored lamp;
(5) An infrared lamp;
(6) A left-hand thread lamp;
(7) A marine lamp;
(8) A marine signal service lamp;
(9) A mine service lamp;
(10) A plant light lamp;
(11) A reflector lamp;
(12) A rough service lamp;
(13) A shatter-resistant lamp (including a shatter-proof lamp and a shatter-protected lamp);
(14) A sign service lamp;
(15) A silver bowl lamp;
(16) A showcase lamp;
(17) A 3-way incandescent lamp;
(18) A traffic signal lamp;
(19) A vibration service lamp;
(20) A G shape lamp (as defined in ANSI C78.20 and ANSI C79.1-2002) with a diameter of 5 inches or more;
(21) A T shape lamp (as defined in ANSI C78.20 and ANSI C79.1-2002) and that uses not more than 40 watts or has a length of more than 10 inches; and
(22) A B, BA, CA, F, G16-1/2, G-25, G30, S, or M-14 lamp (as defined in ANSI C79.1-2002 and ANSI C78.20) of 40 watts or less.
In the March 2016 GSL ECS NOPR, DOE declined to make a determination about discontinuing the 22 exemptions from the GSIL definition. In the NOPR, DOE initially concluded that, because the Appropriations Rider
A number of commenters stated that EPCA requires DOE to determine whether the exemptions of incandescent lamps should be discontinued or maintained as required under 42 U.S.C. 6295(i)(6)(A)(i)(II). (ASAP, Public Meeting Transcript, No. 54 at p. 12; NRDC, Public Meeting Transcript, No. 54 at pp. 16-17; CEC, No. 69 at p. 20; Earthjustice, No. 61 at pp. 2-3; Philips, No. 71 p. 4) Earthjustice stated that the definition of GSL proposed in the March 2016 GSL ECS NOPR unlawfully maintained exemptions for certain incandescent lamps, including the 22 types of lamps excluded from EPCA's definition of “general service incandescent lamp.” (Earthjustice, No. 61 at p. 1) CEC commented that DOE should either correctly interpret the Appropriations Rider as allowing DOE to determine whether to discontinue the 22 lamp exemptions and examine them as technology neutral, or exempt all 22 lamp types regardless of technology and allow states to set appropriate standards. (CEC, No. 69 at pp. 20-21)
Several other commenters disagreed with DOE's approach in the proposed rule regarding the 22 exemptions for GSILs. NEMA asserted that DOE has impermissibly read EPCA's use of the terms “exempted” and “excluded” as the same term, and that 42 U.S.C. 6295(i)(6)(A)(i)(II) does not authorize DOE to discontinue the exemptions for the 22 lamps listed under the GSIL definition. (NEMA, No. 66 at pp. 17-18) DOE acknowledges that EPCA uses both the terms “exclusion” and “exempted”; however, in the context of GSLs and GSILs, DOE understands the term “exempted” to reference lamps listed under the “Exclusions” heading in the GSIL definition. EPCA does not establish any “exemptions” for GSLs or GSILs using that term; so if “exempted” does not refer to “exclusions” or something comparable then the instruction in 42 U.S.C. 6295(i)(6)(A)(i)(II) has no application. The word that EPCA uses for the concept of “exempting” certain lamps from being GSILs or GSLs is “excluding”; and DOE accordingly takes “exempted” to refer to those exclusions. Furthermore, DOE interprets Congress' intent to be for DOE to evaluate whether certain lamps that have been excluded from the GSIL definition should be subject to any future GSL standards. DOE concludes that to leave certain of the exemptions in place would diminish the energy savings that would otherwise be achieved because the excluded lamps would provide a less efficient option to meet the same general lighting application.
Upon consideration of the comments received on the March 2016 GSL ECS NOPR and further review of the relevant authorities, DOE has revisited its interpretation with respect to the proposed definition of GSL and application of the Appropriations Rider. In the March 2016 GSL ECS NOPR, DOE stated that it believed it is prohibited by the Appropriations Rider from modifying the existing exemptions for GSILs in this rulemaking. 81 FR 14540.
A lamp exempted from the GSIL definition is not a covered GSIL and is not subject to the regulations for GSILs. However, DOE is directed as part of the GSL rulemaking to determine whether certain of these exemptions should be maintained or discontinued based, in part, on exempted lamp sales collected from manufacturers. (42 U.S.C. 6295(i)(6)(A)(i)(II)). If DOE discontinues a given exemption, medium screw base incandescent lamps subject to that exemption will become GSILs and thus GSLs; CFLs and general service LED and OLED lamps of that lighting application or bulb shape will become GSLs; and other lamps of that lighting application or bulb shape will also become GSLs, to the extent DOE determines those lamps are used to satisfy lighting applications traditionally served by general service incandescent lamps.
In this proposed rule, DOE evaluates the 22 lighting applications or bulb shapes exempted under the GSIL definition to determine whether such exemptions should be maintained or discontinued.
As stated previously, the definition of GSIL lists 22 lamp types that are not included in the definition, and these lamps are described under the heading “Exclusions.” (42 U.S.C. 6291(30)(D)(ii)) Under the authority for the GSL rulemaking, EPCA directs DOE to consider whether to maintain the “exemptions” for certain incandescent lamps, based, in part, on exempted lamp sales data collected by DOE. (42 U.S.C. 6295(i)(6)(A)(i)(II)) For four of the lamps included in the list of 22 lamps (
NEMA also argued that because incandescent appliance lamps; T shape lamps, B, BA, CA, F, G16-1/2, G25, G30, S, or M14-shaped lamps; and vibration service incandescent lamps are subject to standards, there is no exemption from energy conservation standards to maintain or discontinue for these lamps under 42 U.S.C. 6295(i)(6)(a)(i)(II). NEMA stated that in defining these specialty lamps, Congress imposed a maximum quantity of energy use standard that had the actual effect of eliminating higher wattage versions of these lamps from the market and saving energy. Thus, these wattage caps are energy conservation standards. (NEMA, No. 66 at p. 18)
DOE disagrees with NEMA's interpretation of the definitions of the identified lamps. The “standards” to which NEMA refers for these lamps are the maximum wattage limits set under EPCA in defining the lamps for the purpose of excluding them from the definition of GSIL. The maximum wattage provides definitional boundaries, not standards. (42 U.S.C. 6291(30)(T), (D)(ii)(XXI) and (D)(ii)(XXII)) Appliance lamps and T, B, BA, CA, F, G16-1/2, G-25, G30, S, and M-14 shape incandescent lamps are expressly listed under the exclusion provision in the definition of GSIL. (42 U.S.C. 6291(30)(D)(ii)(I), (XXI), and (XXII))
DOE also received comments regarding subjecting specialty lamp types to the backstop. NEMA disagreed with DOE's position that the backstop will apply to specialty lamps typically used in niche applications. (NEMA, No. 66 at p. 84) NEMA and Osram Sylvania, Inc (OSI) noted that it is not necessary to establish standards for lamps used in unique applications and that do not consume significant amounts of energy. (NEMA, No. 66 at pp. 83-84; OSI, No. 73 at pp. 12-13) NEMA pointed out that one of the more popular exempt specialty lamps, globe shaped incandescent lamps, did not meet the annual energy use threshold to be considered for regulation under EPCA. NEMA also stated that the market will remove specialty CFLs without regulatory action and that standards on such products would impose an unnecessary additional regulatory burden. (NEMA, No. 66 at p. 48)
NEMA appears to be arguing that DOE lacks authority to establish an energy conservation standard for lamps that would otherwise be subject to the exemptions listed as part of the GSIL definition. DOE disagrees. As discussed previously, in a paragraph entitled “Standards for general service lamps,” EPCA directs DOE to consider whether to establish or maintain the exemptions for certain incandescent lamps as part of a rulemaking to establish energy conservation standards for GSLs. In doing so, EPCA gives DOE authority to evaluate the scope of lamps that are GSLs and to set standards for them.
Based on the comments received and further review of DOE's obligations, DOE is evaluating each of the 22 exemptions to see whether it should be maintained or discontinued, based in part on sales data. DOE proposes to make these decisions in light of the fact that GSLs will become subject to the 45 lm/W statutory standard in 2020. Lamps
The following sections assess the exemptions and present DOE's preliminary determination of whether the exemption should be maintained or discontinued. DOE referenced a combination of sources for available information on lamp sales. Specifically, DOE considered the sales data submitted by NEMA as required by 42 U.S.C. 6295(l)(4)(B) for rough service lamps, vibration service lamps, 3-way incandescent lamps, 2,601-3,300 lumen general service incandescent lamps, and shatter-resistant lamps;
In addition to considering sales data, DOE also considered whether an exempted lamp could be used as a replacement for a GSIL. This consideration of “lamp switching” is to minimize the potential for creating a loophole in any GSL standard(s). If DOE were to maintain an exemption for a lamp that has the same consumer utility as a lamp subject to a standard, the use of such lamps could increase in response to standards. This would result in less energy savings being realized as the market shifted to an increased use of the unregulated lamps.
Table II.1 summarizes the status of the exemptions, the sales data underlying DOE's decision, and the reasons supporting DOE's decision.
As shown in Table II.1, based on the compiled sales data and a consideration of additional, applicable factors, DOE has tentatively determined to discontinue eight GSIL exemptions. DOE is proposing to maintain 14 of the GSIL exemptions due to low sales and low potential for use in GSL applications. DOE discusses each of the exemptions in the sections that follow.
As stated, DOE is proposing to discontinue eight exemptions from the definition of GSIL. DOE assessed data available for medium screw base
While DOE is discontinuing the exemption for reflector lamps generally, R20 short lamps will continue to not be subject to standards. R20 short lamps are defined as R20 incandescent reflector lamps that have a rated wattage of 100 watts; have a maximum overall length of 3 and
DOE also collected data for medium screw base incandescent lamps of the following specific shapes: B, BA, CA, F, G16-1/2, G25, G30, S, M-14 lamps (as defined in ANSI C78.20 and ANSI C79.1-2002) of 40 W or less; G-shape lamps (as defined in ANSI C78.20 and ANSI C79.1-2002) with a diameter of 5 inches or more; T-shape lamps (as defined in ANSI C78.20 and ANSI C79.1-2002) that use not more than 40 W or has a length of more than 10 inches. For B, BA, CA, F, G16-1/2, G25, G30, S, and M-14 lamps of 40 W or less, DOE estimated the annual sales as approximately 42 million. For G-shape lamps with a diameter of 5 inches or more, DOE estimated the annual sales as approximately 8 million units. In addition to the sizeable sales of larger globe shape lamps, DOE believes it is likely that larger globe shape lamps may be used as substitutes for the G16.5, G25, and G30 lamps if the exemption is not also discontinued. Regarding T-shape lamps that use not more than 40 W or have a length of more than 10 inches, DOE estimated the annual sales of these lamps as roughly 7 million units. Further, the lamps of the specific shapes discussed in this paragraph are frequently used in general lighting applications and thus DOE believes there is a significant risk for lamp switching. Therefore, due to high sales and high potential for lamp switching, DOE is proposing to discontinue the GSIL exemption for these specific shapes.
Pursuant to 42 U.S.C. 6295(l)(4), DOE is required to collect unit sales data for rough service, shatter-resistant, 3-way incandescent lamps, and vibration service lamps. Section 321(a)(3)(B) of EISA 2007 in part amends paragraph 325(l)(4) of EPCA by adding paragraphs (D) through (H), which direct DOE to take regulatory action if the actual annual unit sales of any of these lamp types are more than 200 percent of the predicted shipments (
As stated, DOE is required to prescribe standards for rough service incandescent lamps, vibration service incandescent lamps, 3-way incandescent lamps, 2,601-3,300 lumen general service incandescent lamps,
In contrast, NRDC expressed concern that 3-way incandescent lamps, shatter-resistant incandescent lamps, and vibration service incandescent lamps may become loopholes if DOE does not establish standards for them. (NRDC, Public Meeting Transcript, No. 54 at pp. 16-17) EEAs commented that vibration service incandescent lamps, rough service incandescent lamps, shatter-resistant incandescent lamps, and 3-way incandescent lamps are loophole risks because they are capable of serving in general lighting applications; are available in shapes, sizes, and lumen packages that allow them to replace common GSILs; and are relatively inexpensive. (EEAs, No. 64 at pp. 6-7) EEAs stated DOE should review whether they should be included within the definition of GSL as part of the current rulemaking in the same way it is required to review the other 18 exempted lamp types. ASAP also commented that these lamps should be included in the definition of a GSL. (ASAP, Public Meeting Transcript, No. 54 at p. 53-54)
EEAs indicated that the shipment tracking approach is only effective if DOE receives comprehensive shipment data for the U.S. market, which is dependent upon comprehensive reporting by NEMA's manufacturer members. The actual shipments and sales of the exempted lamp types could be significantly higher than reported if non-NEMA members serve the market. (EEAs, No. 64 at p. 7) Further, EEAs noted that the wattage limit requirements for vibration service, rough service, and shatter-resistant lamps that would be triggered if DOE did not establish standards as required are less stringent than the GSL backstop and may be insufficient to stop these types of lamps from becoming loopholes. EEAs also stated that the backstop for 3-way incandescent lamps should apply to each filament in the lamp. (EEAs, No. 64 at pp. 6-7)
NEMA noted that sales of shatter-resistant incandescent lamps, 3-way incandescent lamps, and incandescent lamps from 2,601-3,300 lumens have declined substantially since the baseline period 1990-2006. NEMA commented that these three specialty incandescent lamps are costly to make and consequently have higher retail prices than incandescent, fluorescent, or LED lamps used in a majority of lighting applications. Based on these factors, NEMA asserted DOE should maintain these exemptions. (NEMA, No. 66 at p. 46)
EEAs noted that shipments of rough service lamps are significantly higher than DOE's model and that they expect to see further increases in the shipments of these lamps. (EEAs, No. 64 at pp. 6-7) NEMA acknowledged that the sales of rough service incandescent lamps have declined but not at a rate as fast as the modeled decline. Thus, NEMA suggested that DOE adopt the following standard for rough service incandescent lamps: a maximum wattage of 40 watts and sold at retail only in a package containing one lamp. (NEMA, No. 66 at p. 47) DOE notes that after providing these comments, NEMA submitted data indicating that the sales of rough service lamps had increased such that they were more than 200 percent of the predicted shipments in 2015 (
EEAs, GE, CEC, and NEMA noted that the shipments of vibration service lamps have exceeded the projected sales limit and now require regulation. (EEAs, No. 64 at pp. 6-7; GE, No. 70 at p. 12; CEC, No. 69 at p. 22; NEMA, No. 66 at p. 47) NEMA suggested DOE incorporate the accelerated rulemaking for vibration service incandescent lamps into this rulemaking and adopt the following standard: A maximum wattage of 40 watts and sold at retail only in a package containing one lamp. (NEMA, No. 66 at p. 47) GE concurred that DOE should address vibration service incandescent lamps in this rulemaking. (GE, No. 70 at p. 12) However, CEC recommended an accelerated rulemaking for vibration service lamps and urged DOE to adopt a technology neutral standard that aligns with standards adopted in this rulemaking. (CEC, No. 69 at p. 22)
As stated previously, the sales threshold has been triggered for vibration service lamps. Subsequent data submitted by NEMA indicates that the sales threshold has also been triggered for rough service lamps. Therefore, DOE agrees with the suggestion from several stakeholders to include vibration service and rough service incandescent lamps as GSLs and proposes to discontinue the exemptions from GSIL for vibration service and rough service lamps in this NOPDDA. In addition, as discussed previously, DOE is proposing to discontinue the exemptions for shatter-resistant and 3-way lamps from the definition of GSIL in this NOPDDA due to lamp sales and the likelihood of lamp switching and potential loopholes if these exemptions were to remain.
DOE requests comment on the eight GSIL exemptions that are proposed to be discontinued in this rule. In particular, DOE requests comment on the estimated annual unit sales, potential for lamp switching, and any other factors that DOE should consider.
As stated previously, DOE is proposing to maintain 14 exemptions from the definition of GSIL. DOE found that medium screw base incandescent lamps that are appliance; black light; bug; colored; infrared; left-hand thread; marine; marine signal service; mine service; plant light; sign service; silver bowl; showcase; and traffic signal lamps had low sales data thus indicating that these are low volume products. DOE estimates that 12 of the 14 exemptions have annual unit sales of 1 million units or less. The remaining two exemptions, appliance lamps and colored lamps, are estimated to have less than 3 million annual unit sales and less than 2 million annual unit sales, respectively. DOE has also tentatively concluded that several of these exempted lamp types are unable to serve in general lighting applications and cannot provide overall illumination. Specifically, black light; bug; colored; infrared; and plant light lamps produce radiant power in specific wavelengths of the electromagnetic spectrum that would prevent these lamps from serving in general lighting applications. Further, DOE believes that proposing definitions for these exempted lamp types will help to prevent them from becoming loopholes. (See section II.B for a discussion of the definitions proposed for exemptions.)
DOE requests comment on the 14 GSIL exemptions proposed to be maintained in this proposed rule. In particular, DOE requests comment on the estimated annual unit sales, potential for lamp switching, and any other factors that DOE should consider. DOE also requests any additional sales data from stakeholders that could be considered when determining whether to maintain or discontinue the GSIL exemptions.
Based on these preliminary determinations, DOE is proposing to
General service incandescent lamp means a standard incandescent or halogen type lamp that is intended for general service applications; has a medium screw base; has a lumen range of not less than 310 lumens and not more than 2,600 lumens or, in the case of a modified spectrum lamp, not less than 232 lumens and not more than 1,950 lumens; and is capable of being operated at a voltage range at least partially within 110 and 130 volts; however this definition does not apply to the following incandescent lamps—
(1) An appliance lamp;
(2) A black light lamp;
(3) A bug lamp;
(4) A colored lamp;
(5) An infrared lamp;
(6) A left-hand thread lamp;
(7) A marine lamp;
(8) A marine signal service lamp;
(9) A mine service lamp;
(10) A plant light lamp;
(11) An R20 short lamp;
(12) A sign service lamp;
(13) A silver bowl lamp;
(14) A showcase lamp; and
(15) A traffic signal lamp.
As noted previously, GSILs are included in the definition of GSL. (42 U.S.C. 6291(30)(BB)(i)(I)) Thus, any lamp that meets the proposed definition of a GSIL would consequently also be a GSL. DOE requests comment on the proposed definition for GSIL.
CFLs are also included in the definition of GSL; however, the term “compact fluorescent lamp” was not previously defined. DOE determined the term “compact fluorescent lamp” applied to both integrated (
In response to the March 2016 GSL ECS NOPR, NEMA and OSI stated that non-integrated CFLs comprise a small portion of the GSL commercial market with declining sales. (NEMA, No. 66 at p. 5; OSI, No. 73 at p. 13) As such, NEMA recommended that non-integrated CFLs only be subject to the 45 lm/W backstop requirement. (NEMA, No. 66 at p. 5) As discussed previously, DOE determined that the term compact fluorescent includes both integrated and non-integrated CFLs, and therefore non-integrated CFLs meet the definition of GSL. Further, DOE found that the market share of non-integrated CFLs is not negligible given the vast number of product offerings and common use in commercial applications.
General service LED lamps are included in the definition of GSL under 42 U.S.C. 6291(30)(BB). DOE does not currently have a definition for “general service LED lamp,” however “light-emitting diode or LED” is defined at 10 CFR 430.2 as a p-n junction solid-state device of which the radiated output, either in the infrared region, the visible region, or the ultraviolet region, is a function of the physical construction, material used, and exciting current of the device. In addition, the July 2016 LED TP final rule adopted a definition for the term “integrated LED lamp” in order to define the scope of the test procedure. 81 FR 43404, 43426 (July 1, 2016). The term “integrated LED lamp” was defined using the industry standard ANSI/IES RP-16-2010 and was adopted as follows:
However, because LED lamps can be integrated or non-integrated, DOE proposed a definition for the term “general service LED lamp” to include both integrated and non-integrated lamps in the March 2016 GSL ECS NOPR. DOE proposed the following definition for general service LED lamps:
Similarly, general service OLED lamps are also included in the definition of GSL. DOE does not currently have a definition for “OLED lamp,” however, “OLED” is defined at 10 CFR 430.2 as a thin-film light-emitting device that typically consists of a series of organic layers between two electrical contacts (electrodes). DOE proposed the following definition for OLED lamp in the March 2016 GSL ECS NOPR:
NEMA and OSI suggested modifications to the proposed definitions of “general service light-emitting diode (LED) lamp” and “organic light-emitting diode or OLED lamp”—specifically to change the phrase “for use in general lighting applications” to either of the following phrases: “for use in a majority of lighting applications” or “for use in general service applications.” If DOE preferred the latter phrase, they recommended a definition for “general service applications” that specified majority of lighting installations and excluded minority of lighting applications. (NEMA, No. 66 at p. 73; OSI, No. 73 at p. 5)
DOE is proposing to maintain the use of the phrase “general lighting applications” in the definitions where it was previously proposed, including those for “general service light-emitting diode (LED) lamp” and “organic light-emitting diode or OLED lamp.” (See section II.A.4 for more information.) For consistency, DOE is proposing here to adopt the term “general service organic lighting-emitting diode or OLED lamp” rather than “organic lighting-emitting diode or OLED lamp” as originally proposed in the March 2016 GSL ECS NOPR.
NEMA also recommended DOE specify that general service LED lamps include lamps marketed as vibration service, vibration resistant, or rough service lamps. (NEMA, No. 66 at p. 105) DOE preliminarily determines that this inclusion is unnecessary and, furthermore, would be confusing unless every sub-lamp type within general service LED lamps were also specified.
Therefore, DOE proposes the following definitions for “general service light-emitting diode (LED)
As stated previously, the definition of GSL includes any other lamps that DOE determines are used to satisfy lighting applications traditionally served by GSILs. (42 U.S.C. 6291(30)(BB)(i)(IV)) In addition to GSILs, CFLs and general service LED and OLED lamps, DOE proposed in the March 2016 GSL ECS NOPR, a determination that any other lamps that are intended to serve in general lighting applications and have specific features would meet the statutory criterion of lamps used to satisfy lighting applications traditionally served by GSILs. To implement this determination, DOE proposed to define general service lamps as lamps intended to serve in general lighting applications and that have the following basic characteristics: (1) An ANSI base (with the exclusion of light fixtures); (2) a lumen output of 310 lumens or greater; (3) an ability to operate at any voltage; (4) are not or could not be the subject of other rulemakings; and (5) no designation or label for use in certain non-general applications. 81 FR 14628. “General lighting application” is currently defined at 10 CFR 430.2 as lighting that provides an interior or exterior area with overall illumination. The key aspects of the proposed definition of GSL and specific comments received regarding these features are discussed in the following sections.
As stated previously, the term GSL includes any other lamps that DOE determines are used to satisfy lighting applications traditionally served by GSILs (“other lamps” authority). (42 U.S.C. 6291(30)(BB)(i)(IV)) In response to the March 2016 GSL ECS NOPR, NEMA argued that DOE exceeded its statutory authority by proposing to define GSL to include lamps intended to serve in general lighting applications. (NEMA, No. 66 at p. 2) NEMA stated that the EISA 2007 amendment to EPCA did not include the phrases “general lighting applications” or “provides . . . overall illumination” in the definitions of “general service incandescent lamp” or “general service lamp.” Relying on the language of the GSIL definition established in the Energy Policy Act of 1992 (Pub. L. 102-486; October 24, 1992), NEMA stated that the definition of GSL should be limited to lamps that are used to satisfy the majority of lighting applications. (NEMA No. 66, pp. 24-25)
NEMA and OSI noted that the phrases “general lighting application,” and “overall illumination” were introduced to EPCA in EISA 2007 in the context of “metal halide lamp fixtures” and that DOE was improperly incorporating it into the definition of GSL. (NEMA, No. 66 at p. 8, OSI No. 73 at p. 5) NEMA further commented that the statutory list of lamps excluded from the definitions of both incandescent and fluorescent “general service” lamps in EPAct 1992 are specialty lamps that did not satisfy a majority of lighting applications; accordingly, they were and are not “general service” lamps. (NEMA, No. 66 at pp. 8, 25) NEMA added that several incandescent and fluorescent lamps on the EPAct 1992 list of excluded lamps are capable of providing “an interior or exterior area with overall illumination,” including “shatter resistant,” “street lighting service,” “airway” and “airport” service incandescent lamps, further evidencing that Congress never intended for “overall illumination” to be a consideration in the definition of a GSL. (NEMA, No. 66 at p. 8) By including lamps that provide “overall illumination” in the definition of GSL, NEMA argued, DOE would cover speciality lamps in the definition of GSL contrary to the intent of Congress. (NEMA, No. 66 at p. 8) NEMA asserted that if DOE were to consider establishing standards for CFL and LED lamps of the types exempted from the GSIL definition, DOE must determine that these speciality lamps are covered products according to 42 U.S.C. 6292(b), then initiate a rulemaking procedure under 42 U.S.C. 6295(l). (NEMA, No. 66 at p. 16)
GE and OSI added that, in order to be considered a GSL, a lamp must be designed to satisfy the majority of applications traditionally serviced by GSILs, and based on DOE's 2010 U.S. Lighting Market Characterization report, 98 percent of GSILs are used in residential homes, and therefore, a lamp must have a residential application to satisfy this requirement. GE stated that a majority of residential lighting applications include GSIL, reflector, candelabra base or intermediate base decorative, general service MR reflector, integrated CFL, integrated LED, and linear fluorescent lamps. However, niche incandescent or niche halogen lighting product with low and declining sales volumes, unique shapes, specialty bases, or operating on non-residential voltages should not be considered as satisfying a majority of lighting applications traditionally served by GSILs. (GE, No. 70 at p. 9; OSI, No. 73 at p. 6)
NEMA and OSI stated DOE should conform to the clear intent of Congress indicated by its reference to GSLs as lamps that are used in a majority of lighting applications and exclusion of those that are used in a minority of lighting applications. NEMA and OSI recommended DOE create a new definition for the term “general service applications” to mean the majority of lighting installations and not including specialty lamps designed for special purposes or special applications that represent a minority of lighting applications. (NEMA, No. 66 at p. 73; OSI, No. 73 at p. 5)
As stated previously, EISA 2007 added the definition of GSL to EPCA and defined the term, in part, to include GSILs, CFLs, general service LED and OLED lamps, and any other lamp that DOE determines is used to satisfy lighting applications traditionally served by GSILs. The term GSIL was originally added to EPCA by EPAct 1992, and defined, in part, to include any incandescent lamp that “can be used to satisfy the majority of lighting applications.” (EPAct 1992, section 123; 106 Stat 2776, 2817) The definition of GSIL was subsequently amended by EISA 2007, which removed the reference to lamps that “can be used to satisfy the majority of lighting applications,” and instead specified that a GSIL is a lamp intended for general service applications. (EISA 2007, sec. 321; 121 Stat. 1492, 1574) EISA did not define “general service application” but did provide DOE discretion to determine which lamps satisfy lighting applications traditionally served by GSILs. (42 U.S.C. 6291(30)(BB)(i)(IV))
The definition of GSIL and the determination to be made under the definition of GSL are in the context of the capabilities of a lamp to serve a particular lighting application. DOE must look at the applications traditionally served by GSILs and then determine whether a lamp is used in those applications. EPCA directs DOE to consider how GSILs have traditionally been used—what applications GSILs served—not how a lamp under consideration for inclusion in the definition of GSL has traditionally been used. In looking at the application of a GSIL, DOE considered the lighting
The fact that some of the lamps listed under the exemptions provided in 42 U.S.C. 6391(30)(D)(ii) may provide overall illumination does not preclude the consideration of general illumination as an element to the underlying definition of GSL. DOE does not read the list of exemptions as necessitating a narrowed interpretation of the underlying definition. Instead, the exemptions list includes lamps that may be considered GSLs (
DOE's proposed definition of GSL in the March 2016 GSL ECS NOPR included the requirement for an ANSI base but excluded light fixtures. CEC supported DOE's proposal not to limit the GSL definition to medium screw base lamps. (CEC, No. 69 at p. 18) GE agreed that a GSL is not a light fixture or an LED downlight retrofit kit. (GE, No. 70 at p. 10) Similarly, Eaton, NEMA, Philips, and OSI agreed with excluding LED downlight retrofit kits from the definition of GSLs. (Eaton, Public Meeting Transcript, No. 54 at pp. 58-59; Philips, No. 71 at p. 4; OSI, No. 73 at p. 5; NEMA, No. 66 at p. 73) CA IOUs commented that the term, “ANSI-based” is not clearly defined, and it was not clear if it was based on a particular ANSI standard, such as ANSI C81.61, and how, for example, bases of linear LED lamps are classified. (CA IOUs, Public Meeting Transcript, No. 54 at pp. 51-52)
DOE considers an ANSI base to be a lamp base standardized by the American National Standards Institute. DOE clarifies that if a linear LED lamp utilizes a base defined and standardized by ANSI, the lamp would meet that requirement of the GSL definition. DOE continues to propose that a GSL must have an ANSI base, with the exclusion of light fixtures and LED downlight retrofit kits. To better clarify the term ANSI base, DOE proposes the following definition:
In the March 2016 GSL ECS NOPR, DOE did not prescribe a maximum lumen output when defining GSL. GE stated that DOE should not define lamps with lumens higher than 2,600 as GSLs as these lamps are designed for commercial, industrial, or specialty applications, and are not used in the residential sector. GE stated that some lamps go up to 50,000 lumens, and consumers would never use them in a home due to the cost and unnecessarily high light output. GE added that such products also do not have direct CFL and LED substitutes. (GE, No. 70 at pp. 9-10; GE, Public Meeting Transcript, No. 54 at pp. 64-65) The Appliance Standards Awareness Project (ASAP), however, asserted that until a decade ago, the torchiere with a 500 W halogen lamp was one of the most popular consumer luminaires. (ASAP, Public Meeting Transcript, No. 54 at p. 65) GE stated that torchieres with 500 W quartz halogen lamps for residential use were briefly on the market but no longer are sold due to safety concerns. (GE, Public Meeting Transcript, No. 54 at pp. 64-65)
DOE continues to believe that lamps with lumen outputs greater than 2,600 can be used in overall illumination and therefore would meet the definition of GSL. However, DOE reviewed available product information and is now proposing a maximum lumen output in the definition of GSL. DOE notes that overall product offerings of general service lamps significantly decrease around 4,000 lumens. Using product offerings as a proxy for overall sales, DOE concludes that sales of lamps with lumen outputs greater than 4,000 lumens are also much lower than lamps with lumen outputs between 310 and 4,000 lumens. While sales are not necessarily an indication of use in general lighting applications, DOE has tentatively concluded that the limited and unique product offerings above 4,000 lumens indicate that these lamps may be used mainly in specialty applications rather than for purposes traditionally served by GSILs. EISA 2007 directs DOE to track sales of five exempt lamp types, including 2,601 to 3,300 lumen incandescent lamps. While DOE acknowledges that reported data show that sales of these incandescent lamps have been decreasing over the last several years, DOE notes that the majority of product offerings between 2,601 and 3,300 lumens are CFLs or LED lamps and thus are not captured in the sales data. For the reasons described in this paragraph, DOE is proposing that general service lamps must have lumen outputs greater than or equal to 310 lumens and less than or equal to 4,000 lumens. DOE will continue to monitor the market and may re-evaluate this lumen range in future rulemakings. DOE requests comment on the proposed GSL lumen range, and also on whether DOE should adopt different upper and lower bounds for the range or should have no upper or lower limit to the lumen capacity of GSLs.
In the March 2016 GSL ECS NOPR, DOE did not propose a voltage range when defining GSL. GE commented that any lamp designed to operate at a voltage outside of 12V or 120V should not be included in the definition of GSL. (GE, No. 70 at p. 10) DOE believes that lamps with operating voltage outside of 12 V or 120 V can be used in general lighting applications. Therefore, DOE is not proposing a specific voltage range for the GSL definition.
By definition, GSL does not apply to any lighting application or bulb shape described in the exemptions under the “general service incandescent lamp” definition. (42 U.S.C. 6291(30)(BB))(ii)(I)) In the March 2016 GSL ECS NOPR, DOE initially applied the exemptions to the GSL definition identified under 42 U.S.C. 6291(30)(BB)(ii)(I) only to medium screw base incandescent lamps, as the referenced descriptions of the exempted lamps were from the GSIL definition. 81 FR at 14545 (March 17, 2016). Although DOE applied these exemptions only to medium screw base incandescent lamps, DOE evaluated whether the 22 exemptions should also apply to CFL and LED lamps. 81 FR at 14545 (March 17, 2016).
CA IOUs, NEEP, and ASAP cautioned DOE to prevent potential loopholes with lamps exempted from the GSL
NEMA stated that exempted lamp type versions of CFLs or LED lamps should remain exempt if they are not on the market and may never be manufactured; are not likely to consume an average of more than 100 kWh per household per year; and/or are exclusively for commercial use. NEMA asserted that DOE could easily determine to maintain the exemption for a number of lamps that NEMA stated are commercial lamps, and lamps that NEMA stated could not produce an average annual household energy use in excess of 100 kWh per year, and therefore would not be covered products. (NEMA, No. 66 at p. 45) NEMA provided detailed information regarding its position on each of the exempted lamp types in Tables A, B, and C of their written comments. (NEMA, No. 66 at pp. 48-49, 75-81)
Moreover, NEMA disagreed with DOE's interpretation of the “exclusions” provision under the definition of GSL. NEMA argued that under the statutory definition of GSL, lamps that provide lighting applications, or are of the same bulb shape, as described in the list of GSIL exempted lamps, regardless of lamp technology, are “excluded” from the definition of GSL. (NEMA, No. 66 at pp. 82-83.) NEMA further argued that these specialty lamps do not become “general service lamps” until they cease becoming designed for and used in special applications that represent a minority of lighting applications. (
Upon further consideration of the statutory language, DOE agrees with NEMA in that the language of the “exclusions provision” under 42 U.S.C. 6291(30)(BB)(ii)(I) is not limited to lamps that are medium screw base or lamps that use incandescent technology. The GSL definition excludes lamps that serve the lighting application or are of the same lamp shape described in the GSIL “exclusions” provision, and makes no express reference to lighting technology or base type. Consequently, DOE is changing its interpretation in the March 2016 GSL ECS NOPR; DOE considers the language of 42 U.S.C. 6291(30)(BB)(ii)(I) to exclude from GSLs any lamps—whether GSILs, CFLs, general service LED and OLED lamps and any “other lamps” DOE includes in the GSL definition—that serve the listed lighting application or are of the same lamp shape described in the GSIL “exclusions” provision. Nonetheless, although the language of 42 U.S.C. 6291(30)(BB)(ii)(I) is not specific to incandescent technology, some of the lamp applications and bulb shapes described under the exemptions to the GSIL definition may be specific to incandescent lamps.
In section II.A.1, DOE assessed each of the 22 lamp categories within the GSIL exemptions to determine whether the Secretary should discontinue or maintain these exemptions for purposes of the GSL definition. DOE has tentatively concluded in that section that 14 of the 22 GSIL exemptions for medium screw base incandescent lamps should be maintained, while eight of the GSIL exemptions should be discontinued and considered as GSLs. Consistent with that tentative determination, DOE is now assessing the remaining 14 lamp categories in the GSIL exemptions to determine whether the application or lamp shape described is specific to an incandescent technology in order to determine the applicability of each exemption to GSLs other than GSILs.
As discussed in section II.A.1, DOE maintained exemptions from the GSIL definition for the following lamp types: appliance; black light; bug; colored; infrared; left-hand thread; marine; marine signal service; mine service; plant light; sign service; silver bowl; showcase; and traffic signal lamps. DOE then considered whether each of these exemptions were specific to incandescent technology. If the exemption was determined to be specific to incandescent technology, then by its own terms it did not apply to other (
DOE received comments regarding the discontinued exemption for reflector lamps. NEMA and OSI asserted that DOE does not have the authority to impose a 45 lm/W standard on halogen MR-shaped lamps, as it would be technologically infeasible and eliminate the lamp, and there are no adequate CFL or LED lamp substitutes. (NEMA, 66 at p. 56; OSI, No. 73 at p. 13) NEMA noted that the most common halogen MR16 lamps are available in wattages of 20 W, 35 W, 50W and 70/75 W at 12 V or 120 V. Instead of subjecting these lamps to the backstop, NEMA recommended DOE adopt a maximum 50W standard for MR11, MR14, MR16 and MR20 incandescent/halogen lamps. (NEMA, No. 66 at pp. 69-70, 82-83) Similarly, CEC argued that allowing the backstop to take effect instead of analyzing efficacy levels for small-diameter directional lamps, including MR16 lamps, could lead to a backsliding of energy savings in California, where standards for these lamp types are set at 80 lm/W, effective for lamps manufactured on or after January 1, 2018. (CEC, No. 69 at p. 19) CEC stated that the backstop would decrease the standard to 45 lm/W, effective for lamps sold on or after January 1, 2020, resulting in both a loss of energy savings and a potential gap in lamp availability for manufacturers who decline to make a California line of lamps during the two-year gap. (CEC, No. 69 at p. 19) CA IOUs agreed with CEC and stated that DOE is missing significant additional energy savings by not setting a standard higher than 45 lm/W for MR16 lamps and other small diameter directional lamps (SDDLs). They noted that CEC will require small diameter directional lamps to meet an efficacy range of 70-80 lm/W depending on CRI by 2018 and there are already ENERGY STAR-certified MR16 LED lamps meeting 85-90 lm/W. (CA IOUs, No. 65 at pp. 13-14)
NEMA, OSI, and GE expressed the view that, based on DOE's authority to include other lamps as GSLs, DOE can only include the MR lamp (with a pin base or medium screw base) operated at between 115 and 130 V, or at 12 V on a 120 V transformer. They stated that this lamp type is commonly used in a
As discussed in section II.A.1, DOE has proposed to discontinue the exemption for reflector lamps from the definition of GSIL.
GE and NEMA also commented that there are specialty MR-shaped lamps that should not be included in the GSL definition. (GE, No. 70 at p. 9; NEMA, No. 66 at p. 24) GE specified that there are several MR-shaped lamps with smaller diameters than the typical MR16 lamp, and they are often designed at odd voltages for use in specialty equipment and applications. GE also added that there are not currently LED versions of these specialty MR-shaped lamps on the market. (GE, No. 70 at p. 9) NEMA noted that these lamp types typically have uncommon base types and, because of low market share, do not contribute significantly to energy consumption. (NEMA, No. 66 at p. 24)
DOE surveyed the market for MR-shaped lamps with smaller diameters than the common MR16 lamps. DOE confirmed that these lamps are typically marketed for use in non-general lighting applications such as projectors, scientific illumination equipment, theater lighting, studio lighting, stage lighting, film lighting, medical equipment lighting, and emergency lighting. In addition, DOE found that these lamps are significantly more expensive and have shorter lifetimes than MR-shaped lamps designed for general lighting applications. Further, DOE is unsure whether higher efficacy replacements are technologically feasible for these lamps due to their specific optical working distances and smaller form factors. Due to their use in specialty applications and lack of more efficacious replacements, DOE proposes that MR-lamps with diameter less than 2 inches that are designed and marketed for use in projectors, scientific illumination equipment, theater lighting, studio lighting, stage lighting, film lighting, medical equipment lighting, and emergency lighting would not be included in the GSL definition. DOE is proposing a definition for “specialty MR-lamp” to clarify which MR lamps meet the definition of GSL. (See section II.B.9 for more information.) DOE requests comment on its preliminary determination that specialty MR-lamps should not be included in the GSL definition and the proposed definition for the term “specialty MR-lamp.”
As noted in section II.A.1, DOE determined in a final rule published on November 14, 2013 that standards for R20 short lamps would not result in significant energy savings because such lamps are designed for special applications or have special characteristics not available in reasonably substitutable lamp types. 78 FR 68331, 68340. Therefore, DOE maintained the exemption for these lamps from GSIL and is exempting R20 short lamps from the definition of GSL.
In the March 2016 GSL ECS NOPR, DOE proposed that a GSL cannot be a lamp that is the subject of other rulemakings. 81 FR 14543. Philips, OSI, and GE agreed that lamps subject to other rulemakings (
Earthjustice disagreed with DOE's position specifically concerning IRLs, stating that the fact that these lamps are addressed in a separate rulemaking should not prevent DOE from evaluating whether to maintain their exemption from GSLs. Earthjustice stated that DOE has engaged in several rulemakings that satisfy several statutory requirements in a single action (
DOE notes that although MBCFLs and GSILs are currently subject to their own standards, these lamp types are included in the statutory definition of GSL and therefore expressly included in the scope of this rulemaking. When evaluating whether to include other lamp types as GSLs, DOE proposed the criteria that a GSL cannot be a lamp evaluated in other rulemakings that are or were ongoing at the time of the GSL rulemaking to limit the possibility that one lamp type might be subject to two different standards. Due to differences in scope and other factors, separate rulemakings for the same lamp type may result in two different efficacy requirements.
In this NOPDDA, DOE has revised this criteria regarding other rulemakings. DOE continues to exempt GSFLs from the definition of GSL. Because the definition of GSFL and the supporting definition of fluorescent lamp are structured in a certain way, DOE is adding some exemptions in this rule to exclude lamps that are specifically and currently excluded from the GSFL and fluorescent lamp definitions from the definition of GSL. However, DOE is not exempting other lamps that were the subject of other ongoing rulemakings. As described in section II.A.1, DOE has discontinued the exemption for reflector lamps and therefore discontinued the exemption for IRLs. DOE is also not specifically exempting high intensity discharge (HID) lamps that otherwise meet the GSL criteria.
As in the March 2016 GSL ECS NOPR, DOE is proposing to define general service lamp as a lamp intended to serve in general lighting applications and that has the following basic characteristics: (1) An ANSI base (with the exclusion of light fixtures and LED downlight retrofit kits); (2) a lumen output of greater than or equal to 310 lumens and less than or equal to 4,000 lumens; (3) an ability to operate at any voltage; and (4) no designation or label for use in non-general applications.
DOE is proposing a definition of “general service lamp” in 430.2 to capture the criteria and the exemptions discussed in previous sections. DOE proposes to define GSL as follows:
DOE requests comment on its proposed definition of GSL.
In the March 2016 GSL ECS NOPR, DOE proposed several definitions to support its proposed definition of “general service lamp.” Specifically, DOE proposed definitions for “integrated lamp,” “non-integrated lamp,” “light fixture,” “pin base lamp,” “GU24 base,” “LED downlight retrofit kit,” and several terms to better define the lamp types described in section II.A.4 that are exempt from the definition of general service lamp. EEAs expressed concern that certain proposed exempted lamp type definitions may allow exempted incandescent lamps to be converted for use in general lighting applications. (EEAs, No. 64 at p. 7) In this proposed rule, DOE re-evaluated its proposed definitions for exempted lamp types and determined that they provide sufficient detail to prevent possible loopholes. DOE also received several specific comments regarding the proposed definitions as discussed in the following sections.
Eaton, NEMA, Philips, and OSI agreed with the proposed definition of the “LED downlight retrofit kit.” (Eaton, Public Meeting Transcript, No. 54 at pp. 58-59; Philips, No. 71 at p. 4; OSI, No. 73 at p. 5; NEMA, No. 66 at p. 73) DOE received no other comments on the proposed definition of “LED downlight retrofit kit.” DOE continues to propose a definition for “LED downlight retrofit kit” in this document. DOE has replaced the term “intended” with “designed and marketed” as the latter provides more clarity. The proposed definition reads as follows:
NEMA agreed with the proposed definition of “reflector lamp.” (NEMA, No. 66 at p. 24) DOE received no other comments on the proposed definitions of “reflector lamp” or “non-reflector” lamp. As such, DOE continues to propose the following definitions for “reflector lamp” and “non-reflector lamp” in this document:
Regarding the definitions of lamps that are colored (
DOE has preliminary determined that the technical criteria specified in these definitions would be sufficient to prevent possible loopholes. DOE notes that the stipulations in the definitions for “black light lamp,” “bug lamp,” and “plant light lamp” regarding the range of the electromagnetic spectrum within which each of these lamps' radiant power peaks must fall prevents such loopholes. A similar outcome occurs with the definition of “colored lamp,” as DOE proposed in this definition, two different criteria for CRI and correlated color temperature (CCT) that the lamp's light output must exhibit. Hence, DOE continues to propose these definitions as presented in the March 2016 GSL ECS NOPR and as follows:
(1) A CRI less than 40, as determined according to the method set forth in CIE Publication 13.3 (incorporated by reference; see § 430.3); or
(2) A correlated color temperature less than 2,500 K or greater than 7,000 K as determined according to the method set forth in IES LM-66 or IES LM-79 as appropriate (incorporated by reference; see § 430.3).
Philips supported the proposed definition for “mine service lamp.” (Philips, No. 71 at p. 4) However, ASAP expressed concern that it was too broad. ASAP noted that the original reasoning for a separate definition for mine service lamp was due to concerns of CFLs being used in hazardous gas environments, a risk that is avoided with solid-state lighting technology, and asked if this remained the reasoning for this
DOE received comments on its use of the statutory definition of “appliance lamp,” which is defined at 42 U.S.C. 6291(30)(T) as:
(1) Is specifically designed to operate in a household appliance, has a maximum wattage of 40 watts, is sold at retail (including an oven lamp, refrigerator lamp, and vacuum cleaner lamp); and
(2) Is designated and marketed for the intended application, with
(i) The designation on the lamp packaging; and
(ii) Marketing materials that identify the lamp as being for appliance use.
NEEP recommended DOE revisit its definition of “appliance lamp” to prevent the exploitation of that lamp type as a loophole from standards. They requested DOE limit the definition to lamps that must operate at high temperatures in applications such as ovens and clothes dryers. (NEEP, No. 67 at pp. 3-4) Regarding a potential loophole with this lamp type, DOE is proposing a revised definition of “designed and marketed” to clarify that the term means that a lamp is exclusively designed to fulfill the indicated application and, when distributed in commerce, is designated and marketed solely for that application, with the designation on the packaging and all publicly available documents (
NEEP requested DOE define “marine lamps” to avoid confusion with “marine signal service lamps.” (NEEP, No. 67 at p. 5) DOE initially determined in the March 2016 GSL ECS NOPR that marine lamps provide overall illumination and can serve in general lighting applications, therefore, DOE did not propose an exemption for marine lamps from the GSL definition. However, in this rule, DOE has revised its position and proposed to maintain the exemption for marine lamps. (See sections II.A.1 and II.A.4 for more information.) Therefore, to provide clarity regarding the exempted lamp type, DOE proposes to define “marine lamp” as follows:
With regard to marine signal service lamps, DOE's proposed definition states the lamp must be “designed and marketed for marine signal service applications,” which should prevent marine lamps from being used as a replacement lamp. Philips commented in support of the proposed definitions for “marine signal service lamp.” (Philips, No. 71 at p. 4) DOE continues to propose defining “marine signal service lamp” as follows:
NEMA suggested DOE revise the definition of “vibration service lamp” to remove the wattage limit and number of packages sold in retail to prevent a conflict with its proposed standard for vibration service lamps. (NEMA, No. 66 at pp. 5, 107) NEEP noted that “vibration service lamp” and “rough service lamp” are nearly interchangeable and DOE should reconsider their definitions to avoid confusion particularly, after shipment data for vibration service lamps triggers their own rulemaking. (NEEP, No. 67 at p. 5)
DOE is proposing to discontinue the exemptions for vibration service lamps and rough service lamps in this rule, thus revised definitions are not necessary as these would be considered GSLs.
NEMA recommended DOE modify the definition of “covered product” to include the several additional lamp types that describe GSLs. (NEMA, No. 66 at pp. 5, 71) OSI urged DOE to explicitly state within the definition of covered product which covered products are affected by preemption. (OSI, No. 73 at p. 3)
As mentioned, DOE is proposing a definition that specifies the lamps that are GSLs, (see section II.A for details on the definition of “general service lamp”) which should explicitly address which lamps are subject to the GSL regulations.
NEMA recommended a definition for “MR lamp,” describing it as “a curved focusing reflectorized bulb which may have a multifaceted inner surface that is generally dichroic coated and referred to as a multifaceted reflector lamp with a GU10, GU11, GU5.3, GUX5.3, GU8, GU4, or E26 base” and providing information regarding common light sources and diameters used in the lamp type. (NEMA, No. 66 at pp. 5, 106) As in the March 2016 GSL ECS NOPR, in this rule, DOE does not find that a general definition for MR-shaped lamps is necessary to clarify the scope of this rulemaking. However, DOE is proposing a definition for “specialty MR lamp.” As specified in II.A.4, DOE is proposing to exempt certain MR-shaped lamps that have smaller diameters than MR16 lamps, operate at odd voltages, and are marketed for use in specialty applications. In doing so, DOE finds it necessary to establish a definition for “specialty MR lamp” to describe the lamps used in these specialty applications. The details regarding the bulb shape provided in NEMA's definition are very similar to those in the ANSI standard that DOE references in its definition of “specialty MR lamp.” Specifically, DOE proposes the following definition for “specialty MR lamp:”
DOE also received comments from Philips supporting the proposed definitions for “infrared lamp,” “sign service lamp,” “silver bowl lamp,” “showcase lamp,” and “traffic signal lamp.” (Philips, No. 71 at p. 4) DOE received no other comments on these definitions. DOE continues to propose
DOE received no comments on the proposed definitions or revisions to existing definitions for “light fixture,” “integrated lamp,” “non-integrated lamp,” “pin base lamp,” and “GU24 base”; therefore DOE continues to propose definitions for these terms as in the March 2016 GSL ECS NOPR:
DOE is proposing a new definition for the term “left-hand thread lamp” in this rule to better define the lamps that meet this definition and therefore are proposed to be exempt. The proposed definition is as follows:
Lastly, DOE is proposing slight modifications to the definition proposed for “designed and marketed” in the March 2016 GSL ECS NOPR to improve clarity. The proposed definition is as follows:
DOE is proposing editorial modifications to regulatory text to align with the recently adopted test procedure for integrated LED lamps. Specifically, DOE is proposing changes to 10 CFR 429.56 regarding the certification and reporting requirements of integrated LED lamps. In the July 2016 LED test procedure (TP) final rule, DOE adopted the requirement that testing of integrated LED lamps be conducted by test laboratories accredited by an Accreditation Body that is a signatory member to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA). 81 FR 43404, 43419 (July 1, 2016). To align with this requirement, DOE is proposing in this NOPDDA to modify the certification report language in 429.56(b)(2) to specify that the testing laboratory's ILAC accreditation body's identification number or other approved identification assigned by the ILAC accreditation body must be included in the certification report. In addition, DOE is proposing that manufacturers must also report color rendering index (CRI) in the certification report for integrated LED lamps. DOE requests comment on the proposed changes regarding the certification and reporting requirements of integrated LED lamps.
For the proposed changes described in the various definitions in this document, DOE is proposing a January 1, 2020 effective date. DOE understands that the proposed definitions, especially those proposed expirations within the GSIL definition, will require that certain exempted lamps comply with the current Federal energy conservation standards for GSILs upon the effective date of this rulemaking. By aligning the proposed effective date with the 45 lm/W statutory standard beginning on January 1, 2020, DOE believes this will allow reasonable time for manufacturers to transition, while reducing the number of redesigns needed.
The Office of Management and Budget (OMB) has determined that this NOPDDA does not constitute a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, 58 FR 51735 (Oct. 4, 1993). This proposed rule neither implements nor seeks to enforce any standard. Rather, this proposed rule merely seeks to define what constitutes a GSIL and what constitutes a GSL. Accordingly, this action was not subject to review under the Executive Order by the Office of Information and Regulatory Affairs (OIRA) in the OMB.
The Regulatory Flexibility Act (5 U.S.C. 601
DOE reviewed the definitions for GSL and related terms proposed in this
For manufacturers of GSLs, the SBA has set a size threshold, which defines those entities classified as “small businesses” for the purposes of the statute. DOE used the SBA's small business size standards to determine whether any small entities would be subject to the requirements of the rule See 13 CFR part 121. The size standards are listed by NAICS code and industry description and are available at
To estimate the number of companies that could be small businesses that manufacture GSLs covered by this rulemaking, DOE conducted a market survey using publicly available information. DOE's research involved information provided by trade associations (
DOE notes that this proposed rule merely seeks to define what constitutes a GSIL and what constitutes a GSL. General service lamps are required to use DOE's test procedures to make representations and certify compliance with standards, if required. The test procedure rulemakings for compact fluorescent lamps, integrated LED lamps, and other general service lamps
Manufacturers of GSLs must certify to DOE that their products comply with any applicable energy conservation standards. In certifying compliance, manufacturers must test their products according to the DOE test procedures for GSLs, including any amendments adopted for those test procedures. DOE has established regulations for the certification and recordkeeping requirements for all covered consumer products and commercial equipment. 76 FR 12422 (March 7, 2011). The collection-of-information requirement for the certification and recordkeeping is subject to review and approval by OMB under the Paperwork Reduction Act (PRA). This requirement has been approved by OMB under OMB control number 1910-1400. DOE requested OMB approval of an extension of this information collection for three years, specifically including the collection of information proposed in the present rulemaking, and estimated that the annual number of burden hours under this extension is 30 hours per company. In response to DOE's request, OMB approved DOE's information collection requirements covered under OMB control number 1910-1400 through November 30, 2017. 80 FR 5099 (January 30, 2015).
Notwithstanding any other provision of the law, no person is required to respond to, nor shall any 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.
In this proposed rule, DOE proposes definitions for and related to GSLs. DOE has determined that this rule falls into a class of actions that are categorically excluded from review under the National Environmental Policy Act of 1969 (42 U.S.C. 4321
Executive Order 13132, “Federalism,” 64 FR 43255 (August 10, 1999), imposes certain requirements on federal agencies formulating and implementing policies or regulations that preempt state law or that have Federalism implications. The Executive Order requires agencies to examine the constitutional and statutory authority supporting any action that would limit the policymaking discretion of the states and to carefully assess the necessity for such actions. The Executive Order also requires agencies to have an accountable process to ensure meaningful and timely input by state and local officials in the development of regulatory policies that have Federalism implications. On March 14, 2000, DOE published a statement of policy describing the intergovernmental consultation process it will follow in the development of
With respect to the review of existing regulations and the promulgation of new regulations, section 3(a) of Executive Order 12988, “Civil Justice Reform,” imposes on federal agencies the general duty to adhere to the following requirements: (1) Eliminate drafting errors and ambiguity; (2) write regulations to minimize litigation; (3) provide a clear legal standard for affected conduct rather than a general standard; and (4) promote simplification and burden reduction. 61 FR 4729 (Feb. 7, 1996). Regarding the review required by section 3(a), section 3(b) of Executive Order 12988 specifically requires that Executive agencies make every reasonable effort to ensure that the regulation: (1) Clearly specifies the preemptive effect, if any; (2) clearly specifies any effect on existing federal law or regulation; (3) provides a clear legal standard for affected conduct while promoting simplification and burden reduction; (4) specifies the retroactive effect, if any; (5) adequately defines key terms; and (6) addresses other important issues affecting clarity and general draftsmanship under any guidelines issued by the Attorney General. Section 3(c) of Executive Order 12988 requires Executive agencies to review regulations in light of applicable standards in section 3(a) and section 3(b) to determine whether they are met or it is unreasonable to meet one or more of them. DOE has completed the required review and determined that, to the extent permitted by law, this proposed rule meets the relevant standards of Executive Order 12988.
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) requires each federal agency to assess the effects of federal regulatory actions on state, local, and tribal governments and the private sector. Public Law 104-4, sec. 201 (codified at 2 U.S.C. 1531). For a proposed regulatory action likely to result in a rule that may cause the expenditure by state, local, and tribal governments, in the aggregate, or by the private sector of $100 million or more in any one year (adjusted annually for inflation), section 202 of UMRA requires a federal agency to publish a written statement that estimates the resulting costs, benefits, and other effects on the national economy. (2 U.S.C. 1532(a), (b)) The UMRA also requires a federal agency to develop an effective process to permit timely input by elected officers of state, local, and tribal governments on a proposed “significant intergovernmental mandate,” and requires an agency plan for giving notice and opportunity for timely input to potentially affected small governments before establishing any requirements that might significantly or uniquely affect them. On March 18, 1997, DOE published a statement of policy on its process for intergovernmental consultation under UMRA. 62 FR 12820. DOE's policy statement is also available at
DOE examined this proposed rule according to UMRA and its statement of policy and determined that the rule contains neither an intergovernmental mandate, nor a mandate that may result in the expenditure of $100 million or more in any year, so these requirements do not apply.
Section 654 of the Treasury and General Government Appropriations Act, 1999 (Pub. L. 105-277) requires federal agencies to issue a Family Policymaking Assessment for any rule that may affect family well-being. This rule would not have any impact on the autonomy or integrity of the family as an institution. Accordingly, DOE has concluded that it is not necessary to prepare a Family Policymaking Assessment.
Pursuant to Executive Order 12630, “Governmental Actions and Interference with Constitutionally Protected Property Rights,” 53 FR 8859 (March 15, 1988), DOE has determined that this proposed rule would not result in any takings that might require compensation under the Fifth Amendment to the U.S. Constitution.
Section 515 of the Treasury and General Government Appropriations Act, 2001 (44 U.S.C. 3516 note) provides for federal agencies to review most disseminations of information to the public under information quality guidelines established by each agency pursuant to general guidelines issued by OMB. OMB's guidelines were published at 67 FR 8452 (Feb. 22, 2002), and DOE's guidelines were published at 67 FR 62446 (Oct. 7, 2002). DOE has reviewed this NOPDDA under the OMB and DOE guidelines and has concluded that it is consistent with applicable policies in those guidelines.
Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use,” 66 FR 28355 (May 22, 2001), requires federal agencies to prepare and submit to OIRA at OMB, a Statement of Energy Effects for any proposed significant energy action. A “significant energy action” is defined as any action by an agency that promulgates or is expected to lead to promulgation of a final rule, and that: (1) Is a significant regulatory action under Executive Order 12866, or any successor order; and (2) is likely to have a significant adverse effect on the supply, distribution, or use of energy, or (3) is designated by the Administrator of OIRA as a significant energy action. For any proposed significant energy action, the agency must give a detailed statement of any adverse effects on energy supply, distribution, or use should the proposal be implemented, and of reasonable alternatives to the action and their expected benefits on energy supply, distribution, and use.
This regulatory action to propose definitions for GSL and related terms is not a significant regulatory action under Executive Order 12866. Moreover, it would not have a significant adverse effect on the supply, distribution, or use of energy, nor has it been designated as a significant energy action by the Administrator of OIRA. Therefore, it is not a significant energy action, and, accordingly, DOE has not prepared a Statement of Energy Effects.
On December 16, 2004, OMB, in consultation with the Office of Science and Technology Policy (OSTP), issued its Final Information Quality Bulletin for Peer Review (the Bulletin). 70 FR
The proposed definitions incorporate information contained in certain sections of the following commercial standards:
(1) ANSI C81.61-2016, “American National Standard for Electrical Lamp Bases—Specifications for Bases (Caps) for Electric Lamps,” 2016;
(2) IEC Standard 60061, “Lamp caps and holders together with gauges for the control of interchangeability and safety, Amendment 35, Edition 3,” 2005-01;
(3) UL 1598C-2014, “Standard for Light-Emitting Diode (LED) Retrofit Luminaire Conversion Kits, First Edition,” 2014;
DOE has evaluated these standards and is unable to conclude whether they fully comply with the requirements of section 32(b) of the FEAA (
In this NOPDDA, DOE proposes to incorporate by reference the standard published by ANSI, titled “Electric Lamp Bases—Specifications for Bases (Caps) for Electric Lamps,” ANSI C81.61-2016. ANSI C81.61-2016 is an industry accepted standard that describes the specifications for bases (caps) used on electric lamps. This NOPDDA references ANSI C81.61-2016 for the definition of the term “ANSI base.” ANSI C81.61-2016 is readily available on
DOE also incorporates by reference the standard published by IEC, titled “Lamp caps and holders together with gauges for the control of interchangeability and safety—Part 1: Lamp caps,” IEC 60061-1:2005. IEC 60061-1:2005 is an industry accepted standard that describes the specifications for lamp caps. This NOPDDA references IEC 60061-1:2005 for the definition of the term “ANSI base.” IEC 60061-1:2005 is readily available on
DOE also incorporates by reference the standard published by UL, titled “Standard for Light-Emitting Diode Retrofit Luminaire Conversion Kits,” First Edition, dated January 16, 2014, UL 1598C-2014. UL 1598C-2014 is an industry accepted standard that describes the requirements for LED retrofit luminaire conversion kits intended to replace existing incandescent, fluorescent, induction, and HID systems that comply with existing requirements for luminaires. This NOPDDA references UL 1598C-2014 for the definition of the term “LED Downlight Retrofit Kit.” UL 1598C-2014 is readily available on
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Include contact information each time you submit comments, data, documents, and other information to DOE. If you submit via mail or hand delivery/courier, please provide all items on a CD, if feasible, in which case it is not necessary to submit printed copies. No telefacsimiles (faxes) will be accepted.
Comments, data, and other information submitted to DOE electronically should be provided in PDF (preferred), Microsoft Word or Excel, WordPerfect, or text (ASCII) file format. Provide documents that are not secured, that are written in English, and that are free of any defects or viruses. Documents should not contain special characters or any form of encryption and, if possible, they should carry the electronic signature of the author.
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 that would result from public disclosure; (6) when such information might lose its confidential character due to the passage of time; and
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).
Although DOE welcomes comments on any aspect of this proposal, DOE is particularly interested in receiving comments and views of interested parties concerning the following issues:
(1) DOE requests comment on the eight GSIL exemptions that are proposed to be discontinued in this notice. In particular, DOE requests comment on the estimated annual unit sales, potential for lamp switching, and any other factors that should be considered.
(2) DOE requests comment on the 14 GSIL exemptions that are proposed to be maintained in this notice. In particular, DOE requests comment on the estimated annual unit sales, potential for lamp switching, and any other factors that should be considered.
(3) DOE requests any additional sales data from stakeholders that could be considered when determining whether to maintain or discontinue the GSIL exemptions.
(4) DOE requests comment on the proposed definition for GSIL.
(5) DOE requests comment on its preliminary determination that the following exemption types are not specific to incandescent technology: Appliance lamps; black light lamps; bug lamps; colored lamps; infrared lamps; left-hand thread lamps; marine lamps; marine signal service lamps; mine service lamps; plant light lamps; sign service lamps; silver bowl lamps; showcase lamps; and traffic signal lamps.
(6) DOE requests comment on the proposed GSL lumen range of greater than or equal to 310 lumens and less than or equal to 4,000 lumens.
(7) DOE requests comment on its preliminary determination that specialty MR-lamps warrant an exemption and the proposed definition for the term “specialty MR-lamp.”
(8) DOE requests comment on its proposed definition of GSL.
(9) DOE requests comment on the various definitions proposed to better delineate the GSL definition.
(10) DOE requests comment on the proposed changes regarding the certification and reporting requirements of integrated LED lamps.
The Secretary of Energy has approved publication of this notice of proposed definition and data availability.
Confidential business information, Energy conservation, Household appliances, Imports, Reporting and recordkeeping requirements.
Administrative practice and procedure, Confidential business information, Energy conservation, Household appliances, Imports, Incorporation by reference, Intergovernmental relations, Small businesses.
For the reasons set forth in the preamble, DOE proposes to amend parts 429 and 430 of chapter II, subchapter D, of title 10 of the Code of Federal Regulations, as set forth below:
42 U.S.C. 6291-6317; 28 U.S.C. 2461 note.
(b) * * *
(2)
42 U.S.C. 6291-6309; 28 U.S.C. 2461 note.
The additions and revisions read as follows:
(1) A CRI less than 40, as determined according to the method set forth in CIE Publication 13.3 (incorporated by reference; see § 430.3); or
(2) A correlated color temperature less than 2,500 K or greater than 7,000 K as determined according to the method set forth in IES LM-66 or IES LM-79 as appropriate (incorporated by reference; see § 430.3).
(1) An appliance lamp;
(2) A black light lamp;
(3) A bug lamp;
(4) A colored lamp;
(5) An infrared lamp;
(6) A left-hand thread lamp;
(7) A marine lamp;
(8) A marine signal service lamp;
(9) A mine service lamp;
(10) A plant light lamp;
(11) An R20 short lamp;
(12) A sign service lamp;
(13) A silver bowl lamp;
(14) A showcase lamp; and
(15) A traffic signal lamp.
The additions read as follows:
(e) * * *
(12) ANSI C81.61-2016, (“ANSI C81.61-2016”), American National Standard for Electrical Lamp Bases—Specifications for Bases (Caps) for Electric Lamps, approved April 20, 2016, IBR approved for § 430.2.
(p) * * *
(2) IEC Standard 60061, (“IEC 60061-1:2005”), Lamp caps and holders together with gauges for the control of interchangeability and safety, Amendment 35, Edition 3, 2005-01; IBR approved for § 430.2.
(u) * * *
(4) UL 1598C-2014 (“UL 1598C-2014”), Standard for Light-Emitting Diode (LED) Retrofit Luminaire Conversion Kits, First Edition, dated January 16, 2014, IBR approved for § 430.2.
Natural Resources Conservation Service (NRCS) and the Commodity Credit Corporation (CCC), United States Department of Agriculture (USDA).
Final rule.
NRCS published an interim rule, with request for comments, on February 27, 2015, to implement the Agricultural Conservation Easement Program (ACEP) that was authorized by the Agricultural Act of 2014. NRCS received 1,055 comments from 102 respondents to the interim rule. In this document, NRCS responds to comments, makes adjustments to the rule in response to some of the comments received, and issues a final rule for ACEP implementation.
This rule is effective October 18, 2016.
Kim Berns, Director, Easement Programs Division, U.S. Department of Agriculture, Natural Resources Conservation Service, Post Office Box 2890, Washington, DC 20013-2890; or email:
Persons with disabilities who require alternative means for communication (Braille, large print, audio tape, etc.) should contact the USDA TARGET Center at: (202) 720-2600 (voice and TDD).
The Agricultural Conservation Easement Program (ACEP) is a voluntary program to help farmers and ranchers preserve their agricultural land and restore, protect, and enhance wetlands on eligible lands. The program has two easement enrollment components: (1) Agricultural land easements; and (2) wetland reserve easements. Under the agricultural land easement component, NRCS provides matching funds to State, Tribal, and local governments, and nongovernmental organizations with farm and ranch land protection programs to purchase agricultural land easements. Agricultural land easements may be permanent or the maximum duration authorized by State law. Under the wetland reserve easement component, NRCS protects wetlands by purchasing directly from landowners a reserved interest in eligible land or entering into 30-year contracts on acreage owned by Indian Tribes, in each case providing for the restoration, enhancement, and protection of wetlands and associated lands. Wetland reserve easements may be permanent, 30-years, or the maximum duration authorized by State law.
The 2014 Act kept much of the substance of the statutory provisions that originally existed for the Wetlands Reserve Program (WRP) and Farm and Ranch Lands Protection Program (FRPP), with land eligibility elements from the Grassland Reserve Program (GRP) incorporated. In particular, ACEP as authorized by the 2014 Act:
• Consolidates FRPP, GRP, and WRP easement options into one program, and repeals these three programs; and
• Incorporates elements of FRPP and GRP into the agricultural land easement component of ACEP, and elements of WRP into the wetland reserve easement component of ACEP.
The significant statutory differences from the source programs include:
• The agency has program-wide authority to subordinate, modify, exchange, or terminate an easement under certain circumstances, an expansion of authority that had previously applied only to WRP.
• The non-Federal contribution towards the purchase of the agricultural land easement varies slightly from the previous FRPP non-Federal contribution. In particular, if a landowner makes a charitable donation of a large percentage of the agricultural land easement's fair market value, the landowner donation will reduce the Federal government's contribution to a greater extent than previously required under FRPP.
• All ACEP easements will be subject to an easement plan. Previously, WRP and GRP required some form of easement plan for all easements and FRPP only required a conservation plan on highly erodible cropland.
• The landowner tenure requirement for wetland reserve easements is 24 months compared to 7 years under the former WRP.
On February 27, 2015, NRCS published an interim rule with request for comments in the
NRCS organized the ACEP regulation into 3 subparts. Subpart A includes those provisions that affect the entire program, Subpart B includes those provisions that affect only the Agricultural Land Easement (ALE) component, and Subpart C includes those provisions that affect only the Wetland Reserve Easement (WRE) component.
In particular, Subpart A of the interim rule addressed:
• Identification of the following lands as ineligible—
○ Federal lands except lands held in trust for Indian Tribes.
○ State-owned lands, including lands owned by agencies or subdivisions of the State or unit of local government.
○ Land subject to an existing easement or deed restriction that provides similar protection that would be achieved by enrollment.
○ Lands that have onsite or offsite conditions that would undermine meeting the purposes of the program.
• Authorization for easement subordination, modification, exchange, or termination of easements under specific criteria.
• Identification that lands enrolled in FRPP, GRP, and WRP are considered enrolled in ACEP.
Subpart B of the interim rule addressed the ALE component, including:
• Limiting the Federal share of the easement cost for projects that are not
• Identifying that eligible entities may include Indian Tribes, State governments, local governments, or nongovernmental organizations that have farmland or grassland protection programs that purchase agricultural land easements.
• Authorizing NRCS to pay up to 75 percent of the fair market value of the agricultural land easement for the enrollment of grassland of special environmental significance.
• Authorizing NRCS to waive the eligible entity cash contribution requirement with no increase in Federal share for projects of special significance where the landowner voluntarily increases the landowner contribution commensurate to the amount of the waiver and the property is in active agricultural production.
• Maintaining a certification process for eligible entities.
• Prohibiting the assigning of a higher priority to an application solely on the basis of lesser cost to the program.
• Requiring all easements to be subject to an
Subpart C of the interim rule addressed the WRE component including:
• Maintaining most elements of the WRP eligibility and administrative framework.
• Authorizing a waiver process to allow enrollment of Conservation Reserve Program (CRP) lands established to trees.
• Allowing ranking criteria to consider the extent to which a landowner or other person or entity leverages the Federal investment.
• Reducing length of ownership requirement prior to enrollment from 7 years to 24 months.
• Exempting “subclass w” soils in the land capability classes IV through VIII from county cropland limitations.
• Keeping the WRP easement compensation framework for wetland reserve easements.
NRCS originally solicited comments on the interim final rule for 60 days ending April 28, 2015. NRCS extended the comment period an additional 30 days to May 28, 2015, to provide interested parties additional time to review the new regulatory provisions and associated policy.
NRCS received 102 timely submitted responses to the rule, constituting of 1,055 discrete comments. NRCS welcomes this enthusiastic response to its new, consolidated, easement program, and will continue to obtain input from interested parties throughout its administration. This final rule responds to the comments received through the public comment period and makes changes that NRCS believes contribute to the effectiveness, equity, transparency, and clarity of the program.
In this preamble, the comments have been organized in alphabetic order by topic. Given the range of the number of comments received on each topic, NRCS attempts to enumerate the level of interest received for each subtopic within a topic area. The topics include: ACEP general information; ALE agreements; ALE deed requirements; ALE entity certification; ALE entity eligibility; application process and requirements; cost-share assistance and match requirements; definitions; easement closing and payment procedures; easement valuation and consideration; easement monitoring, management, and enforcement; land and landowner eligibility; national and State allocations; national priorities and initiatives; participation in other USDA programs; planning; ranking; Regional Conservation Partnership Program (RCPP); restoration; State Technical Committees; subordination, modification, exchange, and termination; Wetland Reserve Enhancement Partnerships (WREP); WRE Reservation of Grazing Rights, and WRE-miscellaneous.
The comments were generally supportive with recommendations for improvement. Most comments related to the ALE component of the program. In particular, most recommendations pertained to program eligibility, minimum easement deed terms and requirements, the criteria for the agricultural land easement plan, and ranking.
NRCS received 182 comments related to ALE deed requirements. Prior to discussing the specific comments and NRCS responses, NRCS would like to respond to those comments that requested NRCS provide clarification regarding the difference between the inter-related concepts of “minimum deed requirements” and “minimum deed terms.”
Section 1265B(b)(4)(C) of the ACEP statute identifies that an eligible entity will be allowed to use its own deed terms and conditions provided that NRCS determines that such terms and conditions are “consistent with the purposes of the program” and “permit effective enforcement of the conservation purposes of such easements.” To streamline program delivery, increase the transparency of program requirements, ease the deed review process and provide consistency and fairness between eligible entities, NRCS identified in the interim rule minimum deed requirements for ALE and then made available standard language that would meet these minimum deed requirements,
NRCS explained in the preamble of the interim rule that an agricultural land easement deed may be determined to meet program purposes by the eligible entity drafting all of the deed terms and conditions for an individual easement and submitting the entire deed to NRCS for review to ensure that the regulatory deed requirements have been met. Alternatively, the eligible entity may adopt the NRCS minimum deed terms as a whole along with the entity's own deed terms. In either scenario, the eligible entity may use their own terms and conditions, the difference being the review process by which NRCS ensures the purposes and requirements of the program are met. NRCS may review and approve at the State level those deeds submitted by eligible entities that have the NRCS minimum deed terms attached as written, whereas NRCS at the national level must review and approve all other deeds submitted by eligible entities.
NRCS further explained in the interim rule that the former approach was taken under FRPP and, based on the inconsistencies that arise with individual deed negotiations, NRCS decided it would provide more transparent and consistent implementation under ACEP to adopt the latter approach of requiring regulatory deed requirements and encouraging the adoption of minimum deed terms. An eligible entity, especially certified entities, can be confident that they have met ACEP funding and regulatory deed requirements if the easement deed incorporates the language from the available minimum deed terms.
The subtopics addressed by the ALE deed requirement comments included the following: Regulatory deed requirements in general (61 comments); modification and termination provisions (11 comments); incorporation of the ALE plan (8 comments); permitted and other uses (2 comments); mining, minerals, oil, and gas (5 comments); construction and building envelope (14 comments); commercial activities (1 comment); impervious surface limitations (12 comments); subdivision (17 comments); advisory committee (8 comments); right of enforcement (17 comments); access (3 comments); acquisition purpose restrictions (8 comments); and miscellaneous (10 comments).
• Four comments expressed support for the minimum deed terms;
• Eight comments recommended eliminating the minimum deed term requirement; NRCS has determined that identifying regulatory deed requirements that address statutory purposes, including specific statutory requirements, provides an equitable and transparent basis upon which to achieve program purposes and make consistent programmatic decisions. In particular, this final rule retains the following regulatory deed requirements at § 1468.25, including provisions that must address: (1) Right of enforcement—statutory requirement; (2) compliance with an agricultural land easement plan—statutory requirement; (3) impervious surface limitation—statutory requirement; (4) indemnification—standard clause in conservation easements; (5) amendments must be in compliance with ALE purposes—ensure that deed will further statutory program purposes for easement term; (6) prohibition of commercial and industrial activities except those activities determined consistent with the agricultural use of the land—statutory purpose for limiting conversion to non-agricultural uses or protecting grazing uses and related conservation values; (7) prohibition or limitation of the subdivision of the property subject to the agricultural land easement, except where State or local regulations explicitly require subdivision to construct residences for employees working on the property or where otherwise authorized by NRCS and the Grantee—statutory purpose for limiting conversion to non-agricultural uses or protecting grazing uses and related conservation values; (8) specific protections related to the purposes for which the easement is acquired—statutory requirement; and (9) other terms as identified by the Chief in the agreement between NRCS and the eligible entity—necessary flexibility to address emerging resource issues. NRCS determined that these regulatory deed requirements ensure the financial and programmatic integrity of the program. This approach also retains flexibility for cooperating entities to determine regional, State, or local priorities within their deeds and for enrolling projects.
• Two comments recommended eliminating the minimum deed terms; NRCS did not adopt this recommendation because minimum deed terms provide consistency and transparency to eligible entities and landowners about NRCS program requirements, and are required to ensure effective program delivery.
• Nine comments recommended eliminating priority given to eligible entities that adopt the minimum deed terms, while two comments supported the priority. Given the mid-fiscal year publication of the interim rule and the requirement to incorporate into the ALE-agreement the agreed-upon terms for funded easements, NRCS identified that it would give fund priority in fiscal year (FY) 2015 to eligible entities who were willing to adopt NRCS minimum deed terms. Several eligible entities, especially those accustomed to negotiating deed terms required as a condition of receiving Federal funds, expressed concern about priority being given to eligible entities willing to adopt the minimum deed terms. NRCS reiterates that eligible entities are authorized to use their own deed terms and that the minimum deed terms are in addition to the entity's deed terms. As described above, participation in ACEP requires the regulatory deed requirements to be addressed in the deed. Therefore, NRCS will continue to encourage eligible entities to adopt NRCS minimum deed terms because such adoption addresses the regulatory deed requirements and greatly facilitates reviews of both the ALE-agreements and the deeds, streamlines program delivery, and ensures long term consistency and equitable treatment of eligible entities and landowners. This encouragement will be implemented through a National ranking factor among other factors, and if an eligible entity adopts the minimum deed terms then such eligible entity will receive priority in the ranking. Eligible entities may opt to negotiate an entity-specific template that incorporates the minimum deed terms and are encouraged to do this prior to the start of a funding year. States may also decide whether they wish to screen applications from eligible entities that request such individualized negotiation dependent upon the State's ability to manage its workload. If an entity has an entity-specific template deed that has been approved by the national level in the fiscal year prior to ranking, this entity-specific template deed will also be captured in the ranking. However, any subsequent requests for changes to either the minimum deed terms or
• Three comments recommended NRCS create a process to allow approved minimum deed terms to be developed at the State level and two comments recommended allowing for modification of the minimum deed terms to create a better balance between national oversight and local needs by allowing more flexibility for easements to include local deed restrictions. NRCS has determined that program consistency is better served by the development of a standard set of minimum deed terms at the National level. However, State Conservationists in consultation with the State Technical Committee, may propose additional minimum deed terms that are State specific to address actual, local concerns that are not adequately encompassed by the National set of minimum deed terms. The proposed State-specific terms must be submitted by the State Conservationist to the National office for review and if the National office approves the additional State-specific terms, such terms would then be utilized uniformly throughout the State as the standard set of minimum deed terms for that State. Submissions for additional minimum deed terms that are State-specific must occur in the fiscal year prior to their proposed use to ensure adequate time for review and approval. Eligible entities may be authorized to use an approved set of State-specific minimum deed terms on any unclosed ACEP-ALE easements through an amendment to the ALE-agreement.
• Three comments recommended that State entities should be exempt from the regulatory deed requirements specified in the ACEP regulation; NRCS did not adopt this recommendation. ALE is a voluntary funding source that is available to eligible entities where mutual purposes can be met through a partnership arrangement. Just as State entities must ensure that their program purposes will continue to be met through the partnership arrangement, NRCS must ensure that ACEP purposes will be furthered by the expenditure of ACEP funds. NRCS recognizes that State entities may have special statutory restrictions, and State entities, like other eligible entities, have flexibility to use their own deed terms, and with the exception of the United States Right of Enforcement language, can request review and approval of an individual template deed if they are unable to use the standard minimum deed terms. NRCS will work with State entities, and others, where there are programmatic conflicts that must be addressed in order to create an effective partnership arrangement.
• Five comments recommended replacing the minimum deed terms with an entity specific template that could be further modified on a per project basis. NRCS recognizes that individually-tailored provisions provide eligible entities with negotiation flexibility in their discussions with landowners. However, NRCS experience has revealed that individually-negotiated provisions create inconsistencies in how eligible entities and landowners are treated, which is inconsistent with how Federal funds should be administered. NRCS also has extensive and successful experience in administering Federal conservation program funds through the use of standard agreement and contract language and has found that the use of such standard language increases the transparency of the programs, ensures the equitable treatment of landowners and program participants, and ultimately aids in the enforceability of the agreement or contract to ensure the purposes for which the Federal funds have been invested are achieved and protected consistent with the statutory intent of the conservation program. An entity-specific template that is then further negotiated on an individual project basis is not considered a template but rather an individually negotiated deed and may affect any ranking consideration given for the use of an approved template. Therefore, NRCS encourages that the regulatory deed requirements be met through use of the minimum deed terms.
• One comment recommended that any easement template deed waiver should require approval of the other funding partners; NRCS did not adopt this recommendation. NRCS works with an eligible entity that must meet ACEP-ALE terms and conditions to receive ACEP funding, including having an easement deed that meets ALE program requirements. NRCS does not have a direct relationship with the other funding partners of the eligible entity and therefore it is the eligible entity's responsibility to ensure that its partners are notified about any matters that may affect the transaction and the partners' funding commitments.
• One comment recommended that NRCS provide more flexibility and clarity in determining whether an eligible entity's deed terms are consistent with program purposes. NRCS has outlined in the regulation the deed requirements that must be addressed in an eligible entity's deed, and has also made available minimum deed terms that have been determined to be consistent with program purposes and that satisfy the regulatory deed requirements. NRCS will work with an eligible entity to answer questions that arise with respect to other deed provisions that the eligible entity may wish to include and how such provisions could further or inhibit ALE purposes.
• Two comments recommended that certified entities should be authorized to use their own deed terms and conditions so long as those terms and conditions meet the statutory requirements of the program, and two comments recommended that NRCS should review them upon request; NRCS did not adopt these recommendations. NRCS regulatory requirements apply to all eligible entities, including certified eligible entities. NRCS has determined the regulatory deed requirements specified in this regulation are essential to meeting ALE program purposes and statutory requirements. While an eligible entity may avail itself of a streamlined administrative process if certified, such streamlined process must also result in meeting ALE program purposes. NRCS believes that an eligible entity that has sufficient familiarity with ALE program purposes to be certified is also knowledgeable of the deed provisions that NRCS considers sufficient to meet program purposes. A certified entity has gained this familiarity through NRCS approval of an eligible entity's template deed prior to certification, and the transparent manner in which NRCS has made available the minimum deed terms that are similarly determined to be sufficient to meet program purposes. The availability of a grant agreement for certified entities is to minimize NRCS involvement in the prior review of each of the certified entity's easement transactions. The certified entity can use their own deed terms provided that the deed meets the regulatory deed requirements.
• Three comments recommended that NRCS ensure that future habitat restoration is not prohibited on an ALE easement, and that good riparian and floodplain management necessary to achieve salmon recovery and shellfish protection are implemented. NRCS recognizes that conservation organizations have different understanding about whether habitat restoration activities are consisted with agricultural uses of land. NRCS has determined that habitat restoration is generally consistent with ALE program purposes. However, NRCS does not believe that habitat restoration is a minimum program requirement for ALE enrollment like it is for WRE
• Three comments recommend NRCS clarify the difference between minimum deed terms and regulatory deed requirements and when they are or are not mandatory. As discussed above, NRCS identified in the interim rule the regulatory deed requirements that are the topics that must be addressed in an ACEP-funded easement, and addressing these regulatory deed requirements is mandatory in order to receive ALE funding. Alternatively, minimum deed terms, provide specific phraseology that NRCS has vetted as effective enforceable language for meeting the regulatory deed requirements. Mechanisms for the adoption and incorporation of the minimum deed terms into the eligible entities agricultural land easement deed are described in this rulemaking and more specifically addressed in policy and in the terms of the ALE-agreement.
• NRCS received one comment recommending that a specific minimum threshold be required for public access, particularly for those properties where there is not visual access from a public right-of-way. NRCS requires that a landowner provide the Grantee with access to facilitate required easement monitoring, and ensure that NRCS has sufficient access should NRCS ever need to exercise its right of enforcement. However, public access is a matter beyond the scope of protections needed to meet ALE purposes, and the landowner reserves the right to control public access consistent with the terms of an ALE easement deed.
• NRCS received one comment requesting clarification of the regulatory provision that the regulatory deed requirements may include “other minimum deed terms required by NRCS to insure that ACEP ALE purposes are met.” This provision provides the Chief with the flexibility to identify resource concerns that may be necessary to meet program objectives. For example, where ALE funds are used specifically to protect grassland habitat for sage grouse, the Chief may require a provision that prohibits the conversion of grassland to other uses.
• NRCS received two comments recommending that the regulatory deed requirements be consistent with other Federal law, including the Endangered Species Act and fiduciary obligations to protect tribal treaty reserved rights. NRCS implements ALE, including its regulatory deed requirements, consistent with the legal framework associated with the implementation of a Federal program. No changes are required in response to these comments.
• NRCS received one recommendation to alter the language in the minimum deed terms to conform to the language found at § 1468.28(c) related to the protection of the interests of the United States. NRCS will ensure the United States Right of Enforcement language provided in the ALE-agreements and minimum deed terms are consistent with the applicable regulation and statute.
• NRCS received three recommendations related to having a clear template review and decision process. NRCS agrees and has established the following process for reviewing ALE deed templates for non-certified eligible entities that are outlined in the ALE-agreements. Those methods are:
1. Non-certified eligible entities seeking approval of an entity-specific ALE deed template will review the regulatory deed requirements and the minimum deed terms. Entities should notify NRCS whether they will be requesting an entity-specific ALE deed template as early in the process as possible, preferably prior to ranking. Such entities are likewise encouraged to submit the proposed entity-specific ALE deed template as early in the process as possible, preferably in the fiscal year prior to submitting an application and at a minimum prior to entering into the ALE-agreement.
2. The entity will draft a proposed entity-specific ALE deed template that addresses all of the regulatory deed requirements, incorporates the required United States Right of Enforcement language without alteration, and to the greatest extent practicable will incorporate the minimum deed terms as written. The entity will identify in their request for approval the specific terms within the proposed ALE deed template that meet the regulatory deed requirements by citation and where applicable the minimum deed terms.
3. Eligible Entities will submit the proposed entity-specific ALE deed template to the State Conservationist of the State in which they plan to apply for ACEP-ALE funding.
4. The State Conservationist will review the proposed entity-specific ALE deed template for conformance with program requirements and submit the template for National review.
5. The Easement Programs Division (EPD) Director will review the proposed entity-specific ALE deed template and then approve, reject, or approve with required changes.
6. The EPD Director decision will be communicated in writing to the eligible entity and the State Conservationist.
7. Eligible entities with an approved entity-specific ALE deed template must use the language of the template as approved, and if further changes are made, the deed must be re-submitted for EPD Director approval and will be treated as an individual deed for review.
8. If an entity is provided ranking points for having an approved entity-specific ALE deed template, that template must have National-level approval in the fiscal year prior to submitting an application for that parcel.
• NRCS received one recommendation to remove requirements of the Grantee,
NRCS recognizes that several parties have an interest in the implementation of the easement administration provisions in the deed, especially as these provisions may affect the future
Option 1: Outright prohibition of future subdivision.
Option 2: Future subdivision allowed and boundaries identified prior to easement closing and approved by the entity and NRCS as part of the initial easement acquisition.
Option 3: Future subdivision allowed, but must be reviewed and approved by the entity and NRCS, prior to division occurring.
Under option 2, NRCS evaluates the proposed parcels identified for potential subdivision using the program eligibility criteria. Under option 3, since the entity is electing to have the flexibility to identify the subdivision of parcels after the easement has closed, NRCS does not use all of the program eligibility criteria to evaluate the individual parcels proposed for subdivision but rather has adopted the threshold of the median size of farms, including ranches, in the county or parish as an objective criterion upon which to base decisions. The use of median farm size is an objective indicator that the subdivided parcels are of a minimum size, based on county-level data that indicates the parcels would remain viable for agricultural use. Since the data is evaluated at the county level, it accounts for localized agricultural trends and the use of the median rather than the mean data provides a more generous threshold for the minimum size.
Section 1265B(b)(4)(C)(iii) requires that any easement purchased with ACEP-ALE funds: “(iii) include a right of enforcement for the Secretary, that may be used only if terms of the easement are not enforced by the holder of the easement.” Additionally, Section 1265B(b)(4)(E) sets forth the authorities in the event of a violation “If a violation occurs of a term or condition of an agreement under this subsection—(i) the Secretary may terminate the agreement; and (ii) the Secretary may require the eligible entity to refund all or part of any payments received by the entity under the program, with interest on the payments as determined appropriate by the Secretary.”
NRCS held numerous meetings with stakeholder organizations about the scope and wording of the United States right of enforcement language, incorporating and addressing most of the stakeholder comments and concerns. However, several aspects of
All NRCS program participants are required to meet the terms of the program requirements, and if they fail to do so, NRCS has the ability to recover costs. However, unlike the 30-day timeframe given financial assistance participants under other NRCS conservation programs, ALE participants are given 180 days to correct any deficiencies prior to NRCS taking further action with respect to violations. Additionally, recovery of costs is authorized specifically by the ALE statute and ensures that the eligible entity maintains its role as primary title holder of the easement under the terms of the ALE agreement. Given the statutory basis for the level of recovery and that such level is consistent with the administration of other NRCS conservation programs, NRCS has modified the minimum deed term language and the regulation to limit NRCS' cost recovery from a Grantee for the Grantee's failure to enforce the easement to the amount of financial assistance provided to the eligible entity by NRCS. Further, NRCS reserves the right to pursue other equitable or legal remedies should the conduct of the eligible entity be considered scheme, device, fraud, misrepresentation, waste, or abuse.
1. Use of roads owned and maintained by the United States and managed by Federal agencies such as the Bureau of Land Management (BLM) or United States Forest Service (USFS), this may include numbered system roads;
2. Use of rights of way established under the Federal Land Management Policy Act of 1976;
3. Use of reciprocal rights of way between the landowner and a Federal agency;
4. Long-term access permits issued by a Federal agency, 30 years or greater in length that may be renewed upon agreement of the landowner and the Federal agency; and
5. A letter from an authorized representative of a Federal agency establishing the landowner's permission to cross the Federal land for casual use.
• One comment recommended that NRCS require additional deed restriction language for grassland of special environmental significance (GSS). Currently NRCS requires protection for grassland resources to be addressed in the easement deed but allows the eligible entity to provide greater protection.
• One comment recommended that NRCS retain the GSS deed restriction language in the final rule; NRCS has maintained the GSS deed restriction language in this final rule.
• Three comments recommended that NRCS change the term related to management activities during nesting season to include additional language to allow haying during nesting season if it provides critical habitat outside the breeding season; NRCS did not adopt this recommendation because of the critical need to protect at-risk species during the nesting season.
• One comment recommended that NRCS clarify that bird nesting restrictions are required for grassland enrollments only, and are not required for traditional ALE projects; the bird nesting season restrictions are required for all ALE enrollments that have grassland uses but only for at-risk species. Determinations of nesting seasons for at-risk bird species will be made in writing to the landowners prior to closing, or set forth within the ALE plan developed with the landowners. Please see preamble discussion below under “Definitions” section about comments related to NRCS adding a definition of at-risk species to this regulation.
• One comment recommended that new roads on grassland enrollments should be allowed with the prior approval of the eligible entity and subject to the 2 percent impervious surface limit; NRCS did not adopt this recommendation because allowing new roads on grassland enrollments would create fragmentation of habitat.
• One comment expressed support for the language in the minimum deed term language.
• One comment recommended revising the fencing language for grassland enrollments; NRCS has adopted this recommendation and updated the minimum deed terms.
• One comment recommended NRCS remove the deed language that specifies the terms that are controlling between NRCS terms and the eligible entity's; The language referenced in the comment applies to provisions that NRCS included in the minimum deed terms when such terms would be appended to an eligible entity's deed as a separate attachment. NRCS included this language to ensure that in the event of a conflict between the minimum deed terms language in the Federal attachment and the eligible entity's deed, the Federal minimum deed term language would control. However, there are several deed terms where an eligible entity may have more stringent requirements, and the statement identifies that where the terms in the main body of the eligible entity's deed are more stringent than the attached Federal minimum deed terms, the deed
• One comment recommended revising the environmental warranty to reference the Phase I audit report, identifying that a landowner should not warrant that they are in compliance with environmental laws when that is contradicted by the Phase I report accepted by and approved by NRCS. NRCS is not adopting the language recommended by the comment because a landowner must be able to warrant that they are in compliance with environmental laws. However, NRCS is reviewing the concern with the deed language raised by this comment about awareness of known prior environmental law violations that have since been remediated, and may adjust the deed language accordingly.
• One comment recommended NRCS list the activities that are and are not consistent with the agricultural uses of the land; NRCS did not adopt this recommendation because it is impractical to list all such potential activities. Activities that are consistent with the agricultural use of the land are highly site- and region-specific. An eligible entity can include its own additional deed terms that are more specific.
• One comment recommended NRCS remove the reference to the Chief in the oversight and approval requirements. NRCS did not adopt this recommendation because the purpose of identifying the Chief is to ensure that NRCS has maximum flexibility with respect to delegating such responsibilities in the future.
The ACEP statute specifies the statutory deed requirements that any eligible entity, including a certified entity, must meet. Based upon statutory deed requirements and the statutory purposes of ALE to protect the agricultural use and future viability, and related conservation values, of the easement area by limiting non-agricultural uses or to protect grazing uses and related conservation values, NRCS identified as regulatory deed requirements the provisions it believed were necessary to meet those statutory requirements and purposes. In the ACEP interim rule, the regulatory deed requirements that meet specific statutory requirements include the right of enforcement (16 U.S.C. 3865B(b)(4)(C)(iii)), ALE plan (16 U.S.C. 3865B(b)(4)(C)(iv)), impervious surface limitations (16 U.S.C. 3865B(b)(4)(C)(v)), and an amendment clause requiring post-recordation changes to be consistent with deed and ALE purposes (16 U.S.C. 3865D(c)). To ensure the deed terms are consistent with ALE statutory requirements that they meet program purposes (16 U.S.C. 3865(b)(4)(C)(i)) and permit effective enforcement (16 U.S.C. 3865B(b)(4)(C)(ii)), the regulatory deed requirements also include: (1) An indemnification clause concerning landowner actions; (2) a prohibition of commercial and industrial activities except those activities that are consistent with the agricultural use of the land; (3) a limitation of subdivisions except where State or local regulations explicitly require subdivision to construct residences for employees working on the property or where otherwise authorized by NRCS; (4) specific protections related to the purposes for which the agricultural land easement is being purchased; and (5) other minimum deed terms specified by NRCS to ensure that ACEP-ALE purposes are met.
NRCS has determined that there is no basis for exempting certified entities from its regulatory determination of the deed requirements that are essential for meeting ALE program purposes and statutory requirements, and therefore all eligible entities will remain subject to the regulatory deed requirements in the regulation. Certified entities have flexibility to use their own policies and procedures and, with the exception of specific language of the United States Right of Enforcement, are not required to use the minimum deed terms.
Of the comments related to regulatory corrections, NRCS has made the corrections to the typographical errors that the comments identified were in the interim rule.
The five comments related to the dedicated pool requirement requested clarification and increased flexibility in a certified entity's ability to meet the requirement. NRCS requires by policy that a dedicated fund be capitalized with a minimum of $50,000, and such requirement only applies with respect to certified nongovernmental entities. NRCS has amended the definition of “dedicated fund” to clarify that the requirement only applies to certified eligible entities that are nongovernmental organizations. Eligible entities are able to form or participate in a risk pool with sufficient resources to satisfy the dedicated fund requirements for certified nongovernmental organizations, provided it is explicit about what activities are encompassed. For example, most risk pools cover enforcement and associated litigation, but not monitoring, so monitoring would need to be specifically identified.
The remaining two comments related to the request that certified entities be able to set their own thresholds for impervious surface area, that they not be required to obtain a waiver on a parcel-by-parcel basis, and that certification of eligible entities provide flexibility to allow contracting of monitoring to conservation districts. NRCS requires a parcel-by-parcel determination because impervious surface limitations are fact-specific, and NRCS believes that certification should not equate to reduced protection of the parcels being protected with ALE funding. NRCS wishes to clarify that there is no limitation on whether monitoring can be done by conservation districts.
Of the five comments about contribution agreements, one comment recommended NRCS hold title to the grassland easements instead of the eligible entity, which NRCS cannot do under the program statute; one comment recommended that NRCS only be able to charge costs of enforcement against the landowner or eligible entity if NRCS is the prevailing party, which NRCS believes is counter to the purposes for which it obtains the right of enforcement; two comments recommended that all references to the term “cooperative agreement” in the eligible entity certification section at § 1468.27 of the ACEP rule be changed to reference the term “grant agreement”, which NRCS has addressed by amending the definitions in § 1468.3 by removing the definition for “cooperative agreement” and introducing a new term, “ALE-agreement”, which includes references to the use of either a “cooperative agreement” that is the type of ALE-agreement used with non-certified eligible entities or “grant agreement” that is the type of ALE-agreements used with certified entities. NRCS use of either a cooperative agreement or a grant agreement used in ACEP implementation is governed by the Federal Grants and Cooperative Agreements Act. NRCS believes this more global term and definition, ALE-agreement, more effectively addresses the concern raised by the comments; one comment recommended that the terms of ALE-agreements be negotiable, which NRCS currently allows non-certified eligible entities to make a request for limited changes to the terms of the template ALE-agreement if there are specific circumstances that prohibit the entity from executing the agreement as written, such as a statutory prohibition. Beyond these limited circumstances, NRCS does not allow the terms of the ALE-agreements to be individually negotiated as the ALE-agreement is the program level agreement between NRCS and the eligible entity. Executing a standard program enrollment agreement is a standard practice across all NRCS cost-share programs and ensures that all eligible entities are subject to the same terms and conditions to be a recipient of Federal cost-share assistance. Furthermore, template ALE-agreements are reviewed and approved pursuant to the Federal Grant and Cooperative Agreement Act of 1977 and the uniform regulation for grants and agreements at 2 CFR parts 25, 170, 200 and 400, such that the published templates have been determined to meet the applicable policy and regulations governing agreements generally as well as ACEP specifically. As a result, changes to the template ALE-agreements require the agreement to be re-reviewed at the National-level for compliance with applicable authorities; therefore, NRCS also identifies that such agreements may not obtain the same priority. However, the terms of the ALE-agreement with certified entities, which uses a template grant agreement for certified entities, unlike the ALE-agreements with non-certified entities that use a template cooperative agreement format, are not negotiable, as the terms of the grant agreement are inherently more flexible and the entity's agreement to use the template grant agreement as published is a condition of certification.
The comment about policy development recommended that eligible entities be involved in the creation of certification processes and procedures. NRCS used the opportunity of the interim rule's public comment period to obtain input from the public, including eligible entities, about the certification process. Additionally, NRCS may receive input on program implementation matters, including the certification processes and procedures, through the State Technical Committee process. The State Technical Committees are exempt from the Federal Advisory Committee Act and provide the best opportunity for all stakeholders to have fair and equal access to provide NRCS input on program implementation.
Two comments recommended that NRCS combine forms 41 and 41A into the SF-424 forms. NRCS did not adopt this recommendation because the SF-424 forms are Standard Forms used government-wide, and thus not subject to change for a particular agency program.
Four comments recommended NRCS provide greater clarity about the restriction related to donations of easement value, including donations to stewardship funds. NRCS established its policy about the limits to which a landowner contributes to an eligible entity's endowment fund to ensure that the eligible entity meets its responsibilities under the ACEP statute requiring contribution of its own cash resources towards an easement transaction. Several eligible entities have been investigated by the Office of Inspector General (OIG) over the years and were found to be fraudulently representing their contribution of cash resources, hiding landowner donations in other entity accounts and then representing these funds as independent entity cash resources. More troubling, many of these same entities required the landowner to make such donations in order for the eligible entity to fund their transaction.
Two of the comments expressed concern about IRS requirements to ensure that landowners could continue to claim charitable deductions, and NRCS will consider alternative deed language addressing valuation of proceeds in the event of an approved condemnation or other termination actions proposed by eligible entities in an effort to reduce potential conflicts between IRS and NRCS requirements as was discussed above in the topic about ALE deed requirements.
NRCS identified in the interim rule the criteria by which a project may be determined to be one of special significance, including but not limited to, if:
• The project is listed on the National Register of Historic Places;
• the location is within a micropolitan statistical area and 50 percent of the adjacent land is agricultural land;
• the location is within a metropolitan statistical area;
• the project will increase participation in agriculture by underserved communities, veterans, or beginning or disabled farmers and ranchers;
• the farm or ranch is used as an education or demonstration farm focused on agricultural production and natural resource conservation.
Among the recommended changes to the criteria, several comments recommended changes that were not based upon the attributes of the parcel itself, but aspect of the eligible entity's program, such as the incorporation of an Option for Purchase at Agriculture Value (OPAV). NRCS did not adopt the criteria that were not based upon the conservation benefits of enrolling a particular parcel. However, among the recommended criteria, NRCS will adopt the following:
• Several parcels within a special project area being offered for enrollment in that fiscal year that are being protected pursuant to a comprehensive plan approved by the State Conservationist, with input from the State Technical Committee, for the permanent protection of a large block of farm or ranch land.
• A parcel that is part of a comprehensive plan to facilitate transfers to new and beginning farmers approved by the State Conservationist, with input from the State Technical Committee, for the permanent protection of a block of farm or ranch land that, if implemented, will facilitate the transfer of farmland to a next generation farmer.
• A parcel that is the subject of a conservation buyer transaction where a member of underserved community, veteran, beginning farmer or rancher, or a disabled farmer or rancher has a valid purchase and sale agreement to acquire the property subject to an agricultural land easement. Or
• A parcel that has an existing NRCS Resource Management System (RMS) level plan with NRCS conservation practices applied or under contract to be applied in accordance with NRCS standards and specifications, and the landowner has agreed that the ALE plan will be developed at the RMS level in accordance with the purposes for which the ALE easement is being acquired.
Five of the 11 comments about the match requirements for standard projects requested clarification, especially as the match requirements related to the enrollment of forest land. The remaining six of the comments either expressed support for the cash requirement, requested reduction in the cash requirement, or complete removal of the cash requirement of the eligible entity. In the interim rule, NRCS identified that NRCS may approve a waiver of the two-third limitation for forest land eligibility for sugar bushes. If so, then the acreage associated with the sugar bush are to be included in the eligible land for which cost-share is provided. Forest land beyond the two-thirds, if not waived for sugar bush, is not eligible for ALE cost-share assistance. NRCS cannot adopt the recommendation that NRCS provide a “no cash match” option, with easements using only NRCS funding and the donation of value by the landowner. Not only does this option not meet statutory requirements, but it undermines the nature of the transaction where all parties have financially invested in its success from the outset. The circumstances under which the entity cash contribution can be lowered are described above in the section on ALE `projects of special significance'.
Of the 11 comments about the requirement that the eligible entity document that they have their match available at the time they apply for ALE funding, two comments supported the requirement; five comments recommended that standard of evidence for cash match availability should be one of high probability as can be evidenced by a successful history in being awarded matching funds in the past; two comments recommended that NRCS substitute this requirement with a requirement that eligible entities be allowed to adequately demonstrate their ability to obtain the requisite funds; and two comments recommending allowing eligible entities to submit a plan for obtaining matching funds when they do not have cash match available on hand. NRCS has always required an eligible entity to certify the availability of match at the time of application as it is a matter of eligibility in determining whether the entity is in fact eligible for the program. Prior to tying up Federal funds for the eligible entity's transaction, an entity must establish that it is eligible and that it is able to perform under the terms of the ALE-agreement. The easement transaction is the eligible entity's transaction, for which they are acquiring title and for which they wish to obtain cost-share assistance from the Federal government for the entity's purchase of an agricultural land easement. Therefore, the NRCS funds are to match an eligible entity's funds that have been set aside for the eligible entity's transaction, not an eligible entity's funds to match NRCS funds that have been set aside for the transaction. NRCS recognizes that an eligible entity may not have its match in its own account, and therefore already provides flexibility for the match to be established through self-certification and, as needed, supplemental documentations such as an award letter or other documentation that the funds have been set aside for the transaction. NRCS believes it has balanced maximum flexibility for the eligible entities with responsible administration of Federal funds and thus no additional flexibility is warranted.
Of the four comments about the restrictions that NRCS has identified in the interim rule related to landowner contributions, two comments recommended eliminating the restriction on landowner contributions to eligible entities and two other comments recommended that NRCS eliminate the reference to landowner contributions to a stewardship endowment. As explained above, NRCS adopted these restrictions to meet the statutory requirement that an eligible entity contribute its own cash resources to a transaction. During the OIG investigations referenced above, landowners had been misled, threatened, and otherwise coerced into making contributions to other accounts of an eligible entity to hide the eligible entity's inability to contribute its own cash resources. NRCS recognizes that this behavior is limited, but believes strongly that providing reasonable parameters on what NRCS will accept as evidence of a voluntary landowner contribution removes the potential for these types of inappropriate behaviors. NRCS did not make any changes to the regulation in response to this comment, but is reviewing the policy levels established for this limitation.
Of the four comments about the availability of other NRCS assistance, two comments recommended that NRCS reimburse land trusts for transaction costs once the easement has been recorded; one comment recommended NRCS provide 10 percent of the administrative costs to eligible entities to reduce financial burden; and one comment recommending that NRCS make funding available to cover the conservation organizations' dedicated fund in NRCS funded transactions. NRCS did not adopt any of these recommendations as they are not supported by the statute. Under ALE, NRCS only has authority to provide cost-share assistance for the cost of an easement, and appropriate technical assistance, and no other activities are authorized to be funded. All other financial responsibilities belong to the purchaser of the easement that is the eligible entity.
Of the five comments about the WREP match requirements, three comments recommended NRCS use the 5 percent minimum requirements instead of the new 25 percent requirement, and two comments recommended that the WREP match requirements be available through the Regional Conservation Partnership Program (RCPP). NRCS did not adopt either recommendation. WREP is a component of ACEP-WRE through which NRCS enters into agreements with eligible partners to target and leverage resources to carry out high-priority wetland protection, restoration, and enhancement activities and improve wetland and associated habitats on eligible lands. In FY 2015, NRCS published a request for WREP proposals and awarded approximately $30 million in financial assistance (FA) funds to competitive projects. NRCS believes the 25 percent match requirement encourages meaningful partnership effort and represents a match requirement well-established in similar watershed and conservation efforts. The non-Federal match also expands the number of wetland acres that can be protected and restored, resulting in an even more cost-effective use of Federal financial resources. NRCS provides flexibility concerning the component of the project upon which a partner's contribution will be based. Given the match requirements that must be met in WREP, NRCS prefers not to complicate WREP implementation efforts with RCPP implementation efforts and allow each partnership effort to remain distinct.
To ease readability, NRCS describes the comments received for each of the definitions in its response to such recommendations below.
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Of the four comments about the definitions for the various types of easement administration actions—easement exchange, easement modification, easement subordination, and easement termination—one comment recommended minor changes to the easement modification definition; two comments requested clarification to each of the definitions; and one comment requested clarification to the definition of “compelling public need.” NRCS developed the definitions to provide a clear distinction between each type of easement administration action so, for example, an easement modification is readily distinguished from an easement exchange. NRCS based these definitions on its experience with processing easement administration action requests under the predecessor authorities, and familiarity with other Federal agency requirements under similar authorities. NRCS finds that these definitions provide clarity to landowners, provide for the long-term protection of critical resources, and ensure the integrity of the Federal investment in easements.
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NRCS recognizes the benefit of these recommendations and has adopted many of them in the definition. In particular, NRCS has provided guidance to its State offices to obtain State Technical Committee input about highly sensitive natural resources within the State, including the ability of States to consider whether such lands are identified in special initiatives or plans.
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There were two comments that recommended that NRCS define additional terms, one comment recommending that “Future Viability of Agricultural Land” be defined, and one comment recommending that “Amendment for the minimum deed terms” be defined. NRCS has added a definition of Future Viability, as described above. NRCS has also provided further clarification on the purpose and use of the minimum deed terms, and has determined that an additional definition is not necessary to provide further clarification.
Of the four comments related to easement management, one comment recommended NRCS increase opportunities and incentives to utilize haying and grazing as a wetlands management tool, which NRCS does through the compatible use authorization process to improve quality of management on WRE easements; one comment recommended eliminating “lesser of 2% or $20,000” restriction on landowner contributions to endowments, which NRCS explained above that a limitation on endowment contributions is important to ensure the voluntary nature of landowner donations to ALE easement acquisitions and adherence to the statutory requirements but the level of the limitation may be adjusted upon review and approval by NRCS prior to closing. One comment recommended that NRCS require ALE eligible entities to incorporate necessary deed restrictions related to grasslands of special environmental significance, which NRCS already does, and one comment recommended existing easements should not be retroactively subject to and required to comply with new stewardship and management requirements of ACEP, the passage of the new ACEP does not affect the terms of any existing recorded easements or the terms of agreements entered into prior to February 7, 2014. However, the statute identifies that lands enrolled in the predecessor programs are considered enrolled in ACEP, therefore the new authorities related to easement administration actions and delegations are applicable to all FRPP, GRP, WRP, and ACEP easements.
Of the 11 comments about easement monitoring, one comment requested that NRCS clarify that NRCS may only monitor an ALE easement after formally exercising the right of enforcement. This is inaccurate because NRCS monitors easements, including review of eligible entities' monitoring reports, to ascertain whether there is cause for NRCS to exercise its right of enforcement. Three comments recommended NRCS prohibit NRCS staff from monitoring an ALE easement when visiting a property for other reasons. NRCS did not adopt this recommendation because it is irresponsible for the Agency to ignore possible violations it becomes aware of in the performance of its duties. Two comments recommended that NRCS clarify when certified entities will lose certification or an ALE-agreement due to failure to monitor or enforce its easements, which NRCS has done in its ACEP policy manual at 440 CPM 528.75. One comment recommended increasing monitoring and enforcement to ensure easement compliance, which NRCS will consider when it updates its monitoring policy for all easements. For current entity-held easements, NRCS policy requires NRCS to conduct onsite monitoring 1 in 5 years and review of the entity's monitoring documents the remaining 4 in 5 years. However, NRCS recognizes that the Grantee has primary responsibility to conduct monitoring and enforcement. Two comments recommended NRCS work with eligible entities to add, if necessary, additional questions to the eligible entities existing monitoring forms, such as any “required questions”, which NRCS will do. The NRCS monitoring form is available to the public on the NRCS Web site and it contains the required monitoring questions that NRCS must answer to complete its annual report on easement condition. One comment recommended NRCS provide review and comment about an eligible entity's monitoring activities, which NRCS will do upon request by the eligible entity. One comment recommended NRCS clarify the required conditions regarding dedicated funds. NRCS clarifies these conditions at 440 CPM 528.72, including specifying the dedicated fund will be considered committed to these purposes if it is held in a separate account and may not be used for other purposes, the dedicated fund is considered sufficient if it has at least $50,000 for legal defense and $3,000 per easement for management and monitoring, and clarification that a sufficiently capitalized risk pool will satisfy the requirement of a dedicated fund.
Of the nine comments about easement violations, one comment recommended NRCS notify the eligible entity's other funding partners when there is a violation, which NRCS did not adopt as it is the eligible entity's responsibility to notify the partners from which the entity received funding; three comments recommended that damage or destruction caused by natural events should not be considered an easement violation, which is already the case; one comment recommended clarifying violations of the ALE plan, which as NRCS has explained is the responsibility of the eligible entity with the exception of violations of the conservation plan component of the agricultural land easement plan for which verification of compliance is the responsibility of NRCS in accordance with the conservation compliance provisions at 7 CFR part 12. One comment recommended always requiring notice to landowners about violations, which by policy, NRCS notifies the landowner for WRE easements and notifies the Grantee for ALE easements if NRCS discovers the violation prior to the Grantee despite the Grantee having primary enforcement responsibility, though there may, however, be emergency circumstances where written notice prior to addressing a violation is not practicable; two comments recommended that a violation notice does not negate or circumvent the role of funding partners to assist in determinations of violations, entitlements to recovery of fees and expenses, determination of easement termination valuations, and proportional dispensation of termination proceeds, which NRCS agrees it does not; and two comments that NRCS should only be entitled to recover costs if the eligible entity was negligent in its enforcement role, which would be the most likely circumstance if the eligible entity failed to enforce its easement.
Of the five comments related to the right of enforcement, two comments recommended that NRCS notify land trusts if they are inadequately reporting and also create an opportunity to resolve any issues before NRCS asserts its enforcement rights, which NRCS will do in situations where all parties are acting in good faith; one comment recommend NRCS amend the right of enforcement language to include a provision by which the entity could repay the value of the easement to avoid enforcement action, which NRCS finds fundamentally in opposition to the statutory purposes of the program; and one comment recommended that the ACEP manual should not focus on NRCS' stewardship, monitoring, and enforcement responsibilities because entities have primary responsibility in these areas, which NRCS recognizes in policy. But this does not alleviate NRCS' responsibility to ensure that the statutory program purposes are met and
Of the three comments related to the availability of alternative valuation methodologies for ALE, one comment expressed support; one comment sought assurance that industry-approved appraisal standards will be sufficient; and one comment recommended that NRCS use the Farm Credit Association's “benchmark valuation” model. NRCS will review any standards submitted by eligible entity and compare to the appraisal standards under USPAP or the Uniform Appraisal Standards for Federal Land Acquisition (UASFLA) to determine if the alternative methodology sufficiently determines the fair market value of the easement. NRCS reviewed the benchmark valuation model but has determined that this methodology alone is not sufficient because it only derives market value of the fee estate, and does not derive easement value as required by statute.
The three comments about the adjustments to the ALE appraisal effective date supported the change that NRCS made to policy allowing approved appraisals to have an effective date that is either within one year of the closing date, or within six months on either side of the signing of the ALE-agreement.
Of the seven comments about the appraisal review process, one comment expressed support for the process; one comment recommended NRCS review the current appraisal contracts and instructions to review appraisers; one comment recommended NRCS work with eligible entities to review the current contract for review appraisers; one comment requested NRCS clarify the definition of technical appraisal review; one comment recommended NRCS require communication between the appraiser and the review appraiser during the development of the preliminary scope of work; one comment recommended that review appraisers meet an ASFMRA Real Property Review Appraiser program, ASA Appraisal Review and Management, or NAIFA Independent Fee Appraiser Agricultural (IFAA) designation to be qualified to competently perform as a review appraiser; and one comment recommended that NRCS strengthen the review appraisal function.
NRCS continuously reviews the appraisal instructions with its contracted technical review appraisers. It is difficult to make reviews consistent since they are professional opinions and not simply a checklist. However, NRCS will note that it may identify problems with an appraisal that do not affect validity of the determination of value. NRCS has not adopted the recommendation that would allow eligible entities to review the current contract NRCS has with review appraisers because the review appraisers are to provide an independent review of the appraisal submitted by the eligible entity. A technical appraisal review is a review completed by a State certified general appraiser. NRCS cannot require communication between the review appraiser and appraiser during the development of the preliminary scope of work of the appraisal because of the timing issues since the eligible entity often does not know that NRCS funding will be sought or obtained at the time the appraisal is being conducted. However, the NRCS appraisal specification and scope of work and appraisal technical review specification and scope of work are both publically available on the NRCS Web site and can be accessed by the eligible entities or the appraisers at any time. Additionally, the appraiser always has access to the NRCS National Appraiser should questions arise during the development of the original appraisal. With respect to the comment recommending various designations, NRCS requires review appraisers to meet strict qualifications, though the referenced designations are not required. NRCS continually reviews its procedures to ensure the quality of the appraisal and appraisal review functions meet program requirements.
Of the eight comments about NRCS appraisal specifications, one comment requested NRCS clarify the appraisal scope of work to bar appraisers who have had disciplinary actions that did not result in suspension but did result in a license restriction, which NRCS will adopt as an appropriate additional consideration. One comment requested NRCS specify that USPAP and UASFLA be identified as appraisal thresholds, which NRCS already does in both the regulation and policy manual. One comment recommended that a survey should not be required as part of the appraisal report if a current recorded deed meets closure requirements under State law, which is the current standard NRCS applies, if a survey is available then it should be included, but otherwise the existing recorded legal description is sufficient if it meets the State law and describes the area to be encumbered by the easement. One comment recommended using an UASFLA appraisal instead of USPAP when discounted cash flow valuation method is used, which NRCS did not adopt as UASFLA actually discourages the use of the cash flow valuation method. One comment recommended NRCS allow landowners to obtain the appraisal and another comment recommended that NRCS allow the landowner to be listed as a client on an appraisal, neither of which NRCS adopted because conflict of interest concerns prohibit such steps, as do prior OIG audit management actions. NRCS policy, however, does allow landowners to be identified as a user and to pay for the appraisal, but does not allow the landowner to select the appraiser or direct the appraiser as the client. One comment opined that UASFLA is the most accurate and proven method for developing an opinion of “fair market value” for fractional and partial interests, such as those involved in the ALE program, which is why NRCS considers it as an acceptable methodology to use. One comment requested NRCS clarify that a farm with excess forestland can be protected under one easement as long as the additional forestland is not included in the appraisal, which NRCS considers as much a program issue as an appraisal issue, and simply requires that the
Of the 11 comments about projects of special significance, three of the comments recommended establishing a time limit for NRCS consideration of requests of an eligible entity's cash contribution, which NRCS will not adopt as an unnecessary prioritization of a program implementation action; additionally the eligible entity has the flexibility to request a project of special significance determination before or after the ALE-agreement is entered into. The remaining comments requested clarification or recommended replacing the national criteria with considerations such as whether the parcel is: Owned by a new or beginning farmer; part of a comprehensive plan to protect a block of farms or ranchland adjacent to Federal or State lands dedicated to conservation or military use; an education or demonstration farm; or would include an Option to Purchase at Agricultural Value (OPAV) in the deed, or the project would have significantly lower probability of happening without a reduction in the required eligible entity cost-share.
Section 1265B(b)(2) requires that the Federal share of the cost of the purchase of an agricultural land easement must not exceed 50 percent of the fair market value of the agricultural land easement. The eligible entity must provide a share that is at least equivalent to that provided by NRCS, but may include a charitable donation by the landowner provided the eligible entity contributes its own cash resources in an amount that is at least 50 percent of the NRCS contribution. However, for projects of special significance, NRCS may waive any portion of the eligible entity cash contribution requirement, subject to an increase in the private landowner donation that is equal to the amount of the waiver, if the donation is voluntary, and the property is in active agricultural production.
While at first it appears that identifying parcels owned by a new or beginning farmer as a project of special significance would prioritize such enrollment, the actual impact of such identification would result in the eligible entity providing less financial compensation to a landowner who, given the newness of the operation, would best benefit from the capital investment of the eligible entity. Therefore, NRCS has incorporated criteria specifically to encourage enrollment of parcels owned by historically underserved landowners as projects of special significance where such criteria do not have such unintended consequences. NRCS does consider “buy-sell-protect” or “conservation buyer” parcels that are subject to a valid purchase and sale agreement to transfer land to historically underserved buyer at the closing of the ALE as a project of special significance. NRCS has added such criteria, as discussed above, to the regulation. NRCS also believes that a parcel could qualify as a project of special significance if it is one of several parcels within a special project area being offered for enrollment in that fiscal year that are being protected pursuant to a comprehensive plan approved by the State Conservationist, with input from the State Technical Committee, for the permanent protection of a large block of farm or ranch land. However, agricultural zoning or being identified for protection by an established farmland protection program is not sufficient to meet this standard. NRCS already provides priority for enrollment of parcels near military installations or other conservation lands, and while these efforts are standard among farmland protection efforts, the proximity of a parcel to such lands in conjunction with other factors may qualify a parcel as a project of special significance. As discussed above, OPAVs are an administrative tool used by eligible entities and do not represent any special resource condition of the parcel itself, and therefore NRCS will not identify parcels that will have OPAV provisions as a project of special significance.
The statutory definition of “eligible land” is private or tribal agricultural land that is “subject to a pending offer for purchase of an agricultural land easement from an eligible entity.” Section 1265A(3)(A)(i) (Emphasis supplied).
As to limitations imposed by the definition of eligible landowners, to qualify as an eligible landowner an eligible entity would need to comply with adjusted gross income limitations (AGI) and conservation compliance requirements. Currently under ACEP-ALE, eligible entities are not evaluated for AGI or conservation compliance as the benefits of the program and therefore the landowner eligibility requirements are attributed to the landowner. However, if an eligible entity were to apply for ACEP-ALE as a landowner then they would be subject to AGI and conservation compliance checks. While AGI is unlikely to limit eligible entities, the conservation compliance check would present a new and significant hurdle for an eligible entity. Furthermore, because only private and tribal land is eligible an eligible entity that is a State or local government cannot be an eligible landowner.
Further, under Section 1265B(b)(1) of the ACEP statute, cost-share assistance is only authorized to be provided for “purchasing agricultural land easements.” In a situation where the eligible entity already owns the land, an agricultural land easement is not being purchased but reserved and the residual fee title is being sold to a private landowner. NRCS has developed policy to address temporary buy-sell-protect situations. By including within the definition of a landowner those buying
Six of the 15 comments recommended that Confined Animal Feeding Operations (CAFOs) should be ineligible for ACEP-ALE funding by adding CAFOs at § 1468.20e “ineligible land criteria” as these lands impair groundwater, surface water, and air quality. For any proposed easement containing a CAFO, the confined area is a heavy use area that must be evaluated by NRCS to determine if the on-site or off-site conditions render the site ineligible and make a determination whether the land meets the required land eligibility criteria. This is necessarily a case specific determination and therefore broad categorization of land eligibility simply based on type of operation would not be appropriate.
With respect to WRE land eligibility, one comment requested clarification about the WRE water depth factor for determining eligibility of potholes and closed basins. As an eligibility determination, the “6.5 foot or less” criterion refers to the depth of flooding at the time of application and is not based upon any hydrologic features that could be planned to be constructed for the project. One comment requested NRCS give flexibility at the NRCS State level when consulting with the United States Fish and Wildlife Service to determine how to maximize wildlife benefits and wetland values and functions, which NRCS already does. One comment recommended prohibiting commercial game farms and shooting preserves on NRCS easements, which NRCS will not do as some related activities may be consistent with the long term wetland purposes of the easement, as determined by NRCS through the compatible use authorization process.
Two of the 15 comments requested that NRCS emphasize that land enrolled in WRE would not be eligible for wetland mitigation credit. WRE easements and contracts provide NRCS the authority to restore, protect, and enhance enrolled wetlands and associated habitats in a manner that will maximize wildlife habitat and other wetland functions and values. The assumption is that WRE lands will receive the conservation attention from NRCS necessary to achieve this full degree of protection, restoration, and enhancement. Therefore, NRCS does not allow another entity to expend mitigation funds on any of the land treatment conservation actions that would be appropriate and practicable to fund under WRE. This policy extends to any compensatory action taken by a third party to mitigate adverse ecological impacts, including but not limited to, the Federal Water Pollution Control Act (
However, there may be limited opportunities when enhancement activities under a mitigation project would go beyond those conservation actions normally carried out under a WRE. NRCS notifies landowners who wish to enter into mitigation arrangements that if they enter into an agreement with a third party that such agreements are subordinate to the WRE and that if the agreement requires the exercise of rights held by the United States, such actions are subject to the compatible use authorization process.
Furthermore, NRCS recognizes that environmental benefits will be achieved by implementing conservation practices, components, measures, and activities funded through WRE, and that environmental credits may be gained as a result of implementing activities compatible with the purposes of a WRE easement or contract. NRCS asserts no direct or indirect interest in credits generated by activities not funded through WRE. Landowners should be aware that any applicable credits may be subject to additional requirements
The remaining three comments expressed support for the exemption of wetland land capability classes from the county cropland limitation. NRCS would like to clarify that the subclass w exemption also applies to easements enrolled through the predecessor program, the Wetlands Reserve Program.
NRCS cannot adopt the recommendations to eliminate the written pending offer requirements as it is a statutory requirement. However, a purchase agreement is not required. NRCS has made available, upon request, an example model pending offer that can be adopted by eligible entities.
Of the ALE grasslands eligibility recommendations, three comments recommend adopting flexibility to include grasslands of special environmental significance with noxious or invasive species where the grasslands are supported by State, regional, or national plans, and three comments recommended that NRCS clarify that land eligible for grazing uses and other conservation values do not need to contain historical or archaeological resources to be eligible. To be eligible as grasslands of special environmental significance, NRCS requires that the grassland have little to no noxious or invasive species. If a grassland is supported by State, regional or National plans, but contains noxious or invasive species that occupy more than a minor extent of the grassland or are not under effective control, those lands may be eligible as a general ALE grassland enrollment, but would not be eligible as a grassland of special environmental significance. NRCS has clarified that land eligible for grazing uses and related conservation values does not also need to contain historical or archaeological resources by listing more discretely the eligibility criteria as outlined in § 1468.20(d).
NRCS will not eliminate the 50 percent prime or unique farmland requirement as this requirement can be waived, is only one of four land eligibility options, and the agency already has significant flexibility to ensure that the most important lands, whether identified nationally or locally, are eligible for enrollment.
NRCS will not adopt the recommendation that agricultural historic resources receive a priority review during land eligibility determinations, since State screening criteria or ranking factors can accommodate this concern for priority if identified at the State level.
Of the two comments about ALE State or local policy consistent with the purposes of the ACEP-ALE, one comment requested NRCS clarify the process whereby an eligible entity may meet this requirement, and one comment recommended NRCS eliminate the deed requirement that the agricultural land easement must address the purposes for which the land was acquired if the land is being acquired because it “furthers a State or local policy.” NRCS does not define what constitutes a State or local farmland protection policy that is consistent with ALE as such a definition may inadvertently limit the potential for effective farmland protection efforts. However, if an easement transaction depends upon the eligibility of the land being based on the protection of land furthering a State or local policy, the eligible entity must submit to NRCS the documentation necessary for NRCS to
While it is unlikely that a parcel will be enrolled as eligible solely because it furthers a State or local policy consistent with ALE, if its enrollment is based upon such criteria then NRCS must ensure that such criteria will be furthered by the purchase of an agricultural land easement. For parcels determined eligible based this eligibility type, the agricultural land easement deed must address the ACEP-ALE purposes that are being supported by a specific State or local policy.
With respect to infrastructure projects, if there is an existing or known infrastructure project that introduces disturbances or risks that could undermine the purposes of the easement and there are documented routes approved by a government authority, the land may be determined ineligible or may require reconfiguration in order to become eligible because NRCS will not knowingly interfere with the proposed infrastructure project objectives of another agency. However, if an infrastructure project is not definitive as to its location and scope, then NRCS will not determine a parcel ineligible simply because an infrastructure project is under consideration in an area.
Additional comments related to planning included 6 comments related to regulatory references; 29 comments related to the development of the ALE plan; 13 comments related to the voluntary nature of ALE plans; 33 comments related to the monitoring and enforcement of ALE plans; three comments related to the stringency of plans; one comment related to plans required by other programs; and one comment related to WRE wetland restoration plan of operations (WRPO).
(1) Describe the activities that promote the long-term viability of the land to meet the purposes for which the easement was acquired;
(2) Identify required and recommended conservation practices that address the purposes and resource concerns for which the parcel was selected;
(3) Identify additional or specific criteria associated with permissible and prohibited activities consistent with the terms of the deed; and
(4) If the agricultural land easement contains certain land use types, a component plan must be incorporated by reference into the agricultural land easement plan for grasslands, forest lands required by § 1468.20(d)(3) to have a forest management plan, and highly erodible land.
In the interim rule's preamble, NRCS encouraged the development of a robust and comprehensive agricultural land easement plan, such as a plan at the NRCS Resource Management System (RMS) planning level, and identified that such a plan could include both required and recommended practices. NRCS recommended that NRCS' planning procedures, conservation practices, and standards and specifications be used to develop the agricultural land easement plans.
An ALE plan identifies conservation practices or management standards necessary to meet statutory requirements and recommends conservation practices based on landowner goals and the purposes of the individual easement. Eligible entities may, at their option, address additional resource concerns in the ALE plan. NRCS will continue to conduct outreach about the relationship between deed terms and the plan, to clarify that the ALE plan is a living document that can be adjusted as landowner operations or objectives change and is intended to provide flexibility for management of the land within the purposes of the easement over the term of the easement. Additionally, NRCS has made available example plans as exhibits to the ACEP manual available on the NRCS Web site to help alleviate concern about the “unknown.”
The comments related to the development of the ALE plan focused
○ Seven comments recommended that the national criteria should comprise no more than half of the total score. NRCS believes that the existing weighting provides ample opportunity for resource priorities within States to be addressed. In particular, State Conservationist have discretion to have State factors provide up to 50 percent of the weighting, and can also weight the national criteria in a manner that corresponds with the resource concerns in the State.
○ One comment recommended that NRCS provide a clear and consistent national framework for project selection, but also maintain the role of the State Technical Committee. NRCS agrees and believes the current balance between National and State criteria furthers this goal.
○ One comment recommended that NRCS revise the ACEP manual to allow representatives of eligible entities that are seeking ALE funding to serve as State Technical Committee members and participate in State ranking criteria and weighting discussions, as long as they do not vote on recommendations. NRCS did not adopt this recommendation as an ethical matter. Even without voting on the recommendations, the influence upon the State ranking criteria and weighting factors could affect the selection of particular parcels the eligible entity is seeking funding for and represent an inherent conflict of interest.
○ Three comments recommended that general ALE and grassland of special environmental significance should be ranked separately. NRCS would like to clarify that while these projects are ranked using the same form, the specific ranking questions applicable to the different types of enrollments have offsetting scores such that the applications are competitive within and between enrollment types. Furthermore, the State Conservationist has the ability to request separate allocations of ALE funds split into general ALE and GSS and thus not have the applications compete against each other for access to the same funds.
○ One comment recommended consistent ranking scoring. NRCS agrees that consistent ranking scoring provides greater transparency and is one of the changes NRCS made from FRPP implementation to how it is implementing ALE. NRCS will also explore the implementation of using a consistent total ranking score across WRE as well.
○ One comment expressed support for the use of thresholds in setting priority ranking and one comment expressed support for the ALE eligibility requirements that help ensure enrollment of priority acres that meet objectives of the program.
○ One comment advised that project ranking should not be penalized for delays generated by NRCS and that some accommodation should be made if the delay is not the fault of the eligible entity. NRCS must maintain objectivity in the application of the criteria and whether to assess penalties for delays is at the State Conservationist's discretion who is most familiar with the situation.
○ One comment recommended that NRCS prioritize easements with high conservation values that include strong conservation plans. NRCS believes the current ranking criteria addresses this comment.
○ One comment recommended that NRCS release a scoring tool to eligible entities to use to evaluate projects prior to submittal. NRCS State offices make available the ranking criteria at least 30 days prior to the application deadline.
○ One comment recommended that NRCS revise the ranking criteria to ensure the application process does not negatively affect smaller acreage producers. There are many factors that NRCS balances in the development and implementation of its ranking factors and weightings. The State Conservationists have the flexibility to address the impact to smaller acreage producers through the weighting of the different ranking criteria.
○ One comment recommended that if “other criteria” are to be determined, that such criteria should be subject to public comment. Ranking criteria are a topic of discussion at State Technical Committee meetings, and these meetings are publicized by NRCS at the State level and open to the public. Additionally, NRCS at the State level posts the criteria it will use for ranking at least 30 days prior to the end of an application period.
○ One comment recommended that NRCS segment the core of the parcel from incidental land in the ranking form. NRCS did not adopt this recommendation because NRCS is cost-sharing on the entirety of the parcel and therefore the entirety of the parcel must be evaluated in the ranking.
○ One comment recommended that NRCS provide a Web site that outlines State and local program priorities and priority geographies for applicant to evaluate eligibility under those categories. Each NRCS State office has its own Web page and NRCS will provide this greater detail on these NRCS State Web pages.
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• One comment recommending adding a national ranking criterion to score parcels that include a “buy-protect-sell” approach. NRCS did not adopt this recommendation because this type of transaction can present statutory authority issues, and while flexibility exists for certain types of these transactions, NRCS does not believe it is appropriate to prioritize such approaches.
• Five comments recommended adding a national ranking criteria for grassland easements where enrollment of land will contribute to achieving the goals and objectives of national, regional and State fish and wildlife conservation plans and initiatives. NRCS affirms that the existing State Criterion Four, as provided in the current ACEP interim regulation § 1468.22(c)(4), is intended to allow State Conservationists to account for the priorities identified in these types of plans in their State ranking criteria.
• One comment recommended adding a national ranking criteria for lands in areas of high conversion pressure from grasslands to cropland. NRCS believes that this criterion is appropriate given the grassland conservation purposes of ALE, and as described above, has added it to the National criteria.
• One comment recommended adding a national ranking criteria to give special consideration to applications that serve micropolitan and metropolitan statistical areas that have high risk of farm conversion. NRCS believes that the national factor related to population growth factors addresses the priority that would be provided by a micropolitan ranking factor.
• One comment recommended that “effective agricultural zoning” should be considered within the national ranking criteria for eligible ALE parcels. NRCS did not adopt this recommendation because such determination would be too subjective.
• One comment recommended adding State ranking criteria to the list of national ranking questions to address areas of national importance. NRCS did not adopt this recommendation.
• Two comments recommended consolidating national ranking criteria three though six because the commenter believed that such factors weigh against enrollment of remote, intact parcels of significant ecological value. NRCS did not adopt this recommendation because the statutory criteria for the program is to maximize the benefit of the Federal investment with an emphasis on protecting agricultural uses and related conservation values and maximizing the protection of areas devoted to agricultural use. In NRCS' experience in administering conservation easement programs NRCS has determined that if two parcels of similar agricultural and related conservation values are offered for the program, but one is subject to threat of development or conversion, the benefit of the Federal investment is maximized by prioritizing the protection of the agricultural uses on the parcel subject to the most immediate threat of conversion to non-agricultural or non-grassland uses. Ranking criteria three through six are intended to evaluate this risk and provide an objective, transparent, and nationally-available data sources upon which to base this evaluation.
• One comment recommended adding a national ranking criterion to consider the number of development rights to be extinguished. NRCS did not adopt this recommendation because this information is not consistently available nationwide or at the time of ranking. If an individual State has a consistently available data source or mechanism by which to evaluate at the time of ranking the risk of development or conversion, the State Conservationist has the discretion to include such a consideration in the State ranking criteria as provided in § 1468.22(c)(7).
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In many parts of the country, especially the southeast and the Midwest, the original vegetative wetland community was bottomland hardwood forest or forested wetland. However, emergent marsh habitat is very popular amongst landowners and various waterfowl organizations given the utilization of such habitat by migratory birds.
NRCS has interpreted the restoration requirements broadly and NRCS believes that the restoration objectives of ACEP-WRE are best met with adhering to the existing parameters. Achieving full restoration of the wetland functions and values on each acre enrolled in WRE to maximize the environmental benefits for Federal funds expended continues to be a high priority activity for NRCS.
Of the five general comments, three comments supported the provisions; one comment recommended that the easement administration action terms be incorporated directly into the conservation easement deed; and one comment recommended prohibiting any easement administration actions for natural gas and oil exploration and extraction. NRCS identifies in the WRE warranty easement deed the statutory reference to the easement administration action authorities, and the ALE regulatory deed requirements identify that NRCS approval is required for any easement administration actions that may arise on ALE easements. NRCS evaluates all easement administration action requests on a case-by-case basis and determines whether the required criteria have been met.
Of the two comments related to compelling public need, one comment recommended that NRCS eliminate the criteria and the other comment recommended that NRCS clarify that a compelling public need is not limited to Federal agency priorities. NRCS will not eliminate the criterion as it is required by statute and provides a high bar for the requirements that must be met before NRCS will alter the physical boundaries or the terms of an existing ACEP easement on which a significant investment of Federal funds has been made to secure the long-term protection of agricultural and wetland resources for future generations. A compelling public need is not limited to Federal priorities, and may be based upon circumstances that are being addressed by State or local governmental entities.
Of the three comments related to the criterion of limiting the impact of the easement administration action to 10 percent of easement area, two comments recommended eliminating the limitation and one comment recommended adopting a limit of 5 percent of the easement area. NRCS did not adopt either recommendation as 10 percent provides sufficient flexibility, with most easement administration actions affecting much less of the easement area.
The comment received about the limitation that replacement acreage in an easement exchange be within the same 8-digit watershed as the original easement recommended that NRCS allow a waiver for replacement land to go beyond the 8-digit watershed. NRCS did not adopt the recommendation because the nature of the easement values are best served by ensuring that replacement lands are within the same watershed and the criteria serves as an objective and transparent requirement that can be equitably applied.
Of the seven comments about partner issues associated with easement administration actions, one comment recommended that NRCS be required to include the eligible entity in its discussions with the Department of Justice related to condemnation actions; two comments recommended adding language to recognize the role of other funding partners in the approval of changes to easement terms; one comment recommended NRCS consult with the Land Trust Alliance, two comments recommended that in the case of ALE easements, NRCS should notify the eligible entity immediately upon receiving notice of any “infrastructure project request”, and one comment recommended that for condemnation or termination, the eligible entity should reimburse NRCS proportionally to NRCS' initial investment in the easement, provided that the condemnation of the property provides adequate compensation to the eligible entity. The Department of Justice represents the United States and NRCS is a client agency, and it is not appropriate to adopt a requirement to include third parties in its discussions with its own legal representatives. NRCS does not believe it is appropriate for it to include language in the regulation regarding the relationship between the eligible entity and a third-party funding partner of the eligible entity. It is the responsibility of the eligible entity to ensure that it is meeting the requirements of all of its funding partners. NRCS welcomes input from any partner organization. NRCS will notify an eligible entity if it receives an easement administration action or infrastructure project proposal that may affect an ALE easement. NRCS identifies in the minimum deed terms of
Three comments about easement modification recommended that modification actions should be subject to a less stringent standard of review than termination actions, and that these two types of actions should not be addressed in the same provision. NRCS agrees termination actions are more significant than modification actions; however, NRCS did not adopt this recommendation as the statute specified the primary criteria by which all of the easement administration actions should be evaluated, and there are separate definitions and further limitations on easement termination actions than exist for easement modification actions even though they stem from the same section of the ACEP interim regulation.
The three comments specific to easement termination actions included one recommendation that NRCS ensure that easement
The issues raised by the nine comments on the topic of the applicability of the IRS regulations were discussed above under the topic of ALE deed terms. In particular, easement administration actions may impact the availability of a tax deduction for charitable donations of easement value, and therefore NRCS advises that eligible entities and landowners consult with their tax advisor about all aspects of a conservation easement transaction. As mentioned earlier, NRCS will consider requests from eligible entities about how to address in the easement deed valuation concerns associated with easement administration actions.
Executive Order 12866, “Regulatory Planning and Review” and Executive Order 13563, “Improving Regulation and Regulatory Review,” 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). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. Upon implementation of this rule the Natural Resources Conservation Service intends to conduct a retrospective review of this rule with the purpose of improving program performance, and better understanding the longevity of conservation implementation.
The Office of Management and Budget (OMB) designated this final rule a significant regulatory action. The administrative record is available for public inspection at the Department of Agriculture, Natural Resources Conservation Service, 1400 Independence Avenue SW., Room 5831 South Building, Washington, DC. In accordance with Executive Order 12866, NRCS conducted an economic analysis of the potential impacts associated with this program. A summary of the economic analysis can be found at the end of this preamble, and a copy of the analysis is available upon request from Kim Berns, Director, Easement Programs Division, U.S. Department of Agriculture, Natural Resources Conservation Service, Post Office Box 2890, Washington, DC 20013-2890; or at:
The Regulatory Flexibility Act (5 U.S.C. 601-612) (RFA) generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act or any other statute. NRCS did not prepare a regulatory flexibility analysis for this rule because NRCS is not required by 5 U.S.C. 553, or any other provision of law, to publish a notice of proposed rulemaking with respect to the subject matter of this rule. Even so, NRCS has determined that this action, while mostly affecting small entities, will not have a significant economic impact on a substantial number of these small entities. NRCS made this determination based on the fact that this regulation only impacts those who choose to participate in the program. Small entity applicants will not be affected to a greater extent than large entity applicants.
Section 1246(c) of the Food Security Act of 1985 (the 1985 Act), as amended by Section 2608 of the Agricultural Act of 2014, requires that the Secretary of Agriculture use the authority in section 808(2) of title 5, United States Code, which allows an agency to forego the usual 60-day Congressional Review delay of the effective date of a major regulation if the agency finds that there is a good cause to do so. NRCS hereby determines that it has good cause to do so in order to meet the congressional intent to have the conservation programs, authorized or amended under Title XII of the 1985 Act, in effect as soon as possible. NRCS also determined it has good cause to forgo delaying the effective date given the critical need to let agricultural producers know what programmatic changes are being made so that they can make financial plans accordingly. For these reasons, this rule is effective upon [the latter of October 1, 2016, or publication in the
A programmatic Environmental Assessment (EA) was prepared that resulted in a Finding of No Significance (FONSI) for the ACEP interim final rule. No comments were received on that analysis. Minor modifications to the previous EA were made to support this rulemaking but the analysis remains the same. As a result, the EA again resulted in a FONSI and therefore an Environmental Impact Statement (EIS) is not required to be prepared (40 CFR part 1508.13). The EA and FONSI are available for review and comment for 30 days from the date of publication of this final rule in the
A copy of the EA and FONSI may be obtained from the following Web site:
USDA has determined through a Civil Rights Impact Analysis that this final rule discloses no disproportionately adverse impacts for minorities, women, or persons with disabilities. The data presented in the Civil Rights Impact Analysis indicate producers who are members of the protected groups have participated in NRCS conservation programs at parity with other producers. Extrapolating from historical participation data, it is reasonable to conclude that ACEP will be administered in a non-discriminatory manner as the predecessor programs have been. Outreach and communication strategies are in place to ensure all producers will be provided the same information to allow them to make informed compliance decisions regarding the use of their lands that will affect their participation in U.S. Department of Agriculture (USDA) programs. NRCS conservation programs apply to all persons equally regardless of their race, color, national origin, gender, sex, or disability status. Therefore, this final rule portends no adverse civil rights implications for women, minorities, and persons with disabilities. Copies of the Civil Rights Impact Analysis are available, and may be obtained from Kim Berns, Director, Easement Programs Division, U.S. Department of Agriculture, Natural Resources Conservation Service, Post Office Box 2890, Washington, DC 20013-2890, or electronically at:
Section 1246 of the Food Security Act of 1985 (the 1985 Act) as amended by the Agricultural Act of 2014 (the 2014 Act) requires that the implementation of this provision be carried out without regard to the Paperwork Reduction Act, chapter 35 of Title 44, U.S.C. Therefore, NRCS is not reporting recordkeeping or estimated paperwork burden associated with this interim rule.
NRCS is committed to compliance with the Government Paperwork Elimination Act and the Freedom to E-File Act, which require government agencies, in general, to provide the public the option of submitting information or transacting business electronically to the maximum extent possible.
Pursuant to section 304 of the Federal Crop Insurance Reform Act of 1994, (Pub. L. 103-354), USDA classified this rule as non-major. Therefore, a risk analysis was not conducted.
Pursuant to Title II of the Unfunded Mandates Reform Act of 1995, Public Law 104-4, USDA assessed the effects of this final rule on State, local, and Tribal governments, and the public. This rule does not compel the expenditure of $100 million or more by any State, local, or Tribal governments or anyone in the private sector; therefore, a statement under section 202 of the Unfunded Mandates Reform Act of 1995 is not required.
This final rule has been reviewed in accordance with the requirements of Executive Order 13132, Federalism. NRCS has determined that this final rule conforms with the Federalism principles set forth in the Executive Order; would not impose any
This final rule has been reviewed in accordance with the requirements of Executive Order 13175, Consultation and Coordination with Indian Tribal Governments. Executive Order 13175 required Federal agencies to consult and coordinate with Tribes on a government-to-government basis on policies that have Tribal implications, including regulations, legislative comments or proposed legislation, and other policy statements or actions that have been substantial direct effects on (1) one or more Indian Tribes, (2) the relationship between the Federal Government and Indian Tribes, or (3) the distribution of power and responsibilities between the Federal Government and Indian Tribes. NRCS has assessed the impact of this interim rule on Indian Tribes and determined that this rule does not, to NRCS' knowledge, have Tribal implication that requires Tribal consultation under E.O. 13175. The Agency has developed an outreach/collaboration plan that it is implementing as it administers the Farm Bill. If a Tribe requests consultation, NRCS will work with the Office of Tribal Relations to ensure meaningful consultation is provided where changes, additions, and modifications identified herein are not expressly mandated by Congress. Among other activities, in April 2015, USDA held a series of tribally-focused webinars on this rule, and in December 2016, USDA held an informational discussion of the rule at the Intertribal Agriculture Council Annual Membership Meeting. On February 23, 2016, at the request of the Swinomish Indian Tribal Community (Swinomish Tribe), USDA consulted with the Swinomish Tribe on ACEP as well as other programs operated by USDA.
Title II of the Agricultural Act of 2014 (the 2014 Act) amended Title XII of the Food Security Act of 1985 to establish the Agricultural Conservation Easement Program (ACEP) in a new Subtitle H. Title II of the 2014 Act repeals the previously authorized programs, Wetlands Reserve Program (WRP), Farm and Ranch Lands Protection Program (FRPP), and Grassland Reserve Program (GRP), but maintains the purposes of these programs in ACEP. Pursuant to Executive Order 12866, Regulatory Planning and Review, NRCS has conducted a Regulatory Impact Analysis and Initial Regulatory Flexibility Analysis (RIA) of ACEP using historical data and information, including information from WRP, FRPP, and GRP. This RIA describes both the potential impact of the ACEP regulation on benefits and costs and the regulatory flexibility in the rule implementation. Implementation of this regulation is required to complete the Congressional Action.
In considering alternatives for implementing ACEP, the agency followed the legislative intent to establish an open participatory process, optimize environmental/conservation benefits, and address natural resource concerns. Because ACEP is a voluntary program, the program will not impose any obligation or burden upon agricultural landowners who choose not to participate.
The 2014 Act requires establishment of ACEP to retain the provisions in the current easement programs by establishing two types of easements: Wetland reserve easements (WRE) that protect and restore wetlands as previously available under WRP, and agricultural land easements (ALE) that limit non-agricultural uses on productive farm or grassland as previously available under FRPP and the easement component of GRP. The WRE component provides technical and financial assistance to landowners to restore and protect wetlands and associated habitats through conservation easements. ACEP-WRE addresses wetlands, wildlife habitat, soil, water, and related natural resource concerns on private lands. The ALE component protects the natural resources and agricultural value of agricultural cropland, pasture and other working land, promotes agricultural viability for future generations, preserves open space, provides scenic amenities, and protects grazing uses and related conservation values by restoring and conserving eligible land and limiting non-agricultural uses.
The 2014 Act also identified ACEP as a covered program for implementation of the Regional Conservation Partnership Program (RCPP), authorized by Subtitle I of Title XII of the Food Security Act of 1985, as amended (16 U.S.C. 3871
Most of the ACEP rule's impacts consist of transfer payments from the Federal Government to farmers, landowners, and producers. Although these transfers create incentives that very likely cause changes in the way society uses its resources, we lack data with which to quantify the resulting social costs or benefits. Under the 2014 Act, ALE and WRE enrollments are limited by funding. As set forth in the 2014 Act, total proposed ACEP funding and associated transfer payments by fiscal year is presented in Table ES-1.
Land enrolled in ACEP-WRE easements will produce onsite and offsite environmental impacts. Those include: Restoration and protection of high value wetlands; control of sheet and rill erosion as lands are restored from cropland to wetlands and associated habitats; restoration, enhancement, and protection of habitat for fish and wildlife, including threatened and endangered species and migratory birds; improving water quality by filtering sediments and chemicals; reducing flooding and flood-related damage; recharging groundwater; protecting biological diversity; controlling invasive species with planting of native vegetation; and providing opportunities for educational, scientific, and recreational activities. Soil health and air quality are improved by reduced wind erosion, reduced soil disturbance, increased organic matter accumulation, and an increase in carbon sequestration. Many of those conservation impacts are difficult to quantify at a national scale, but have been described by studies at an individual project, watershed, or flyway scale.
For land enrolled in ACEP-ALE, the suite of conservation effects on protected grasslands are different than those on protected farmland. ACEP-ALE easements on grasslands limit agricultural activities to predominately grazing and haying, whereas easements on farmland allow crop cultivation and pasture-based agriculture. As such, farmland protection effects are derived from onsite and ecological services, as well as preserving highly productive agricultural areas from development or fragmentation. Impacts on grasslands are derived from onsite and ecological impacts as well as preventing conversion to non-grassland uses. The net conservation effects through time from farmland protection include direct access benefits (pick-your-own, agritourism, and nature-based activities like hunting) indirect access benefits (open spaces and scenic views) and non-use benefits (wildlife habitat and existence values). Grassland protection conservation effects include the direct, indirect, and non-use benefits, but also include on-farm production gains and carbon sequestration.
The main program costs are the purchase of easements and associated restoration expenses under the ACEP-WRE component. Agricultural production ceases on lands enrolled in ACEP-WRE. At the same time, disaster payments, crop loss payments, and other commodity payments are eliminated.
Through ACEP-ALE, landowners voluntarily restrict the land to agricultural uses by the sale of conservation easements to eligible entities. Local cooperating entities are key drivers in farmland
The public and private costs of ACEP-ALE are: (1) The actual cost of purchasing the easement; (2) a reduced tax base that includes the opportunity cost of lower local economic activity, which for this analysis we assume is offset by a reduction in needed public infrastructure and associated taxes to support that infrastructure; and (3) the forgone economic activity fostered by new development. These costs are not social costs and we do not estimate them in this analysis.
NRCS allocates ACEP funding based upon State-generated assessments of priority natural resource needs and associated work necessary to address identified resource concerns. These State-developed assessments, following national guidance to assure accuracy and consistency, are submitted to agency leadership for review. At the national level, NRCS analyzes in a systematic manner these State-reported resource needs and requests along with factors including NRCS landscape initiatives or other nationally established conservation priorities; regional factors such as development pressure, migratory bird flyways, multi-state watersheds with water quality resource concerns; existing State capacity, workload, and performance; and other factors. This approach provides flexibility to address nationally and locally important natural resource concerns. Once funds are allocated to the States, individual project selection occurs at the State level based on the prioritization of the eligible applications using the NRCS ranking criteria.
Over the course of the Food, Conservation, and Energy Act of 2008 (the 2008 Farm Bill), the three easement programs (WRP, GRP, and FRPP) received an average of $691 million annually, which was comprised of $513 million in WRP, $138 million in FRPP, and $39 million in GRP. All three easement programs were combined under ACEP and the purposes of FRPP and GRP were combined under the ACEP-ALE component. The average annual funding available under the new ACEP program will be approximately $368 million annually, about 53 percent of the amount previously available under the repealed programs.
Executive Summary Table ES-2 provides an overview of the potential benefits from both sub-program areas of ACEP. For the private landowner, the end products of the ACEP-WRE include assurances of the restoration of the property and associated recreational use, the potential to engage in compatible uses on the property, and the elimination of negative impacts to agricultural operations on the property. Outcomes from the private landowner view of the ACEP-ALE include the long-term protection of the agricultural nature of the land and potential increases in productivity (from implementing the ALE plan) and sustainability of the local agricultural market (from local production). In addition, the private landowner, along with the general public, will reap the benefits of recreational waterfowl harvest, upland species harvest, and agritourism. Also in many cases easements that protect farmsteads under ACEP-ALE will provide the general public with an opportunity to engage with and obtain food products from a local farm producer.
Both ACEP-WRE and ACEP-ALE may provide benefits that are achieved for society as a whole, within the limitations of a voluntary program. These include: Improved water quality and water quantity; carbon sequestration; restoration of habitat for endangered or threatened wildlife species; flood prevention and protection; and improvements to scenic quality and rural characteristics. We note that agricultural lands and wetlands sequester carbon at higher rates than lands converted to development.
Participation in ACEP is voluntary and landowners participate in the program for many reasons, such as estate planning, income diversity,
NRCS has a long-term responsibility to ensure ACEP program objectives are achieved and statutory requirements are met on these lands. Monitoring policy for these lands is in place to guide NRCS in meeting these responsibilities and to maintain working relationships with landowners. In addition, the Statement of Federal Financial Accounting Standards 29 (SFFAS 29) considers easements held by the United States as Stewardship Lands that must be accounted for as part of the agency's annual financial accountability reporting. The SFFAS 29 requires that the “Condition” of all Stewardship Lands be reported regularly. Therefore, NRCS incorporates this additional financial accounting responsibility to report on the condition of Stewardship Lands into its monitoring requirements by assessing compliance with the terms of the easement and whether the easement is meeting program objectives. NRCS added functionality to its easement database to aid its State Offices in tracking monitoring events and observations.
NRCS requires an annual monitoring review of all ACEP easements to ensure compliance with easement terms and that program purposes are being met. For ACEP-ALE easements, NRCS requires the eligible entity to submit annual monitoring reports to NRCS for all ALE easements it holds, while NRCS conducts the annual monitoring of all ACEP-WRE easements. For ACEP-WRE, the monitoring conducted by NRCS provides a qualitative assessment of the outcomes of the restoration and management practices implemented on the easements. Additionally, data and information obtained through the Conservation Effects Assessment Project (CEAP) will continue to be used to provide qualitative assessments of the various benefits provided by NRCS easements and the outcomes being achieved in the study areas. Over the next two years as funding allows, NRCS will encourage its State offices to develop and utilize rapid wetland assessment tools or other methodologies that will provide greater ecological information about the condition of its wetland easements over time.
Data, however, currently do not exist that would allow for parsing, or attributing, different potential benefits to the suite of motivations that might result in a producer participating in this program. What can be said, is that the ACEP easement payment compensates the landowner for the rights they are encumbering as a result of participating in ACEP. In addition, those transfer payments from the Federal Government to farmers, landowners, and producers may also create incentives that cause changes in the way society uses its resources. As mentioned, we lack data with which to estimate and attribute the overall social costs or benefits. The agency will continue to utilize tools such as producer surveys, case studies, and conservation innovation grants to gain knowledge of producer motivations for programs participation.
NRCS is committed to the continual improvement of its collection and analysis of administrative and programmatic data (such as the impact and natural resource outcome of program funding) to ensure that program benefits are being achieved through adoption and implementation of targeted resource-based policies and procedures. Given the agency's lack of outcome-based program data, NRCS will implement other measures to quantify the incremental benefits obtained from this program.
Agricultural operations, Conservation practices, Conservation payments, Conservation easements, Farmland protection, Grasslands, Natural resources, Soil conservation, Wetlands, and Wildlife.
Accordingly, the interim rule revising 7 CFR part 1468, which was published at 80 FR 11032 on February 27, 2015, is adopted as a final rule with the following changes:
15 U.S.C. 714b and 714c; 16 U.S.C. 3865-3865d.
(a) The regulations in this part set forth requirements, policies, and procedures for implementation of the Agricultural Conservation Easement Program (ACEP) administered by the Natural Resources Conservation Service (NRCS). ACEP purposes include:
(1) Combining the purposes and coordinate the functions of the wetlands reserve program established under section 1237, the grassland reserve program established under section 1238N, and the farmland protection program established under section 1238I, as such sections were in effect on the day before the date of enactment of the Agricultural Act of 2014;
(2) Restoring, protecting, and enhancing wetlands on eligible land;
(3) Protecting the agricultural use and future viability, and related conservation values, of eligible land by limiting non-agricultural uses of that land; and
(4) Protecting grazing uses and related conservation values by restoring and conserving eligible land.
The additions and revisions read as follows:
(1) The agricultural use and future viability, and related conservation values, of eligible land by limiting non-agricultural uses of that land; or
(2) Grazing uses and related conservation values by restoring and conserving eligible land.
(1)(i) Rangeland, pastureland, shrubland, or wet meadows on which the vegetation is dominated by native grasses, grass-like plants, shrubs, or forbs, or
(ii) Improved, naturalized pastureland, rangeland, and wet meadows; and
(2)(i) Provides, or could provide, habitat for threatened or endangered species or at-risk species,
(ii) Protects sensitive or declining native prairie or grassland types or grasslands buffering wetlands, or
(iii) Provides protection of highly sensitive natural resources as identified by NRCS, in consultation with the State Technical Committee.
(1) Is organized for, and at all times since the formation of the organization, has been operated principally for one or more of the conservation purposes specified in clause (i), (ii), (iii), or (iv) of section 170(h)(4)(A) of the Internal Revenue Code of 1986;
(2) Is an organization described in section 501(c)(3) of that Code that is exempt from taxation under 501(a) of that Code; and
(3) Is described in—
(i) Section 509(a)(1) and (2) of that Code, or
(ii) Section 509(a)(3) of that Code and is controlled by an organization described in section 509(a)(2) of that Code.
(1) The agricultural use and future viability, and related conservation values, of eligible land by limiting non-agricultural uses of that land; or
(2) Grazing uses and related conservation values by restoring and conserving eligible land.
(c) Easement administration determinations under ACEP after easement closing. NRCS determinations that are made pursuant to its rights in an ACEP-funded easement after closing may be appealed to the State Conservationist as specified in the notice provided to the landowner when NRCS exercises its rights under the easement. Such determinations are not subject to appeal under 7 CFR part 11 or part 614.
(a) In addition to other penalties, sanctions, or remedies that may apply, if it is determined by NRCS that anyone has employed a scheme or device to defeat the purposes of this part, any part of any program payment otherwise due or paid during the applicable period may be withheld or be required to be refunded with interest, thereon, as determined appropriate by NRCS.
(b) * * *
(4) * * *
(ii) If there is no practicable alternative that exists other than impact to the conservation value of the easement area, such adverse impacts have been minimized to the greatest extent practicable, and any remaining adverse impacts mitigated by enrollment of other lands that provide equal or greater conservation functions and values, as determined by NRCS, at no cost to the government;
(6) The subordination, exchange, modification, or termination action will result in comparable conservation functions and value and equivalent or greater economic value to the United States as determined pursuant to paragraph (d) of this section.
(d) A determination of equal or greater economic value to the United States under paragraph (b) of this section will be made in accordance with an approved easement valuation methodology for ALE easements under subpart B or for WRE easements under subpart C. In addition to the value of the easement itself, NRCS may consider other financial investments it has made in the acquisition, restoration, and management of the original easement to ensure that the easement administration action results in equal or greater economic value to the United States.
(f) When reviewing a proposed action under this section, the preferred alternative is to avoid the easement area. If the easement area cannot be avoided entirely, then the preferred alternative must minimize impacts to the original easement area and its conservation functions and values.
(g) Easement modifications, including subordinations, are preferred to easement exchanges that may involve lands that are not physically adjacent to the original easement area. Easement exchanges are limited to circumstances where there are no available lands adjacent to the original easement area that will result in equal or greater conservation and economic values to the United States.
(i) Where NRCS determines that recordation of a new deed is necessary to effect an easement administration action under this section, NRCS may use the most recent version of the ACEP deed document or deed terms approved by NRCS.
(c) ACEP funds may not be used to enter agreements to implement conservation practices that the landowner is required to establish as a result of a court order or to satisfy any mitigation requirement for which the ACEP landowner is otherwise responsible.
(a) * * *
(1) Under ACEP-ALE, NRCS will facilitate and provide cost-share assistance for the purchase by eligible entities of agricultural land easements or other interests in eligible private or Tribal land that is subject to a written pending offer from an eligible entity.
(2) To participate in ACEP-ALE, eligible entities as identified in (b) below must submit applications to NRCS State offices to partner with NRCS to acquire conservation easements on eligible land. Eligible entities with applications selected for funding must enter into an ALE-agreement with NRCS and use the NRCS required minimum deed terms specified therein, the effect of which is to protect natural resources and the agricultural nature of the land and permit the landowner the right to continue agricultural production and related uses subject to an agricultural land easement plan as approved by NRCS, the landowner, and the Grantee.
(d) * * *
(1) * * *
(ii)(A) Contains at least 50 percent prime or unique farmland, or designated farm and ranch land of State or local importance unless otherwise determined by NRCS,
(B) Contains historical or archaeological resources,
(C) The enrollment of which would protect grazing uses and related conservation values by restoring and conserving land, or
(D) Furthers a State or local policy consistent with the purposes of the ACEP-ALE.
(3) Eligible land, including eligible incidental land, may not include forest land of greater than two-thirds of the easement area unless waived by NRCS with respect to lands identified by NRCS as sugar bush that contributes to the economic viability of the parcel. Land with contiguous forest that exceeds the greater of 40 acres or 20 percent of the easement area will have a forest management plan before the easement is purchased and compensation paid to the landowner.
(c) NRCS will determine the entity, land, and landowner eligibility for the fiscal year of enrollment based on the application materials provided by the eligible entity, onsite assessments, and the criteria set forth in § 1468.20.
(b) * * *
(1) Percent of prime, unique, and other important soils in the parcel to be protected;
(8) Proximity of the parcel to other protected land, such as military installations; land owned in fee title by the United States or an Indian Tribe, State or local government, or by a nongovernmental organization whose purpose is to protect agricultural use and related conservation values; or land that is already subject to an easement or deed restriction that limits the conversion of the land to non-agricultural use or protects grazing uses and related conservation values;
(10) Maximizing the protection of contiguous or proximal acres devoted to agricultural use;
(12) Decrease in the percentage of acreage of permanent grassland, pasture, and rangeland, other than cropland and woodland pasture, in the county in which the parcel is located between the last two USDA Censuses of Agriculture; and
(13) Other additional criteria as determined by NRCS.
(c) * * *
(3) Multifunctional conservation values of farm and ranch land protection including:
(i) Social, economic, historical, and archaeological benefits;
(ii) Enhancing carbon sequestration;
(iii) Improving climate change resiliency;
(iv) At-risk species protection; or
(v) Other related conservation benefits;
(4) Geographic regions where the enrollment of particular lands may help achieve national, State, and regional agricultural or conservation goals and objectives, or enhance existing government or private conservation projects;
(5) Diversity of natural resources to be protected or improved;
(a) * * *
(1) The interests in land to be acquired, including the United States' right of enforcement, the deed requirements specified in this part, as well as the other terms and conditions of the easement deed;
(b) * * *
(4) * * *
(vi) * * *
(G) One of several parcels within a special project area being offered for enrollment in that fiscal year that are being protected pursuant to a comprehensive plan approved by the State Conservationist, with input from the State Technical Committee, for the permanent protection of a large block of farm or ranch land;
(H) Part of a comprehensive plan to facilitate transfers to new and beginning farmers approved by the State Conservationist, with input from the State Technical Committee, for the permanent protection of a block of farm or ranch land that, if implemented, will facilitate the transfer of farmland to a next generation farmer;
(I) Subject of a conservation buyer transaction where a member of an underserved community, veteran, beginning farmer or rancher, or a disabled farmer or rancher has a valid purchase and sale agreement to acquire the property subject to an agricultural land easement;
(J) Parcel has an existing NRCS Resource Management System (RMS) level plan with NRCS conservation practices applied or under contract to be applied in accordance with NRCS standards and specifications, and the landowner has agreed that the ALE plan will be developed at the RMS level in accordance with the purposes for which the ALE easement is being acquired; or
(K) Meets the definition of grassland of special environmental significance.
(a) Under ACEP-ALE, a landowner grants an easement to an eligible entity with which NRCS has entered into an ALE-agreement. The easement deed will require that the easement area be maintained in accordance with ACEP-ALE goals and objectives for the term of the easement.
(b) Written pending offers by an eligible entity must be for acquiring an easement in perpetuity, except where State law prohibits a permanent easement. In such cases where State law limits the term of a conservation easement, the easement term will be for the maximum duration allowed under State law.
(c) The eligible entity may use its own terms and conditions in the agricultural land easement deed, but the agricultural land easement deed must address the deed requirements as specified by this part and by NRCS in the ALE-agreement.
(d) All deeds, as further specified in the ALE-agreement, must address the following regulatory deed requirements:
(1) Include a right of enforcement clause for NRCS. NRCS will specify the terms for the right of enforcement clause, including that such interest in the agricultural land easement remains in effect for the duration of the easement and any changes that affect NRCS' interest in the agricultural land easement must be reviewed and approved by NRCS under § 1468.6 of this part.
(2) Ensure compliance with an agricultural land easement plan that is provided by the eligible entity in consultation with the landowner, approved by NRCS, and implemented according to NRCS requirements. NRCS may provide technical assistance for the development or implementation of the agricultural land easement plan. If the parcel contains highly erodible land, the conservation plan component of the agricultural land easement plan will be developed and managed in accordance with the Food Security Act of 1985, as amended, and its associated regulations. The access must be sufficient to provide the United States ingress and egress to the easement area to ensure compliance pursuant to its right of enforcement.
(3) Specify that impervious surfaces will not exceed 2 percent of the ACEP-ALE easement area, excluding NRCS-approved conservation practices unless NRCS grants a waiver as follows:
(i) The eligible entity may request a waiver of the 2 percent impervious surface limitation at the time that a parcel is approved for funding,
(ii) NRCS may waive the 2 percent impervious surface limitation on an individual easement basis, provided that no more than 10 percent of the
(iii) Before waiving the 2 percent limitation, NRCS will consider, at a minimum, population density; the ratio of open, prime, and other important farmland versus impervious surfaces on the easement area; the impact to water quality concerns in the area; the type of agricultural operation; parcel size; and the purposes for which the easement was acquired,
(iv) Eligible entities may submit an impervious surface limitation waiver process to NRCS for review and consideration. The eligible entities must apply any approved impervious surface limitation waiver processes on an individual easement basis, and
(v) NRCS will not approve blanket waivers or entity blanket waiver processes of the impervious surface limitation. All ACEP-ALE easements must include language limiting the amount of impervious surfaces within the easement area.
(4) Include an indemnification clause requiring the landowner to indemnify and hold harmless the United States from any liability arising from or related to the property enrolled in ACEP-ALE.
(5) Include an amendment clause requiring that any changes to the easement deed after its recordation must be consistent with the purposes of the agricultural land easement and this part. Any substantive amendment, including any subordination of the terms of the easement or modifications, exchanges, or terminations of the easement area, must be approved by NRCS prior to recordation or else the action is null and void.
(6) Prohibit commercial and industrial activities except those activities that NRCS has determined are consistent with the agricultural use of the land.
(7) Limit the subdivision of the property subject to the agricultural land easement, except where State or local regulations explicitly require subdivision to construct residences for employees working on the property or where otherwise authorized by NRCS.
(8) Include specific protections related to the purposes for which the agricultural land easement is being purchased, including provisions to protect historical or archaeological resources or grasslands of special environmental significance.
(9) Other minimum deed terms specified by NRCS to ensure that ACEP-ALE purposes are met.
(e) NRCS reserves the right to require additional specific language or require removal of language in the agricultural land easement deed to ensure the enforceability of the easement deed, protect the interests of the United States, or to otherwise ensure ALE purposes will be met.
(f) For eligible entities that have not been certified, the deed document must be reviewed and approved by NRCS in advance of use as provided herein:
(1) NRCS will make available for an eligible entity's use a standard set of minimum deed terms that could be wholly incorporated along with the eligible entity's own deed terms into the agricultural land easement deed, or as an addendum that is attached and incorporated by reference into the deed. The standard minimum deed terms addendum will specify that if such terms conflict with other terms of the deed, the NRCS terms prevail.
(2) If an eligible entity agrees to use the standard set of minimum deed terms as published by NRCS, NRCS and the eligible entity will identify in the ALE-agreement the use of the standard minimum deed terms as a requirement and the National Office review of individual deeds may not be required. NRCS may place priority on applications where an eligible entity agrees to use the standard set of minimum deed terms as published.
(3) The eligible entity must submit all individual agricultural land easement deeds to NRCS at least 90 days before the planned easement purchase date and be approved by NRCS in advance of use.
(4) Eligible entities with multiple eligible parcels in an ALE-agreement may submit an agricultural land easement deed template for review and approval. The deed templates must be reviewed and approved by NRCS in advance of use.
(5) NRCS may conduct an additional review of the agricultural land easement deeds for individual parcels prior to the execution of the easement deed by the landowner and the eligible entity to ensure that they contain the same language as approved by the National Office and that the appropriate site-specific information has been included.
(g) The eligible entity will acquire, hold, manage, monitor, and enforce the easement. The eligible entity may have the option to enter into an agreement with governmental or private organizations that have no property rights or interests in the easement area to carry out easement monitoring, management and enforcement responsibilities.
(h) All agricultural land easement deeds acquired with ACEP-ALE funds must be recorded. The eligible entity will provide proof of recordation to NRCS within the timeframe specified in the ALE-agreement.
(a) * * *
(1) An explanation of how the entity meets the requirements identified in § 1468.20(b) of this section;
(b) * * *
(3) The terms of the ALE-agreement will include the regulatory deed requirements specified in § 1468.25 of this part that must be addressed in the deed to ensure that ACEP-ALE purposes will be met by the certified entity without requiring NRCS to pre-approve each easement transaction prior to closing.
(f) If NRCS exercises its rights identified under an agricultural land easement NRCS will provide written notice to the eligible entity at the eligible entity's last-known address. The notice will set forth the nature of the non-compliance by the eligible entity and provide a 180-day period to cure. If the eligible entity fails to cure within the 180-day period, NRCS will take the action specified under the notice. NRCS reserves the right to decline to provide a period to cure if NRCS determines that imminent harm may result to the conservation values or other interest in land that it seeks to protect.
(a) * * *
(3) Whether the landowner or another person or entity is offering to contribute financially to the cost of the easement or other interest in the land to leverage Federal funds;
(d) * * *
(3) The terms of the easement identified in paragraph (d)(2)(i) of this section includes the landowner's agreement to the implementation of a
(4) At the time NRCS enters into an agreement to purchase, NRCS agrees, subject to paragraph (e) of this section, to acquire and provide for restoration of the land enrolled into the program.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Final rule.
This final action revises the guidelines for National Standards (NS) 1, 3, and 7 of the Magnuson-Stevens Fishery Conservation and Management Act (MSA or The Act) and to the General section of the NS guidelines. This action is necessary to improve and clarify the guidance within the NS guidelines. The purpose of this action is to facilitate compliance with requirements of the MSA to end and prevent overfishing, rebuild overfished stocks, and achieve optimum yield (OY).
This rule is effective October 18, 2016.
Copies of supporting documents prepared for this final rule, such as the proposed rule and public comments that were received, can be found at the Federal e-Rulemaking portal:
Stephanie Hunt, 301-427-8563.
The MSA serves as the chief authority for fisheries management in the U.S. Exclusive Economic Zone (EEZ). The Act sets ten national standards (NS) for fishery conservation and management, and requires that the Secretary of Commerce (the Secretary) establish advisory guidelines based on the NS to assist in the development of fishery management plans. Guidelines for the NS are codified in subpart D of 50 CFR part 600. This final action amends the General section of the NS guidelines and the guidelines for NS1, NS3, and NS7.
Since 2007, fisheries management within the U.S. has experienced many changes, in particular the development and implementation of annual catch limits (ACLs) and accountability measures (AMs) under all fishery management plans to end and prevent overfishing. Due to a number of concerns raised during the implementation of ACLs and AMs, NMFS initiated a revision of the NS guidelines in 50 CFR 600.305, 600.310, 600.320, and 600.340 in order to improve the utility of the guidelines for managers and the public. NMFS published an Advance Notice of Public Rulemaking (ANPR) on May 3, 2012, (77 FR 26238, May 3, 2012) to solicit public comments on potential adjustments to the NS guidelines. The comment period on the ANPR was extended once (77 FR 39459, July 3, 2012), and then reopened (77 FR 58086, September 12, 2012), and ended on October 12, 2012. In March 2013, NMFS published a report that summarizes the comments received on the ANPR (
NMFS solicited public comment on the proposed revisions to the guidelines through June 30, 2015, and during that time made presentations on the proposed revisions to seven of the eight Regional Fisheries Management Councils (Councils) and held one public meeting on March 25, 2015 (Silver Spring, Maryland). NMFS received more than 102,000 comments on all aspects of the proposed revisions. Many of the comment letters were form letters or variations on a form letter. In general, the fishing industry and the Councils supported the majority of the provisions in the proposed action meant to provide flexibility within the current statutory limits but stated that many of the new provisions required additional guidance in the final action. In general, the environmental community opposed the proposed revisions, stating that they would reverse recent successes in U.S. fisheries management and did not address pertinent issues such as ecosystem-based fisheries management (EBFM), forage fish, and climate change.
Some of the major items covered in the proposed guidelines included the following: (1) Add a recommendation that Councils reassess the objectives of their fisheries on a regular basis; (2) consolidate and clarify guidance on identifying whether stocks require conservation and management; (3) provide additional flexibility in managing data limited stocks; (4) revise the guidance on stock complexes to encourage the use of indicator stocks; (5) describe how aggregate maximum sustainable yield (MSY) estimates can be used; (6) develop a definition for a depleted stock; (7) provide increased stability in fisheries by providing guidance on the use of multi-year overfishing determinations; (8) revise the guidance on optimum yield (OY) to improve clarity and better describe the role of OY under the ACL framework; (9) clarify the guidance on acceptable biological catch (ABC) control rules, describe how ABC control rules can allow for phase-in adjustments to ABC, and allow for carry-over of all or some of an unused portion of the ACL; (10) revise the guidance on AMs to improve clarity; (11) clarify the guidance on establishing ACL and AM mechanisms in FMPs; (12) clarify the guidance on adequate progress in rebuilding and extending rebuilding timelines; and (13) provide flexibility in rebuilding stocks.
The approaches proposed under items #1, 3-5, 8, and 10-11 above are retained in this final action. The main substantive change in the final action pertains to the proposed definition for
In response to public comment, this final action also clarifies text on stocks that require conservation and management (#2), multi-year approaches to overfishing stock status determinations (#7), phase-in and carry-over ABC control rules (#9), adequate progress determinations for rebuilding plans (#12), and discontinuing rebuilding plans (#13), and makes minor clarifications to other text. Further explanation of why changes were or were not made is provided in the “Response to Comments” section below. Details on changes made in the codified text are provided in the “Changes from Proposed Action” section.
NMFS received numerous comments on proposed § 600.305(c), which contains new guidance to Councils on determining, pursuant to their obligation under MSA section 302(h)(1), whether stocks require (or, are in need of) conservation and management. The MSA establishes that each Council should prepare an FMP for each fishery under its authority that requires conservation and management. 16 U.S.C. 1801(b)(1). Because not every fishery requires federal management, NMFS believes that consolidated, streamlined guidance on determining which stocks are in need of conservation and management and thus, federal management, will be beneficial to managers. Further background and rationale for this proposed revision to the guidelines was provided on pages 2788-2789 of the proposed rule.
Sections V and VI (Responses to Comments and Changes from Proposed Rule) provide a detailed explanation of changes made from the proposed to final action. Here, NMFS highlights a few of those changes. Final § 600.305(c)(1) provides—unchanged from the proposed action—that stocks that are predominately caught in Federal waters and are overfished or subject to overfishing, or likely to become overfished or subject to overfishing, are considered to require conservation and management. 16 U.S.C. 1853(a)(1)(A) (requiring that FMPs contain conservation and management necessary to prevent overfishing and rebuild overfished stocks). However, the final action clarifies that Federal management is not limited to such stocks (
The final action adds an explanation at § 600.305(c)(3) that, when considering adding a stock to an FMP, no single factor is dispositive or required. One or more of the factors may provide a basis for determining a stock is in need of conservation and management. When considering removing a stock from an FMP, final § 600.305(c)(4) provides—as proposed—that Councils should consider each of the ten factors. NMFS received many comments on § 600.305(c)(1)(x) in particular. Section 600.305(c)(1)(x) speaks to the consideration of other existing management regimes when determining whether Federal management is necessary. In response to comments, the final action deletes the phrase “could be or” from § 600.305(c)(1)(x), which implied that the mere possibility that other management regimes may exist is an appropriate consideration for determining whether a stock requires conservation and management, which was not the intention behind the proposed revisions.
Finally, while nothing in the proposed revisions changed previous guidance on the optional usage of ecosystem component (EC) species, NMFS clarifies in the final action that Councils may still use EC species at their discretion and re-inserts a definition of EC species. However, the definition of EC species in the final action does not include criteria for designation because a Council is free to designate any stock, that is determined not in need of conservation of management, as an EC species at their discretion. Criteria for the designation of EC species is no longer necessary because the factors listed in § 600.305(c)(1)(i)-(x) of this final action clarify which stocks are in need of conservation and management and therefore cannot be designated as EC species. Because the designation of EC species may be done to accomplish several different goals, NMFS does not believe it is appropriate to prescribe specific guidance on the requirements for managing and monitoring EC species.
Another major aspect of the revised NS1 guidelines is the inclusion of guidance on a method for determining the overfishing status of a stock based on a multi-year approach. The MSA defines overfishing as a “rate or level of fishing mortality that jeopardizes the capacity of a fishery to produce the MSY on a continuing basis.” 16 U.S.C. 1802(34). Thresholds for deciding whether a stock is subject to overfishing can be determined either by comparing rates of fishing mortality (F) to the maximum fishing mortality threshold (MFMT) or catch to the overfishing limit (OFL).
Pursuant to MSA section 304(e)(1), NMFS must report annually to Congress and the eight Councils on the status of all Federally-managed fish stocks. 16 U.S.C. 1854(e)(1). Overfishing status determinations are typically made based on the most recent year for which there is information. When utilizing the F-based approach, the estimate of F for the most recent year for which there is data is often more uncertain than the estimates of F in prior years (NRC 1998). In addition, the extent to which the effort or catch exceeded the threshold for overfishing has not traditionally been considered when determining whether the stock was subject to overfishing. Small amounts of excess effort or catch in a single year may not jeopardize a stocks' ability to produce MSY over the long term, thus an overfishing stock status determination based on that single year's reference point may not be the most appropriate characterization of stock status. To
Public comments reflected confusion regarding proper use of this provision. Thus, the final action clarifies that, under certain circumstances, a Council may determine that it is appropriate to use a multi-year approach for overfishing status determination criteria (SDC). Such circumstances may include, but are not limited to, situations where there is high uncertainty in the estimate of F in the most recent year, cases where stock abundance fluctuations are high and assessments are not timely enough to forecast such changes, or other circumstances where the most recent catch or F data does not reflect the overall status of the stock. The final action clarifies that a Council must identify, within its FMP or FMP amendment, the circumstances (such as those listed above) in which a multi-year approach to overfishing SDC will be used. The final action also emphasizes that a multi-year approach is to be used only for retrospective stock status determinations,
An ABC control rule accounts for scientific uncertainty in the OFL and for the Council's risk policy when establishing an ABC. The proposed guidelines would allow Councils to develop an ABC control rule that would phase-in changes to the ABC over a period of time not to exceed 3 years, so long as overfishing is prevented.
NMFS received a variety of public comments expressing concern that phase-in and carry-over provisions would increase the risk of overfishing. The final action emphasizes that Councils should conduct a comprehensive analysis of every ABC control rule—which would include those with phase-in and/or carry-over provisions—that shows how the control rule prevents overfishing.
MSA section 304(e)(7) requires the Secretary to review rebuilding plans to ensure that adequate progress toward ending overfishing and rebuilding affected fish stocks is being made. 16 U.S.C. 1854(e)(7). NMFS received several comments in response to the ANPR requesting additional guidance on adequate progress determinations and thus, NMFS proposed guidance to clarify that the review of rebuilding progress could include the review of recent stock assessments, comparisons of catches to the ACL, or other appropriate performance measures. NMFS also proposed that the Secretary may find that adequate progress in rebuilding is not being made if: (1) F
The NS1 guidelines provide guidance on determining the minimum (T
NMFS received many comments on the proposed additional methods to calculate T
After taking into consideration public comment, NMFS has decided to keep the additional T
Furthermore, while Councils may use T
Due to scientific uncertainty in the biomass estimates of fish stocks, occasionally a stock is identified as overfished, but is later determined to have never been overfished. In the past, NMFS' approach has been that, once a rebuilding plan has been implemented, the rebuilding plan cannot be discontinued until the stock has been rebuilt to B
Based on public comments, this final action adds that the stock must be shown to have never been overfished in subsequent years following the original overfished determination, including the current year. This revision effectively covers the two criteria, thus the final action deletes the proposed second criteria.
If, following reassessment, a Council finds that an FMP's management objectives are no longer meeting the needs of the fishery and do not properly address relevant social, economic, and ecological factors, NMFS encourages Councils to adjust their management objectives. As with the issue of time periods for review, NMFS believes that it is important to preserve Council flexibility in determining how best to make these adjustments and therefore declines to establish a single process to address issues raised in the reassessments. NMFS urges Councils to
Finally, while NMFS agrees that the fishery monitoring systems and data collection programs set up to deliver the necessary data for FMP implementation are crucial to successfully meeting FMP management objectives, a review of these systems and programs does not need to be included in the reassessment of an FMP's management objectives.
As MSA section 1852(h)(1) is broadly worded, the proposed regulatory guidance was intended to assist Councils in making determinations under this section. To make sure that NMFS' intent is clear, the final action includes clarifying edits to emphasize the agency's approach with regard to overfishing/overfished stocks and other stocks.
As discussed further in response to comment 7, the factors are drawn in the first instance from the statutory definition of “conservation and management.” 16 U.S.C. 1802(5). The proposed action cited to that definition,
The factors incorporate the general principle from the 1998 NS7 guidelines at § 600.340(b)(1) that not every fishery needs Federal management.
NMFS disagrees that the factors curtail Council discretion. The list of factors is non-exhaustive, and Councils may take into account any additional considerations that may be relevant to the particular stock.
NMFS agrees, particularly with respect to stocks that may require conservation and management to address biological or ecological concerns, that the cause of those concerns would be a useful consideration for the Councils. The final guidance does not preclude such considerations, and in fact provides a framework for a Council to consider these very relevant questions. Furthermore, based on factor 3, which considers whether an FMP can improve or maintain the condition of the stocks, NMFS has added language within § 600.305(c)(3)-(4) that emphasizes that if the amount and/or type of catch that occurs in Federal waters is a significant contributing factor to the stock's status, such information would weigh heavily in favor of inclusion of the stock within an FMP.
Finally, NMFS agrees that Councils may implement discretionary measures for species, even if they do not “require conservation and management” pursuant to section 302(h)(1). Section 303(b)(12) of the MSA provides that Councils may include management measures in the plan to conserve target and non-target species and habitats, considering the variety of ecological factors affecting fishery populations. 16 U.S.C. 1853(b)(12). Additionally, in implementing measures to comply with National Standard 9's requirement that an FMP's conservation and management measures minimize bycatch and bycatch mortality to the extent practicable, Councils can take measures that conserve and protect bycatch species even if those bycatch species are not, themselves, included as stocks in a fishery under an FMP.
“Conservation and management” and “fishery” are defined in terms of practical use or benefit and the ability to manage, which supports the inclusion of predominately in 600.305(c). “Conservation and management” refers to regulations, measures, etc., which are
As noted above, NMFS does not believe it is appropriate to require inclusion of overfishing/overfished stocks in an FMP, if a Council lacks the authority or ability to adopt measures that will prevent or end overfishing or rebuild the stocks. NMFS proposed, and is retaining in this final action, use of the phrase “predominately caught in Federal waters” to address this concern. A similar phrase—fishing “engaged in predominately within the exclusive economic zone and beyond that zone”—is one of two factors that allow NMFS to regulate a fishery within the boundaries of a State.
NMFS notes that, even if a stock is not required to be included in an FMP (
With respect to factor (x), NMFS continues to believe that MSA section 302(h)(1) does not require preparation of FMPs for all fisheries in the EEZ. Among other things, the MSA recognizes the authority of a State to regulate fisheries within its boundaries and authorizes a State under certain circumstances to regulate its vessels outside state boundaries. Furthermore, the MSA mandates that the conservation and management measures for stocks under an FMP, where practicable, minimize costs and avoid unnecessary duplication. 16 U.S.C. 1851(a)(7) (National Standard 7) and 1856(a)(3) (state jurisdiction);
For clarity, NMFS revised the phrase “keeping an existing stock within an FMP” (proposed § 600.305(c)(2)) to “removing a stock from, or continuing to include a stock in, an FMP” (final § 600.305(c)(4)). The final action explains that, when considering such action, Councils should analyze all ten factors. Factors (i) through (ix) are all factors that counsel for inclusion of stocks, and factor (x) counsels against inclusion.
In this final action, NMFS is providing further guidance on the question of what stocks require conservation and management. Nothing in these proposed provisions changes previous guidance on the optional usage of EC species. To make clear this intent, NMFS has made minor modifications in this final action to more closely follow the language discussing EC species in the 2009 action. Additionally, NMFS has re-inserted a definition of EC species.
Because the designation of EC species is discretionary and may be done to accomplish several different goals, NMFS is not providing further specific guidance on EC species. Determining whether the EC species designation is appropriate requires a case-specific look at stocks or stock complexes in light of § 600.305(c) as well as the broader mandates and requirements of the MSA. NMFS has worked closely with Councils who have decided to pursue EC species designation and will continue to provide support and guidance going forward.
With regard to the comments proposing improvements to alternative SDC text, NMFS notes that specification of MSY and OY are statutory requirements (16 U.S.C. 1853 (a)(3)), and the intent of § 600.310(e)(2)(ii) is to help address circumstances where data are not available to specify SDCs based on MSY or MSY based proxies. Because stock assessment models are used to set reference points within the ACL framework, model uncertainty is best addressed when accounting for scientific uncertainty within the ABC reference point. While an analysis of the regional applicability of different data limited methodologies may be useful to a Council, it may not always be necessary or informative and NMFS does not believe such an analysis needs to be prescribed as part of the NS1 guidelines. With regard to defining “data limited stocks,” the characteristics of such stocks are so wide-ranging that a definition would not be meaningful and could lead to additional confusion when applying the NS1 guidelines. Finally, as discussed in the preamble to the proposed action, § 600.310(h)(2) does not provide an exemption from any statutory requirements, including the requirement to establish ACLs.
NMFS also believes that the guidelines give sufficient guidance on using stock complexes and indicator stocks, and give Councils the flexibility to weigh the costs and benefits of utilizing these management tools. While the MSA does not address management of stock complexes, NMFS believes the use of stock complexes and indicator stocks in accordance with the guidelines can serve a useful role in managing data poor stocks and/or stocks that cannot be targeted independently of one another. Finally, NMFS recommends the use of indicator stocks in order to reduce the likelihood of overfishing in cases of high scientific uncertainty among stocks within a complex (
The term “common” in § 600.310(e)(1)(iv) was intended to provide further context as to how aggregate MSY can be estimated using multi-species, aggregated, and ecosystem modeling. Upon further consideration, the phrase “common biomass (energy) flow” is not considered a widely used phrase within relevant scientific fields, and thus the term “common” is not included within the final action to avoid confusion. However, the final action retains the phrase “biomass (energy) flow” to clarify that the models used for estimating aggregate MSY should account for the flow of energy through the aggregate group of stocks under consideration. A Council's SSC should assist a Council using an aggregate MSY to use the best scientific information available with regards to biomass (energy) flows.
Finally, aggregate MSY is not intended to be used to track long-term environmental or ecological conditions. Instead, aggregate MSY is intended to ensure that fishery management measures are reflecting how environmental variability within the ecosystem is impacting fisheries as a whole.
Some commenters objected to the proposed changes to the definitions of overfished and MSST, arguing that NMFS improperly replaced the pre-existing, statutory-based definition with a new, less supportable definition. Commenters expressed concern with linking a determination that a stock is overfished with a Council-specified MSST because, according to commenters, MSSTs are not always properly specified or updated. Other commenters believed that connecting MSST to “overfished” was too restrictive and that a preferable definition would connect the ability of a stock to return to its B
Other commenters took issue with the proposed change to the provision regarding the specification of MSST. Some commenters felt that the language from the 2009 action set a clearer standard and that the proposed language made the MSST specification depend on criteria that are not easily quantifiable. Especially concerning for some were the “social and/or economic” considerations. Commenters argued that the proposed revisions increase the likelihood that stocks declared overfished will not be able to rebuild within ten years. Others felt that the factors in the proposed revisions provided needed additional flexibility to the Councils should they wish to revisit MSST specifications.
NMFS disagrees that the revisions to the MSST specification provision would prevent stocks from being classified as overfished. The 2009 guidelines provided two options for specifying MSST: one-half the MSY stock size, or the minimum stock size at which the stock could rebuild to the MSY level within 10 years if the stock was fished at MFMT. The guidelines stated that MSST should be set equal to the greater of the two options.
NMFS also disagrees that the MSST specification provision will decrease the likelihood that overfished stocks will be able to rebuild within 10 years. Although the provision no longer includes a reference to 10 years in the
Furthermore, based on public comment, NMFS has removed the phrase “social and/or economic impacts on the fishery,” from the list of factors that could inform MSST. MSST is a biological reference point and is based on the level of biomass below which the capacity of the stock to produce MSY on a continuing basis is jeopardized. Thus, it is not appropriate to consider social and economic impacts when determining MSST.
Finally, NMFS disagrees that reliance upon quantitative data invariably yield more accurate or precautionary MSST values. Councils should consult with their SSCs to ensure that the information used to specify MSST, whether quantitative or qualitative, is the best scientific information available.
Regardless of which SDC specification method is used, the MSA requires that NMFS report annually to Congress on the status of stocks. 16 U.S.C. 1854(e)(1). Thus, a multi-year approach to overfishing stock status determinations would not allow Councils to ignore available information and wait for additional years' information before evaluating stock status, nor would it allow an overfishing trend to go unaddressed or impact the timeliness of a Council and/or agency response to overfishing.
NMFS acknowledges that wording in proposed § 600.310(e)(2)(ii)(A)(
In this final action, NMFS adds in § 600.310(e)(2)(ii)(A)(
NMFS disagrees that one method for specifying SDCs to determine overfishing status is invariably superior to another. Councils should select a method using the best scientific information available. NMFS agrees that robust annual catch specification processes and accountability measures can reduce the likelihood of overfishing. However, there are circumstances where NMFS believes a multi-year approach is a useful tool to protect a stock while providing stability to the fishery. In addition, NMFS believes the proposed action preamble (
ACLs and other annual reference points are annual limits and cannot be defined in terms of OY, which is a long-term average. While the ACL framework supports achieving OY, OY (as well as annualized OY values) and the ACL framework are two separate concepts which cannot be defined in terms of one another. Thus, an ACL may not be set to exceed the stock's ABC/OFL reference points in order to achieve OY and correspondingly, annual catch reference points such as ABC cannot be used to specify OY.
With regard to the SSC, the 2009 NS1 Guidelines explained that “[t]he Council should use the advice of its science advisors in developing [the ABC] control rule,” (
Finally, NMFS disagrees that phase-in and carry-over provisions should be addressed through the ACL setting process, rather than ABC control rules. ACLs cannot exceed ABCs, and are the level of annual catch based on management uncertainty that serve as the basis for invoking AMs. In contrast, the ABC control rule is an established policy for establishing an ABC that accounts for scientific uncertainty in the OFL and for the Council's risk policy. NMFS believes that scientific uncertainty and the Council's risk policy are the two factors that are most relevant to the decision of whether to use phase-in and/or carry-over provisions. It should be noted that, carry-over can impact ACL specifications, as explained in response to comment 34 and in the final action. However, NMFS maintains that carry-over provisions are most appropriately addressed through ABC control rules that are based on scientific uncertainty and the Council's risk policy because carry-over ABC control rules instruct Councils on how to account for increased stock abundance resulting from the fishery harvesting less than the full ACL as well as articulate when the carry-over provision can and cannot be used and how it prevents overfishing.
Carry-over provisions are intended to allow the fishery to catch unused portions of the previous year's ACL while preventing overfishing. They may be appropriate if the ACL for the second year was established based on an analysis that assumes the full ACL for the first year is caught. If in reality the full ACL in year one is not caught, then more fish may be available in year two, and it may be appropriate to adjust the ACL in year two upwards. NMFS acknowledges that the wording in the last sentence of proposed § 600.310(f)(2)(ii)(B) may have caused confusion and clarifies within the final action on this section that carry-over provisions could allow an ACL to be adjusted upwards as long as the revised ACL does not exceed the specified ABC.
Regarding “guaranteed carry-over provisions,” the final action explains that a Council must articulate within its FMP when carry-over provisions of the control rule can and cannot be used and how the provision prevents overfishing, based on a comprehensive analysis.
NMFS believes that there are benefits to using phase-in provisions, particularly for stocks with large degrees of scientific uncertainty (which accordingly should have large buffers between the OFL and ABC). Such stocks are most likely to experience a dramatic shift in reference points from one assessment to another, and thus, NMFS believes that phase-in provisions will give managers additional flexibility and increase stability within fisheries.
Section 600.310(j)(4) of the final action is based on MSA section 304(e)(6), which authorizes NMFS to take interim measures to reduce, but not necessarily end, overfishing during the development of an FMP or FMP amendment needed to rebuild overfished stocks. 16 U.S.C. 1854(e)(6) (authorizing interim measures for 180 days plus an additional 186 days). As such measures likely would deviate from the ABC control rule in an existing FMP, or from a new ABC control rule that is developed, the interim measures would not be included as part of any phase-in that might be adopted in an ABC control rule in a new FMP or FMP amendment.
The guidelines do not preclude a Council from considering the use of a phase-in provision for stocks under a rebuilding plan. However, in addition to preventing overfishing, the Councils should consider the vulnerability of stocks that are overfished and/or in rebuilding plans when considering using a phase-in provision. NMFS has added in this final action that Councils should evaluate the appropriateness of phase-in provisions for stocks that are overfished and/or rebuilding. See § 600.310(f)(2)(ii)(A) of the final action. A Council may determine that certain stocks subject to rebuilding plans are particularly vulnerable and should not have phase-in provisions within their ABC control rules. If a Council makes use of a phase-in provision, the provision must allow a stock to meet its specified timeframe for rebuilding (16 U.S.C. 1854(e)(4)). Thus, a rebuilding ABC must be set to reflect the amount of catch consistent with the designated fishing mortality rate (
Finally, under § 600.310(f)(2)(ii)(A), a Council may consider the short-term effects of a phase-in ABC control rule on a fishing industry, as well as long-term ecosystem effects. NMFS believes that economic, social, and ecological trade-offs are all relevant considerations when determining an ABC control rule risk policy. The fact that these considerations are important in fishery management is reflected in the National Standards and other MSA provisions.
The OFL is the threshold above which a stock is determined to be subject to overfishing. Thus, NMFS does not believe that phasing-in changes to the OFL is appropriate, given that any catch level above the OFL would subject the stock to overfishing and the MSA requires preventing overfishing. While NMFS supports the use of the “slow up/full down” approach as an appropriate option to consider for phase-in provisions, NMFS believes that the Councils should have the flexibility to design their own phase-in provisions, based on a comprehensive analysis that prevents overfishing.
NMFS agrees that having frequent stock assessments may reduce the need for phase-in provisions. However, the phase-in provision will address the current levels of uncertainty and accommodate reduced uncertainty in the future, as improvements in the stock assessment process are made. Finally, NMFS does not believe that revisions are needed to the language on phase-in provisions to explicitly refer to increases and decreases in catch levels. The text refers generally to “changes to ABC,” thus allowing for potential application of phase-in provisions in both directions.
The Secretary reviews ABC control rules and the Council's risk policy when conducting its review of FMPs or FMP amendments, as required under MSA section 304(a). A risk policy for ABC control rules is a policy decision made by the Council, based on the fishery management objectives (ecological, economic, and social) identified within the FMP. NMFS believes that social and economic factors, as well as biological and ecological ones, are relevant when developing risk policies in light of a Council's fishery management objectives. The fact that these considerations are important in fishery management is reflected in the National Standards and other MSA provisions.
While the guidelines recommend Councils consider reducing fishing mortality as stock size declines below B
Furthermore, the definitions for ABC, scientific uncertainty, and management uncertainty are clearly established within the guidelines and do not need to be cross-referenced. Finally, the guidelines clearly state that when scientific uncertainty cannot be directly calculated, a proxy for uncertainty itself should be established based on the best scientific information available.
The guidelines clearly state within § 600.310(g)(3) that biological consequences on the status of the stock (
NMFS disagrees that the provision is contrary to § 600.310(e)(2)(ii)(C) of the NS1 guidelines or NS9. Section 600.310(e)(2)(ii)(C) provides for accounting for all sources of mortality “where practicable,” when evaluating stock status with respect to reference points.
NMFS also disagrees that the provision conflicts with
NMFS does not agree with limiting the exception to “unfished populations” or to stocks that experience a rate of natural mortality that far exceeds the effects of fishing morality. The exception itself does not include these limitations, and NMFS does not believe that they are necessary, given that the exception will not apply if “the Secretary has determined the fishery is subject to overfishing of that species.” 16 U.S.C. 1853 note.
NMFS continues to believe that the National Standard 1 guidelines should not include overly prescriptive guidance as to which stocks meet the criteria for the exception; this is a decision that is best made by the Councils, subject to Secretarial review and approval under MSA section 304(a). To the extent that questions arise as to the application of the exemption, NMFS will provide case-specific guidance to the Councils as necessary.
NMFS disagrees with the suggestion to relocate the flexibility provision in § 600.310(h)(2). NMFS believes the guidance in § 600.310(h)(2) is clear and that further revision is not necessary. Section § 600.310(h)(2) is meant to only provide flexibility in establishing ACLs and AMs. The revisions to § 600.310(h)(2) were not meant to expand what it applies to but rather to connect the proposed change in § 600.310(e)(2)(ii) to the requirement to specify ACLs and AMs because a Council specifying SDC in a manner that deviates from the standard NS1 guidelines approach will also likely need to deviate from the standard approach to setting ACLs and AMs.
As noted in the 2009 final action, T
Finally, NMFS has already developed technical guidance on calculating mean generation time for use in rebuilding plans, which includes a definition for mean generation time (Restrepo et al., 1998). NMFS believes this technical guidance document is sufficient and does not believe an exact method should be specified in the NS1 guidance.
Finally, NMFS acknowledges that hypothetically, there could be a situation where T
The limitations imposed by this final action on the Secretary's use of MSA section 304(e)(6) were adopted as a means of reconciling the new mandate in the 2007 revisions to the MSA to “end overfishing immediately,” 16 U.S.C. 1854(e)(3)(A), and the provision in MSA section 304(e)(6) that allows for some reduced level of overfishing while a rebuilding plan is developed. Noting the tension between these two provisions, NMFS strove to find a way to give effect to 304(e)(6) without undermining Congress's explicit direction in 304(e)(3)(A). Because 304(e)(6) grants discretionary authority, NMFS is well within its authority to adopt limitations on its application in order to avoid undermining the agency's other competing obligations under the statute.
The final action requires three conditions before the Secretary uses section 304(e)(6) authority to allow overfishing to occur. First, interim measures taken under section 304(e)(6) must be necessary to address an unanticipated and significantly changed understanding of the status of the stock or stock complex. This ensures that action is taken to address either (1) a new overfished determination or (2) a failure of a rebuilding plan that has resulted, not from clear management failures (
Finally, NMFS cannot extend the effective length of emergency rules and interim measures to 2 years. While MSA section 304(e)(3) provides 2 years to develop or revise a rebuilding plan, MSA section 305(c) specifies that an emergency rule or interim measure shall remain in effect for not more than 180 days after publication, and may be extended by publication in the
In contrast, some commenters expressed concern that this provision would move away from a precautionary approach to rebuilding stocks and achieving OY. Specifically, commenters expressed concerns that this provision will encourage assumptions in a stock assessment model to be changed in order to achieve a desired outcome (
Section 600.310(j)(5) allows Councils to be responsive to the best scientific information available while managing stocks to meet MSA mandates, including NS1's requirement to prevent overfishing while achieving OY on a continuing basis. The provision does not interfere or conflict with MSA conservation mandates because a Council may only discontinue a plan when new information shows the stock was not overfished in the year it was originally determined to be overfished, nor in subsequent years. NMFS disagrees that management action under this provision will encourage assumptions in stock assessment models to be changed, because assumptions within a stock assessment model are based on the best scientific information available.
NMFS disagrees with the suggestion that the provision should also include “any of the five years prior to the original overfished determination.” NMFS does not believe it has a scientific basis to specify a particular number of years prior to an original overfished determination where the discontinuation of a rebuilding plan would be inappropriate in all cases and for all Federally-managed stocks and stock complexes. Discontinuing a rebuilding plan based on new information for a stock that was not overfished in the original year of the overfished determination, but was overfished in a subsequent year would not have the same repercussions on a stock as stocks that have not been overfished in subsequent years.
Other commenters raised concerns about the impact of limited data availability on management of the recreational sector, noting a disconnect between the state of recreational fisheries data collection and management. One commenter suggested that NMFS develop a methodology for calculating the mortality on all forage fish attributable to the recreational sector and develop a better understanding of the role of forage fisheries that supply bait for the recreational fishing industry.
NMFS does not believe that it is necessary to formally define the private angler and for hire sectors as the specific composition, needs, and objectives of recreational sectors will differ across regions. NMFS does not state in this final action what specific objectives of fishing sectors to consider; instead NMFS merely requires that Councils consider and incorporate the objectives of sectors that are impacted by their FMPs.
As discussed in the preamble to the proposed action, NMFS did not propose recreational-specific provisions in the guidelines. Instead, NMFS chose to highlight how various flexibility provisions that were proposed could be used to address needs raised by the recreational community. These flexibility provisions, such as conditional AMs, are universally applicable and not limited to the recreational sector. Also, in the 2009 revisions to the guidelines, the use of sector-ACLs and corresponding AMs and ACTs were discussed as an option for Councils should they decide that fishing sectors require different types of management strategies and measures.
NOAA's Marine Recreational Information Program is continuously working to improve how it collects, analyzes, and reports information. Recent improvements include the 2013 implementation of the Access Point Angler Intercept Survey that removes sources of potential bias from the sampling process. More information about data collection improvements is located at
The same commenter, while acknowledging that the purpose of NMFS' proposed deletion of the list of factors in § 600.320(d)(1) was for streamlining purposes, requested that the ecological factor be retained because it is important to manage species that are associated with the same ecosystem or dependent on similar habitat.
Another commenter opposed the proposed change to § 600.320(d) that used the phrase “stocks in the fishery management unit” because the issue of stocks in need of conservation and management is addressed with different language in § 600.305 of the proposed action.
NMFS does not agree with the need to retain the “as comprehensive as practicable” language in § 600.320(e). The deletion of this language from the guidance does not change the requirements of the guidelines; Councils still “should include” the information contained in § 600.320(e)(1)-(4).
Although NMFS agrees that ecological similarity is an important factor in determining an appropriate management unit, retaining the specific language that slightly expands on the ecosystem factor is not necessary. The final action retains language that establishes that biological, geographic, economic, technical, social, and ecological perspectives are all valid considerations when organizing a management unit based on the FMP's objectives.
NMFS agrees that the issue of whether a stock requires conservation and management is adequately addressed in § 600.305 and thus, NMFS has deleted the last sentence of § 600.320(d) to avoid any potential confusion.
Another commenter recommended that § 600.340(c) of the proposed action be revised so that an evaluation of benefits and costs is limited to situations where alternative management measures are being considered, as opposed to FMPs justifying their own existence.
Other commenters requested that NMFS add language to the guidelines to note the value of engaging with enforcement agencies to solicit feedback when considering an action's costs, as directed under NS7.
National Standard 7 requires that for those stocks determined to be in need of conservation and management and therefore included in an FMP, Councils should develop conservation and management measures that, where practicable, minimize costs and avoid unnecessary duplication. 16 U.S.C. 1851(7). The language retained in the final NS7 guidelines, which was not changed by this action, explains how to implement this requirement through supporting analyses for FMPs. Such analyses should demonstrate “real and substantial” benefits of fishery regulation, taking into account the added research, administrative, and enforcement costs, as well as costs to the industry for compliance.
NMFS agrees that enforcement costs are an important consideration, which is why they are noted for consideration several times in the NS7 guidelines. Certainly one way to acquire information about these costs would be to engage directly with enforcement agencies, but NMFS does not believe that the guidelines should mandate such engagement.
Pursuant to MSA section (3)(33), OY is prescribed on the basis of MSY as reduced by ecological, economic, and social (“EES”) factors. The NS1 guidelines set forth examples of different considerations for each factor, and NMFS believes the examples provide sufficient guidance on how to apply these factors when setting OY.
With regard to the comment requesting that “alternative management strategies” for forage stocks (
Finally, the National Standard 3 guidelines address the case where a stock moves between Council jurisdictions. The guidelines state that the entities involved should coordinate during the development of an FMP and, if a stock's range covers multiple Council areas, the preferred approach is to establish one FMP that covers the stock's entire range.
The deletion in § 600.310(b)(3) of the language “intended to avoid overfishing and achieve sustainable fisheries” was proposed to streamline the text. NS1 requires preventing overfishing and achieving OY, so the limits and accountability measures being discussed in § 600.310(b)(3) logically pertain to avoiding overfishing and achieving sustainable fisheries. NMFS does not believe that the deletion will lead to any confusion or change the intended meaning of this section.
The deletion of the last sentence from § 600.310(j)(2)(ii) was also proposed to avoid repetition and because it was not pertinent given the purpose of this subsection. As the commenter noted, this sentence is repeating what 16 U.S.C. 1854(e)(3)(A) already commands—to end overfishing immediately and rebuild affected stocks. Furthermore, § 600.310(j)(2) addresses the “Timing of actions” with regards to an overfished fishery. Thus, this subsection is mainly about when the Councils must take certain actions. The last sentence that was deleted from § 600.310(j)(2)(ii) was not pertinent to the purpose of this subsection because it prescribed the actions to take to address an overfished fishery. Due to the focus of this subsection on timing and because the language to be deleted is stated clearly in the statute, this final action deletes the text from the end of § 600.310(j)(2)(ii), as proposed.
Another commenter appreciated the attention given to environmental and ecological considerations but believed differentiating between short-term and long-term effects will take too long given the time sensitive economic realities of a fishery. The commenter suggested defining what are “prevailing ecological, environmental conditions” in the definition of MSY, and how and in what specific time frame those conditions are to be accounted.
The guidelines include language requiring a high standard for changing SDC that is consistent with NMFS technical guidance (Restrepo et al. 1998). NMFS outlines the relationship of SDC to environmental and habitat change in both the short and long-term in § 600.310(e)(2)(iii) of the final action. Total mortality of fish includes many factors other than fishing mortality. Short-term environmental changes may alter the size of a stock or complex, for instance, by episodic recruitment failures, but these events are not likely to change the reproductive biology or reproductive potential of the stock over the long-term. Thus, in such cases, a Council should not change the SDC. Other environmental, ecosystem, or habitat changes, such as some changes in ocean conditions, can alter both a stock's short-term size, and alter long-term reproductive biology. To respecify the SDC, Councils should indicate how such changes impact the stock's long-term reproductive potential and must provide an analysis, based on the best scientific information available, of how the SDC were chosen and how changes to the SDC impact the stock's long-term reproductive potential.
The language in § 600.310(e)(2)(iii)(B) is not redundant because it clarifies how to treat different kinds of environmental and habitat change when considering whether to respecify the SDC. Furthermore, NMFS believes distinguishing between short-term and long-term environmental changes is needed in order to determine whether respecifying the SDC is necessary. Finally, while “prevailing” in the context of § 600.310(e)(1)(i)(A) indicates the existing ecological and environmental conditions of the fishery at the time MSY is specified, the guidance also clarifies that MSY should be re-estimated as required by changes in long-term environmental or ecological conditions (§ 600.310(e)(1)(v)(A) of the final action).
NMFS does not intend to delay these revisions to the NS1 guidelines because it is unclear when any Congressional revisions to the MSA will be finalized. It is important that the clarity and adjustments that this final action provides is in place as soon as possible to improve fisheries management decisions. When MSA reauthorization is concluded and if it contains changes pertaining to the provisions in these guidelines, NMFS will make any necessary revisions. Comments related to what should be included in the MSA reauthorization and thoughts on current legislative proposals before Congress are outside the scope of these NS1 guidelines.
For the above reasons, NMFS does not believe the exception should be expanded. In addition, NMFS does not agree that flexibility similar to the approach taken for phase-in ABC control rules and multi-year overfishing determinations is appropriate. Those provisions address a different issue than the mixed stock exception, specifically, data limitation issues that make it difficult to set overfishing thresholds and determine with certainty if overfishing has occurred.
As discussed in the preamble to the final 2009 guidelines, NMFS believes that ESA listing is an inappropriate threshold for application of the mixed stock exception and that stocks should be managed so that they retain their potential to achieve MSY.
A number of commenters also suggested moving § 600.310(l) to § 600.305 (General section), as that would introduce the national standards at the outset rather than at the end of the NS1 section. Some commenters also suggested modifying subsection § 600.310(l) to state that SSCs “shall” rather than “should” advise their Councils regarding the best scientific information available for fishery management decisions. Finally, several commenters also recommended a change to § 600.305(b) to clarify that fishery management plans resolve conflicting objectives by giving NS1 priority.
NMFS disagrees with the need to eliminate references to “trade-offs.” The references to “trade-offs” properly reflects the delicate balance that Councils must perform in deciding what fishery management practices to implement so that there is compliance with all ten national standards and other MSA requirements. When considering the different means by which the conservation goals of the MSA can be achieved, Councils can consider the potential trade-offs between the national standards.
NMFS does not agree with the proposed change from “should” to “shall” with respect to SSC advice to Councils. The MSA specifies at 16 U.S.C. 1852(g)(1)(B) the scientific advice that the SSC “shall” provide to the Councils, and best scientific information available is not explicitly referenced there.
NMFS also addressed broadening the definition of “international agreement” in its response to comment 78 in the final 2009 guidelines.
NMFS believes there is no need to add language to § 600.310(h)(1)(ii) clarifying that § 600.310(f) and § 600.310(g) do not apply to stocks and stock complexes to which the international exception applies because § 600.310(h)(2)(ii) is clear that stocks or stock complexes subject to an international agreement are exempt from ACL and AM requirements. ACLs are detailed in § 600.310(f) and AMs are detailed in § 600.310(g). The title of § 600.310(h)(2) is “Exceptions from ACL and AM requirements” and includes “International fishery agreements” as one of the exceptions at § 600.310(h)(2)(ii).
In the revisions to § 600.305, paragraph (a)(3) was revised to clarify the approval process for FMP and FMP amendments. The last sentence of the paragraph was removed and replaced with a sentence clarifying that FMPs that are not formulated according to the guidelines may not be approved by the Secretary if the FMP or FMP amendment is inconsistent with the MSA or other applicable law (16 U.S.C. 1854(a)(3)).
Section 600.305(b)(2) was revised to clarify the discussion of fishery management objectives.
Section 600.305(c)(1) was revised to reference the MSA definition of “conservation and management,” and relevant cross-references. The sentence was also revised to clarify that based on this definition, and other relevant provisions of the Magnuson-Stevens Act, a Council should consider the non-exhaustive list of factors when deciding whether additional stocks require conservation and management.
Paragraph (c)(1)(iii) was revised for clarity by replacing “stocks” with “stock.” Paragraph (c)(1)(vi) was also revised for clarity by replacing “and” with “or.” Paragraph (c)(1)(x) was revised by removing the phrase “could be or” in order to clarify the conditions in which Councils should consider existing management regimes when
Paragraph (c)(2) was reorganized into three paragraphs to break out and clarify considerations for adding a stock to an FMP versus removing a stock from an FMP. Paragraph (c)(2) retains the last sentence of proposed paragraph (c)(2) with the addition of a cross-reference and the text “and should” after the word “can.”
Paragraph (c)(3) retains some text from the proposed paragraph (c)(2) and gives further explanation on what the proposed paragraph meant by no single factor being dispositive or required. New paragraph (c)(3) explains that, when considering adding a stock to an FMP, no single factor is dispositive or required. One or more of the above factors, and any additional considerations that may be relevant to the particular stock, may provide the basis for determining that a stock requires conservation and management. Based on the factor in paragraph (c)(1)(iii) of this section, if the amount and/or type of catch that occurs in Federal waters is a significant contributing factor to the stock's status, such information would weigh heavily in favor of adding a stock to an FMP. However, Councils should consider factor (c)(1)(x) before deciding to include a stock in an FMP. In many circumstances, adequate management of a fishery by states, state/Federal programs, or another Federal FMP would weigh heavily against a Federal FMP action.
Paragraph (c)(4) retains the bulk of the text from proposed paragraph (c)(2), except for sentences broken out into paragraphs (c)(2)-(3) as described above. For clarity, paragraph (c)(4) revises the phrase “keeping an existing stock within an FMP” to “removing a stock from, or continuing to include a stock in, an FMP.” The second sentence in paragraph (c)(4) was revised to provide further explanation on how to consider stocks whose status is impacted by catch in Federal waters. In addition, the first phrase in the 6th sentence of proposed paragraph (c)(2) was simplified to “Finally,” in the 6th sentence of paragraph (c)(4).
Paragraph (c)(5) retains the bulk of the text from proposed paragraph (c)(3). However, the 1st sentence was edited to clarify the circumstances under which a Council may designate stocks as EC species. The phrase “or for other reasons” at the end of the last sentence of the paragraph is also replaced with “and/or to address other ecosystems” to improve clarity of the paragraph. Other minor clarifying revisions were made to the citations within paragraph (c)(5).
Paragraph (c)(7) retains the text from proposed paragraph (c)(5), except for two instances where “a FMP” was corrected to “an FMP.”
Paragraph (d)(3) was revised to clarify the definition of the term “SOPP” and correct “a FMP” to “an FMP.” Paragraph (d)(11) was revised to clarify that target stocks may include, but are not limited to, economic and regulatory discards. Furthermore, economic discards are, by definition, part of a target stock. On the other hand, regulatory discards may or may not be part of a target stock, depending on the stock in question. Paragraphs (d)(12-13) were added to § 600.305 to further clarify how a Council may refer to certain species. Paragraph (d)(12) explains that `Non-target species' and `non-target stocks' are fish caught incidentally during the pursuit of target stocks in a fishery. Non-target stocks may require conservation and management and, if so, must be included in a FMP and be identified at the stock level. If non-target species are not in need of conservation and management, they may be identified in an FMP as ecosystem component species. Paragraph (d)(13) explains that Ecosystem Component Species (
Section 600.310(l) of the proposed rule was moved to the “General” section and designated as § 600.305(e) because the discussion of the relationship of the National Standards to each other is more appropriately discussed in the General section of the NS guidelines. The beginning of the paragraph further clarifies the relationship between NS1 and the other National Standards by reiterating that National Standard 1 addresses preventing overfishing and achieving optimum yield. Other minor clarifying revisions were made to the citations within paragraphs § 600.305(e)(1)-(2). New § 600.310(l)(4) was revised to add the phrase “and other MSA provisions” at the end of first sentence to clarify the scope of National Standard 8. Section 600.310(m) was re-designated as paragraph (1).
In the revisions to § 600.310, paragraph (b)(1)(ii) was revised to replace “that require, or are in need of, conservation and management” with “in an FMP” to simplify the text. To clarify the relationship between the SSC and the peer review process, the 3rd sentence of paragraph (b)(2)(v)(C) now explains that, for Regional Fishery Management Councils, the peer review process is not a substitute for the SSC and both the SSC and peer review process should work in conjunction with each other. Paragraph (b)(4) was also revised to remove “or overfished” to restore the original language used in this sentence, prior to the introduction of the proposed depleted definition.
Paragraph (d)(1) was revised to replace “and” with “or” after the term “other reference points” in the last sentence for clarification purposes. Other minor updates were made to the citations within paragraph (d)(1).
Paragraph (e)(1)(iv) was revised to remove the term “common” text from the description of aggregate MSY. This text is unnecessary and may cause confusion.
The following phrase was added after “annually,” in paragraph (e)(1)(v)(A): “but it must be based on the best scientific information available (
To clarify that MFMT and all reference points that stem from it are required to be specified on an annual basis, the words “on an annual basis,” were restored to the first sentence of paragraph (e)(2)(i)(C).
Paragraph (e)(2)(ii)(A) was revised to clarify the relationship between paragraphs (e)(2)(ii)(A)(
Subparagraph (e)(2)(ii)(A)(
Paragraph (e)(2)(i)(F), which addressed “depleted” stocks, was deleted in response to public comment and given the need for further consideration of this issue. A minor grammatical edit was also made in the 6th sentence of paragraph (e)(2)(ii). Finally, the word “may” was added after “Long-term environmental changes” in paragraph (e)(2)(iii) to clarify the nature of the expected relationship between long-term environmental changes and a stock or stock complex.
Paragraph (e)(2)(ii)(B) was revised to remove the phrase “social and/or economic impacts on the fishery,” from the list of factors that could inform MSST to clarify that MSST is a biological reference point and is based on the level of biomass below which the capacity of the stock to produce MSY on a continuing basis is jeopardized.
Paragraph (e)(3)(ii) was revised by removing the last sentence and explaining that if conservation and management measures cannot meet the dual requirements of NS1 (preventing overfishing, while achieving, on a continuing basis, OY), Councils should either modify the measures or reexamine their OY specifications to ensure that the dual NS1 requirements can be met. To clarify how summaries of OY specifications should be included in FMPs, paragraph (e)(3)(iii) was revised by removing the words: “which documents how the OY will produce the greatest benefits to the nation and prevent overfishing” from the 1st sentence and combining the 2nd and 3rd sentences to explain that the OY assessment should include: a summary of information utilized in making such specification, an explanation of how the OY specification will produce the greatest benefits to the nation and prevent overfishing and rebuild overfished stocks; and a consideration of the economic, social, and ecological factors relevant to the management of a particular stock, stock complex, or fishery. Finally, paragraph (e)(3)(iv)(D) was revised to clarify the relationship between internationally-managed stocks and specifying OY.
Paragraph (f)(2)(i) was revised to clarify the level of analysis required when establishing ABC control rules by explaining that the Council must provide a comprehensive analysis and articulate within their FMP when the control rule can and cannot be used and how the control rule prevents overfishing.
Paragraph (f)(2)(i) was revised to further explain how to properly establish ABC control rules. The 1st sentence of paragraph (f)(2)(i) explains that Councils must establish an ABC control rule that accounts for scientific uncertainty in the OFL and for the Council's risk policy, and that is based on a comprehensive analysis that shows how the control rule prevents overfishing. Paragraph (f)(2)(ii) was revised by removing “directed” from the phrase: “and may establish a stock abundance level below which directed fishing would not be allowed.” Finally, the words “in which case,” “provide a comprehensive analysis,” and “the control rule” were removed from the last sentence of the paragraph so the last two sentences of the paragraph.
Paragraph (f)(2)(ii)(A) was revised to clarify that phase-in ABC control rules must be designed to prevent overfishing every year. In addition, the end of the paragraph explains that the Councils should evaluate the appropriateness of phase-in provisions for stocks that are overfished and/or rebuilding, as the overriding goal for such stocks is to rebuild them in as short a time as possible.
Paragraph (f)(2)(ii)(B) was revised to clarify the proper use of carry-over ABC control rules. To explain the meaning of the term “ACL underage,” the following words were added after “unused portion of” in the first sentence of paragraph (f)(2)(ii)(B): “an ACL (
Paragraph (f)(3) was revised to clarify the meaning of the term “implementation of the ABC control rule.” The second sentence of the paragraph explains that Councils and their SSCs should develop a process by which the SSC can access the best scientific information available when implementing the ABC control rule (
To clarify that Councils may use varying terms to describe ACTs, the words “or functional equivalent,” were added to the third sentence of paragraph (f)(4)(i) that explains that, if an annual catch target (ACT), or functional equivalent, is not used, management uncertainty should be accounted for in the ACL. The words “or the functional equivalent,” were also added to paragraph (g)(4) so it reads: “ACTs, or the functional equivalent, . . .” for consistency.
Paragraph (f)(4)(iv) was revised to clarify how ABC is set in relation to OY. The words “and is designed to prevent overfishing” were removed from the 2nd sentence of paragraph (f)(4)(iv). Minor related revisions were also made to the 4th and 5th sentences of paragraph (f)(4(iv).
Minor revisions were made to the 5th sentence in paragraph (g)(3) to make the language consistent with the MSA.
A minor correction was made to paragraph (h)(1)(i) by replacing “has”
Paragraph (i)(2) was revised to replace “
Paragraph (j)(1) was revised to clarify that, consistent with MSA section 304(e), the Secretary will immediately notify in writing a Regional Fishery Management Council whenever the Secretary determines that one of the circumstances listed in subparagraphs (j)(1)(i)-(iv) is occurring.
Paragraph (j)(3)(i)(B)(
Minor edits were made to the 1st sentence of paragraph (j)(3)(i)(C) to align the paragraph more closely with the MSA.
Paragraph (j)(3)(iv) was revised so that the word “are” was replaced with “is” before “exceeded” and “and” was replaced with “nor” before “caused the overage” in the 3rd sentence of paragraph (j)(3)(iv). In addition, paragraph (j)(3)(iv) now explains that, for Secretarially-managed fisheries, the Secretary would take immediate action necessary to achieve adequate progress toward rebuilding and ending overfishing.
Paragraph (j)(3)(vi) was revised to explain that the one of the circumstances under which the fishing mortality rate for a stock or stock complex that has not rebuilt by T
Paragraphs (j)(5)(i)-(ii) were removed. Paragraph (j)(5) clarifies the criteria for discontinuing rebuilding plans by explaining that a Council may discontinue a rebuilding plan for a stock or stock complex before it reaches B
Paragraph (j)(6) was deleted because the definition for depleted stocks was removed from the final action.
Paragraph (l)(2) was revised to replace “characteristic” with “characteristics” for clarification purposes.
In the revisions to § 600.320, the last sentences of paragraphs (b)-(d) were removed to clarify, streamline, and reduce duplication between § 600.320 and § 600.305(c).
A complete list of all the references cited in this final action is available upon request from Stephanie Hunt (
Pursuant to section 301(b) of the MSA, the NMFS Assistant Administrator has determined that this final rule is consistent with the Magnuson-Stevens Act and other applicable law.
This rule has been determined to be significant for purposes of Executive Order 12866 because it may raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in E.O. 12866.
The provision of the Administration Procedure Act (5 U.S.C. 553) requiring a delay in effective date is inapplicable because this rule is a statement of policy. 5 U.S.C. 553(d)(2).
The Chief Council for Regulation of the Department of Commerce certified to the Chief Council for Advocacy of the Small Business Administration during the proposed rule stage that this rule, if adopted, would not have a significant economic impact on a substantial number of small entities. The factual basis for the certification was published in the proposed action .
NMFS notes that on January 26, 2016, the Small Business Administration (SBA) issued a final rule revising the small business size standards for several industries, effective February 26, 2016 (81 FR 4469). The rule increased the size standard for Seafood Product Preparation and Packaging (NAICS code 311710) from 500 to 750 employees. Furthermore, on December 29, 2015, NMFS issued a final rule establishing a small business size standard of $11 million in annual gross receipts for all businesses primarily engaged in the commercial fishing industry (NAICS 11411) for Regulatory Flexibility Act (RFA) compliance purposes only.
Therefore, the Chief Counsel for Regulation of the Department of Commerce hereby reaffirms that the rule will not have a significant economic impact on a substantial number of small entities. Thus, NMFS has determined that the certification established during the proposed rule stage is still appropriate for this final action and a final regulatory flexibility analysis has not been prepared for this final action.
Administrative practice and procedure, Confidential business information, Fisheries, Fishing, Fishing vessels, Foreign relations, Intergovernmental relations, Penalties, Reporting and recordkeeping requirements, Statistics.
For the reasons stated in the preamble, 50 CFR part 600 is amended as follows:
5 U.S.C. 561 and16 U.S.C. 1801
(a)
(2) In developing FMPs, the Councils have the initial authority to ascertain factual circumstances, to establish management objectives, and to propose management measures that will achieve the objectives. The Secretary will determine whether the proposed management objectives and measures are consistent with the national standards, other provisions of the Magnuson-Stevens Act (MSA), and other applicable law. The Secretary has an obligation under section 301(b) of the MSA to inform the Councils of the Secretary's interpretation of the national standards so that they will have an understanding of the basis on which FMPs will be reviewed.
(3) The national standards are statutory principles that must be followed in any FMP. The guidelines summarize Secretarial interpretations that have been, and will be, applied under these principles. The guidelines are intended as aids to decision-making; FMPs formulated according to the guidelines will have a better chance for expeditious Secretarial review, approval, and implementation. FMPs that are not formulated according to the guidelines may not be approved by the Secretary if the FMP or FMP amendment is inconsistent with the MSA or other applicable law (16 U.S.C. 1854(a)(3)).
(b)
(2) To reflect the changing needs of the fishery over time, Councils should reassess the FMP's management objectives on a regular basis.
(3) How objectives are defined is important to the management process. Objectives should address the problems of a particular fishery. The objectives should be clearly stated, practicably attainable, framed in terms of definable events and measurable benefits, and based upon a comprehensive rather than a fragmentary approach to the problems addressed. An FMP should make a clear distinction between objectives and the management measures chosen to achieve them. The objectives of each FMP provide the context within which the Secretary will judge the consistency of an FMP's conservation and management measures with the national standards.
(c)
(i) The stock is an important component of the marine environment.
(ii) The stock is caught by the fishery.
(iii) Whether an FMP can improve or maintain the condition of the stock.
(iv) The stock is a target of a fishery.
(v) The stock is important to commercial, recreational, or subsistence users.
(vi) The fishery is important to the Nation or to the regional economy.
(vii) The need to resolve competing interests and conflicts among user groups and whether an FMP can further that resolution.
(viii) The economic condition of a fishery and whether an FMP can produce more efficient utilization.
(ix) The needs of a developing fishery, and whether an FMP can foster orderly growth.
(x) The extent to which the fishery is already adequately managed by states, by state/Federal programs, or by Federal regulations pursuant to other FMPs or international commissions, or by industry self-regulation, consistent with the requirements of the Magnuson-Stevens Act and other applicable law.
(2) In evaluating factors in paragraphs (c)(1)(i) through (x) of this section, a Council should consider the specific circumstances of a fishery, based on the best scientific information available, to determine whether there are biological, economic, social and/or operational concerns that can and should be addressed by Federal management.
(3) When considering adding a stock to an FMP, no single factor is dispositive or required. One or more of the above factors, and any additional considerations that may be relevant to the particular stock, may provide the basis for determining that a stock requires conservation and management. Based on the factor in paragraph (c)(1)(iii) of this section, if the amount and/or type of catch that occurs in Federal waters is a significant contributing factor to the stock's status, such information would weigh heavily in favor of adding a stock to an FMP. However, Councils should consider the factor in paragraph (c)(1)(x) of this section before deciding to include a stock in an FMP. In many circumstances, adequate management of a fishery by states, state/Federal
(4) When considering removing a stock from, or continuing to include a stock in, an FMP, Councils should prepare a thorough analysis of factors in paragraphs (c)(1)(i) through (x) of this section, and any additional considerations that may be relevant to the particular stock. As mentioned in paragraph (c)(3) of this section, if the amount and/or type of catch that occurs in Federal waters is a significant contributing factor to the stock's status, such information would weigh heavily in favor of continuing to include a stock in an FMP. Councils should consider weighting the factors as follows. Factors in paragraphs (c)(1)(i) through (iii) of this section should be considered first, as they address maintaining a fishery resource and the marine environment.
(5) Councils may choose to identify stocks within their FMPs as ecosystem component (EC) species (
(6) A stock or stock complex may be identified in more than one FMP. In this situation, the relevant Councils should choose which FMP will be the primary FMP in which reference points for the stock or stock complex will be established. In other FMPs, the stock or stock complex may be identified as “other managed stocks” and management measures that are consistent with the objectives of the primary FMP can be established.
(7) Councils should periodically review their FMPs and the best scientific information available and determine if the stocks are appropriately identified. As appropriate, stocks should be reclassified within an FMP, added to or removed from an existing FMP, or added to a new FMP, through an FMP amendment that documents the rationale for the decision.
(d)
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
(12)
(13)
(e)
(1)
(2)
(3)
(4)
(5)
(a)
(b)
(i) Specifying maximum sustainable yield (MSY) and OY;
(ii) Specifying status determination criteria (SDC) so that overfishing and overfished determinations can be made for stocks and stock complexes in an FMP;
(iii) Preventing overfishing and achieving OY, incorporation of scientific and management uncertainty in control rules, and adaptive management using annual catch limits (ACL) and measures to ensure accountability (
(iv) Rebuilding stocks and stock complexes.
(2)
(ii)
(iii)
(iv)
(v)
(A) Each Regional Fishery Management Council shall establish an SSC as described in section 302(g)(1)(A) of the Magnuson-Stevens Act.
(B) Each SSC shall provide its Regional Fishery Management Council recommendations for ABC as well as other scientific advice, as described in Magnuson-Stevens Act section 302(g)(1)(B).
(C) The Secretary and each Regional Fishery Management Council may establish a peer review process for that Council for scientific information used to advise the Council about the conservation and management of a fishery (
(D) Each Council shall develop ACLs for each of its managed fisheries that may not exceed the “fishing level recommendations” of its SSC or peer review process (Magnuson-Stevens Act section 302(h)(6)). The SSC recommendation that is the most relevant to ACLs is ABC, as both ACL and ABC are levels of annual catch.
(3)
(4)
(c)
(1) MSY and SDC (
(2) OY at the stock, stock complex, or fishery level and provide the OY specification analysis (
(3) ABC control rule (
(4) Mechanisms for specifying ACLs (
(5) AMs (
(6) Stocks and stock complexes that have statutory exceptions from ACLs and AMs (
(d)
(1)
(2)
(i) At the time a stock complex is established, the FMP should provide, to the extent practicable, a full and explicit description of the proportional composition of each stock in the stock complex. Stocks may be grouped into complexes for various reasons, including where stocks in a multispecies fishery cannot be targeted independent of one another; where there is insufficient data to measure a stock's status relative to SDC; or when it is not feasible for fishermen to distinguish individual stocks among their catch. Where practicable, the group of stocks should have a similar geographic distribution, life history characteristics, and vulnerabilities to fishing pressure such that the impact of management actions on the stocks is similar. The vulnerability of individual stocks should be considered when determining if a particular stock complex should be established or reorganized, or if a particular stock should be included in a complex.
(ii)
(B) Where practicable, stock complexes should include one or more indicator stocks (each of which has SDC and ACLs). Otherwise, stock complexes may be comprised of: Several stocks without an indicator stock (with SDC and an ACL for the complex as a whole), or one or more indicator stocks (each of which has SDC and management objectives) with an ACL for the complex as a whole (this situation might be applicable to some salmon species). Councils should review the available quantitative or qualitative information (
(C) If an indicator stock is used to evaluate the status of a complex, it should be representative of the typical vulnerability of stocks within the complex. If the stocks within a stock complex have a wide range of vulnerability, they should be reorganized into different stock complexes that have similar vulnerabilities; otherwise the indicator stock should be chosen to represent the more vulnerable stocks within the complex. In instances where an indicator stock is less vulnerable than other members of the complex, management measures should be more conservative so that the more vulnerable members of the complex are not at risk from the fishery.
(D) More than one indicator stock can be selected to provide more information about the status of the complex.
(E) When indicator stocks are used, the stock complex's MSY could be listed as “unknown,” while noting that the complex is managed on the basis of one or more indicator stocks that do have known stock-specific MSYs, or suitable proxies, as described in paragraph (e)(1)(v) of this section.
(e)
(i)
(B)
(C)
(ii)
(iii)
(iv)
(v)
(B) When data are insufficient to estimate MSY directly, Councils should adopt other measures of reproductive potential that can serve as reasonable proxies for MSY, F
(C) The MSY for a stock or stock complex is influenced by its interactions with other stocks in its ecosystem and these interactions may shift as multiple stocks in an ecosystem are fished. Ecological and environmental information should be taken into account, to the extent practicable, when assessing stocks and specifying MSY. Ecological and environmental information that is not directly accounted for in the specification of MSY can be among the ecological factors considered when setting OY below MSY.
(D) As MSY values are estimates or are based on proxies, they will have some level of uncertainty associated with them. The degree of uncertainty in the estimates should be identified, when practicable, through the stock assessment process and peer review (
(2)
(B)
(C)
(D)
(E)
(F)
(G)
(ii)
(A)
(
(B)
(C) Where practicable, all sources of mortality including that resulting from bycatch, scientific research catch, and all fishing activities should be accounted for in the evaluation of stock status with respect to reference points.
(iii)
(A) If environmental changes cause a stock or stock complex to fall below its MSST without affecting its long-term reproductive potential, fishing mortality must be constrained sufficiently to allow rebuilding within an acceptable time frame (
(B) If environmental, ecosystem, or habitat changes affect the long-term reproductive potential of the stock or stock complex, one or more components of the SDC must be respecified. Once SDC have been respecified, fishing mortality may or may not have to be reduced, depending on the status of the stock or stock complex with respect to the new criteria.
(C) If manmade environmental changes are partially responsible for a stock or stock complex's biomass being below MSST, in addition to controlling fishing mortality, Councils should recommend restoration of habitat and other ameliorative programs, to the extent possible (
(iv)
(A) Is based on the best scientific information available;
(B) Contains the elements described in paragraph (e)(2)(ii) of this section;
(C) Provides a basis for objective measurement of the status of the stock or stock complex against the criteria; and
(D) Is operationally feasible.
(3)
(i)
(B) In NS1, use of the phrase “achieving, on a continuing basis, the OY from each fishery” means: producing, from each stock, stock complex, or fishery, an amount of catch that is, on average, equal to the Council's specified OY; prevents overfishing; maintains the long term average biomass near or above B
(ii)
(iii)
(A)
(
(
(
(B)
(
(
(
(iv)
(A) The OY can be expressed in terms of numbers or weight of fish, and either as a single value or a range. When it is not possible to specify OY quantitatively, OY may be described qualitatively.
(B) The determination of OY is based on MSY, directly or through proxy. However, even where sufficient scientific data as to the biological characteristics of the stock do not exist, or where the period of exploitation or investigation has not been long enough for adequate understanding of stock dynamics, or where frequent large-scale fluctuations in stock size diminish the meaningfulness of the MSY concept, OY must still be established based on the best scientific information available.
(C) An OY established at a fishery level may not exceed the sum of the MSY values for each of the stocks or stocks complexes within the fishery. Aggregate level MSY estimates could be used as a basis for specifying OY for the fishery (
(D) For internationally-managed stocks, fishing levels that are agreed upon by the U.S. at the international level are considered to be consistent with OY requirements under the MSA and these guidelines.
(v)
(A) The OY specification is the basis for establishing any total allowable level of foreign fishing (TALFF).
(B) Part of the OY may be held as a reserve to allow for domestic annual harvest (DAH). If an OY reserve is established, an adequate mechanism should be included in the FMP to permit timely release of the reserve to domestic or foreign fishermen, if necessary.
(C)
(D)
(E)
(f)
(ii)
(iii)
(iv)
(v)
(vi)
(2)
(ii) The ABC control rule must articulate how ABC will be set compared to the OFL based on the scientific knowledge about the stock or stock complex and taking into account scientific uncertainty (
(A)
(B)
(3)
(i)
(ii)
(4)
(ii)
(iii)
(iv)
(g)
(2)
(3)
(4)
(5)
(6)
(7)
(h)
(1)
(ii)
(2)
(i)
(1) Sources of fishing mortality (both landed and discarded), including commercial and recreational catch and bycatch in other fisheries;
(2) Description of the data collection and estimation methods used to quantify total catch mortality in each fishery, including information on the management tools used (
(3) Description of the methods used to compile catch data from various catch data collection methods and how those data are used to determine the relationship between total catch at a given point in time and the ACL for stocks and stock complexes that require conservation and management.
(j)
(1)
(i) Overfishing is occurring;
(ii) A stock or stock complex is overfished;
(iii) A stock or stock complex is approaching an overfished condition; or
(iv) Existing remedial action taken for the purpose of ending previously identified overfishing or rebuilding a previously identified overfished stock or stock complex has not resulted in adequate progress (
(2)
(ii)
(3)
(A)
(B)
(
(
(
(
(
(
(C)
(ii) Council action addressing an overfished fishery must allocate both overfishing restrictions and recovery benefits fairly and equitably among sectors of the fishery.
(iii) For fisheries managed under an international agreement, Council action addressing an overfished fishery must reflect traditional participation in the fishery, relative to other nations, by fishermen of the United States.
(iv)
(v) While a stock or stock complex is rebuilding, revising rebuilding timeframes (
(vi) If a stock or stock complex has not rebuilt by T
(4)
(i) The interim measures are needed to address an unanticipated and significantly changed understanding of the status of the stock or stock complex;
(ii) Ending overfishing immediately is expected to result in severe social and/or economic impacts to a fishery; and
(iii) The interim measures will ensure that the stock or stock complex will increase its current biomass through the duration of the interim measures.
(5)
(k)
(1) Develop recommendations for domestic regulations to address the relative impact of the U.S. fishing vessels on the stock. Council recommendations should be submitted to the Secretary.
(2) Develop and submit recommendations to the Secretary of State, and to the Congress, for international actions that will end overfishing in the fishery and rebuild the affected stocks, taking into account the relative impact of vessels of other nations and vessels of the United States on the relevant stock. Councils should, in consultation with the Secretary, develop recommendations that take into consideration relevant provisions of the Magnuson-Stevens Act and NS1 guidelines, including section 304(e) of the Magnuson-Stevens Act and paragraph (j)(3)(iii) of this section, and other applicable laws. For highly migratory species in the Pacific, recommendations from the Western Pacific, North Pacific, or Pacific Councils must be developed and submitted consistent with Magnuson-Stevens Reauthorization Act section 503(f), as appropriate.
(3)
(l)
(1) Such action will result in long-term net benefits to the Nation;
(2) Mitigating measures have been considered and it has been demonstrated that a similar level of long-term net benefits cannot be achieved by modifying fleet behavior, gear selection/configuration, or other technical characteristics in a manner such that no overfishing would occur; and
(3) The resulting rate of fishing mortality will not cause any stock or stock complex to fall below its MSST more than 50 percent of the time in the long term, although it is recognized that persistent overfishing is expected to cause the affected stock to fall below its B
(a)
(b)
(c)
(d)
(1)
(2)
(e)
(1) The range and distribution of the stocks, as well as the patterns of fishing effort and harvest.
(2) Alternative management units and reasons for selecting a particular one. A less-than-comprehensive management unit may be justified if, for example, complementary management exists or is planned for a separate geographic area or for a distinct use of the stocks, or if the unmanaged portion of the resource is immaterial to proper management.
(3) Management activities and habitat programs of adjacent states and their effects on the FMP's objectives and management measures. Where state action is necessary to implement measures within state waters to achieve FMP objectives, the FMP should identify what state action is necessary, discuss the consequences of state inaction or contrary action, and make appropriate recommendations. The FMP should also discuss the impact that Federal regulations will have on state management activities.
(4) Management activities of other countries having an impact on the fishery, and how the FMP's management measures are designed to take into account these impacts. International boundaries may be dealt with in several ways. For example:
(i) By limiting the management unit's scope to that portion of the stock found in U.S. waters;
(ii) By estimating MSY for the entire stock and then basing the determination of OY for the U.S. fishery on the portion of the stock within U.S. waters; or
(iii) By referring to treaties or cooperative agreements.
(a)
(b)
(c)
(1)
(2)
Environmental Protection Agency (EPA).
Final rule.
Based on the Environmental Protection Agency's (EPA's) review of the air quality criteria and the national ambient air quality standards (NAAQS) for lead (Pb), the EPA is retaining the current standards, without revision.
This final rule is effective on November 17, 2016.
The EPA has established a docket for this action under Docket ID No. EPA-HQ-OAR-2010-0108. Incorporated into this docket is a separate docket established for the Integrated Science Assessment for this review (Docket ID No. EPA-HQ-ORD-2011-0051). All documents in these dockets are listed on the
Dr. Deirdre L. Murphy, Health and Environmental Impacts Division, Office of Air Quality Planning and Standards, U.S. Environmental Protection Agency, Mail code C504-06, Research Triangle Park, NC 27711; telephone: (919) 541-0729; fax: (919) 541-0237; email:
A number of the documents that are relevant to this action are available through the EPA's Office of Air Quality Planning and Standards (OAQPS) Technology Transfer Network (TTN) Web site at
This document describes the completion of our current review of the NAAQS for Pb. This review of the standards and the air quality criteria (the scientific information upon which the standards are based) is required by the Clean Air Act on a periodic basis. In conducting this review, the EPA has carefully evaluated the currently available scientific literature on the health and welfare effects of Pb, focusing particularly on the information newly available since the conclusion of the last review in 2008. Between 2008 and 2014, the EPA prepared draft and final versions of the Integrated Science Assessment and the Policy Assessment, multiple drafts of which were subject to public review and comment and were reviewed by the Clean Air Scientific Advisory Committee, an independent scientific advisory committee established pursuant to the Clean Air Act and charged with providing advice to the Administrator. The EPA issued a proposed decision on the standards on January 5, 2015 (80 FR 278), and provided a 3-month period for submission of comments from the public. After consideration of public comments on the proposed decision and advice from the Clean Air Scientific Advisory Committee, the EPA has developed this document, which is the final step in the review process.
The prior review of the NAAQS for Pb was completed in 2008. As a result of that review, we significantly revised
The health effects evidence newly available in this review of the 2008 standard, as critically assessed in the ISA in conjunction with the full body of evidence, reaffirms conclusions on the broad array of effects recognized for Pb in the last review. Further, the currently available evidence is generally consistent with the evidence available in the last review, particularly with regard to key aspects of the evidence on which the current standard (set in 2008) is based. These key aspects include those regarding the relationships between air Pb concentrations and the associated Pb in the blood of young children as well as between total blood Pb levels and effects on children's IQ.
Based on consideration of the currently available health effects evidence in the context of this framework, and with support from the exposure/risk information, recognizing the uncertainties attendant in both, as well as the increasing uncertainty of risk estimates for lower air Pb concentrations, the Administrator concludes that the current primary standard provides the requisite protection of public health with an adequate margin of safety, including protection of at-risk populations. With regard to the secondary standard, the EPA has considered the currently available welfare effects evidence and screening-level risk information, including the general consistency of the current evidence with that available in the last review and the substantial limitations in the current evidence that complicate conclusions regarding the potential for Pb emissions under the current, much lower standard to contribute to welfare effects. Based on these considerations, the Administrator concludes that the current secondary standard is requisite to protect public welfare from known or anticipated adverse effects. Thus, based on the EPA's review of the air quality criteria and the NAAQS for Pb, the EPA is retaining the current standards, without revision.
Two sections of the Clean Air Act (CAA or the Act) govern the establishment and revision of the NAAQS. Section 108 (42 U.S.C. 7408) directs the Administrator to identify and list certain air pollutants and then to issue air quality criteria for those pollutants. The Administrator is to list those air pollutants that in her “judgment, cause or contribute to air pollution which may reasonably be anticipated to endanger public health or welfare;” “the presence of which in the ambient air results from numerous or diverse mobile or stationary sources;” and “for which . . . [the Administrator] plans to issue air quality criteria . . .” Air quality criteria are intended to “accurately reflect the latest scientific knowledge useful in indicating the kind and extent of all identifiable effects on public health or welfare which may be expected from the presence of [a] pollutant in the ambient air . . .” 42 U.S.C. 7408(b). Section 109 (42 U.S.C. 7409) directs the Administrator to propose and promulgate “primary” and “secondary” NAAQS for pollutants for which air quality criteria are issued. Section 109(b)(1) defines a primary standard as one “the attainment and maintenance of which in the judgment of the Administrator, based on such criteria and allowing an adequate margin of safety, are requisite to protect the public health.”
The requirement that primary standards provide an adequate margin of safety was intended to address uncertainties associated with inconclusive scientific and technical information available at the time of standard setting. It was also intended to provide a reasonable degree of protection against hazards that research has not yet identified.
In addressing the requirement for an adequate margin of safety, the EPA considers such factors as the nature and severity of the health effects involved, the size of sensitive population(s) at risk,
In setting primary and secondary standards that are “requisite” to protect public health and welfare, respectively, as provided in section 109(b), the EPA's task is to establish standards that are neither more nor less stringent than necessary for these purposes. In so doing, the EPA may not consider the
Section 109(d)(1) requires that “not later than December 31, 1980, and at 5-year intervals thereafter, the Administrator shall complete a thorough review of the criteria published under section 108 and the national ambient air quality standards . . . and shall make such revisions in such criteria and standards and promulgate such new standards as may be appropriate. . . .” Section 109(d)(2) requires that an independent scientific review committee “shall complete a review of the criteria . . . and the national primary and secondary ambient air quality standards . . . and shall recommend to the Administrator any new . . . standards and revisions of existing criteria and standards as may be appropriate . . .” Since the early 1980s, this independent review function has been performed by the Clean Air Scientific Advisory Committee (CASAC).
States are primarily responsible for ensuring attainment and maintenance of the NAAQS. Under section 110 of the Act (42 U.S.C. 7410) and related provisions, states are to submit, for EPA approval, state implementation plans that provide for the attainment and maintenance of such standards through control programs directed to sources of the pollutants involved. The states, in conjunction with the EPA, also administer the Prevention of Significant Deterioration program (42 U.S.C. 7470-7479) for these pollutants.
The NAAQS is only one component of the EPA's programs to address Pb in the environment. Federal programs additionally provide for nationwide reductions in air emissions of these and other air pollutants through the Federal Motor Vehicle Control Program under Title II of the Act (42 U.S.C. 7521-7574), which involves controls for automobile, truck, bus, motorcycle, nonroad engine, and aircraft emissions; the new source performance standards under section 111 of the Act (42 U.S.C. 7411); emissions standards for solid waste incineration units and the national emission standards for hazardous air pollutants (NESHAP) under sections 129 (42 U.S.C. 7429) and 112 (42 U.S.C. 7412) of the Act, respectively.
The EPA has taken a number of actions associated with these air pollution control programs since the last review of the Pb NAAQS (completed in 2008), including completion of several regulations that will result in reduced Pb emissions from stationary sources regulated under the CAA sections 112 and 129. For example, in January 2012, the EPA updated the NESHAP for the secondary lead smelting source category (77 FR 555, January 5, 2012). These amendments to the original maximum achievable control technology standards apply to facilities nationwide that use furnaces to recover Pb from Pb-bearing scrap, mainly from automobile batteries (13 existing facilities). This action was estimated to result in a Pb emissions reduction of 13.6 tons per year (tpy) across the category (a 68 percent reduction). Somewhat lesser Pb emissions reductions are also expected from regulations completed in 2013 for commercial and industrial solid waste incineration units (78 FR 9112, February 7, 2013), as well as several other regulations since 2007 (72 FR 73179, December 26, 2007; 72 FR 74088, December 28, 2007; 73 FR 225, November 20, 2008; 78 FR 10006, February 12, 2013; 76 FR 15372, March 21, 2011; 78 FR 7138, January 31, 2013; 74 FR 51368, October 6, 2009; Policy Assessment, Appendix 2A).
The presentation below briefly summarizes additional ongoing activities that, although not directly pertinent to the review of the NAAQS, are associated with controlling environmental Pb levels and human Pb exposures more broadly. Among those identified are the EPA programs intended to encourage exposure reduction programs in other countries.
Reducing Pb exposures has long been recognized as a federal priority as environmental and public health agencies continue to grapple with soil and dust Pb levels from the historical use of Pb in paint and gasoline and from other sources (Alliance to End Childhood Lead Poisoning, 1991; 62 FR 19885, April 23, 1997; 66 FR 52013, October 11, 2001; 68 FR 19931, April 23, 2003). A broad range of federal programs beyond those that focus on air pollution control provide for nationwide reductions in environmental releases and human exposures.
Pursuant to section 1412 of the Safe Drinking Water Act (SDWA), EPA sets public health goals and enforceable standards for drinking water quality. The Lead and Copper Rule (LCR) is a treatment technique rule. The LCR requires public water systems to treat the water to reduce corrosion of Pb and copper from premise plumbing and drinking water distribution system components. When corrosion control treatment isn't enough, water systems must educate the public about Pb in drinking water and replace lead service lines, which are the pipes that connect buildings to the drinking water mains (40 CFR 141.80-141.91). The importance of corrosion control treatment was illustrated by the recent events in Flint, MI, when Pb levels in drinking water increased after the water system did not maintain corrosion control treatment when the system changed its water supply. Section 1417 of the SDWA additionally prohibits the use of any pipe, any pipe or plumbing fitting or fixture, any solder, or any flux in the installation or repair of any public water system or any plumbing in a residential or non-residential facility providing water for human consumption, that is not lead free as defined by the Act.
Additionally, federal Pb abatement programs provide for the reduction in human exposures and environmental releases from in-place materials containing Pb (
Federal programs to reduce exposure to Pb in paint, dust, and soil are specified under the comprehensive federal regulatory framework developed under the Residential Lead-Based Paint Hazard Reduction Act (Title X). Under Title X (codified as Title IV of the Toxic Substances Control Act [TSCA]), the EPA has established regulations and associated programs in six categories: (1) Training, certification and work practice requirements for persons engaged in Pb-based paint activities (abatement, inspection and risk assessment); accreditation of training providers; and authorization of state and tribal Pb-based paint programs; (2) training, certification, and work practice requirements for persons engaged in home renovation, repair and painting (RRP) activities; accreditation of RRP training providers; and authorization of
Programs associated with the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA or Superfund) and Resource Conservation Recovery Act (RCRA) also implement abatement programs, reducing exposures to Pb and other pollutants. For example, the EPA determines and implements protective levels for Pb in soil at Superfund sites and RCRA corrective action facilities. Federal programs, including those implementing RCRA, provide for management of hazardous substances in hazardous and municipal solid waste (
A variety of federal nonregulatory programs also provide for reduced environmental release of Pb-containing materials by encouraging pollution prevention, promotion of reuse and recycling, reduction of priority and toxic chemicals in products and waste, and conservation of energy and materials. These include the “National Waste Minimization Program” (
The EPA's research program identifies, encourages and conducts research needed to develop methods and tools to characterize and help reduce risks related to Pb exposure. An example of one such effort is the EPA's Integrated Exposure Uptake Biokinetic Model for Lead in Children (IEUBK model), which is widely used and accepted as a tool that informs the evaluation of site-specific data. More recently, in recognition of the need for a single model that predicts Pb concentrations in tissues for children and adults, the EPA has been developing the All Ages Lead Model (AALM) to provide researchers and risk assessors with a pharmacokinetic model capable of estimating blood, tissue, and bone concentrations of Pb based on estimates of exposure over the lifetime of the individual (USEPA, 2006a, sections 4.4.5 and 4.4.8; USEPA, 2013a, section 3.6). The EPA's research activities on substances including Pb, such as those identified here, focus on improving our characterization of health and environmental effects, exposure, and control or management of environmental releases (see
Other federal agencies also participate in programs intended to reduce Pb exposures. For example, programs of the Centers for Disease Control and Prevention (CDC) provide for the tracking of children's blood Pb levels in the U.S. and provide guidance on levels at which medical and environmental case management activities should be implemented (CDC, 2012; ACCLPP, 2012). As a result of coordinated, intensive efforts at the national, state and local levels, including those programs described above, blood Pb levels in all segments of the population have continued to decline from levels observed in the past. For example, blood Pb levels for the general population of children 1 to 5 years of age have dropped to a geometric mean level of 1.17 μg/dL in the 2009-2010 National Health and Nutrition Examination Survey (NHANES)
The EPA also participates in a broad range of international programs focused on reducing environmental releases and human exposures in other countries. For example, the Partnership for Clean Fuels and Vehicles program engages governments and stakeholders in developing countries to eliminate Pb in gasoline globally.
The EPA is a contributor to the Global Alliance to Eliminate Lead Paint, a voluntary public-private partnership jointly led by the World Health Organization and the United Nations Environment Programme (UNEP) to prevent children's exposure to Pb from paints containing Pb and to minimize occupational exposures to Pb paint. The objective of this alliance is to promote a phase-out of the manufacture and sale of paints containing Pb and eventually to eliminate the risks that such paints
Unlike pollutants such as particulate matter and carbon monoxide, air quality criteria had not been issued for Pb as of the enactment of the CAA of 1970, which first set forth the requirement to set NAAQS based on air quality criteria. In the years just after enactment of the CAA, the EPA did not list Pb under section 108 of the Act, having determined to control Pb air pollution through regulations to phase out the use of Pb additives in gasoline (see 41 FR 14921, April 8, 1976). However, the decision not to list Pb under section 108 was challenged by environmental and public health groups, and the U.S. District Court for the Southern District of New York concluded that the EPA was required to list Pb under section 108.
The first review of the Pb standards was initiated in the mid-1980s. The scientific assessment for that review is described in the 1986
The last review of the air quality criteria and standards for Pb was initiated in November 2004 (69 FR 64926, November 9, 2004); the agency's plans for preparation of the Air Quality Criteria Document (AQCD) and conduct of the NAAQS review were presented in documents completed in 2005 and early 2006 (USEPA, 2005a; USEPA 2006b).
The scientific assessment for the review is described in the 2006
Immediately subsequent to completion of the Staff Paper, the EPA issued an advance notice of proposed rulemaking (ANPR) that was signed by the Administrator on December 5, 2007 (72 FR 71488, December 17, 2007).
The November 2008 preamble to the final rule described the EPA's decision to revise the primary and secondary standards for Pb, as discussed more fully in sections II.A.1 and III.A below. In consideration of the much-expanded health effects evidence on neurocognitive effects of Pb in children, the EPA substantially revised the primary standard level from 1.5 µg/m
On February 26, 2010, the EPA formally initiated its current review of the air quality criteria and standards for Pb, requesting the submission of recent scientific information on specified topics (75 FR 8934, February 26, 2010). Soon after this, the EPA held a workshop to discuss the policy-relevant science, which informed identification of key policy issues and questions to frame the review (75 FR 20843, April 21, 2010). Drawing from the workshop discussions, the EPA developed the draft Integrated Review Plan (draft IRP, USEPA, 2011d). The draft IRP was made available in late March 2011 for consultation with the CASAC Pb Review Panel and for public comment (76 FR 20347, April 12, 2011). This document was discussed by the Panel via a publicly accessible teleconference consultation on May 5, 2011 (76 FR 21346, April 15, 2011; Frey, 2011a). The final
In developing the Integrated Science Assessment (ISA)
In June 2011, the EPA developed and released the
A draft of the PA was released for public comment and review by CASAC in January 2013 (USEPA, 2013b; 77 FR 70776, November 27, 2012) and was the subject of a public meeting on February 5-6, 2013 (78 FR 938, January 7, 2013). Comments provided by the CASAC in a June 4, 2013, letter (Frey, 2013b), as well as public comments received on the draft PA were considered in preparing the final PA, which was released in May 2014 (USEPA, 2014; 79 FR 26751, May 9, 2014). The proposed decision (henceforth “proposal”) on this review of the NAAQS for Pb was signed on December 19, 2014, and published in the
As in prior NAAQS reviews, the EPA is basing its decision in this review on studies and related information included in the ISA and PA,
The decision to rely on studies and related information included in the ISA, REAs and PA, which have undergone CASAC and public review, is consistent with the EPA's practice in prior NAAQS reviews and its interpretation of the requirements of the CAA. Since the 1970 amendments, the EPA has taken the view that NAAQS decisions are to be based on scientific studies and related information that have been assessed as a part of the pertinent air quality criteria, and the EPA has consistently followed this approach. This longstanding interpretation was strengthened by new legislative requirements enacted in 1977, which added section 109(d)(2) of the Act concerning CASAC review of air quality criteria. See 71 FR 61144, 61148 (October 17, 2006, final decision on review of NAAQS for particulate matter) for a detailed discussion of this issue and the EPA's past practice.
As discussed in the EPA's 1993 decision not to revise the NAAQS for ozone, “new” studies may sometimes be of such significance that it is appropriate to delay a decision on revision of a NAAQS and to supplement the pertinent air quality criteria so the studies can be taken into account (58 FR at 13013-13014, March 9, 1993). In the present case, the EPA's provisional consideration of “new” studies concludes that, taken in context, the “new” information and findings do not materially change any of the broad scientific conclusions regarding the health and welfare effects and exposure pathways of Pb in ambient air made in the air quality criteria. For this reason, reopening the air quality criteria review would not be warranted.
Accordingly, the EPA is basing the final decisions in this review on the studies and related information included in the Pb air quality criteria that have undergone CASAC and public review. The EPA will consider the “new” studies for purposes of decision making in the next periodic review of the NAAQS for Pb, which the EPA expects to begin soon after the conclusion of this review and which will provide the opportunity to fully assess these studies through a more rigorous review process involving the EPA, CASAC, and the public.
Since Pb is distributed from air to other media and is persistent, our review of the NAAQS for Pb considers the protection provided against effects associated both with exposures to Pb in ambient air and with exposures to Pb that makes its way into other media from ambient air. Additionally, in assessing the adequacy of protection afforded by the current NAAQS, we are mindful of the long history of greater and more widespread atmospheric emissions that occurred in previous years (both before and after establishment of the 1978 NAAQS) and that contributed to the Pb that is in human populations and ecosystems today. Likewise, we also recognize the role of other, nonair sources of Pb now and in the past that also contribute to the Pb that is in human populations and ecosystems today.
Lead emitted to ambient air is transported through the air and is also distributed from air to other media. This multimedia distribution of Pb emitted into ambient air (air-related Pb) contributes to multiple air-related pathways of human and ecosystem exposure (ISA, sections 3.1.1 and 3.7.1). Air-related pathways may also involve media other than air, including indoor and outdoor dust, soil, surface water and sediments, vegetation and biota. Air-related Pb exposure pathways for humans include inhalation of ambient air or ingestion of food, water or other materials, including dust and soil, that have been contaminated through a pathway involving Pb deposition from ambient air (ISA, section 3.1.1.1). Ambient air inhalation pathways include both inhalation of air outdoors and inhalation of ambient air that has infiltrated into indoor environments. The air-related ingestion pathways occur as a result of Pb passing through the ambient air, being distributed to other environmental media and contributing to human exposures via contact with and ingestion of indoor and outdoor dusts, outdoor soil, food and drinking water.
Lead currently occurring in nonair media may also derive from sources other than ambient air (nonair Pb sources) (ISA, sections 2.3 and 3.7.1). For example, Pb in dust inside some houses or outdoors in some urban areas may derive from the common past usage of leaded paint, while Pb in drinking water may derive from the use of leaded pipe or solder in drinking water distribution systems (ISA, section 3.1.3.3). We also recognize the history of much greater air emissions of Pb in the past, such as that associated with leaded gasoline usage and higher industrial emissions which have left a legacy of Pb in other (nonair) media.
The relative importance of different pathways of human exposure to Pb, as well as the relative contributions from Pb resulting from recent and historic air emissions and from nonair sources, vary across the U.S. population as a result of both extrinsic factors, such as a home's proximity to industrial Pb sources or its history of leaded paint usage, and intrinsic factors, such as a person's age and nutritional status (ISA, sections 5.1, 5.2, 5.2.1, 5.2.5 and 5.2.6). Thus, the relative contributions from specific pathways are situation specific (ISA, p. 1-11), although a predominant Pb exposure pathway for very young children is the incidental ingestion of indoor dust by hand-to-mouth activity (ISA, section 3.1.1.1). For adults, however, diet may be the primary Pb exposure pathway (2006 CD, section 3.4). Similarly, the relative importance of air-related and nonair-related Pb also varies with the relative magnitudes of
The distribution of Pb from ambient air to other environmental media also influences the exposure pathways for organisms in terrestrial and aquatic ecosystems. Exposure of terrestrial animals and vegetation to air-related Pb can occur by contact with ambient air or by contact with soil, water or food items that have been contaminated by Pb from ambient air (ISA, section 6.2). Transport of Pb into aquatic systems similarly provides for exposure of biota in those systems, and exposures may vary among systems as a result of differences in sources and levels of contamination, as well as characteristics of the systems themselves, such as salinity, pH and turbidity (ISA, section 2.3.2). In addition to Pb contributed by current atmospheric deposition, Pb may occur in aquatic systems as a result of nonair sources such as industrial discharges or mine-related drainage, of historical air Pb emissions (
The persistence of Pb contributes an important temporal aspect to lead's environmental pathways, and the time (or lag) associated with realization of the impact of air Pb concentrations on concentrations in other media can vary with the media (
Lead emitted to the air is predominantly in particulate form. Once emitted, particle-bound Pb can be transported long or short distances depending on particle size, which influences the amount of time spent in the aerosol phase. In general, larger particles tend to deposit more quickly, within shorter distances from emissions points, compared with smaller particles that remain in the aerosol phase and travel longer distances before depositing (ISA, section 1.2.1). Accordingly, airborne concentrations of Pb near sources are much higher (and the representation of larger particles generally greater) than at sites not directly influenced by sources (PA, Figure 2-11; ISA sections 2.3.1 and 2.5.3).
Ambient air monitoring data for Pb, in terms of Pb-TSP, Pb-PM
The Pb NAAQS surveillance network regulations (40 CFR part 58, appendix D, paragraph 4.5) require source-oriented monitoring sites, and also the collection of one year of Pb-TSP measurements at 15 specific airports. The indicator for the current Pb NAAQS is Pb-TSP, although in some situations,
Since the phase-out of Pb in on-road gasoline, Pb is widely recognized as a near-source air pollutant, the ambient air concentrations of which generally fall off quickly with distance from sources. Variability in ambient air Pb concentrations is highest in areas including a Pb source, “with high concentrations downwind of the sources and low concentration at areas far from sources” (ISA, p. 2-92). The current requirements for source-oriented monitoring include placement of monitor sites near sources of air Pb emissions that are expected to or have been shown to contribute to ambient air Pb concentrations in excess of the NAAQS. At a minimum, there must be one source-oriented site located to measure the maximum Pb concentration in ambient air resulting from each non-airport Pb source that emits 0.50 or more tons of Pb per year and from each airport that emits 1.0 or more tons of Pb per year.
Monitoring agencies may also conduct non-source-oriented Pb monitoring at the NCore monitoring sites.
The long-term record of Pb monitoring data documents the dramatic decline in atmospheric Pb concentrations that has occurred since the 1970s in response to reduced emissions (PA, Figures 2-1 and 2-7). Currently, the highest concentrations occur near some metals industries where some individual locations have concentrations that exceed the NAAQS (PA, Figure 2-10). Concentrations at non-source-oriented monitoring sites are much lower than those at source-oriented sites and well below the standard (PA, Figure 2-11).
For reasons discussed in the proposal and summarized in sections II.B.1 and III.B.1 below, the Administrator proposed to retain the current primary and secondary standards for Pb, without revision.
This action presents the Administrator's final decisions in the current review of the primary and secondary Pb standards. The final decisions addressing standards for Pb are based on a thorough review in the ISA of scientific information on known and potential human health and welfare effects associated with exposure to Pb associated with levels typically found in the ambient air. These final decisions also take into account the following: (1) Staff assessments in the PA of the most policy-relevant information in the ISA as well as quantitative health and welfare exposure and risk information; (2) CASAC advice and recommendations, as reflected in its letters to the Administrator and its discussions of drafts of the ISA and PA at public meetings; (3) public comments received during the development of these documents, both in connection with CASAC meetings and separately; and (4) public comments received on the proposal.
The primary standard is addressed in section II and the secondary standard is addressed in section III. Section IV addresses applicable statutory and executive order reviews.
This section presents the rationale for the Administrator's decision to retain the existing primary Pb standard. This rationale is based on a thorough review in the ISA of the latest scientific information, generally published through September 2011, on human health effects associated with Pb and pertaining to the presence of Pb in the ambient air. This decision also takes into account: (1) The PA's staff assessments of the most policy-relevant information in the ISA and staff analyses of air quality, human exposure and health risks, upon which staff conclusions regarding appropriate considerations in this review are based; (2) CASAC advice and recommendations, as reflected in discussions of drafts of the ISA and PA at public meetings, in separate written comments, and in the CASAC's letters to the Administrator; (3) public comments received during the development of these documents, either in connection with CASAC meetings or separately, and (4) public comments received on the proposal.
Section II.A provides background on the general approach for review of the primary standard for Pb and brief summaries of key aspects of the currently available health effects and exposure/risk information. Section II.B presents the Administrator's conclusions on adequacy of the current standard, drawing on consideration of this information, advice from the CASAC, and comments from the public. Section II.C summarizes the Administrator's decision on the primary standard.
As in prior reviews, the general approach to reviewing the current primary standard is based, most fundamentally, on using the EPA's assessment of the current scientific evidence and associated quantitative analyses to inform the Administrator's judgment regarding a primary standard for Pb that protects public health with an adequate margin of safety. In drawing conclusions with regard to the primary standard, the final decision on the adequacy of the current standard is largely a public health policy judgment to be made by the Administrator. The
To evaluate whether it is appropriate to consider retaining the current primary Pb standard, or whether consideration of revision is appropriate, the EPA has adopted an approach in this review that builds upon the general approach used in the last review and reflects the broader body of evidence and information now available. As summarized in section II.A.1 below, the Administrator's decisions in the prior review were based on an integration of information on health effects associated with exposure to Pb with that on relationships between ambient air Pb and blood Pb; expert judgments on the adversity and public health significance of key health effects; and policy judgments as to when the standard is requisite to protect public health with an adequate margin of safety. These considerations were informed by air quality and related analyses, quantitative exposure and risk assessments, and qualitative assessment of impacts that could not be quantified.
Similarly in this review, as described in the PA, we draw on the current evidence and quantitative assessments of exposure pertaining to the public health risk of Pb in ambient air. In considering the scientific and technical information here as in the PA, we consider both the information available at the time of the last review and information newly available since the last review, including most particularly that which has been critically analyzed and characterized in the current ISA. We additionally consider the quantitative exposure/risk assessments from the last review that estimated Pb-related IQ decrements associated with different air quality conditions in simulated at-risk populations in multiple case studies (PA, section 3.4; 2007 REA). The evidence-based discussions presented below draw upon evidence from epidemiological studies and experimental animal studies evaluating health effects related to exposures to Pb, as discussed in the ISA. The exposure/risk-based discussions have drawn from the quantitative health risk analyses for Pb performed in the last Pb NAAQS review in light of the currently available evidence (PA, section 3.4; 2007 REA; REA Planning Document). Sections II.A.2 through II.A.4 below provide an overview of the current health effects and quantitative exposure and risk information with a focus on the specific policy-relevant questions identified for these categories of information in the PA (PA, chapter 3).
The current primary standard was established in the last review, which was completed in 2008 (73 FR 66964, November 12, 2008), and is set at a level that is one-tenth the level of the prior standard. The 2008 decision to substantially revise the primary standard was based on the extensive body of scientific evidence published over almost three decades, from the time the standard was originally set in 1978 through 2005-2006. While recognizing that Pb has been demonstrated to exert “a broad array of deleterious effects on multiple organ systems,” the 2008 review focused on the effects most pertinent to recent ambient air exposures, which are those associated with relatively lower exposures and associated blood Pb levels (73 FR 66975, November 12, 2008). Given the general scientific consensus that the developing nervous system in children is among the most sensitive health endpoints associated with Pb exposure, if not the most sensitive one, primary attention was given to consideration of nervous system effects, including neurocognitive and neurobehavioral effects, in children (73 FR 66976, November 12, 2008). The body of evidence included associations of such effects in study populations of variously aged children with mean blood Pb levels below 10 µg/dL, extending from 8 down to 2 µg/dL (73 FR 66976, November 12, 2008). Particular focus was given to the public health implications of effects of air-related Pb on cognitive function (
The conclusions reached by the Administrator in the 2008 review were based primarily on the scientific evidence, with the risk- and exposure-based information providing support for various aspects of the decision. In reaching his conclusion on the adequacy of the then-current standard, which was set in 1978, the Administrator placed primary consideration on the large body of scientific evidence available in the review including significant new evidence concerning effects at blood Pb concentrations substantially below those identified when the standard was initially set (73 FR 66987, November 12, 2008; 43 FR 46246, October 5, 1978). He gave particular attention to the robust evidence of neurotoxic effects of Pb exposure in children, recognizing: (1) That while blood Pb levels in U.S. children had decreased notably since the late 1970s, newer epidemiological studies had investigated and reported associations of effects on the neurodevelopment of children with those more recent lower blood Pb levels and (2) that the toxicological evidence included extensive experimental laboratory animal evidence substantiating well the plausibility of the epidemiological findings observed in human children and expanding our understanding of likely mechanisms underlying the neurotoxic effects (73 FR 66987, November 12, 2008). Additionally, within the range of blood Pb levels investigated in the available evidence base, a threshold level for neurocognitive effects was not identified (73 FR 66984, November 12, 2008; 2006 CD, p. 8-67). Further, the evidence indicated a steeper concentration-response (C-R) relationship for effects on cognitive function at those lower blood Pb levels than at higher blood Pb levels that were more common in the past, “indicating the potential for greater incremental impact associated with exposure at these lower levels” (73 FR 66987, November 12, 2008).
Based on consideration of the health effects evidence, supported by the quantitative risk analyses, the Administrator concluded that, for exposures projected for air Pb concentrations at the level of the 1978
With regard to indicator, the Administrator decided to retain Pb-TSP as the indicator. The EPA recognized that the difference in particulate Pb captured by TSP and PM
With regard to averaging time and form for the revised standard, after giving consideration to a monthly averaging time, with a form of second maximum, and to 3-month and calendar quarter averaging times, with not-to-be exceeded forms, two changes were made. These were to a rolling 3-month average, thus giving equal weight to all 3-month periods, and to the method for deriving the 3-month average to provide equal weighting to each month. Both of these changes afford greater weight to each individual month than did the calendar quarter form of the 1978 standard, thus tending to control both the likelihood that any month will exceed the level of the standard and the magnitude of any such exceedance. The Administrator decided on these changes in recognition of the complexity inherent in this aspect of the standard which is greater for Pb than in the case of other criteria pollutants due to the multimedia nature of Pb and its multiple pathways of human exposure. In this situation for Pb, the Administrator emphasized the importance of considering in an integrated manner all of the relevant factors, both those pertaining to the human physiological response to changes in Pb exposures and those pertaining to the response of air-related Pb exposure pathways to changes in airborne Pb, recognizing that some factors might imply support for a period as short as a month for averaging time, and others supporting use of a longer time, with all having associated uncertainty. Based on such an integrated consideration of the range of relevant factors, the averaging time was revised to a rolling 3-month period with a maximum (not-to-be-exceeded) form, evaluated over a 3-year period (73 FR 66996, November 12, 2008).
In reaching the decision on level for the revised standard, that, in combination with the specified choice of indicator, averaging time, and form, the Administrator judged requisite to protect public health, including the health of sensitive groups, with an adequate margin of safety, he considered the evidence using a very specifically defined framework, referred to as an air-related IQ loss evidence-based framework (73 FR 67004, November 12, 2008). This framework integrates evidence for the relationship between Pb in air and Pb in young children's blood with evidence for the relationship between Pb in young children's blood and IQ loss (73 FR 66987, November 12, 2008). This evidence-based approach considers air-related effects on neurocognitive function (using the quantitative metric of IQ loss) associated with exposure in those areas with elevated air concentrations equal to potential alternative levels for the Pb standard. In simplest terms, the framework focuses on children exposed to air-related Pb in those areas with elevated air Pb concentrations equal to specific potential standard levels, providing for estimation of a mean air-related IQ decrement for young children with air-related exposures that are in the high end of the national distribution of such exposures. Thus, the conceptual context for the framework is that it provides estimates of air-related IQ loss for the subset of U.S. children living in close proximity to air Pb sources that contribute to such elevated air Pb concentrations. Consideration of this framework additionally recognizes that in such cases when a standard of a particular level is just met at a monitor sited to record the highest source-oriented concentration in an area, the large majority of children in the larger surrounding area would likely experience exposures to concentrations well below that level.
The two primary inputs to the air-related IQ loss evidence-based framework are air-to-blood ratios
Use of the air-related IQ loss evidence-based framework to inform selection of the standard level involved consideration of the evidence for the two primary input parameters mentioned above. With regard to air-to-blood ratio estimates, the evidence in the 2008 review indicated a broad range of estimates, each with limitations and associated uncertainties. Based on this evidence, the Administrator concluded that 1:5 to 1:10 represented a reasonable range to consider and focused on 1:7 as a generally central value (73 FR 67004, November 12, 2008). With regard to C-R functions, in light of the evidence of nonlinearity and of steeper slopes at lower blood Pb levels, the Administrator concluded it was appropriate to focus on C-R analyses based on blood Pb levels that most closely reflected the then-current population of young children in the U.S.,
In considering the use of the air-related IQ loss evidence-based framework to inform his judgment as to the appropriate degree of public health protection that should be afforded by the NAAQS to provide requisite protection against risk of neurocognitive effects in sensitive populations, such as IQ loss in children, the Administrator recognized in the 2008 review that there were no commonly accepted guidelines or criteria within the public health community that would provide a clear basis for such a judgment. During the 2008 review, CASAC commented regarding the significance from a public health perspective of a 1-2 point IQ loss in the entire population of children and, along with some commenters, emphasized that the NAAQS should prevent air-related IQ loss of a significant magnitude, such as on the order of 1-2 IQ points, in all but a small percentile of the population. Similarly, the Administrator stated that “ideally air-related (as well as other) exposures to environmental Pb would be reduced to the point that no IQ impact in children would occur” (73 FR 66998, November 12, 2008). The Administrator further recognized that, in the case of setting a national ambient air quality standard, he was required to make a judgment as to what degree of protection is requisite to protect public health with an adequate margin of safety (73 FR 66998, November 12, 2008). The NAAQS must be sufficient but not more stringent than necessary to achieve that result, and the Act does not require a zero-risk standard (73 FR 66998, November 12, 2008). The Administrator additionally recognized that the air-related IQ loss evidence-based framework did not provide estimates pertaining to the U.S. population of children as a whole. Rather, the framework provided estimates (with associated uncertainties and limitations) for the mean of a subset of that population, the subset of children assumed to be exposed to the level of the standard. As described in the final decision “[t]he framework in effect focuses on the sensitive subpopulation that is the group of children living near sources and more likely to be exposed at the level of the standard” (73 FR 67000, November 12, 2008). Further description of the EPA's consideration of this issue is provided in the preamble to the final decision rule (73 FR 67000, November 12, 2008):
EPA is unable to quantify the percentile of the U.S. population of children that corresponds to the mean of this sensitive subpopulation. Nor is EPA confident in its ability to develop quantified estimates of air-related IQ loss for higher percentiles than the mean of this subpopulation. EPA expects that the mean of this subpopulation represents a high, but not quantifiable, percentile of the U.S. population of children. As a result, EPA expects that a standard based on consideration of this framework would provide the same or greater protection from estimated air-related IQ loss for a high, albeit unquantifiable, percentage of the entire population of U.S. children.
In reaching a judgment as to the appropriate degree of protection, the Administrator considered advice and recommendations from CASAC and public comments and recognized the uncertainties in the health effects evidence and related information as well as the role of, and context for, a selected air-related IQ loss in the application of the framework, as described above. Based on these considerations, the Administrator identified an air-related IQ loss of 2 points for use with the framework, as a tool for considering the evidence with regard to the level for the standard (73 FR 67005, November 12, 2008). In so doing, the Administrator was not determining that such an IQ decrement value was appropriate in other contexts (73 FR 67005, November 12, 2008). Given the various uncertainties associated with the framework and the scientific evidence base, and the focus of the framework on the sensitive subpopulation of children that are more highly exposed to air-related Pb, a standard level selected in this way, in combination with the selected averaging time and form, was expected to significantly reduce and limit for a high percentage of U.S. children the risk of experiencing an air-related IQ loss of that magnitude (73 FR 67005, November 12, 2008). At the standard level of 0.15 µg/m
In reaching the decision in 2008 on a level for the revised standard, the Administrator also considered the results of the quantitative risk assessment to provide a useful
Based on consideration of the entire body of evidence and information available in the review, as well as the recommendations of CASAC and public comments, the Administrator decided that a level for the primary Pb standard of 0.15 µg/m
The Administrator additionally noted that a standard with this level would reduce the risk of a variety of health effects associated with exposure to Pb, including effects indicated in the epidemiological studies at lower blood Pb levels, particularly including neurological effects in children, and the potential for cardiovascular and renal effects in adults (73 FR 67006, November 12, 2008). The Administrator additionally considered higher and lower levels for the standard, concluding that a level of 0.15 µg/m
The Administrator concluded, based on review of all of the evidence (including the evidence-based framework), that when taken as a whole the selected standard, including the indicator, averaging time, form, and level, would be “sufficient but not more than necessary to protect public health, including the health of sensitive subpopulations, with an adequate margin of safety” (73 FR 67007, November 12, 2008).
In this section, we provide an overview of the information presented in section II.B of the proposal on policy-relevant aspects of the health effects evidence available for consideration in this review. Section II.B of the proposal provides a detailed summary of key information contained in the ISA and in the PA on health and public health effects of Pb, focusing particularly on the information most relevant to consideration of effects associated with the presence of Pb in ambient air (80 FR 290-297, January 5, 2015). The subsections below briefly outline this information in the five topic areas addressed in section II.B of the proposal.
Lead has been demonstrated to exert a broad array of deleterious effects on multiple organ systems as described in the assessment of the evidence available in this review and consistent with conclusions of past CDs (ISA, section 1.6; 2006 CD, section 8.4.1). A sizeable number of studies on Pb health effects are newly available in this review and are critically assessed in the ISA as part of the full body of evidence. The newly available evidence reaffirms conclusions on the broad array of effects recognized for Pb in the last review (see ISA, section 1.10).
Among the nervous system effects of Pb, the newly available evidence is consistent with conclusions in the previous review which recognized that “[t]he neurotoxic effects of Pb exposure are among those most studied and most extensively documented among human population groups” (2006 CD, p. 8-25) and took note of the diversity of studies in which such effects of Pb exposure early in development (from fetal to postnatal childhood periods) have been observed (2006 CD, p. E-9). While some studies are newly available of other effects in children with somewhat lower blood Pb levels than previously available for these effects, nervous system effects continue to receive prominence in the current review, as in previous reviews, with particular emphasis on those affecting cognitive function and behavior in children (ISA, section 4.3), with conclusions that are consistent with findings of the last review. For example, based on the extensive assessment of the full body of evidence available in this review, the major conclusions drawn by the ISA regarding health effects of Pb in children include the following (ISA, p. lxxxvii).
Multiple epidemiologic studies conducted in diverse populations of children consistently demonstrate the harmful effects of Pb exposure on cognitive function (as measured by IQ decrements, decreased academic performance and poorer performance on tests of executive function). . . . Evidence suggests that some Pb-related cognitive effects may be irreversible and that the neurodevelopmental effects of Pb exposure may persist into adulthood (Section 1.9.4). Epidemiologic studies also demonstrate that Pb exposure is associated with decreased attention, and increased impulsivity and hyperactivity in children (externalizing behaviors). This is supported by findings in animal studies demonstrating both analogous effects and biological plausibility at relevant exposure levels. Pb exposure can also exert harmful effects on blood cells and blood producing organs, and is likely to cause an increased risk of symptoms of depression and anxiety and withdrawn behavior (internalizing behaviors), decreases in auditory and motor function, asthma and allergy, as well as conduct disorders in children and young adults. There is some uncertainty about the Pb exposures contributing to the effects and blood Pb levels observed in epidemiologic studies; however, these uncertainties are greater in studies of older children and adults than in studies of young children (Section 1.9.5).
As in prior reviews of the Pb NAAQS, this review is focused on those effects most pertinent to ambient air Pb exposures. Given the reductions in ambient air Pb concentrations over the past decades, these effects are generally those associated with the lowest levels of Pb exposure that have been evaluated. Additionally, we recognize the limitations on our ability to draw conclusions regarding the exposure conditions contributing to the findings from epidemiological analyses of blood Pb levels in populations of older children and adults, particularly in light of their history of higher Pb exposures. For example, the evidence newly available for Pb relationships with cardiovascular effects in adults includes some studies with somewhat lower blood Pb levels than in the last review. However, the long exposure histories of these cohorts, as well as the generally higher Pb exposures of the past, complicate conclusions regarding exposure levels that may be eliciting observed effects (ISA, sections 4.4.2.4 and 4.4.7).
A large body of evidence from both epidemiologic studies of adults and experimental studies in animals demonstrates the effect of long-term Pb exposure on increased blood pressure (BP) and hypertension (Section 1.6.2). In addition to its effect on BP, Pb exposure can also lead to coronary heart disease and death from cardiovascular causes and is associated with cognitive function decrements, symptoms of depression and anxiety, and immune effects in adult humans. The extent to which the effects of Pb on the cardiovascular system are reversible is not well-characterized. Additionally, the frequency, timing, level, and duration of Pb exposure causing the effects observed in adults has not been pinpointed, and higher past exposures may contribute to the development of health effects measured later in life.
In the last review, while recognizing the range of health effects in variously aged populations related to Pb exposure, we focused on the health effects for which the evidence was strongest with regard to relationships with the lowest exposure levels, neurocognitive effects in young children. Similarly, given the strength of the evidence, including the greater confidence in conclusions regarding the exposures contributing to the observed effects, we focus in this review, as in the last, on neurocognitive effects in young children.
As in the last review, we base our current understanding of health effects associated with different Pb exposure circumstances at various stages of life or in different populations on the full body of available evidence and primarily on epidemiological studies of health effects associated with population Pb biomarker levels (as discussed further in section II.B.3 of the proposal). The epidemiological evidence is overwhelmingly composed of studies that rely on blood Pb for the exposure metric, with the remainder largely including a focus on bone Pb. Because these metrics reflect Pb in the body (
A critical aspect of much of the epidemiological evidence, particularly studies focused on adults (and older children) in the U.S. today, is the backdrop of generally declining environmental Pb exposure (from higher exposures during their younger years) that is common across many study populations (ISA, p. 4-2).
Epidemiological analyses evaluating risk of neurocognitive impacts (
In summary, as in the last review, we continue to recognize a number of uncertainties regarding the circumstances of Pb exposure, including timing or lifestages, eliciting specific health effects. Consideration of the evidence newly available in this review has not appreciably changed our understanding on this topic. The relationship of long-term exposure to Pb with hypertension and increased blood pressure in adults is substantiated despite some uncertainty regarding the exposure circumstances contributing to blood Pb levels measured in epidemiological studies. For example, the evidence does not indicate the exposure magnitude and timing that are eliciting such effects. Across the full evidence base, the effects for which our understanding of relevant exposure circumstances is greatest are neurocognitive effects in young children. Moreover, available evidence does not suggest a more sensitive endpoint. Thus, we continue to recognize and give particular attention to the role of Pb exposures relatively early in childhood in contributing to neurocognitive effects, some of which may persist into adulthood.
The evidence currently available with regard to the magnitude of blood Pb levels associated with neurocognitive effects in children is generally consistent with that available in the review completed in 2008. Nervous system effects in children, specifically effects on cognitive function, continue to be the effects that are best substantiated as occurring at the lowest blood Pb concentrations (ISA, pp. lxxxvii-lxxxviii). Associations of blood Pb with effects on cognitive function measures in children have been reported in many studies across a range of childhood blood Pb levels, including study group (mean/median) levels ranging down to 2 µg/dL (
Among the analyses of lowest study group blood Pb levels at the youngest ages are analyses available in the last review of Pb associations with neurocognitive function decrement in study groups with mean levels on the order of 3-4 μg/dL in children aged 24 months or ranging from 5 to 7 years (73 FR 66978-66979, November 12, 2008; ISA, sections 4.3.2.1 and 4.3.2.2; Bellinger and Needleman, 2003; Canfield et al., 2003; Lanphear et al., 2005; Tellez-Rojo et al., 2006; Bellinger, 2008; Canfield, 2008; Tellez-Rojo, 2008; Kirrane and Patel, 2014).
Newly available in this review are also several studies in older children on neurocognitive effects and other nervous system effects. As described in section II.B.3 of the proposal, however, these studies are focused on population groups of ages for which the available information indicates exposure levels were higher earlier in childhood. Thus, in light of this information, although the blood Pb levels in the studies in older child population groups are lower (at the time of the study) than the younger child study levels, the studies of older
Recognizing the complexity associated with interpretation of studies involving older cohorts,
We additionally note that, as in the last review, a threshold blood Pb level with which nervous system effects, and specifically cognitive effects, occur in young children cannot be discerned from the currently available studies (ISA, sections 1.9.3 and 4.3.12). Epidemiological analyses have reported blood Pb associations with cognitive effects (FSIQ or BSID MDI
Important uncertainties associated with the evidence of effects at low exposure levels are similar to those recognized in the last review, including the shape of the concentration-response relationship for effects on neurocognitive function at low blood Pb levels in today's young children. Also of note is our interpretation of associations between blood Pb levels and effects in epidemiological studies, with which we recognize uncertainty with regard to the specific exposure circumstances (timing, duration, magnitude and frequency) that have elicited the observed effects, as well as uncertainties in relating ambient air concentrations (and associated air-related exposures) to blood Pb levels in early childhood, as recognized in section II.A.2.b above. We additionally recognize uncertainties associated with conclusions drawn with regard to the nature of the epidemiological associations with blood Pb (
Based primarily on studies of FSIQ, the assessment of the currently available studies, as was the case in the last review, continues to recognize a nonlinear relationship between blood Pb levels and effects on cognitive function, with a greater incremental effect (greater slope) at lower relative to higher blood Pb levels within the range thus far studied, extending from well above 10 μg/dL to below 5 μg/dL (ISA, section 4.3.12). This was supported by the evidence available in the last review, including the analysis of the large pooled international dataset comprised of blood Pb measurements and IQ test results from seven prospective cohorts (Lanphear et al., 2005; Rothenberg and Rothenberg, 2005; ISA, section 4.3.12). The blood Pb measurements in this pooled dataset that were concurrent with the IQ tests ranged from 2.5 μg/dL to 33.2 μg/dL.
The study by Lanphear et al. (2005) additionally presented analyses that stratified the dataset based on peak blood Pb levels (
Several studies newly available in the current review have, in all but one instance, also found a nonlinear blood Pb-cognitive function relationship in nonparametric regression analyses of the cohort blood Pb levels analyzed (ISA, section 4.3.12). These studies, however, used statistical approaches that did not produce quantitative results for each blood Pb group (ISA, section 4.3.12). Thus, newly available studies have not extended the range of observation for quantitative estimates of this relationship to lower blood Pb levels than those of the previous review. The ISA further notes that the potential for nonlinearity has not been examined in detail within a lower, narrower range of blood Pb levels than those of the full cohorts thus far studied in the currently available evidence base (ISA, section 4.3.12). Such an observation in the last review supported the consideration of linear slopes with regard to blood Pb levels at and below those represented in Table 1 of the proposal. In summary, the newly available evidence does not substantively alter our understanding of the C-R relationship (including quantitative aspects) for neurocognitive impact, such as IQ, with blood Pb in young children.
In this section, as elsewhere, we use the term “at-risk populations”
In considering factors that increase risk by contributing to increased exposure or to increased blood Pb levels over those otherwise associated with a given Pb exposure, we note that the currently available evidence continues to support a nonlinear relationship between neurocognitive effects and blood Pb that indicates incrementally greater impacts at lower as compared to higher blood Pb levels (ISA, section 4.3.12), as described in section II.B.3 of the proposal and briefly noted in section II.A.2.c above. An important implication of this finding is that while children with higher blood Pb levels are at greater risk of Pb-related effects than children with lower blood Pb levels, on an incremental basis (
The information newly available in this review has not appreciably altered our previous understanding of at-risk populations for Pb in ambient air. As in the last review, the factor most prominently recognized to contribute to increased risk of Pb effects is childhood (ISA, section 1.9.6). As discussed in section II.B.2 of the proposal and briefly noted in section II.A.2.b above, while uncertainties remain with regard to the role of Pb exposures during a particular age of life in eliciting nervous system effects, such as cognitive function decrements, the full evidence base continues to indicate prenatal and early childhood lifestages as periods of increased Pb-related risk (ISA, sections 4.3.11 and 4.3.15). Thus, in the current review, as at the time of the last review of the Pb NAAQS, we recognize young children as an important at-risk population, with sensitivity extending to prenatal exposures and into childhood development.
An additional physiological risk factor that contributes to increased blood Pb levels is nutritional status, which can play a role in Pb absorption from the gastrointestinal tract, with iron-, calcium- and zinc-deficient diets contributing to increased Pb absorption and associated blood Pb levels (ISA, sections 3.2.1.2, 5.1, 5.3.10 and 5.4). Risk factors based on increased exposure include spending time in proximity to sources of Pb to ambient air or other environmental media, such as large active metals industries or locations of historical Pb contamination (ISA, sections 1.9.6, 3.7.1, 5.2.5 and 5.4). Residential factors associated with other sources of Pb exposure (
Lower socioeconomic status (SES) has been associated with higher Pb exposure and higher blood Pb concentration in some study groups, leading the ISA to conclude the evidence is suggestive for low SES as a risk factor (ISA, sections 5.3.16, 5.2.4 and 5.4).
In summary, we recognize the sensitivity of the prenatal period and several stages of childhood to an array of neurocognitive and behavioral effects, and we particularly recognize young children as an important at-risk population in light of current environmental exposure levels. Age or lifestage was used to distinguish potential groups on which to focus in the last review in recognition of its role in exposure and susceptibility, and young children were the focus of the REA in consideration of the health effects evidence regarding endpoints of greatest public health concern and in recognition of effects on the developing nervous system as a sentinel endpoint for public health impacts of Pb. This identification continues to be supported by the evidence available in the current review.
There are several potential public health impacts associated with Pb exposure in the current U.S. population. In recognition of effects causally related to blood Pb levels somewhat near those most recently reported for today's population and for which the weight of the evidence is greatest, the potential public health impacts most prominently recognized in the ISA are population IQ impacts associated with childhood Pb exposure and prevalence of cardiovascular effects in adults (ISA, section 1.9.1). With regard to the latter category, as discussed above, the full body of evidence indicates a role of long-term cumulative exposure, with uncertainty regarding the specific exposure circumstances contributing to the effects in the epidemiological studies of adult populations, for whom historical Pb exposures were likely much higher than exposures that commonly occur today (ISA, section 4.4). There is less uncertainty regarding the exposure patterns contributing to the blood Pb levels reported in studies of younger populations (ISA, sections 1.9.4 and 1.10). Accordingly, the discussion of public health implications relevant to this review is focused predominantly on nervous system effects, including IQ decrements, in children.
The magnitude of a public health impact is dependent upon the type or severity of the effect, as well as the size of populations affected. Intelligence quotient is a well-established, widely recognized and rigorously standardized measure of neurocognitive function, as well as a global measure reflecting the integration of numerous processes (ISA, section 4.3.2; 2006 CD, sections 6.2.2 and 8.4.2). In considering population risk, the distribution of effects across members of the population is important. For example, if Pb-related decrements are manifested uniformly across the range of IQ scores in a population, “a small shift in the population mean IQ may be significant from a public health perspective because such a shift could yield a larger proportion of individuals functioning in the low range of the IQ distribution, which is associated with increased risk of educational, vocational, and social failure” as well as a decrease in the proportion with high IQ scores (ISA, section 1.9.1). Examples of other measures of cognitive function negatively associated with Pb exposure include other measures of intelligence and cognitive development and measures of other cognitive abilities, such as learning, memory, and executive functions, as well as academic performance and achievement (ISA, section 4.3.2). Although some neurocognitive effects of Pb in children may be transient, some may persist into adulthood (ISA, section 1.9.5).
As indicated above, young children are the at-risk population that may be most at risk of health effects associated with exposure to Pb, and children at greatest risk from
This section provides a brief overview of the information summarized in section II.C of the proposal on key aspects of the information available in this review on blood Pb as a biomarker and on relationships of blood Pb with air Pb (80 FR 298-300, January 5, 2015). Blood Pb is well established as a biomarker of Pb exposure and of internal dose, with relationships between air Pb concentrations and blood Pb concentrations informing consideration of the NAAQS for Pb since its initial establishment in 1978. The blood Pb concentration in childhood (particularly early childhood) can more quickly (than in adulthood) reflect changes in total body burden (associated with the shorter exposure history) and can also reflect changes in recent exposures (ISA, section 3.3.5). The relationship of children's blood Pb to recent exposure may reflect their labile bone pool, with their rapid bone turnover in response to rapid childhood growth rates (ISA, section 3.3.5). The relatively smaller skeletal compartment of Pb in children (particularly very young children) compared to adults is subject to more rapid turnover. Multiple studies have demonstrated young children's blood Pb levels to reflect Pb exposures, including exposures to Pb in surface dust (
As blood Pb is an integrated marker of aggregate Pb exposure across all pathways, the blood Pb C-R relationships described in epidemiological studies of Pb-exposed populations do not distinguish among different sources of Pb or pathways of
The evidence for air-to-blood relationships derives from analyses of datasets for populations residing in areas with differing air Pb concentrations, including datasets for circumstances in which blood Pb levels have changed in response to changes in air Pb. The control for variables other than air Pb that can affect blood Pb varies across these analyses. At the conclusion of the last review in 2008, the EPA interpreted the evidence as providing support for use (in informing the Administrator's decision on standard level) of a range of air-to-blood ratios
The evidence on the quantitative relationship between air Pb and air-related Pb in blood is now, as in the past, limited by the circumstances (such as those related to Pb exposure) in which the data were collected. Previous reviews have recognized the significant variability in air-to-blood ratios for different populations exposed to Pb through different air-related exposure pathways and at different air and blood levels, with the 1986 CD noting that ratios derived from studies involving the higher blood and air Pb levels pertaining to occupationally exposed workers are generally smaller than ratios from studies involving lower blood and air Pb levels (ISA, p. 3-132; 1986 CD, p. 11-99). Consistent with this observation, slopes in the range of 3 to 5 were estimated for child population datasets assessed in the 1986 CD (ISA, p. 3-132; 1986 CD p. 11-100; Brunekreef, 1984). Additional studies considered in the last review and those assessed in the ISA provide evidence of ratios above this older range (ISA, p. 3-133). For example, a ratio of 1:6.5 to 1:7 is indicated by the study by Hilts (2003), one of the few studies that evaluate the air Pb-blood Pb relationship in conditions that are closer to the current state in the U.S. (ISA, p. 3-132). We additionally note the variety of factors identified in the ISA that may potentially affect estimates of various ratios (including potentially coincident reductions in nonair Pb sources during the course of the studies) and for which a lack of complete information may preclude any adjustment of estimates to account for their role (ISA, section 3.5).
In summary, as at the time of the last review of the NAAQS for Pb, the currently available evidence includes estimates of air-to-blood ratios, both empirical and model-derived, with associated limitations and related uncertainties. These limitations and uncertainties, which are summarized here and also noted in the ISA, usually include uncertainty associated with reductions in other Pb sources during the study period. The limited amount of new information available in this review has not appreciably altered the scientific conclusions reached in the last review regarding relationships between Pb in ambient air and Pb in children's blood or with regard to the range of ratios. The currently available evidence continues to indicate ratios relevant to the population of young children in the U.S. today, reflecting multiple air-related pathways in addition to inhalation, to be generally consistent with the approximate range of 1:5 to 1:10 given particular attention in the 2008 NAAQS decision, including the “generally central estimate” of 1:7 (73 FR 67002, 67004, November 12, 2008; ISA, pp. 3-132 to 3-133).
This section provides a brief overview of key aspects of the risk and exposure assessment information available in this review, which is based primarily on the exposure and risk assessment developed in the last review of the Pb NAAQS.
The focus for the risk assessment and associated estimates is on Pb derived from sources emitting Pb to ambient air. In order to characterize exposure and risk from these pathways, however, the assessment also recognized the role of Pb exposure pathways unrelated to Pb in ambient air (2007 REA, section 2.1). Sources of human Pb exposure include current and historical air emissions sources, as well as miscellaneous nonair sources, which can contribute to multiple exposure media and associated pathways, such as inhalation of ambient air, ingestion of indoor dust, outdoor soil/dust and diet or drinking water (as recognized in section I.D above). In addition to airborne emissions (recent or
Limitations in our data and modeling tools handicapped our ability to address the various complexities associated with exposure to ambient air Pb and to fully separate the nonair contributions to Pb exposure from estimates of air-related Pb exposure and risk. As a result, the assessment included a number of simplifying assumptions in a number of areas, and the estimates of air-related Pb risk produced are approximate, characterized by bounds within which air-related Pb risk is estimated to fall. The lower bound is based on a combination of pathway-specific estimates that do not completely represent all air-related pathways, while the upper bound is based on a combination of pathway-specific estimates that includes pathways that are not air-related but the separating out of which is precluded by modeling and data limitations (PA, section 3.4).
Key aspects of the 2007 REA, such as the exposure populations, exposure or dose metric, health effects endpoint and risk metric were based on consideration of the then-currently available evidence as assessed in detail in the 2006 CD. As discussed in the REA Planning Document (USEPA, 2011b), these selections continue to be supported by the evidence now available in this review as described in the ISA. The REA focused on risk to the central nervous system in childhood as the most sensitive effect that could be quantitatively assessed, with decrement in IQ used as the risk metric. Exposure and biokinetic modeling was used to estimate blood Pb concentrations in children exposed to Pb up to age 7 years.
The 2007 REA relied on a case study approach to provide estimates that inform our understanding of air-related exposure and risk in different types of air Pb exposure situations. Lead exposure and associated risk were estimated for multiple case studies that generally represent two types of residential population exposures to air-related Pb: (1) Location-specific urban populations of children with a broad range of air-related exposures, reflecting existence of urban concentration gradients; and (2) children residing in localized areas with air-related exposures representing air concentrations specifically reflecting the standard level being evaluated (see PA, Table 3-6). Thus, the two types of case studies differed with regard to the extent to which they represented population variability in air-related Pb exposure.
In drawing on the 2007 REA for our purposes in this review, we focused on two case studies, one from each of these two categories: (1) The location-specific urban case study for Chicago and (2) the generalized (local) urban case study (PA, Table 3-6). The generalized (local) urban case study (also referred to as
Air-related risk estimates for the two case studies are accompanied by a number of uncertainties (summarized in section II.D.3 of the proposal and described in detail in section 3.4 of the PA). Exposure and risk modeling conducted for this analysis was complex and subject to significant uncertainties due to limitations in the data and models, among other aspects, as recognized at the time of the last review.
In drawing conclusions on the adequacy of the current primary Pb standard, in view of the advances in scientific knowledge and additional information now available, the Administrator considers the evidence base, information and policy judgments that were the foundation of the last review and reflects upon the body of evidence and information newly available in this review. The Administrator has taken into account both evidence-based and exposure- and risk-based considerations, advice from CASAC and public comment. Evidence-based considerations draw upon the EPA's assessment and integrated synthesis of the scientific evidence from epidemiological studies and experimental animal studies evaluating health effects related to exposures to Pb,
As described in section II.A.2 of the proposal, consideration of the evidence and exposure/risk information in the PA and by the Administrator is framed by consideration of a series of key policy-relevant questions. Section II.B.1 below summarizes the rationale for the Administrator's proposed decision, drawing from section II.E.4 of the proposal. A fuller presentation of PA considerations and conclusions, and advice from the CASAC, which were taken into account by the Administrator, is provided in sections II.E.1 through II.E.3 of the proposal. Advice received from CASAC in this review is briefly summarized in section II.B.2 below, and public comments on the proposed decision are addressed in section II.B.3. The Administrator's conclusions in this review regarding the adequacy of the current primary standard are described in section II.B.4.
At the time of the proposal, the Administrator carefully considered the assessment of the current evidence and conclusions reached in the ISA; the currently available exposure/risk information, including associated limitations and uncertainties; considerations and staff conclusions and associated rationales presented in the PA; the advice and recommendations from CASAC; and public comments that had been offered up to that point. In reaching her proposed conclusion on the primary standard, the Administrator first took note of the PA discussion with regard to the complexity and associated uncertainties involved in considering the adequacy of protection in the case of the primary Pb standard, which differs substantially from that involved in consideration of the primary standard in other NAAQS reviews. For the pollutants in the other reviews, the focus is on inhalation as the single route of exposures, which provides a relatively simpler context than the multiple exposure pathways that are relevant to Pb. Additionally, an important component of the evidence base for most other NAAQS pollutants is the availability of studies that have investigated an association between concentrations of the pollutant in ambient air and the occurrence of health effects plausibly related to ambient air exposure to that pollutant. Such studies of associations with air concentrations do not figure prominently in the review of the NAAQS for Pb. Rather, the evidence base in this review includes most prominently epidemiological studies focused on associations of blood Pb levels in U.S. populations with health effects plausibly related to Pb exposures occurring by multiple pathways. Support for conclusions regarding the plausibility for ambient air Pb to play a role in such findings derives, in part, from studies linking Pb in ambient air with the occurrence of health effects. However, such studies (dating from the past or from other countries) involve ambient air Pb concentrations many times greater than those that would meet the current standard. Thus, in considering the adequacy of the current Pb standard, rather than considering studies that have directly investigated current concentrations of Pb in ambient air (including in locations where the current standard is met) and the occurrence of health effects, we primarily consider the evidence for, and risk estimated from, models based upon key relationships, such as those among ambient air Pb, Pb exposure, blood Pb and health effects. This evidence, with its associated limitations and uncertainties, contributes to the EPA's conclusions regarding a relationship between ambient air Pb conditions under the current standard and health effects.
In considering the nature and magnitude of the array of uncertainties that are inherent in the scientific evidence and analyses, the Administrator recognized that the current understanding of the relationships between the presence of a pollutant in ambient air and associated health effects is based on a broad body of information encompassing not only more established aspects of the evidence, but also aspects in which there may be substantial uncertainty. In her considerations for the proposal, she took into account both the well-established body of evidence on the health effects of Pb, which continues to support identification of neurocognitive effects in young children as the most sensitive endpoint associated with Pb exposure, and of the recognition in the PA, with which the CASAC concurred, of increased uncertainty in characterizing the relationship of effects on IQ with blood Pb levels below those represented in the evidence base and also in projecting the magnitude of blood Pb response to ambient air Pb concentrations at and below the level of the current standard. In this light, she based her proposed decision on her consideration of the current evidence within the conceptual and quantitative context of the air-related IQ evidence-based loss framework; the available information and advice from CASAC regarding the public health significance of neurocognitive effects; and the limitations and uncertainties inherent in the evidence and its consideration within this framework. The Administrator additionally recognized support from the exposure/risk information, with its attendant uncertainties.
In her consideration of the air-related IQ loss evidence-based framework, the Administrator took note of the PA finding, with which the CASAC concurred, that application of the air-related IQ loss evidence-based framework, developed in the last review, continues to provide a useful approach for considering and integrating the evidence on relationships between Pb in ambient air and Pb in children's blood and risks of neurocognitive effects (for which IQ loss is used as an indicator). She additionally took note of the PA finding (described in section II.E.1 of the proposal, and with which the CASAC concurred) that the currently available evidence base, while somewhat expanded since the last review, is not supportive of appreciably different conclusions with regard to air-to-blood ratios or C-R functions for neurocognitive decrements in young children.
In the Administrator's consideration of the level of public health protection provided by the current standard, she gave weight to CASAC advice in the last review (and similar views expressed in the last review by public health experts, such as the American Academy of Pediatrics), which recognized a population mean IQ loss of 1 to 2 points to be of public health significance and recommended that a very high percentage of the population be protected from such a magnitude of IQ loss (73 FR 67000, November 12, 2008). In so doing, she additionally noted that the EPA is aware of no new information or new commonly accepted guidelines or criteria within the public health community for interpreting public health significance of neurocognitive effects in the context of a decision on adequacy of the current Pb standard, and CASAC provided no alternate advice in this area in the current review (PA, pp. 4-33 to 4-34). Accordingly, with the objective identified in the CASAC advice from the 2008 review in
The Administrator based her proposed conclusions on consideration of the health effects evidence, including consideration of this evidence in the context of the air-related IQ loss evidence-based framework, and with support from the exposure/risk information, recognizing the uncertainties attendant with both. In so doing, she took note of the PA description of the complexities and limitations in the evidence base associated with reaching conclusions regarding the magnitude of risk associated with the current standard, as well as the increasing uncertainty of risk estimates for lower air Pb concentrations. Inherent in the Administrator's proposed conclusions are public health policy judgments on the public health implications of the blood Pb levels and risk estimated for air-related Pb under the current standard, including the public health significance of the Pb effects being considered, as well as aspects of the use of the evidence-based framework that may be considered to contribute to the margin of safety. These public health policy judgments include judgments related to the appropriate degree of public health protection that should be afforded to protect against risk of neurocognitive effects in at-risk populations, such as IQ loss in young children, as well as with regard to the appropriate weight to be given to differing aspects of the evidence and the exposure/risk information, and how to consider their associated uncertainties. Based on these considerations and the judgments summarized here, the Administrator proposed to conclude that the current standard provides the requisite protection of public health with an adequate margin of safety, including protection of at-risk populations, such as young children living near Pb emissions sources where ambient concentrations just meet the standard.
The Administrator's proposed conclusion that the current standard provides the requisite protection and that a more restrictive standard would not be requisite additionally recognized that the uncertainties and limitations associated with many aspects of the estimated relationship between air Pb concentrations and blood Pb levels and associated health effects are amplified with consideration of increasingly lower air concentrations. In reaching her proposed conclusion, she took note of the PA conclusion, with which CASAC has agreed, that based on the current evidence, there is appreciable uncertainty associated with drawing conclusions regarding whether there would be reductions in blood Pb levels and risk to public health from alternative lower levels of the standard as compared to the level of the current standard (PA, pp. 4-35 to 4-36; Frey, 2013b, p. 6). The Administrator judged this uncertainty to be too great for the current evidence and exposure/risk information to provide a basis for revising the current standard. Thus, based on the public health policy judgments described above, including the weight given to uncertainties in the evidence, the Administrator proposed to conclude that the current standard should be retained, without revision.
In comments on the draft PA, the CASAC concurred with staff's overall preliminary conclusions that it is appropriate to consider retaining the current primary standard without revision, stating that “the current scientific literature does not support a revision to the Primary Lead (Pb) National Ambient Air Quality Standard (NAAQS)” (Frey, 2013b, p. 1). The CASAC further noted that “[a]lthough the current review incorporates a substantial body of new scientific literature, the new literature does not justify a revision to the standards” (Frey, 2013b, p. 1).
The CASAC comments additionally indicated agreement with key aspects of staff's consideration of the exposure/risk information and currently available evidence in this review (Frey, 2013b, Consensus Response to Charge Questions, p. 7).
The use of exposure/risk information from the previous Pb NAAQS review appears appropriate given the absence of significant new information that could fundamentally change the interpretation of the exposure/risk information. This interpretation is reasonable given that information supporting the current standard is largely unchanged since the current standard was issued.
The CASAC agrees that the adverse impact of low levels of Pb exposure on neurocognitive function and development in children remains the most sensitive health endpoint, and that a primary Pb NAAQS designed to protect against that effect will offer satisfactory protection against the many other health impacts associated with Pb exposure.
The CASAC concurs with the draft PA that the scientific findings pertaining to air-to-blood Pb ratios and the C-R relationships between blood Pb and childhood IQ decrements that formed the basis of the current Pb NAAQS remain valid and are consistent with current data.
The CASAC concurred with the appropriateness of the application of the evidence-based framework from the last Pb NAAQS review. With regard to the key inputs to that framework, the CASAC concluded that “[t]he new literature published since the previous review provides further support for the health effect conclusions presented in that review” and that the studies newly available in this review “do not fundamentally alter the uncertainties for air-to-blood ratios or C-R functions for IQ decrements in young children” (Frey, 2013b, Consensus Response to Charge Questions, p. 6). The comments from the CASAC also took note of the uncertainties that remain in this review which contribute to the uncertainties associated with drawing conclusions regarding air-related exposures and associated health risk at or below the level of the current standard, stating agreement with “the EPA conclusion that `there is appreciable uncertainty associated with drawing conclusions regarding whether there would be reductions in blood Pb levels from alternative lower levels as compared to the level of the current standard'” (Frey, 2013b, Consensus Response to Charge Questions, p. 6).
The majority of public comments on the proposal supported the Administrator's proposed decision to retain the current primary standard, without revision. This group includes the National Association of Clean Air
Four submissions recommending revision of the standard were received; all four advocated a tightening of the standard. These commenters include two individuals, a secondary Pb smelting company, and the Children's Health Protection Advisory Committee to the EPA (CHPAC).
The four commenters that supported revision of the standard suggested a wide array of alternatives. The CHPAC repeated the view it expressed in the 2008 review that the standard should be revised to the most stringent alternative analyzed in the 2007 REA (a potential standard with an averaging time of one month and a level of 0.02 µg/m
We agree with commenters that a threshold level for neurocognitive effects has not been identified in the current evidence, as stated in section II.A.2.c above, and described in more detail in the ISA. We additionally note that the lack of an established threshold of effects is not uncommon among the criteria pollutant evidence bases. For example, in past reviews of the primary standards for ozone and particulate matter, the EPA has recognized that the available epidemiological evidence neither supports nor refutes the existence of thresholds at the population level, while noting uncertainties and limitations in studies that make discerning thresholds in populations difficult (
In the setting of the current standard in 2008, a key consideration of the Administrator was the recognition of the lack of a discernible threshold level in the evidence with respect to neurocognitive effects associated with Pb exposure. This recognition, which differed from the scientific consensus at the time the previous standard was set in 1978, led the Administrator in 2008 to depart from the threshold-based approach used in setting the 1978 standard and to focus on consideration of air-related Pb in the context of the air-related IQ loss evidence-based framework (described in section II.A.1
The four submissions recommending a revised standard variously cite a number of studies as providing support for their view. Some of these studies have been reviewed in the ISA, some were published too late to be included in the ISA, and a few others were of a type that are not generally included in the ISA (
We respectfully disagree with the comment from CHPAC that studies available since the cut-off date for the ISA contradict the PA conclusions regarding blood Pb levels in children and effects on cognitive function measures, such as IQ.
We further disagree with the suggestion in the CHPAC submission that the evidence related to co-exposures to other pollutants, such as metals, provides a basis for concluding that the current standard is not requisite. The ISA assessment of the strength of the evidence for co-exposures to other pollutants, such as other metals, to contribute to increased risk of a Pb-related health effects concluded the evidence to be suggestive, “but overall the evidence was limited” (ISA, sections 1.9.6 and 5.4). With regard to the articles cited by the CHPAC that have been published subsequent to the ISA, the general conclusions of these review articles (Henn et al., 2014; Grandjean and Landrigan, 2014) are consistent with conclusions of the ISA. As stated in the ISA, “interactions between Pb and co-exposure with other metals were evaluated in recent epidemiologic and toxicological studies of health effects” and “[h]igh levels of other metals, such as Cd and Mn, were observed to result in greater effects for the associations between Pb and various health endpoints but evidence was limited due to the small number of studies” (ISA, p. 5-43). We note that even in raising co-exposure as a concern, the comments recognize that the potential for such impacts is not well understood. Further, the comments do not explain how the limited information regarding this factor supports their conclusion that the current standard does not provide the requisite protection or leads to the specific revisions the comments suggest, and we find no such support in the current evidence.
We additionally disagree with the comment that the currently available evidence indicates that the current standard is not protective of effects such as low birth weight. For example, the
With regard to information related to Pb impacts in minority and low-income populations, which some comments suggested provided a basis for a more stringent standard, we note that we have considered the available information on such impacts, as recognized in section II.A.2.d above and summarized more fully in section II.B.4 of the proposal and in section 3.3 of the PA. As all of these documents have recognized, the ISA identifies non-white populations as at-risk populations, with this conclusion based primarily on findings of higher blood Pb levels in black compared to white populations (ISA, section 5.4).
With regard to consideration of the potential for risk reduction from lower air concentrations, the PA stated that “the uncertainties and limitations associated with many aspects of the estimated relationships between air Pb concentrations and blood Pb levels and associated health effects are amplified with consideration of increasingly lower air concentrations” (PA, p. 4-35). Contrary to the suggestion by the CHPAC and the smelter company, the PA did not conclude that there would be public health benefits from a lower standard and that such benefits were not large enough to warrant revising the standard. Rather, the PA notes that “[a]s recognized at the time of the last review, exposure and risk modeling conducted for [the REA] was complex and subject to significant uncertainties” (PA, p. 3-67) and recognizes “increasing uncertainty of risk estimates” for air Pb concentrations below those associated with the current standard (PA, p. 4-35). The PA further stated that that “there is appreciable uncertainty associated with drawing conclusions regarding whether there would be reductions in blood Pb levels and risk to public health from alternative lower levels of the standard as compared to the level of the current standard” (PA, pp. 4-35 to 4-36). The CASAC stated that it agreed with this conclusion regarding “[t]he obvious uncertainty” articulated in the PA, additionally stating, as noted above, that “[a]lthough there is evidence that even
The comment regarding a potential for increases in air Pb near sources of Pb emissions if the standard is not revised does not explain how such a potential provides support for revising the standard. The comment also suggests that EPA consider two alternative standard levels well below the current standard level while providing no explanation of why a revised standard with either of the suggested levels would be requisite. With regard to the potential for increases in air Pb near sources of Pb emissions if the standard is not revised, we note that such a concern, to the extent it applies to the current standard, would also pertain to any more stringent Pb standard except in the extreme case in which the standard is set such that there is no location with air quality conditions better than those that just meet the standard. As discussed in sections II.B.1 above and II.B.4 below, the Administrator has considered the current evidence and exposure/risk information with regard to the potential for a revised standard to offer additional protection, found there to be substantial uncertainty associated with such a potential, and concluded that the current standard is requisite. Regarding the possibility that air Pb concentrations could increase in some locations, we additionally note that the Clean Air Act and associated EPA permitting regulations restrict increases in air Pb concentrations (and in other pollutants for which there are NAAQS) in various circumstances, both in areas already meeting the NAAQS as well as those in nonattainment (
Regarding the view expressed by some commenters that the most restrictive standard assessed in the 2007 REA should be adopted,
Comments on topics less directly related to consideration of the primary standard included recommendations for addressing data gaps and uncertainties to inform future reviews. Additionally, one comment focused on pathways by which Pb may be further distributed in the environment, recommending use of a “more robust [monitoring] network to adequately estimate children's lead exposures from transient and other sources,” emphasizing building demolition and Pb wheel weights. This comment also states that the PA overlooks the contribution from these and other sources and therefore may underestimate the number of children exposed to Pb from transient sources. Another comment described leaded aviation gasoline and airports as a source of Pb emissions but did not explain how such information was relevant to the Administrator's proposed decision that the current standard provided the requisite protection and should be retained without revision.
With regard to the need for research, the PA highlighted key uncertainties associated with reviewing and establishing NAAQS for Pb and areas for future health-related research, model development, and data gathering. The topic areas of key uncertainties, research questions and data gaps that were highlighted in the PA with regard to review of the health-based primary standard overlap with many raised by commenters. We encourage research in these areas, although we note that research planning and priority setting are beyond the scope of this action.
With regard to the monitoring network in place for Pb NAAQS
In addition to this monitoring required for Pb NAAQS surveillance, state or local agencies may site additional monitors and there are also particulate matter monitoring networks that collect Pb data in specific particle size fractions in many urban areas (40 CFR part 58, appendix D, section 4.5). Further, as described in section I.E above,
As to the comment on the significance of building demolition or Pb wheel weights in contributing to environmental Pb exposure pathways, the ISA and PA considered the very limited available data pertaining to these issues. With regard to building demolition, for which the data are in terms of loading of dust containing Pb on alleys and sidewalks immediately following an event, the ISA concludes that the limited data “suggest that building demolition may be a short-term source of Pb in the environment,” and that “it is unclear if demolition is related to long-term Pb persistence in the environment” (ISA, p. 2-21).
Having carefully considered the public comments, as discussed above, the Administrator believes that the fundamental scientific conclusions on the effects of Pb in ambient air reached in the ISA and PA, and summarized in sections II.B and II.C of the proposal, remain valid. Additionally, the Administrator believes the judgments she reached in the proposal (section II.E.4) with regard to consideration of the evidence and quantitative exposure/risk information remain appropriate. Thus, as described below, the Administrator concludes that the current primary standard provides the requisite protection of public health with an adequate margin of safety and should be retained.
In considering the adequacy of the current primary Pb standard, the Administrator has carefully considered the current policy-relevant evidence and conclusions contained in the ISA; the evaluation of this evidence and the exposure/risk information, rationale and conclusions presented in the PA; the advice and recommendations from the CASAC; and public comments. In the discussion below, the Administrator gives weight to the PA conclusions, with which the CASAC has concurred, as summarized in section II of the proposal, and takes note of key aspects of the rationale for those conclusions that contribute to her decision in this review.
As an initial matter, the Administrator recognizes the complexity involved in considering the adequacy of protection in the case of the primary Pb standard, which differs substantially from that involved in consideration of the health protection provided by the primary standards in other NAAQS reviews. For the pollutants in the other reviews, the more limited focus solely on the inhalation pathways of exposure is a relatively simpler context. Further, as
The Administrator recognizes that in primary NAAQS reviews, our understanding of the relationships between the presence of a pollutant in ambient air and associated health effects is based on a broad body of information encompassing not only more established aspects of the evidence, but also aspects in which there may be substantial uncertainty. In the case of this review of the primary standard for Pb, she takes note of the increased uncertainty in characterizing the relationship of effects on IQ with blood Pb levels below those represented in the evidence base and in projecting the magnitude of blood Pb response to ambient air Pb concentrations at and below the level of the current standard. The PA recognizes this increased uncertainty, particularly in light of the multiple factors that play a role in such a projection (
With regard to the current evidence, as summarized in the PA and discussed in detail in the ISA, the Administrator takes note of the well-established body of evidence on the health effects of Pb, which has been augmented in some aspects since the last review and continues to support identification of neurocognitive effects in young children as the most sensitive endpoint associated with Pb exposure. For example, while the ISA continues to recognize cardiovascular effects in adults, in addition to neurodevelopmental effects in children, as being associated with the lowest blood Pb levels compared to other health effects (ISA, pp. xciii), the ISA also notes uncertainties regarding the timing, frequency, duration and level of Pb exposures contributing to the effects observed in adult epidemiologic studies and indicates that higher exposures in the past (rather than lower current exposures) may contribute to the development of health effects measured later in life (ISA, p. lxxxviii). Given the evidence-based identification of neurocognitive effects in young children as the most sensitive endpoint associated with Pb exposure, the Administrator has accordingly focused on nervous system effects in young children and particularly neurocognitive effects. In so doing, she finds that the evidence, while describing a broad array of health effects associated with Pb, continues to indicate that a standard that provides protection from neurocognitive effects in young children additionally provides protection from other health effects of Pb, such as those reported in adult populations.
The Administrator takes note of the PA finding that application of the air-related IQ loss evidence-based framework, developed in the last review, continues to provide a useful approach for considering and integrating the evidence on relationships between Pb in ambient air and Pb in young children's blood and risks of neurocognitive effects (for which IQ loss is used as an indicator). In so doing, as in the 2008 review, she notes that the framework, and the IQ loss estimates yielded by it for specific combinations of standard level, air-to-blood ratio and C-R function, does not provide an evidence- or risk-based bright line that indicates a single appropriate level for the standard. Further, the Administrator recognizes uncertainties associated with IQ estimates produced by the framework, noting the PA conclusion that the uncertainties increase with estimates associated with successively lower standard levels. She additionally takes note of the PA finding (described in section II.E.1 of the proposal) that the currently available evidence base, while somewhat expanded since the last review, is not appreciably expanded or supportive of appreciably different conclusions with regard to air-to-blood ratios or C-R functions for neurocognitive decrements in young children. The Administrator further notes the concurrence from the CASAC on both of these points and the lack of recommendations in public comments for a change to either of these inputs to the evidence-based framework. Thus, she judges the evidence base and related air-related IQ loss framework to be an appropriate tool for informing her decision on the adequacy of the current standard.
In light of the continuum referenced above, the Administrator additionally recognizes in this review, as in the 2008 review, the role of judgment in reaching conclusions regarding Pb health effects that are important from a public health perspective. Most specifically, the Administrator has considered the public health significance of a decrement of a very small number of IQ points in the at-risk population of young children, in light of associated uncertainties. With regard to making a public health policy judgment as to the appropriate protection against risk of air-related IQ loss and related effects, the Administrator believes, as did the Administrator at the time of the last review, that ideally air-related (as well as other) exposures to environmental Pb would be reduced to the point that no IQ impact in children would occur. She recognizes, however, that in the case of setting NAAQS, she is required to make a judgment as to what degree of protection is requisite (neither more nor less than necessary) to protect public health with an adequate margin of safety. As described in the proposal with regard to considering the public health significance of IQ loss estimates in young children, the Administrator gives weight to the comments of the CASAC and some public commenters in the last review which recognized a population mean IQ loss of 1 to 2 points to be of public health significance and recommended that a very high
With the objective identified by the CASAC in the 2008 review in mind, the Administrator recognizes, as was recognized at the time of the last review, that her judgment on the degree of protection against IQ impacts that should be afforded by the primary standard is particularly focused on consideration of impacts in the at-risk population and is not addressing a specific quantitative public health policy goal for air-related decrements in IQ that would be acceptable or unacceptable for the entire population of children in the U.S. As in the last review, the at-risk population to which she gives particular attention is the small subset of U.S. children living in close proximity to air Pb sources that contribute to elevated air Pb concentrations that equal the level of the standard). Accordingly, she is considering IQ impacts in this small subset of U.S. children that is expected to experience air-related Pb exposures at the high end of the national distribution of such exposures (as described in section II.E.4 of the proposal and summarized in section II.B.1 above), and not a projection of the average air-related IQ loss for the entire U.S. population of children. The evidence-based framework estimates, with which there are associated uncertainties and limitations (as described in section II.A.1 above), relate to this small subset of children exposed at the level of the standard. Based on these considerations, the Administrator judges the conceptual evidence-based framework to continue to be appropriate for her consideration of the public health protection afforded by the current standard. Further, she concurs with the PA findings (summarized in section II.E.1 of the proposal and briefly outlined in II.B.1 above) that the current evidence, as considered within the conceptual and quantitative context of the evidence-based framework, and current air monitoring information indicate that the current standard would be expected to satisfy the public health policy goal recommended by the CASAC in the last Pb NAAQS review, from which it did not indicate a departure in the present review.
In the context of the Administrator's use of the framework as a tool to inform her decision on the adequacy of the current standard, the EPA additionally notes that the maximum, not to be exceeded, form of the standard, in conjunction with the rolling 3-month averaging time, is expected to result in the at-risk population of children being exposed below the level of the standard most of the time (73 FR 67005, November 12, 2008). In light of this and the uncertainty in the relationship between time period of ambient level, exposure, and occurrence of a health effect, the air-related IQ loss considered for the current standard in applying the framework should not be interpreted to mean that a specific level of air-related IQ loss will occur in fact in areas where the standard is just met or that such a loss has been determined as acceptable if it were to occur. Instead, judgment regarding such an air-related IQ loss is one of the judgments that need to be made in using the evidence-based framework to provide useful guidance in the context of public health policy judgment on the degree of protection from risk to public health that is sufficient but not more than necessary, taking into consideration the patterns of air quality that would likely occur upon just meeting the standard and uncertainties in relating those patterns to exposures and effects.
In drawing conclusions regarding adequacy of the current standard based on considering application of the evidence-based framework, the Administrator further recognizes the degree to which IQ loss estimates drawn from the air-related IQ loss evidence-based framework reflect mean blood Pb levels that are below those represented in the currently available evidence for young children, as described in section II.B.4 of the proposal. The Administrator views such an extension below the lowest studied levels to be reasonable given the lack of identified blood Pb level threshold in the current evidence base for neurocognitive effects and the need for the NAAQS to provide a margin of safety. She additionally takes note, however, of the PA finding that the framework IQ loss estimates for standard levels lower than the current standard level represent still greater extrapolations from the current evidence base with corresponding increased uncertainty (PA, section 3.2, pp. 4-32 to 4-33). The Administrator also gives weight to the PA conclusion of greater uncertainty with regard to relationships between concentrations of Pb in ambient air and air-related Pb in children's blood, and with regard to estimates of the slope of the C-R function of neurocognitive impacts (IQ loss) for application of the framework to levels below the current standard, given the weaker linkage with existing evidence as discussed in the PA (PA, sections 3.1, 3.2 and 4.2.1). Thus, consistent with the conceptual continuum referenced above, the Administrator recognizes the increasing uncertainty with regard to likelihood of response and magnitude of the estimates at levels extending below the current standard.
With respect to exposure/risk-based considerations, as in the last review, the Administrator notes the complexity of the REA modeling analyses and the associated limitations and uncertainties. Based on consideration of the risk-related information for conditions just meeting the current standard, the Administrator takes note of the attendant uncertainties, discussed in detail in the PA (PA, sections 3.4 and 4.2.2), while finding that the quantitative risk estimates, with a focus on those for the generalized (local) urban case study, are roughly consistent with and generally supportive of estimates from the air-related IQ loss evidence-based framework. She further takes note of the PA finding of increasing uncertainty for air quality scenarios involving air Pb concentrations increasingly below the current conditions for each case study, due in part to modeling limitations that derive from uncertainty regarding relationships between ambient air Pb and outdoor soil/dust Pb and indoor dust Pb (PA, sections 3.4.3.1 and 3.4.7).
Based on the above evidence- and exposure/risk-based considerations and with consideration of advice from CASAC and public comment, the Administrator concludes that the current standard provides protection for young children from neurocognitive impacts, including IQ loss, that is consistent with advice from CASAC regarding IQ loss of public health significance. Based on consideration of the evidence and exposure/risk information available in this review with its attendant uncertainties and limitations, and information that might inform public health policy judgments, as well as advice from CASAC, including its concurrence with the PA conclusions that revision of the primary Pb standard is not warranted at this time, the Administrator further concludes that it is appropriate to retain
In reaching this conclusion with regard to the adequacy of public health protection afforded by the existing primary standard, the Administrator recognizes that in establishing primary standards under the Act that are requisite to protect public health with an adequate margin of safety, she is seeking to establish standards that are neither more nor less stringent than necessary for this purpose. The Act does not require that primary standards be set at a zero-risk level, but rather at a level that avoids unacceptable risks to public health, even if the risk is not precisely identified as to nature or degree. The CAA requirement that primary standards provide an adequate margin of safety was intended to address uncertainties associated with inconclusive scientific and technical information available at the time of standard setting, as described in section I.A above. This requirement was also intended to provide a reasonable degree of protection from hazards that research has not yet identified.
In this context, the Administrator has considered conclusions drawn in the ISA and PA with regard to interpretation of the information concerning the broader array of health effects of Pb beyond those on the nervous system of young children. Based on the body of evidence in support of identification of neurocognitive effects in young children as the most sensitive endpoint associated with Pb exposure, as noted previously in this section and briefly summarized in section II.A.2 above, she judges that a standard providing protection from such effects additionally provides adequate protection against the risk of other health effects and she further concludes that consideration of the more limited and less certain information concerning Pb exposures associated with such other effects does not lead her to identify a need for any greater protection.
Further, the Administrator's conclusion that the current standard provides the requisite protection and that a more restrictive standard would not be requisite additionally recognizes that the uncertainties and limitations associated with the many aspects of the estimated relationships between air Pb concentrations and blood Pb levels and associated health effects are amplified with consideration of increasingly lower air concentrations. In reaching this conclusion, she additionally takes note of the PA conclusion, with which the CASAC has agreed, that based on the current evidence, there is appreciable uncertainty associated with drawing conclusions regarding whether there would be reductions in blood Pb levels and risk to public health from alternative lower levels of the standard as compared to the level of the current standard (PA, pp. 4-35 to 4-36; Frey, 2013b, Consensus Response to Charge Questions, p. 6). The Administrator judges this uncertainty to be too great for the current evidence and exposure/risk information to provide a basis for revising the current standard. Thus, based on the public health policy judgments described above, including the weight given to uncertainties in the evidence, the Administrator concludes that the current standard should be retained, without revision.
For the reasons discussed above, and taking into account information and assessments presented in the ISA and PA, the advice from CASAC, and consideration of public comments, the Administrator concludes that the current primary standard for Pb is requisite to protect public health with an adequate margin of safety, including the health of at-risk populations, and is retaining the standard without revision.
This section presents the rationale for the Administrator's decision to retain the existing secondary Pb standard, which, as discussed more fully below, is based on a thorough review in the ISA of the latest scientific information, generally published through September 2011, on welfare effects associated with Pb and pertaining to the presence of Pb in the ambient air. This decision also takes into account (1) the PA's staff assessments of the most policy-relevant information in the ISA and staff analyses of potential ecological exposures and risk, upon which staff conclusions regarding appropriate considerations in this review are based; (2) the CASAC advice and recommendations, as reflected in discussions of drafts of the ISA and PA at public meetings, in separate written comments, and in the CASAC's letters to the Administrator; (3) public comments received during the development of these documents, either in connection with CASAC meetings or separately; and (4) public comments on the proposal.
Section III.A provides background on the general approach for the review of the secondary NAAQS for Pb and brief summaries of key aspects of the current body of evidence on welfare effects associated with Pb exposures and the exposure/risk information considered in this review. Section III.B summarizes the basis for the proposed decision and advice from the CASAC, addresses public comments and presents the conclusions the Administrator has drawn from a full consideration of the information. Section III.C summarizes the Administrator's decision on the secondary standard.
As provided in the Act, the secondary standard is to “specify a level of air quality the attainment and maintenance of which in the judgment of the
In the last review, completed in 2008, the current secondary standard for Pb was revised substantially, consistent with the revision to the primary standard (73 FR 66964, November 12, 2008). The 2008 decision considered the body of evidence as assessed in the 2006 CD (USEPA, 2006a) as well as the 2007 Staff Paper assessment of the policy-relevant information contained in the 2006 CD and the screening-level ecological risk assessment (2006 REA; USEPA, 2007b), the advice and recommendations of CASAC (Henderson 2007a, 2007b, 2008a, 2008b), and public comment. At that time, the Staff Paper concluded, based on laboratory studies and current media concentrations in a wide range of locations, that it seemed likely that adverse effects were occurring from ambient air-related Pb, particularly near point sources, under the then-current standard (73 FR 67010, November 12, 2008). Given the limited data on Pb effects in ecosystems, and associated uncertainties, such as those with regard to factors such as the presence of multiple metals and historic environmental burdens, the EPA also considered the evidence of Pb effects on organisms with regard to implications for ecosystem effects. Taking into account the available evidence and information on media concentrations in a wide range of locations, the Administrator concluded that there was potential for adverse effects occurring under the then-current standard; however there were insufficient data to provide a quantitative basis for setting a secondary standard different from the primary (73 FR 67011, November 12, 2008). Therefore, citing a general lack of data that would indicate the appropriate level of Pb in environmental media that may be associated with adverse effects, as well as the comments of the CASAC Pb panel that a significant change to current air concentrations (
Building on the approach and findings in the last review, this current review of the secondary standard considers the currently available scientific and technical information in the context of key policy-relevant questions. This review focuses on the consideration of the extent to which the body of scientific evidence now available calls into question the adequacy of the current standard. In considering the scientific and technical information, we draw on the ecological effects evidence presented in detail in the ISA and aspects summarized in the PA, along with the information associated with the screening-level risk assessment also in the PA. Thus, we have taken into account both evidence-based and risk-based considerations pertaining to the series of policy-relevant questions presented in the PA. These questions generally address the extent to which we are able to characterize effects and the likelihood of adverse effects in the environment under the current standard. Our approach to considering this information recognizes that the available welfare effects evidence generally reflects laboratory-based evidence of toxicological effects on specific organisms exposed to concentrations of Pb (ISA, section 6.5). Additionally, it is widely recognized that environmental exposures from atmospherically derived Pb are likely to be lower than those commonly assessed in laboratory studies and that studies of exposures similar to those in the environment are often accompanied by significant confounding and modifying factors (
Welfare effects include, but are not limited to, “effects on soils, water, crops, vegetation, man-made materials, animals, wildlife, weather, visibility and climate, damage to and deterioration of property, and hazards to transportation, as well as effects on economic values and on personal comfort and wellbeing” (CAA, section 302(h)). In this section, we provide an overview of the key aspects of the current evidence of Pb-related welfare effects that is assessed in the ISA and the 2006 CD, drawing from the summary of policy-relevant aspects in the PA (PA, section 5.1) and section III.B of the proposed rulemaking (80 FR 314-317, January 5, 2015).
Lead has been demonstrated to have harmful effects on reproduction and development, growth, and survival in many species as described in the assessment of the evidence available in this review and consistent with the conclusions drawn in the last review (ISA, section 1.7; 2006 CD, sections 7.1.5 and 7.2.5). A number of studies on ecological effects of Pb are newly available in this review and are critically assessed in the ISA as part of the full body of evidence. The full body of currently available evidence reaffirms conclusions on the array of effects recognized for Pb in the last review (ISA, section 1.7). In so doing, in the context of pollutant exposures considered relevant the ISA determines
As in prior reviews of the Pb NAAQS, this review is focused on those effects most pertinent to ambient air Pb exposures. Given the reductions in ambient air Pb concentrations over the past decades, these effects are generally those associated with the lowest levels of Pb exposure that have been evaluated. Additionally, we recognize the limitations on our ability to draw conclusions about environmental exposures from ecological studies of organism-level effects, as most studies were conducted in laboratory settings which may not accurately represent field conditions or the multiple variables that govern exposure.
The relationship between ambient air Pb and ecosystem response is important in making the connection between current emissions of Pb and the potential for adverse ecological effects. The limitations in the data available on this subject for the last review were significant. There is no new evidence since the last review that substantially improves our understanding of the relationship between ambient air Pb and measurable ecological effects. As stated in the last review, the role of ambient air Pb in contributing to ecosystem Pb has been declining over the past several decades. It remains difficult to apportion exposure between air and other sources to inform our understanding of the potential for ecosystem effects that might be associated with air emissions (ISA, section 6.4). Further, considerable uncertainties also remain in drawing conclusions from effects evidence observed under laboratory conditions with regard to effects expected at the ecosystem level in the environment (ISA, section 6.5). In summary, the ISA concludes that “[r]ecent information available since the 2006 Pb AQCD, includes additional field studies in both terrestrial and aquatic ecosystems, but the connection between air concentration and ecosystem exposure continues to be poorly characterized for Pb and the contribution of atmospheric Pb to specific sites is not clear” (ISA, section 6.5).
The bioavailability of Pb is also an important component of understanding the effects Pb is likely to have on organisms and ecosystems (ISA, section 6.3.3, 6.4.4 and 6.4.14). It is the amount of Pb that can interact within the organism that can lead to toxicity, and there are many factors which govern this interaction (ISA, sections 6.2.1 and 6.3.3). The bioavailability of metals varies widely depending on the physical, chemical, and biological conditions under which an organism is exposed (ISA, section 6.3.3). Studies newly available since the last Pb NAAQS review provide additional insight into factors that influence the bioavailability of Pb to specific organisms (ISA, section 6.3.3). On the whole, the current evidence, including that newly available in this review, supports previous conclusions regarding environmental conditions affecting bioavailability and the associated potential for adverse effects of Pb on organisms and ecosystems (ISA, section 6.3.3). Looking beyond organism-level evidence, the evidence of adversity in natural systems remains sparse due to the difficulty in determining the effects of confounding factors such as co-occurring metals or system characteristics that influence bioavailability of Pb in field studies. As summarized in the ISA, “in natural environments, modifying factors affect Pb bioavailability and toxicity and there are considerable uncertainties associated with generalizing effects observed in controlled studies to effects at higher levels of biological organization” and “[f]urthermore, available studies on community and ecosystem-level effects are usually from contaminated areas where Pb concentrations are much higher than typically encountered in the environment” (ISA, p. xcvi).
There is no new evidence since the last review that substantially improves our understanding of the relationship between ambient air Pb and measurable ecological effects beyond what was understood in the last review. As stated in the last review, the role of ambient air Pb in contributing to ecosystem Pb has been declining over the past several decades. It remains difficult to apportion exposure between air and other sources to better inform our understanding of the potential for ecosystem effects that might be associated with air emissions. As noted in the ISA, “[t]he amount of Pb in ecosystems is a result of a number of inputs and it is not currently possible to determine the contribution of atmospherically-derived Pb from total Pb in terrestrial, freshwater or saltwater systems” (ISA, section 6.5). Further, considerable uncertainties also remain in drawing conclusions from evidence of effects observed under laboratory conditions with regard to effects expected at the ecosystem level in the environment. In many cases it is difficult to characterize the nature and magnitude of effects and to quantify relationships between ambient concentrations of Pb and ecosystem response due to the existence of multiple stressors, variability in field conditions, and differences in Pb bioavailability at that level of organization (ISA, section 6.5). In summary, the ISA concludes that “[r]ecent information available since the 2006 Pb AQCD, includes additional field studies in both terrestrial and aquatic ecosystems, but the connection between air concentration and ecosystem exposure continues to be poorly characterized for Pb and the contribution of atmospheric Pb to specific sites is not clear” (ISA, section 6.5).
The risk assessment information available in this review and summarized
The 2006 screening-level assessment focused on estimating the potential for ecological risks associated with ecosystem exposures to Pb emitted into ambient air (PA, section 5.2; 2006 REA, section 7). Both a national-scale screen and a case study approach were used to evaluate the potential for ecological impacts that might be associated with atmospheric deposition of Pb (2006 REA, section 7.1.2). Detailed descriptions of the location-specific case studies and the national screening assessment, key findings of the risk assessment for each, and an interpretation of the results with regard to past air quality conditions are presented in the 2006 REA. This information, which is outlined below, is summarized more fully in section 5.2 of the PA and section III.C of the proposal for this review (80 FR 317-319, January 5, 2015).
In interpreting the results from the 2006 REA, the PA considers the availability of new evidence that may inform interpretation of risk under the now-current standard (PA, section 5.2). Factors that could alter our interpretation of risk would include new evidence of harm at lower concentrations of Pb, new linkages that enable us to draw more explicit conclusions as to the air contribution of environmental exposures, and new methods of interpreting confounding factors that were largely uncontrolled in the previous risk assessment. In general, however, such new evidence is limited, and the key uncertainties identified in the last review remain today. For example, with regard to new evidence of Pb effects at lower concentrations, it is necessary to consider that the evidence of adversity in natural systems due specifically to Pb is limited, in no small part because of the difficulty in determining the effects of confounding factors such as multiple metals and modifying factors influencing bioavailability in field studies, as noted in section III.A.1 above. Modeling of Pb-related exposure and risk to ecological receptors is subject to a wide array of sources of both variability and uncertainty resulting in differences in Pb bioavailability as well as exposure (USEPA, 2005b). Additionally, there are also significant difficulties in quantifying the role of air emissions under the current standard, which is significantly lower than the previous standard. As recognized in the PA, Pb deposited before the standard was enacted remains in soils and sediments, complicating interpretations regarding the impact of the current standard (PA, section 1.3.2). For example, media in ecosystems across the U.S. are still recovering from the past period of greater atmospheric emissions and deposition, as well as from Pb derived from nonair sources (PA, section 1.3.2).
As summarized in the PA and proposal, we have considered what the risk information from the 2006 REA analyses indicates regarding the potential for adverse welfare effects to result from levels of air-related Pb that would meet the now-current standard. The circumstances assessed in all but one of the case study locations, however, likely include a history of ambient air Pb concentrations that exceeded the NAAQS. Consequently, these analyses are not considered informative for predicting effects at the far lower concentrations associated with the current NAAQS. The nationwide surface water screen was likewise not particularly informative because potential confounding by both nonair inputs and resuspension of Pb related to historic sources was not easily accounted for. The remaining case study was a site remote from Pb sources for which atmospheric deposition was expected to be the primary contributor to media Pb concentrations without obvious confounding inputs. This case study, based on a summary review of published findings for the study site, concluded that atmospheric Pb inputs do not directly affect stream Pb levels because deposited Pb is almost entirely retained in the soil profile, with the soil serving as a Pb sink, appreciably reducing pore water Pb concentrations as it moves through the soil layers to streams. As a result, this case study (and the publications on which it was based) concluded that the contribution of dissolved Pb from soils to streams was insignificant (2006 REA, Appendix E). Additionally, we note that the 2006 CD, in considering the findings for this site and other terrestrial sites with Pb burdens derived primarily from long-range atmospheric transport, found that “[d]espite years of elevated atmospheric Pb inputs and elevated concentrations in soils, there is little evidence that sites affected primarily by long-range Pb transport have experienced significant effects on ecosystem structure or function” (2006 CD, p. AX7-98). The PA and proposal concluded that this information suggests that the now-lower ambient air concentrations associated with meeting the current standard would not be expected to directly impact stream Pb levels (PA, p. 6-10; 80 FR 319, January 5, 2015).
The basis for the proposed decision, which is described in section III.D of the proposal, is very briefly summarized here. In considering the welfare effects evidence and risk-based information with respect to the adequacy of the current secondary standard, the Administrator considered the array of evidence newly assessed in the ISA with regard to the degree to which this evidence supports conclusions about the effects of Pb in the environment that were drawn in the last review and the extent to which it reduces previously recognized areas of uncertainty. Further, she considered the current evidence and associated conclusions about the potential for effects to occur as a result of the much lower ambient Pb concentrations allowed by the current secondary standard (set in 2008) than those allowed by the prior standard, which was the focus of the last review. These considerations informed the Administrator's proposed decision to retain the current standard.
With regard to the evidence, the proposal noted there is very limited evidence to relate specific ecosystem effects with current ambient air concentrations of Pb through deposition to terrestrial and aquatic ecosystems and subsequent movement of deposited Pb through the environment (
With regard to the currently available risk and exposure information, which continues to be sufficient to conclude that the 1978 standard was not providing adequate protection to ecosystems, the proposal concluded that, when considered with regard to air-related ecosystem exposures likely to occur with air Pb levels that just meet the now-current standard, this current information also does not provide evidence of adverse effects under the current standard. Accordingly, in consideration of the risk information in combination with the current evidence and the associated data gaps and uncertainties, the Administrator proposed that the current standards be retained, without revision.
In its review of the draft PA, the CASAC agreed with staff's preliminary conclusions that the available information since the last review is not sufficient to warrant revision to the secondary standard (Frey, 2013b). On this subject, the CASAC letter said that “[o]verall, the CASAC concurs with the EPA that the current scientific literature does not support a revision to the . . . Secondary Pb NAAQS” (Frey, 2013b, p. 1). It additionally stated that “[g]iven the existing scientific data, the CASAC concurs with retaining the current secondary standard without revision” (Frey, 2013b, p. 2). The CASAC additionally noted areas for additional research to address data gaps and uncertainties (Frey, 2013b, p. 2).
All of the public comments on the proposed decision to retain the current secondary standard, without revision, indicated support. These commenters include the NACAA, as well as both of the state agencies and nearly all of the industry organizations that submitted comments. Only a small subset of this group provided rationales for their concurrence with EPA's proposed decision. These commenters emphasized limitations and uncertainties in the welfare effects evidence, including particularly those with regard to relationships between ambient air Pb concentrations, levels of deposition, ecosystem exposures, and adverse public welfare effects. One commenter also noted the CASAC's concurrence with the EPA conclusion that the current evidence does not support revision to the standard, and that information newly available in this review does not substantially improve our understanding in the identified areas of uncertainty or that would indicate that the current standard is inadequate. The EPA generally agrees with these commenters and with the CASAC regarding the adequacy of the current secondary standard and the lack of support for revision of the standard.
Based on the evidence and risk assessment information that is available in this review concerning the ecological effects and potential public welfare impacts of Pb emitted into ambient air, the Administrator concludes that the current secondary standard provides the requisite protection of public welfare from adverse effects and should be retained. In considering the adequacy of the current standard, the Administrator has considered the assessment of the available evidence and conclusions contained in the ISA; the staff assessment of and conclusions regarding the policy-relevant technical information, including screening-level risk information, presented in the PA; the advice and recommendations from CASAC; and public comments. In reaching her decision, the Administrator gives weight to the PA conclusions, with which CASAC has concurred, and takes note of key aspects of the rationale presented for those conclusions which contribute to her decision.
As she did in reaching her proposed decision, the Administrator notes that the body of evidence on the ecological effects of Pb, expanded in some aspects since the last review, continues to support identification of ecological effects in organisms relating to growth, reproduction, and survival as the most relevant endpoints associated with Pb exposure. In consideration of the appreciable influence of site-specific environmental characteristics on the bioavailability and toxicity of environmental Pb in our assessment, there is a lack of studies conducted under conditions closely reflecting the natural environment. The currently available evidence, while somewhat expanded since the last review, does not include evidence of significant effects at lower concentrations or evidence of higher-level ecosystem effects beyond those reported in the last review. There continue to be significant difficulties in relating effects evidence from laboratory studies to the natural environment and linking those effects to ambient air Pb concentrations. Further, as the proposal and the PA note, the EPA is aware of no new critical loads information that would inform our interpretation of the public welfare significance of the effects of Pb in various U.S. ecosystems (PA, section 5.1). In summary, while new research has added to the understanding of Pb biogeochemistry and expanded the list of organisms for which Pb effects have been described, there remains a significant lack of knowledge about the potential for adverse effects on public welfare from ambient air Pb in the environment and the exposures that occur from such air-derived Pb, particularly under conditions meeting the current standard (PA, section 6.2.1). Thus, the scientific evidence presented in detail and assessed in the ISA, inclusive of that newly available in this review, is not substantively changed, most particularly with regard to the adequacy of the now-current standard, from the information that was previously available and supported the decision for revision in the last review (PA, section 6.2.1).
With respect to exposure/risk-based considerations identified in the PA, the Administrator notes the complexity of interpreting the previous risk assessment with regard to the ecological risk of ambient air Pb associated with conditions meeting the current standard and the associated limitations and uncertainties of such assessments. The Administrator additionally takes note that the previous assessment is consistent with and generally supportive of the evidence-based conclusions about Pb in the environment, yet the limitations on our ability to apportion Pb between past and present air contributions and between air and nonair sources remain significant.
In summary, based on the considerations summarized above, the Administrator judges that the information available in this review of the Pb secondary standard, including the currently available welfare effects evidence and exposure/risk information, does not call into question the adequacy of the current standard to provide the requisite protection for public welfare (PA, section 6.3). In so doing, she also notes the advice from CASAC in this review, including that “[g]iven the existing scientific data, the CASAC concurs with retaining the current secondary standard without revision.”
For the reasons discussed above, and taking into account information and assessments presented in the ISA and PA, the advice from CASAC, and consideration of public comments, the Administrator concludes that the current secondary standard for Pb is requisite to protect public welfare from known or anticipated adverse effects and is retaining the standard without revision.
Additional information about these statutes and Executive Orders can be found at
This action is not a significant regulatory action and was, therefore, not submitted to the Office of Management and Budget for review.
This action does not impose an information collection burden under the PRA. There are no information collection requirements directly associated with revisions to a NAAQS under section 109 of the CAA and this action does not make any revisions to the NAAQS.
I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. This action will not impose any requirements on small entities. Rather, this action retains, without revision, existing national standards for allowable concentrations of Pb in ambient air as required by section 109 of the CAA.
This action does not contain any unfunded mandate as described in the UMRA, 2 U.S.C. 1531-1538 and does not significantly or uniquely affect small governments. This action imposes no enforceable duty on any state, local or tribal governments or the private sector.
This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.
This action does not have tribal implications as specified in Executive Order 13175. It does not have a substantial direct effect on one or more Indian tribes. This action does not change existing regulations; it retains the current NAAQS for Pb, without revision. The NAAQS protect public health, including the health of at-risk or sensitive groups, with an adequate margin of safety and protect public welfare from known or anticipated adverse effects. Executive Order 13175 does not apply to this action.
This action is not subject to Executive Order 13045 because it is not economically significant as defined in Executive Order 12866. We note, however, that the primary standard retained with this action provides protection for children and other at-risk populations against an array of adverse health effects, most notably including nervous system effects in children. The health effects evidence and risk assessment information for this action, which focuses on children, is summarized in sections II.A.2, II.A.3 and II.A.4, and described in the ISA and PA, copies of which are in the public docket for this action.
This action is not subject to Executive Order 13211, because it is not a significant regulatory action under Executive Order 12866.
This action does not involve technical standards.
The EPA believes that this action does not have disproportionately high and adverse human health or environmental effects on minority populations, low-income populations and/or indigenous peoples as specified in Executive Order 12898 (59 FR 7629, February 16, 1994). The action described in this document is to retain, without revision, the existing NAAQS for Pb.
The NAAQS decisions are based on an explicit and comprehensive assessment of the current scientific evidence and associated exposure/risk analyses. More specifically, the EPA expressly considers the available information regarding health effects among at-risk populations, including that available for low-income populations and minority populations, in decisions on the primary (health-based) NAAQS. Where low-income populations or minority populations are among the at-risk populations, the decision on the standard is based on providing protection for these and other at-risk populations and lifestages. Where such populations are not identified as at-risk populations, NAAQS that are established to provide protection to the at-risk populations would also be expected to provide protection to all other populations, including low-income populations and minority populations.
As discussed in sections II.A.2.d and II.B above, and in sections II.A and II.B of the proposal, the EPA expressly considered the available information regarding health effects among at-risk populations in reaching the decision that the existing primary (health-based) standard for Pb is requisite. The ISA and PA for this review, which include identification of populations at risk from Pb health effects, are available in the docket, EPA-HQ-OAR-2010-0108. Based on consideration of this information and the full evidence base, quantitative exposure/risk analyses, advice from the CASAC and consideration of public comments, the Administrator concludes that the existing NAAQS for Pb protect public health, including the health of at-risk or sensitive groups, with an adequate margin of safety and protect public welfare from known or anticipated adverse effects (as discussed in sections II.B.4 and III.B.4 above).
Section 307(d)(1)(V) of the CAA provides that the provisions of section
The EPA will submit a rule report to each House of the Congress and to the Comptroller General of the U.S. This action is not a “major rule” as defined by 5 U.S.C. 804(2).
Environmental protection, Air pollution control, Carbon monoxide, Lead, Nitrogen dioxide, Ozone, Particulate matter, Sulfur oxides.
Commodity Futures Trading Commission.
Proposed rule; interpretations.
The Commodity Futures Trading Commission (“Commission” or “CFTC”) is publishing for public comment proposed rules and interpretations (“Proposed Rule”) addressing the cross-border application of certain swap provisions of the Commodity Exchange Act (“CEA”). Specifically, the proposed rule defines key terms for purposes of applying the CEA's swap provisions to cross-border transactions and addresses the cross-border application of the registration thresholds and external business conduct standards for swap dealers and major swap participants, including the extent to which they would apply to swap transactions that are arranged, negotiated, or executed using personnel located in the United States.
Comments must be received on or before December 19, 2016.
You may submit comments, identified by RIN number 3038-AE54, by any of the following methods:
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•
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Please submit your comments using only one method.
All comments must be submitted in English, or if not, accompanied by an English translation. Comments will be posted as received to
The Commission reserves the right, but shall have no obligation, to review, pre-screen, filter, redact, refuse or remove any or all of a submission from
Paul Schlichting, Assistant General Counsel, (202) 418-5884,
In 2010, the Dodd-Frank Wall Street Reform and Consumer Protection Act (“Dodd-Frank Act” or “Dodd-Frank”)
In response to requests from market participants, the Commission published
In this release, the Commission is proposing to codify a central element of the Dodd-Frank regulatory framework for SDs and MSPs, incorporating various aspects of the Commission's recent cross-border rulemaking regarding the margin requirement,
The Proposed Rule also addresses issues related to a Commission request for comment on a 2013 staff advisory, which discussed the staff's view of the application of certain Dodd-Frank swap provisions to non-U.S. SDs if they use personnel located in the United States.
As part of the proposed rule, the Commission is also proposing to define the key terms of “U.S. person” and “Foreign Consolidated Subsidiary” for broad cross-border application in a manner consistent with how the terms were defined in the Cross-Border Margin Rule.
The Proposed Rule does not address the cross-border application of any substantive Dodd-Frank requirements beyond the SD/MSP registration thresholds and external business conduct standards. The Commission expects to address the cross-border application of other Dodd-Frank requirements, including the availability of substituted compliance, in subsequent rulemakings.
In determining how the Commission's SD/MSP registration thresholds should apply to market participants in cross-border transactions and the extent to which the Dodd-Frank swap requirements should apply to ANE transactions, the Commission was informed by its understanding of the current market practices of global financial institutions. Financial groups that are active in the swap market typically operate in multiple market centers
Despite its geographic expanse, a global financial group effectively operates as a single business, with a highly integrated network of business lines and services conducted through various branches or affiliated legal entities that are under the control of the parent entity. While each branch or affiliate may serve a unique purpose, they are highly interdependent and inextricably linked, with affiliated entities within the corporate group providing financial or credit support for each other, such as in the form of a guarantee or the ability to transfer risk through inter-affiliate trades.
A financial group may reflect all of its swaps in the financial statements of one entity (the “booking entity”), realizing netting and operational benefits, a practice referred to as “central booking.” In this case, the booking entity retains all the risk associated with
Regardless of a financial group's booking practices, it typically engages in sales or trading functions in one or more market centers. Performing sales and trading functions in global market centers provides the financial group with access to counterparties in that jurisdiction. The financial group's presence in a particular market center also enables the group to more effectively engage in swaps in that locale on behalf of affiliates in other jurisdictions that are servicing counterparties in those jurisdictions.
In this highly-integrated corporate structure, where financial groups engage in swap dealing activity with counterparties located in multiple jurisdictions, it is not uncommon for a swap to be traded through an affiliate in one jurisdiction (the “market-facing affiliate”) and booked and risk-managed in another (the “booking affiliate”). In such cases, a particular affiliate may become the market-facing affiliate because its trading desk has expertise in relevant products or because it has an established client network in the relevant jurisdiction or market hub.
Large U.S. financial services firms emphasize the importance of operating globally through a unified structure. For example, Goldman Sachs explains that one of its core businesses “serves our clients who come to the firm to buy and sell financial products, raise funding and manage risk. We do this by acting as a market maker and offering market expertise on a global basis . . . . Through our global sales force, we maintain relationships with our clients, receiving orders and distributing investment research, trading ideas, market information and analysis. As a market maker, we provide prices to clients globally across thousands of products in all major asset classes and markets . . . . Much of this connectivity between the firm and its clients is maintained on technology platforms and operates globally wherever and whenever markets are open for trading.”
In sum, the current swap market is global in scale and characterized by a high level of interconnectedness among market participants, with transactions negotiated, executed, and arranged between counterparties in different jurisdictions, (and booked and managed in still other jurisdictions). These market realities suggest that a cross-border framework that focuses only on the domicile of the market participant or location of counterparty risk would fail to effectively advance the policy objectives of the Dodd-Frank swap reforms, which were aimed at increasing market transparency and counterparty protections and mitigating the risk of financial contagion in the swap market.
The Commission is proposing to define the key terms of “U.S. person” and “Foreign Consolidated Subsidiary” for purposes of applying the Dodd-Frank swaps provisions to cross-border transactions. Whether a market participant is a U.S. person or a Foreign Consolidated Subsidiary would, for instance, affect how the SD/MSP registration thresholds apply under the proposed rule.
Under the Proposed Rule, a “U.S. person” would be defined as follows:
• Any natural person who is a resident of the United States (proposed § 1.3(aaaaa)(5)(i));
• Any estate of a decedent who was a resident of the United States at the time of death (proposed § 1.3(aaaaa)(5)(ii));
• Any corporation, partnership, limited liability company, business or other trust, association, joint-stock company, fund or any form of entity similar to any of the foregoing (other than an entity described in proposed paragraph (aaaaa)(5)(iv) or (v) of § 1.3) (“legal entity”), in each case that is organized or incorporated under the laws of the United States or that has its principal place of business in the United States, including any branch of the legal entity
• Any pension plan for the employees, officers or principals of a legal entity described in proposed paragraph (aaaaa)(5)(iii) of § 1.3, unless the pension plan is primarily for foreign employees of such entity (proposed § 1.3(aaaaa)(5)(iv));
• Any trust governed by the laws of a state or other jurisdiction in the United States, if a court within the United States is able to exercise primary supervision over the administration of the trust (proposed § 1.3(aaaaa)(5)(v));
• Any legal entity (other than a limited liability company, limited liability partnership or similar entity where all of the owners of the entity have limited liability) that is owned by one or more persons described in proposed paragraphs (aaaaa)(5)(i) through (v) of § 1.3 who bear(s) unlimited responsibility for the obligations and liabilities of the legal entity, including any branch of the legal entity (proposed § 1.3(aaaaa)(5)(vi)); and
• Any individual account or joint account (discretionary or not) where the beneficial owner (or one of the beneficial owners in the case of a joint account) is a person described in proposed paragraphs (aaaaa)(5)(i) through (vi) of § 1.3 (proposed § 1.3(aaaaa)(5)(vii)).
In line with commenter requests, this definition mirrors the definition of “U.S. person” recently adopted in the context of the Cross-Border Margin Rule.
The proposed U.S. person definition is generally consistent with the U.S. person interpretation set forth in the Guidance, with certain exceptions.
Finally, consistent with the Cross-Border Margin Rule, paragraph (vi) of the proposed U.S. person definition includes legal entities where one or more U.S. person owner(s) bear unlimited responsibility for the obligations and liabilities of the legal entity (“unlimited U.S. responsibility prong”). This paragraph represents a modified version of a similar concept from the Guidance, which interpreted “U.S. person” to include a legal entity “directly or indirectly majority-owned” by one or more U.S. person(s) that bear unlimited responsibility for the legal entity's liabilities and obligations.
In consideration of principles of international comity, the Commission proposes that the term “U.S. person” would not include international financial institutions. Consistent with Commission precedent,
Exchange Act rule 3a71-3(a)(4) defines “principal place of business” to mean the location from which the officers, partners, or managers of the legal person primarily direct, control, and coordinate the activities of the legal person. It also provides that, with respect to an externally managed investment vehicle, this location is the office from which the manager of the vehicle primarily directs, controls, and coordinates the investment activities of the vehicle.
Under the Proposed Rule, the term “Foreign Consolidated Subsidiary” identifies a non-U.S. person that is consolidated for accounting purposes with an ultimate parent entity that is a U.S. person (a “U.S. ultimate parent entity”). Consistent with the Cross-Border Margin Rule, the proposed rule would define “Foreign Consolidated Subsidiary” to mean a non-U.S. person in which an ultimate parent entity that is a U.S. person has a controlling financial interest, in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”), such that the U.S. ultimate parent entity includes the non-U.S. person's operating results, financial position and statement of cash flows in the U.S. ultimate parent entity's consolidated financial statements, in accordance with U.S. GAAP.
The proposed FCS definition offers a clear, bright-line test for identifying non-U.S. persons whose swap activities present a greater supervisory interest relative to other non-U.S. market participants, due to the nature and extent of the FCS's relationship with its U.S. ultimate parent. As described above, the nature of modern finance is such that large financial institutions typically conduct their business operations through a highly integrated network of business lines and services conducted through multinational branches or subsidiaries that are under the control of the ultimate parent entity. Under this structure, U.S. and non-U.S. derivatives trading functions as a single enterprise, using funds, risk management, information systems and trading personnel across the entire consolidated entity in the most efficient manner in effectuating coordinated trading strategies, with the profits and losses from global trading operations aggregated in the consolidated financial statements of the ultimate parent entity. The Commission believes that the FCS definition appropriately encompasses those entities within this consolidated group that are subject to the financial control, and directly impact the financials, of the U.S. ultimate parent entity.
First, consolidation under U.S. GAAP is predicated on the financial control of the reporting entity.
Under these circumstances, the Commission believes that it is appropriate to require FCSs to include relevant swaps for the SD/MSP registration calculation like a U.S. person (and U.S. Guaranteed Entity).
In November 2013, DSIO issued a staff advisory providing that a non-U.S. swap dealer that regularly uses personnel or agents located in the United States to arrange, negotiate, or execute a swap with a non-U.S. person (“Covered Transactions”) would generally be required to comply with the “Transaction-Level Requirements,” as the term was used in the Guidance.
The Commission received seventeen comment letters in response to the Request for Comment.
A few commenters, however, supported the Staff Advisory.
Commenters that disagreed with the Staff Advisory nevertheless offered a few suggestions for its modification, should the Commission determine to adopt it, including offering substituted compliance for Covered Transactions
After considering the views of commenters on the Staff Advisory in response to the Commission's Request for Comment, the Commission is setting forth its views on whether persons engaged in ANE transactions or transactions arising from this activity fall within the scope of the Dodd-Frank Act. The Commission's analysis is guided by the definition of “swap dealer” under the CEA and Commission regulations.
Under both the CEA and Commission regulations, whether a person is a “swap dealer” is a functional test that focuses on whether the person engages in particular types of activities involving swaps.
In the Commission's view, and as further explained below, arranging, negotiating, or executing swaps are functions that fall within the scope of the “swap dealer” definition. That the counterparty risks may reside primarily outside the United States is not determinative. To the extent that a person uses personnel located in the United States (whether its own personnel or personnel of an agent) to arrange, negotiate, or execute its swap dealing transactions, the Commission believes that such person is conducting a substantial aspect of its swap dealing activity within the United States and therefore, falls within the scope of the Dodd-Frank Act.
The Commission further believes that to the extent that ANE transactions raise regulatory concerns of the type that the Dodd-Frank Act is intended to address, applying specific Dodd-Frank swap requirements to ANE transactions may be appropriate. In establishing a comprehensive regulatory regime for swaps under the Dodd-Frank Act, Congress intended to advance several
In making a determination as to whether a particular Dodd-Frank swap requirement (including those specifically applicable to swap dealers) should apply to an ANE transaction, the Commission would consider the extent to which the underlying regulatory objectives would be advanced in light of other policy considerations, including the potential for undue market distortions and international comity. As indicated above, the Proposed Rule addresses the application of the SD registration threshold and external business conduct standards to ANE transactions. The Commission intends to address application of other Dodd-Frank swap requirements to ANE transactions in subsequent cross-border rulemakings as necessary and appropriate.
For purposes of the proposed rule, the Commission uses the terms “arrange” and “negotiate” to refer to market-facing activity normally associated with sales and trading, as opposed to internal, back-office activities, such as ministerial or clerical tasks, performed by personnel not involved in the actual sale or trading of the relevant swap.
In applying the proposed rule, the Commission would look to the activities of personnel assigned to (on an ongoing or temporary basis) or regularly working in a U.S. location.
Swap transactions arranged, negotiated, or executed by personnel located in the United States implicate the Commission's supervisory interests regardless of the reason such U.S. personnel were involved. For example, a swap would not fall outside the scope of the Dodd-Frank Act because a counterparty sought to enter into the swap outside of its jurisdiction's regular trading hours. Additionally, the Commission believes permitting such an exception would only incentivize dealing entities to wait until after hours to enter into a swap, creating the potential for a substantial loophole.
Finally, as the SEC noted in its cross-border rulemaking addressing ANE transactions, the Commission would not view a swap as falling outside the scope of the ANE transactions solely as a result of algorithmic trading.
The Commission's proposed approach to the determination of when a swap is an ANE transaction reflects its consideration of the comments received in response to the Request for Comment and is generally aligned with the SEC's approach to this determination in the context of security-based swaps.
The Commission's treatment of ANE transactions is intended to capture activity that raises a substantial regulatory interest while still promoting a framework that is clear and workable for market participants. By focusing on market-facing activity carried out by personnel located in the United States, the Commission believes its interpretation adequately captures the Commission's inherently strong regulatory interest in dealing activity occurring within its jurisdiction while enabling market participants to apply the definition in a relatively efficient manner.
1. The Commission invites comment on whether its interpretation of ANE transactions is appropriately tailored to capture activity that raises a substantial regulatory interest and sufficiently clear and workable for market participants. Is the Commission's focus on and discussion of market-facing activity understandable and effective in excluding activities that are merely incidental to the swap transaction? Will the Commission's interpretation pose any operational challenges? Please explain and provide specific recommendations for modifications or clarifications.
2. Under what other circumstances, if any, should the Commission determine that U.S. personnel are directing a system for the algorithmic trading within the scope of its interpretation of ANE transactions?
In accordance with CEA section 1a(49)(D), the Commission has exempted from designation as an SD any entity that engages in a de minimis quantity of swap dealing with or on behalf of its customers.
The Commission is now proposing rules to address how the de minimis threshold should apply to the cross-border swap dealing transactions of U.S. and non-U.S. persons.
In developing the proposed cross-border approach to applying the SD and MSP registration thresholds,
Under the Proposed Rule, a U.S. person would include all of its swap dealing transactions in its de minimis threshold calculation without exception. As discussed in section II.A above, the term “U.S. person” encompasses a person who, by virtue of being domiciled or organized in the United States (or in the case of the unlimited U.S. responsibility prong, because U.S. person owner(s) serve as a financial backstop for all of the legal entity's obligations and liabilities), raises the concerns intended to be addressed by the Dodd-Frank Act, regardless of the U.S. person status of its counterparty. Additionally, a person's status as a U.S. person would be determined at the entity level and thus a U.S. person would include the swap dealing activity of foreign branches or operations that are part of the same legal person. The Commission notes that the proposed rule's requirement that a U.S. person include all of its swap dealing transactions in its de minimis calculation is consistent with the Guidance.
The proposed rule would also require a non-U.S. person that is not an FCS to include in its de minimis calculation swap dealing transactions with respect to which it is a U.S. Guaranteed Entity. The Commission believes that this result is appropriate because the swap of a non-U.S. person whose swap obligations are guaranteed by a U.S. person is identical, in relevant aspects, to a swap entered into directly by a U.S. person.
Furthermore, treating U.S. Guaranteed Entities differently from U.S. persons could create a substantial regulatory loophole, incentivizing U.S. persons to conduct their dealing business with non-U.S. counterparties through non-U.S. affiliates, with a U.S. guarantee, to avoid application of the Dodd-Frank swap dealer requirements. Allowing transactions that have a similar economic reality with respect to U.S. commerce to be treated differently depending on how the parties structure their transactions could undermine the effectiveness of the Dodd-Frank swap provisions and related Commission regulations. Applying the same standard to similar transactions instead helps to limit those incentives and regulatory implications.
Under the proposed rule, a Foreign Consolidated Subsidiary would include all of its swap dealing transactions in its de minimis threshold calculation, without exception.
Under the proposed rule, whether an Other Non-U.S. Person would include a particular swap in its de minimis calculation would depend on the status of the counterparty. Specifically, as further explained below, an Other Non-U.S. Person would be required to include in its de minims threshold calculation its dealing activities with U.S. Persons, U.S. Guaranteed Entities, and FCSs, but not with Other Non-U.S. Persons (“Other Non-U.S. counterparties”). Additionally, Other Non-U.S. Persons would not be required to include in their de minimis threshold calculation any transaction that is executed anonymously on a swap execution facility (“SEF”), designated contract market (“DCM”), or foreign board of trade (“FBOT”) and cleared through a registered or exempt derivatives clearing organization (“DCO”).
Under the proposed rule, an Other Non-U.S. Person would generally include in its de minimis calculation all swap dealing transactions with U.S. counterparties, subject to the exception for transactions executed anonymously on a SEF, DCM, or FBOT and cleared (discussed in section 4 below). As a general rule, the Commission believes that all potential SDs should include in their de minimis calculations any swap with a U.S. counterparty.
The Commission notes that the proposed rule's requirement that an Other Non-U.S. Person include in its de minimis calculation all swap dealing
Upon further consideration, however, the Commission believes that incorporating a similar exception into the proposed rule could create a substantial regulatory loophole. As discussed above, a foreign branch is an integral part of a U.S. person, such that a transaction involving a foreign branch of a U.S. SD poses risk to the U.S. SD itself and, consequently, the U.S. financial system. Allowing Other Non-U.S. Persons to engage in potentially unlimited swap dealing with foreign branches of U.S. SDs without having to register as SDs could therefore result in a substantial amount of dealing activity with U.S. counterparties occurring outside the comprehensive Dodd-Frank swap regime, undermining the effectiveness of the proposed rule.
Under the proposed rule, an Other Non-U.S. Person would also include in its de minimis threshold calculation swap dealing transactions with a non-U.S. person that is a U.S. Guaranteed Entity, subject to an exception for transactions executed anonymously on a SEF, DCM, or FBOT and cleared.
Under the proposed rule, an Other Non-U.S. Person would include in its de minimis threshold calculation swap dealing transactions with a non-U.S. person that is an FCS, subject to an exception for transactions executed anonymously on a SEF, DCM, or FBOT and cleared. As discussed above, the default or insolvency of an Other Non-U.S Person could have a direct adverse effect on an FCS, which through the interconnection to its U.S. ultimate parent, could have knock-on effects, potentially leading to disruptions to the U.S. financial system. The Commission believes that such risk would be significant to the extent that the Other Non-U.S. Person's dealing activities with FCSs, U.S. persons and U.S. Guaranteed Entities
Under the proposed rule, an Other Non-U.S. Person would not include in its de minimis calculation its swap dealing transactions with an Other Non-U.S. Person. This approach reflects the Commission's recognition of foreign jurisdictions' strong supervisory interest in the swap transactions between Other Non-U.S. Persons, both of which are domiciled and operate abroad. Consistent with comity principles, the Commission believes that it would be appropriate to except this class of swap transactions from counting against the de minimis threshold.
Further, the proposed rule would not require an Other Non-U.S. Person to include a swap transaction with an Other Non-U.S. Person counterparty in its de minimis threshold calculation even if the swap is arranged, negotiated, or executed by personnel located in the United States. Although, as stated above, a non-U.S. person that engages in ANE transactions is performing dealing activity in the United States, the Commission preliminarily does not believe that requiring Other Non-U.S. Persons to include ANE transactions in their de minimis threshold calculations would be necessary to advance the policy objectives of the Dodd-Frank swap regime when taking the proposed rule in context. In particular, the Commission preliminarily believes that the proposal to require FCSs to include all of their swap dealing transactions in their de minimis threshold calculations would capture a substantial portion of dealing activity engaged in by non-U.S. persons in which the Commission has a strong regulatory interest, such that the level of ANE transactions engaged in by Other Non-U.S. Persons may be comparatively insignificant. Additionally, Other Non-U.S. Persons that engage in ANE transactions could either be registered already by virtue of their swap transactions with U.S. persons or, if the proposed rule is adopted, be required to register as SDs by virtue of their swap transactions with U.S. persons, U.S. Guaranteed Entities or FCSs.
The Commission believes that when an Other Non-U.S. Person enters into a swap that is executed anonymously on a registered SEF, DCM, or FBOT and the swap is cleared through a registered or exempt DCO, the Other Non-U.S. Person may exclude the swap from its de minimis threshold calculation.
As stated above, Commission regulation 1.3(ggg)(4) requires that, in determining whether its swap dealing transactions exceed the de minimis threshold, a person must include the aggregate notional value of any swap dealing transactions entered into by its affiliates under common control. Consistent with CEA section 2(i), the Commission interprets the aggregation requirement in Commission regulation 1.3(ggg)(4) in a manner that applies the same aggregation principles to all affiliates in a corporate group, whether they are U.S. or non-U.S. persons. Accordingly, under the proposed rule, a potential SD, whether a U.S. or non-U.S. person, would aggregate all swaps connected with its dealing activity with those of persons controlling, controlled by, or under common control with
Stated in general terms, the Commission interprets the aggregation requirement to allow both U.S. persons and non-U.S. persons in an affiliated group to engage in swap dealing activity up to the de minimis threshold. When the affiliated group meets the de minimis threshold in the aggregate, one or more affiliate(s) (a U.S. affiliate or a non-U.S. affiliate) would have to register as an SD so that the relevant swap dealing activity of the unregistered affiliates remains below the threshold. The Commission recognizes the borderless nature of swap dealing activities, in which a dealer may conduct swap dealing business through its various affiliates in different jurisdictions, and believes that this interpretation would address the concern that an affiliated group of U.S. and non-U.S. persons engaged in swap dealing transactions with a significant connection to the United States may not be required to register solely because such swap dealing activities are divided among affiliates that all individually fall below the de minimis threshold.
In summary, under the proposed rule, in making its de minimis calculation:
• A U.S. person would include all of its swap dealing transactions.
• A non-U.S. person would include all swap dealing transactions with respect to which it is a U.S. Guaranteed Entity.
• A Foreign Consolidated Subsidiary would include all of its swap dealing transactions.
• An Other Non-U.S. Person would include all of its swap dealing transactions with counterparties that are U.S. persons, U.S. Guaranteed Entities, or FCSs, unless the swap is executed anonymously on a registered SEF, DCM, or FBOT and cleared. It would not, however, include any of its swap dealing transactions with Other Non-U.S. Persons, even if they constitute ANE transactions.
• All potential SDs, whether U.S. or non-U.S. persons, would aggregate their swap dealing transactions with those of persons controlling, controlled by, or under common control with the potential SD to the extent that those affiliates are themselves required to include those swaps in their own de minimis thresholds, unless the affiliated person is a registered SD.
1. The Commission invites comment on the appropriateness, necessity, and potential impact of requiring Other Non-U.S. Persons to include ANE transactions in their de minimis threshold calculations. Should the Commission further harmonize with the SEC by requiring Other Non-U.S. Persons to include ANE transactions in their de minimis threshold calculations?
2. The Commission invites comment on whether and to what extent the Proposed Rule should incorporate certain exceptions for non-U.S. persons that were included in the Guidance.
a. Swap transactions with foreign branches of U.S. SDs? If so, why and how should the Commission interpret the term “foreign branch of a U.S. swap dealer” (
b. Any swap transactions with U.S. Guaranteed Entities? If so, why and under what circumstances?
3. The Commission is concerned that a non-U.S. person that is affiliated with a U.S. SD could act as a conduit or an extension of the affiliated U.S. SD by entering into market-facing swaps in a foreign jurisdiction and then transferring some or all of the risk of such swaps to its affiliated U.S. SD through one or more inter-affiliate swaps. Furthermore, under the Proposed Rule, an Other Non-U.S. Person would not be required to include its market-facing swaps with Other Non-U.S. counterparties in its SD de minimis threshold. The Commission invites comment as to whether Other Non-U.S. Persons should be required to include market-facing swaps with non-U.S. persons in their de minimis threshold calculations if any of the risk of such swaps is transferred to an affiliated U.S. SD through one or more inter-affiliate swaps and as to whether it would be too complex or costly to monitor and implement.
a. Should an Other Non-U.S. Person that is consolidated with an affiliated U.S. SD for financial reporting purposes and that transfers some or all of the risk of a swap with an Other Non-U.S. counterparty, directly or indirectly, to its affiliated U.S. SD (an “SD conduit”) be required to count outward-facing swap as to which it acts as a conduit toward its SD or MSP registration threshold?
b. Should an Other Non-U.S. Person be considered an SD Conduit only when it “regularly” acts as an SD Conduit, and if so, how would the Commission determine whether it “regularly” acts as an SD Conduit?
c. Would it be appropriate to require an SD Conduit to include a market-facing swap in its de minimis threshold calculation in its entirety, for ease of calculation, even if not all of the risk arising out of that swap is transferred to an affiliated U.S. SD through inter-affiliate swaps? Is the Commission's assumption that a formula to calculate the percentage of risk would be too costly and burdensome to implement correct? If not, please propose such a workable formula. Alternatively, should an SD Conduit be required to include all of its swap dealing transactions (and not just those as to which it acts as an SD conduit) in its SD or MSP registration threshold?
d. The Commission understands that a non-U.S. person may aggregate all or a group of its market-facing swaps and then transfer all or a portion of the risk of such swaps as one position to the affiliated U.S. SD. In that case, the Commission understands that it would not be burdensome for the non-U.S. person to disaggregate the netted swap, as the non-U.S. person's trading system would aggregate these trades initially, and therefore should be able to perform a disaggregation function. Is the Commission's understanding correct?
e. Should the proposed rule be modified to require that Other Non-U.S. Persons include swaps in their SD or MSP registration thresholds if their counterparty is acting as an SD Conduit?
f. Should swaps where either one of the counterparties is acting as an SD conduit be subject to other Dodd-Frank requirements (in addition to SD and MSP registration thresholds) in future rulemakings?
CEA section 1a(33) defines “major swap participant” to include persons that are not SDs but that nevertheless pose a high degree of risk to the U.S. financial system by virtue of the “substantial” nature of their swap positions.
The Commission is now proposing rules to address the cross-border application of the MSP thresholds to the swap positions of U.S. and non-U.S. persons.
Under the proposed rule, all of a U.S. person's swap positions would apply
For related reasons, the proposed rule would also require a non-U.S. person that is not an FCS to include in its MSP calculations each swap position with respect to which it is a U.S. Guaranteed Entity. As explained in context of the SD de minimis threshold calculation, the Commission believes that the swap positions of a non-U.S. person whose swap obligations are guaranteed by a U.S. person are identical, in relevant aspects, to those entered into directly by a U.S. person and thus present risks to the stability of the U.S. financial system or of U.S. entities. Treating U.S. Guaranteed Entities differently from U.S. persons could also create a substantial regulatory loophole, allowing transactions that have a similar connection to or impact on U.S. commerce to be treated differently depending on how the parties are structured and thereby undermining the effectiveness of the Dodd-Frank swap provisions and related Commission regulations.
The proposed rule would also require an FCS to include all of its swap positions in its MSP calculations.
Under the proposed rule, an Other Non-U.S. Person would include all of its swaps with U.S. persons, U.S. Guaranteed Entities, and Foreign Consolidated Subsidiaries in its MSP calculations, with a limited exception for transactions executed anonymously on a SEF, DCM, or FBOT and cleared.
The default or insolvency of the Other Non-U.S. Person would also present a financial impact to the U.S. financial system where the counterparty is an FCS because its U.S. ultimate parent would be directly impacted. The Other Non-U.S. Person's default could also impact the United States through a U.S. Guaranteed Entity. Although the default on that swap may not directly affect the U.S. guarantor on that swap, the default could affect the U.S. Guaranteed Entity's ability to meet its other obligations, for which the U.S. guarantor may also be liable. The Commission is also concerned that offering Other Non-U.S. Persons disparate treatment with respect to their swap positions with U.S. Guaranteed Entities compared to their swap positions with FCSs could incentivize Other Non-U.S. Persons to favor transacting with U.S. Guaranteed Entities solely in order to avoid application of the Dodd-Frank swap provisions.
The Commission therefore has a strong regulatory interest in ensuring that Other Non-U.S. Persons are subject to the Dodd-Frank MSP requirements to the extent that their swap positions with U.S. Guaranteed Entities and FCSs exceed a registration threshold. Accordingly, the Commission believes that requiring Other Non-U.S. Persons to include their swap positions with FCSs and U.S. Guaranteed Entities as well as U.S. persons appropriately captures swap positions that present a risk to the U.S. financial system, ensuring that MSP regulation applies once that risk exceeds the relevant thresholds. However, as discussed in the context of the SD de minimis threshold, where the swap is executed anonymously on a SEF, DCM, or FBOT and cleared, the Commission believes that the practical difficulties involved in determining the status of the potential MSP's counterparty would make it reasonable for the swap position to be excluded altogether.
Where the counterparty is an Other Non-U.S. Person, however, the proposed rule would not require an Other Non-U.S. Person to include the swap position in its MSP calculations, as the Commission does not believe the swap would present the type of risk to the U.S. financial system that MSP registration is intended to address.
In the Entities Rule, the Commission and the SEC (collectively, “Commissions”) provided a joint interpretation that an entity's swap positions in general would be attributed to a parent, other affiliate, or guarantor for purposes of the MSP analysis to the extent that the counterparties to those positions have recourse to the parent, other affiliate, or guarantor in connection with the position, such that no attribution would be required in the absence of recourse.
The Commission is also proposing to address the cross-border application of the attribution requirement in a manner consistent with the Entities Rule and CEA section 2(i) and generally comparable to the approach adopted by the SEC.
If recourse is present, however, and the entity subject to a recourse guarantee (“guaranteed entity”) is not subject to capital regulation (as described above), whether the attribution requirement would apply would depend on the U.S. person status of the person to whom there is recourse (
A non-U.S. person would attribute to itself any swap position of an entity for which the counterparty to the swap has recourse against the non-U.S. person
In summary, under the proposed rule, in making its MSP threshold calculations:
• A U.S. person would include all of its swap positions.
• A non-U.S. person would include all swap positions with respect to which it is a U.S. Guaranteed Entity.
• A Foreign Consolidated Subsidiary would include all of its swap positions.
• An Other Non-U.S. Person would include all of its swap positions with counterparties that are U.S. persons, U.S. Guaranteed Entities, or FCSs, unless the swap is executed anonymously on a registered SEF, DCM, or FBOT and cleared. It would not, however, include any of its swap positions with Other Non-U.S. counterparties.
• All swap positions that are subject to recourse should also be attributed to a guarantor, whether it is a U.S. person or a non-U.S. person, unless the guarantor, the guaranteed entity, and its counterparty are Other Non-U.S. Persons.
1. The Commission invites comment on whether it should provide an exception for Other Non-U.S. Persons similar to that included in the Guidance for non-U.S. persons that are not guaranteed affiliates trading with either a foreign branch of a U.S. SD or a guaranteed affiliate that is an SD.
2. In its rulemaking addressing the cross-border application of the MSP thresholds, the SEC determined not to require a non-U.S. person to include in its major security-based swap participant threshold calculations any security-based swap positions for which they (as opposed to their counterparty)
3. Should the Commission modify its interpretation with regard to the attribution requirement to further harmonize with the approach presented in the Guidance
Pursuant to CEA section 4s(h), the Commission has adopted rules establishing business conduct standards governing the conduct of SD/MSPs in transacting with swap counterparties.
The Commission is now proposing a rule to address the cross-border application of the external business conduct standards, including the extent to which they would apply to ANE transactions.
Foreign branches of U.S. SD/MSPs as well as non-U.S. SD/MSPs (including FCSs and U.S. Guaranteed Entities) would be required to comply with all of the Commission's applicable external business conduct standards, without substituted compliance, to the extent that the counterparty is a U.S. person (other than a foreign branch of a U.S. SD/MSP).
With respect to transactions with counterparties that are foreign branches of U.S. SD/MSPs or non-U.S. persons (including FCSs and U.S. Guaranteed Entities), however, non-U.S. SD/MSPs and foreign branches of U.S. SD/MSPs would generally
If adopted, the proposed rule would supersede the Guidance with respect to the cross-border application of the external business conduct standards.
1. The Commission invites comment regarding its determination to distinguish transactions entered into by foreign branches of U.S. persons that are SDs (or MSPs) for purposes of the cross-border application of the external business conduct standards.
2. The Commission invites comment regarding the circumstances under which a swap transaction should be considered as being “with a foreign branch of a U.S. person” that is an SD (or MSP) as opposed to being with the U.S. person itself. Specifically, should the Commission, as proposed, adopt an interpretation consistent with the Guidance
3. The Commission invites comment on the proposed treatment of non-U.S. SD/MSPs and foreign branches of U.S. SD/MSPs. Whether and to what extent should their swap transactions with foreign branches of U.S. SD/MSPs and non-U.S. persons be subject to the external business conduct standards? Should they be required to comply with the external business conduct standards with respect to their transactions with foreign branches of U.S. SD/MSPs or non-U.S. persons? If so, should substituted compliance be available? Relatedly, should transactions conducted through foreign branches of U.S. SD/MSPs receive the same treatment as other transactions conducted by U.S. SD/MSPs? Is limiting the scope of applicable requirements for ANE transactions entered into by foreign branches of U.S. SDs or non-U.S. SDs to the antifraud and fair dealing requirements appropriate, or should other external business conduct requirements in subpart H of part 23 of the Commission's regulations also apply? Why or why not?
The Regulatory Flexibility Act (“RFA”) requires that agencies consider whether the regulations they propose will have a significant economic impact on a substantial number of small entities.
The Commission previously determined that SDs and MSPs are not small entities for purposes of the RFA.
Under the proposed rule, to the extent that there are any affected small entities under the proposed rule, they will need to assess how they are classified under the proposed rule (
Accordingly, for the foregoing reasons, the Commission finds that
The Paperwork Reduction Act of 1995
The proposed rule would result in an amendment to existing collections of information, “Registration of Swap Dealers and Major Swap Participants,” Office of Management and Budget (“OMB”) Control No. 3038-0072, as discussed below. The Commission, therefore, is submitting this proposed rulemaking to OMB for its review and approval in accordance with 44 U.S.C. 3507(d) and 5 CFR 1320.11. If the proposed rule is adopted, the responses to these collections of information would be mandatory. 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 issued by OMB.
The proposed rule provides for the cross-border application of the SD/MSP registration thresholds and external business conduct standards. The Commission estimates that if the proposed rule is adopted, 14 unregistered non-U.S. persons may be classified as FCSs and required to register as new SDs because their swap dealing transactions would be in excess of the SD de minimis threshold.
Comments may be submitted directly to the Office of Information and Regulatory Affairs, by fax at (202) 395-6566 or by email at
As detailed above, the Commission is proposing rules that would define certain key terms for purposes of the Dodd-Frank swap provisions and address the cross-border application of the SD and MSP registration thresholds and the Commission's external business conduct standards, including the extent to which such requirements would apply to ANE transactions.
The baseline against which the costs and benefits of this proposed rule are compared is the status quo,
The costs associated with the key elements of the Commission's proposed cross-border approach to the SD and MSP registration thresholds—requiring market participants to classify themselves as U.S. persons, U.S. Guaranteed Entities, Foreign Consolidated Subsidiaries, or Other Non-U.S. Persons and to apply the rule accordingly—fall into a few categories. Market participants would incur costs determining which category of market participant (
Entities required to register as SDs as a result of the proposed rule would also incur costs associated with complying with the relevant Dodd-Frank requirements applicable to registrants, such as the capital, margin, and business conduct requirements (“programmatic costs”).
In developing the proposed rule, the Commission took into account the potential for creating or accentuating competitive disparities between market participants, which could contribute to market inefficiencies, including market fragmentation or decreased liquidity, as more fully discussed below. Significantly, competitive disparities may arise between U.S.-based financial groups and non-U.S. based financial groups as a result of differences in how the SD/MSP registration thresholds apply to the various classifications of market participants. For instance, dealing subsidiaries with a U.S. ultimate parent entity (
Other factors also create inherent challenges associated with attempting to assess costs and benefits of the Proposed Rule. To avoid the prospect of being regulated as an SD or MSP, or otherwise falling within the Dodd-Frank swap regime, some market participants may restructure their businesses or take other steps (
The Commission nevertheless believes that the proposed rule's approach is necessary and appropriately tailored, consistent with CEA section 2(i) and principles of international comity, to ensure that the regulatory objectives of the Dodd-Frank registration requirements and external business conduct standards are preserved while still establishing a workable approach that recognizes foreign regulatory interests and minimizes competitive disparities and market inefficiencies to the degree possible. Furthermore, as mentioned above, the Commission expects to apply the definitions and classification scheme for market participants resulting from the proposed rule in future cross-border rulemakings; having a uniform set of definitions should mitigate the costs of cross-border compliance with the Dodd-Frank swap regime in the long run.
In the sections that follow, the Commission discusses the costs and benefits associated with the proposed rule, as well as reasonable alternatives. Section 1 begins by addressing the assessment costs associated with the rule, which derive in part from the defined terms used in the proposed rule (the proposed definitions of “U.S. Person” and “Foreign Consolidated Subsidiary,” as well as the definition of “guarantee” adopted in the Cross-Border Margin Rule) and which, as mentioned above, are expected to be relevant outside the context of the cross-border application of the registration thresholds. Sections 2 and 3 consider the costs and benefits associated with the proposed rule's determinations regarding how each classification of market participants (U.S. Persons, U.S. Guaranteed Entities, FCSs, and Other Non-U.S. Persons) should apply to the SD and MSP registration thresholds, respectively. Sections 4, 5, and 6 address the monitoring, registration, and programmatic costs associated with the proposed cross-border approach to the SD (and, as appropriate, MSP) registration thresholds, respectively. Section 7 addresses the costs and benefits associated with the proposed cross-border approach to the external business conduct standards, while Section 8 discusses the factors established in section 15(a) of the CEA. Discussion of the Commission's cost-benefit considerations concludes with an Appendix providing an estimate of the number of new SDs that are expected to register as a result of the Proposed Rule as well as the number of currently registered non-U.S. SDs that the Commission estimates would be classified as FCSs.
The Commission invites comment regarding the nature and extent of any costs and benefits that could result from adoption of the Proposed Rule and, to the extent they can be quantified, monetary and other estimates thereof.
As discussed above, in applying the proposed cross-border approach to the SD and MSP registration thresholds, market participants would be required to first classify themselves as either a U.S. person, an FCS, a U.S. Guaranteed
The Commission expects that the costs to affected market participants of assessing which classification they and their counterparties fall into would generally be marginal and incremental. In most cases, the Commission believes an entity will have performed an initial determination or assessment of its status under either the Cross-Border Margin Rule (which uses substantially similar definitions of “U.S. person,” “Foreign Consolidated Subsidiary,” and “guarantee”) or the Guidance (which interprets “U.S. person” in a manner that is similar but not identical to the proposed definition of “U.S. person”). Additionally, the proposed rule would allow market participants to rely on representations from their counterparties with regard to their classifications.
Even with respect to market participants that have not previously determined their status under the Cross-Border Margin Rule or the Guidance, or that may need to reevaluate their status, the Commission believes that their assessment costs would be small as a result of the Proposed Rule's reliance on relatively clear, objective definitions of the terms “U.S. person,” “Foreign Consolidated Subsidiary,” and “guarantee.” Specifically, the Commission believes that the costs of assessing whether a market participant is a “U.S. person” would be small as a result of certain key differences between the Proposed Rule's U.S. person definition and the “U.S. person” interpretation in the Guidance.
Additionally, the proposed rule relies on the definition of “guarantee” provided in the Cross-Border Margin Rule, which is limited to arrangements in which one party to a swap has rights of recourse against a guarantor with respect to its counterparty's obligations under the swap.
Finally, the Commission believes that proposing consistent U.S. person and Foreign Consolidated Subsidiary definitions, which would apply across all of the Commission's future cross-border rulemakings (unless the specific rule or regulation otherwise provides or the context otherwise requires), would also further reduce costs (including assessment costs) over time by applying a consistent definition across all of the Commission's cross-border swaps rules.
Under the proposed rule, a U.S. person would include all of its swap dealing transactions in its de minimis calculation, without exception. As discussed above, that would include any swap dealing transactions conducted through a U.S. person's foreign branch, as such swaps are directly attributed to, and therefore impact, the U.S. person. Given that this requirement mirrors the Guidance in this respect, the Commission believes that the proposed rule would have a minimal impact on the status quo with regard to the number of registered or potential U.S. SDs.
The proposed rule would also require U.S. Guaranteed Entities (that are not FCSs)
Under the proposed rule, a Foreign Consolidated Subsidiary would include all of its swap dealing transactions in its de minimis threshold calculation without exception. The Guidance did not differentiate FCSs from Other Non-U.S. Persons, and therefore FCSs would generally only include in their de minimis threshold calculations their swap dealing transactions with U.S. persons (excluding foreign branches of U.S. SDs) and with certain guaranteed affiliates.
However, as noted in section II.B, the Commission believes that it would be appropriate to distinguish FCSs from Other Non-U.S. Persons in determining the cross-border application of the SD de minimis threshold to such entities, as well as with respect to the Dodd-Frank swap provisions more generally. As discussed above, by virtue of the close integration between the FCS and its U.S. ultimate parent, counterparties look to both the FCS and its U.S. parent for fulfillment of the FCS's obligations under the swap, even without any explicit guarantee. Therefore, the Commission believes that it is appropriate to require FCSs to include all of their swap dealing transactions in their SD de minimis calculation. In addition, allowing an FCS to exclude non-U.S. swap dealing transactions from its calculation could incentivize U.S. financial groups to book their non-U.S. dealing transactions into an FCS, avoiding swap regulation.
Under the Proposed Rule, the FCS definition is used to distinguish non-U.S. persons with a U.S. ultimate parent entity from Other Non-U.S. Persons for purposes of determining how Dodd-Frank swap provisions should apply. The full market impact of the Proposed Rule's shift of some non-U.S. persons to FCSs cannot be determined at this time in the absence of further rulemakings addressing the cross-border application of substantive requirements under the Dodd-Frank Act. However, to the extent that future cross-border rulemakings apply more stringent requirements to swap transactions with FCSs, non-U.S. counterparties may seek to avoid transacting with such dealers, fragmenting swaps market liquidity into two pools—one for U.S. persons and FCSs and the other for non-U.S. persons (that are not FCSs). Nevertheless, as discussed above, the Commission believes that the proposal to require FCSs to include all of their swap dealing activity in their de minimis threshold calculations is necessary and appropriate to ensure the policy objectives of the Dodd-Frank Act are preserved and not undermined by a substantial regulatory loophole.
Under the proposed rule, Other Non-U.S. Persons would be required to include in their de minimis threshold calculations swap dealing activities with U.S. persons (including foreign branches of U.S. SDs), U.S. Guaranteed Entities, and FCSs. The proposed rule would not, however, require Other Non-U.S. Persons to include swap dealing transactions with Other Non-U.S. Persons. Additionally, Other Non-U.S. Persons would not be required to include in their de minimis calculation any transaction that is executed anonymously on a SEF, DCM, or FBOT and cleared.
The Commission believes that requiring Other Non-U.S. Persons to include their swap dealing transactions with U.S. persons in their de minimis calculations is necessary to advance the goals of the Dodd-Frank SD registration regime, which focuses on U.S. market participants and the market. As discussed above, the Commission considered incorporating an exception from the Guidance allowing non-U.S. persons to exclude from their de minimis thresholds transactions with foreign branches of U.S. SDs but determined that, given the integral nature of the foreign branch to a U.S. person, such an exception would create a potentially significant regulatory loophole, allowing a substantial amount of dealing activity with U.S. counterparties to occur outside the comprehensive Dodd-Frank swap regime.
Under the proposed rule, Other Non-U.S. Persons would not be required to include any swap dealing transactions with Other Non-U.S. Persons in their SD de minimis threshold calculations, including ANE transactions. Although a non-U.S. person that engages in ANE transactions is performing dealing activity in the United States, the Commission does not believe that requiring non-U.S. persons to include ANE transactions in their de minimis threshold calculations would be necessary to advance the policy objectives of the Dodd-Frank swap regime when taking the Proposed Rule in context, particularly the proposal to require FCSs to include all of their swap dealing transactions in their de minimis threshold calculations.
The Commission recognizes that the proposed rule's cross-border approach to the de minimis threshold calculation could contribute to competitive disparities arising between U.S.-based financial groups and non-U.S. based financial groups. Potential SDs that are U.S. persons or that have a U.S. ultimate parent entity (FCSs) would be required to include all of their swap transactions. In contrast, potential non-U.S. SDs with a non-U.S. ultimate parent entity whose obligations under the relevant swap are not subject to a U.S. guarantee (Other Non-U.S. Persons) would be permitted to exclude swaps with Other Non-U.S. Persons, including ANE transactions. As a result, potential SDs with a U.S. ultimate parent entity may be at a competitive disadvantage, as more of their swap activity would apply toward the de minimis threshold and trigger the SD registration threshold relative to Other Non-U.S. Persons. To the extent that a currently unregistered non-U.S. person would be required to register as an SD under the proposed rule, its non-U.S. counterparties (clients and dealers) may possibly cease transacting with it in order to operate outside the Dodd-Frank swap regime.
As described in section V, the Proposed Rule would approach the cross-border application of the MSP registration thresholds in a similar manner as the SD de minimis registration threshold. Specifically, the proposed rule would require U.S. persons, U.S. Guaranteed Entities, and FCSs to include all of their swap positions in their MSP calculations without exception. As further explained in section V, in the Commission's view this result is appropriate because the Commission believes that swap positions with U.S. persons, U.S. Guaranteed Entities, and FCSs can in each case have a significant effect on the U.S. financial system and therefore should be treated in a similar manner for purposes of the MSP registration calculation.
For related reasons discussed in section V.B, the proposed rule would also require Other Non-U.S. Persons to include in their MSP calculations all of their swap positions with U.S. persons, U.S. Guaranteed Entities, and FCSs, with a limited exception for transactions executed anonymously on a SEF, DCM, or FBOT and cleared. The Commission believes that swap positions with U.S. persons, U.S. Guaranteed Entities, and FCSs can in each case have a significant effect on the U.S. financial system and therefore should be treated in a similar manner.
The Commission notes that no entities are currently registered as MSPs. The Commission also does not believe that the proposed cross-border approach to the MSP registration thresholds would result in significant costs to market participants compared to the status quo (
Under the proposed rule, market participants would need to continue to monitor their swap activities in order to determine whether they are, or continue to be, required to register as an SD or MSP. Given that market participants are believed to have developed policies and practices consistent with the cross-border approach to the SD/MSP registration thresholds expressed in the Guidance, the Commission believes that market participants would only incur incremental costs in modifying their existing systems and policies and procedures in response to the proposed rule (
For example, the Commission notes that FCSs are likely to have adopted policies and practices in line with the Guidance approach to non-U.S. persons that are not guaranteed or conduit affiliates and therefore may only be currently counting (or be provisionally registered by virtue of) their swap dealing transactions with U.S. persons, other than foreign branches of U.S. SDs.
As a result of the proposed rule's classification scheme for market participants (
As noted above, if the proposed rule is adopted, certain market participants would likely be required to register as SDs and would become subject to various requirements imposed on swap dealers under the Dodd-Frank Act and related Commission's regulations. To the extent that the proposed rule acts as a “gating” rule by affecting which entities engaged in cross-border swaps activities must comply with the SD requirements, the Proposed Rule could result in increased costs for particular entities that otherwise would not register as an SD and comply with the swap provisions.
Market participants that are already registered (or provisionally registered) as SDs or MSPs prior to adoption of the proposed rule (if it is adopted) could also be affected by the proposal. In particular, the Commission is proposing rules that would define certain key terms for purposes of the Dodd-Frank swaps provisions (including future cross-border rulemakings). Therefore, the proposal could affect the treatment of market participants that are already registered (or provisionally registered) across the Commission's entire cross-border framework and attendant costs and benefits in addition to those that are registering for the first time. The proposal also addresses the cross-border application of the Commission's external business conduct standards, including the extent to which such requirements would apply to swap transactions that are arranged, negotiated, or executed by registered SDs or MSPs using personnel located in the United States.
Further, as a result of the proposed rule, certain other market participants would be categorized differently under the proposal than they were under the Guidance, which could affect how they are treated across the Commission's entire cross-border framework and attendant costs and benefits.
As discussed in section VI above, the proposed rule addresses the cross-border application of the Commission's external business conduct standards to transactions in which at least one of the counterparties is an SD/MSP, including the extent to which they would apply to ANE transactions. Under the proposed rule, U.S. SD/MSPs (other than foreign branches of U.S. SD/MSPs) would be required to comply with the Commission's external business conduct standards without substituted compliance. As discussed above, this requirement reflects the Commission's view that the Dodd-Frank external business conduct standards should apply fully to registered SDs and MSPs domiciled and operating in the United States because their swap activities are particularly likely to affect the integrity of the swaps market in the United States and raise concerns about the protection of participants in those markets. The Commission does not expect that this requirement would impose any additional costs on market participants in comparison to the status quo given that the Commission's external business conduct standards already apply to U.S. SD/MSPs under the Commission's external business conduct standards rulemaking.
Non-U.S. SD/MSPs and foreign branches of U.S. SD/MSPs would only be required to comply with the external business conduct standards if (1) the counterparty is a U.S. person (other than a foreign branch of a U.S. SD/MSP) or (2) a non-U.S. SD or foreign branch of a U.S. SD uses personnel located in the United States to arrange, negotiate, or execute the transaction (or a swap that is offered but not entered into), in which case the antifraud
The proposed rule goes beyond the scope of the Guidance, however, by making clear that non-U.S. SDs and foreign branches of U.S. SDs would be required to comply with the antifraud and fair dealing external business conduct standards with respect to ANE transactions. This requirement would therefore impose additional compliance costs relative to the status quo not only on existing non-U.S. SDs and foreign branches of U.S. SDs, which likely currently do not comply with the external business conduct standards with respect to their transactions with non-U.S. persons or foreign branches of U.S. SD/MSPs, but any non-U.S. persons that are required to register by virtue of the proposed rule's approach to the SD registration threshold. As discussed above, where swaps are arranged, negotiated or executed in the United States, the Commission has a strong supervisory interest both in protecting involved counterparties against fraud, manipulation and other abusive practices of an SD and in requiring that the SD communicate in a fair and balanced manner with these counterparties based on principles of fair dealing and good faith. Taking the proposed rule as a whole, however, the Commission does not believe that application of the remaining external business conduct standards would be necessary to advance the goals of the
Section 15(a) of the CEA requires the Commission to consider the costs and benefits of its actions before promulgating a regulation under the CEA or issuing certain orders. Section 15(a) further specifies that the costs and benefits shall be evaluated in light of five broad areas of market and public concern: (1) Protection of market participants and the public; (2) efficiency, competitiveness, and financial integrity of futures markets; (3) price discovery; (4) sound risk management practices; and (5) other public interest considerations. The Commission considers the costs and benefits resulting from its discretionary determinations with respect to the section 15(a) factors.
The Commission believes the proposed rule would support protection of market participants and the public. By focusing on and capturing swap dealing transactions and swap positions involving U.S. persons and non-U.S. persons with a strong nexus to the United States (
To the extent that the proposed rule leads additional entities to register as SDs, the Commission believes that the proposed rule could enhance the financial integrity of the markets by bringing significant U.S. swaps market participants under Commission oversight, which may reduce market disruptions and foster confidence and transparency in the U.S. market. The Commission recognizes that the Proposed Rule's cross-border approach to the SD and MSP registration thresholds may create competitive disparities among market participants, based on the degree of their connection to the United States, that could contribute to market inefficiencies, including market fragmentation and decreased liquidity, as certain market participants may reduce their exposure to the U.S. market. As a result of reduced liquidity, counterparties may pay higher prices, in terms of bid-ask spreads (or in the case of swaps, the cost of the swap and the cost to hedge). Such competitive effects and market inefficiencies may, however, be mitigated by global efforts to harmonize approaches to swap regulation and by the large inter-dealer market, which may link the fragmented markets and enhance liquidity in the overall market. On balance, the Commission believes that the proposed rule's approach is necessary and appropriately tailored to ensure that the purposes of the Dodd-Frank swap regime and its registration requirements are advanced while still establishing a workable approach that recognizes foreign regulatory interests and minimizes competitive disparities and market inefficiencies to the degree possible. The Commission further believes that the proposed rule's cross-border approach to the external business conduct standards will promote the financial integrity of the markets by fostering transparency and confidence in the major participants in the U.S. swap markets.
The Commission recognizes that the proposed rule's approach to the cross-border application of the SD and MSP registration thresholds could also have an effect on liquidity, which may in turn influence price discovery. As liquidity in the swaps market is lessened and fewer dealers compete against one another, bid-ask spreads (cost of swap and cost to hedge) may widen and the ability to obtain the `true' price of a swap may be hindered. However, as noted above, these negative effects would be mitigated as jurisdictions harmonize their swaps initiative and global financial institutions continue to manage their swaps books (
The Commission believes that the proposed rule's approach could promote the development of sound risk management practices by ensuring that significant participants in the U.S. market are subject to Commission oversight (via registration), including in particular important counterparty disclosure and recordkeeping requirements that will encourage policies and practices that promote fair dealing while discouraging abusive practices in U.S. markets.
The Commission has not identified any public interest considerations related to the costs and benefits of the proposed rule.
1. Is the Commission's assumption that few, if any, market participants will be required to register as MSPs as a result of the proposed rule (as compared to the status quo) correct? If not, please provide an estimate of the number of market participants that are likely to have to register as MSPs as a result of the proposed rule, including an explanation for the basis of the estimate, and associated costs and benefits of the Proposed Rule's provisions for MSPs (including potential MSPs).
2. The Commission preliminarily believes that a requirement that Other Non-U.S. Persons include ANE transactions in their SD registration threshold calculations would not be likely to increase the scope of entities that would be covered under its swap requirements, but may result in significant burdens. Is that belief correct? If not, please provide an
3. The Commission invites information regarding whether and the extent to which specific foreign requirement(s) may affect the costs and benefits of the proposed rule, including information identifying the relevant foreign requirement(s) and any monetary or other quantitative estimates of the potential magnitude of those costs and benefits.
4. The Commission is estimating that 17 currently registered non-U.S. SDs would be classified as FCSs and that 14 unregistered non-U.S. persons may be classified as FCSs and required to register as new SDs because their swap dealing transactions are in excess of the SD de minimis threshold. The basis for these estimates is set forth below in the accompanying Appendix. The Commission seeks comments regarding its estimates of the scope and number of market participants potentially affected by the proposed rule, including its methodology for arriving at the estimates in the Appendix to Cost Benefit Considerations.
In this Appendix, the Commission explains its methodology for estimating, as a result of the proposed rule, the number of new entities that may be required to register with the Commission as SDs and the number of currently registered non-U.S. SDs that would be classified as an FCS. In arriving at this estimate, the Commission relied on SDR data and other data sources.
The Commission is estimating that overall there will not be an increase in the number of persons that will be required to register as U.S. SDs as a result of the proposed rule, as the proposed rule's approach to the swaps of U.S. persons mirrors the approach in the Guidance (
The Commission is also estimating that there will be no increase in the number of new SDs that are U.S. Guaranteed Entities, as the proposed rule uses a narrower definition of a guarantee (compared to the Guidance), which the Commission believes will result in few, if any, U.S. Guaranteed Entities.
If the proposed rule is adopted, the Commission estimates that 17 currently registered non-U.S. SDs would be classified as FCSs and that 14 unregistered non-U.S. persons may be classified as FCSs and required to register as new SDs because their swap dealing transactions are in excess of the SD de minimis threshold. The basis for these estimates is set forth below.
In estimating the number of SDs that, as a result of the proposed rule, would shift from a category of non-U.S. SDs to the new category, FCS, the Commission reviewed its current list of registered SDs. As the definition of an FCS is dependent on whether the SD is a non-U.S. person that has an ultimate U.S. parent entity, the Commission was able to isolate those entities from a list of non-U.S. SDs. From this list, the Commission estimated that out of a total of 54 provisionally registered non-U.S. SDs, 17 would be classified as an FCS under the proposed rule.
The Commission estimates that approximately 14 unregistered non-U.S. persons with a U.S. ultimate parent entity under U.S. GAAP (“potential FCSs”) may be required to register as SDs as a result of the proposed rule. The Commission does not currently collect data on trades between non-U.S. persons (including those of potential FCSs with non-U.S. persons). Therefore, in estimating the number of potential FCSs that may be required to register as SDs, the Commission relied on SDR data regarding inter-affiliate trades between potential FCSs and their affiliated U.S. SDs (“inter-affiliate trades”).
The Commission believes that SDR data on inter-affiliate trades provide a reasonable basis upon which to estimate the outward-dealing trades of potential FCSs with non-U.S. persons, provided that the estimate is scaled to the global swap market (as detailed below).
However, there is an important limitation on the use of this inter-affiliate data which is likely to cause it to be under-inclusive as a proxy for the outward-facing trades of these potential FCSs with non-U.S. persons, as the Commission's SDR data only includes swaps that are between a potential FCS and an affiliated U.S. SD. Potential FCSs may also transfer the risk of some of their outward-facing dealing activities to affiliated non-U.S. SDs located in market centers outside the United States (
Based on the foregoing assumptions, the Commission obtained SDR data on inter-affiliate swaps for each potential FCS with affiliated U.S. SDs during the period between March 5, 2015 and March 4, 2016 (the “Reference Period”). Because this inter-affiliate trade data only includes open trades as of the end of the Reference Period (
The Commission is unable to estimate the number of new SDs that may be required to register as a result of the proposed rule's requirement that an Other Non-U.S. Person include swaps with an FCS for SD registration threshold purposes due to the lack of SDR data regarding transactions between non-U.S. persons. The Commission also is not estimating the number of new SDs that may be required to register as a result of the proposed rule's requirement that an Other Non-U.S. Person include swaps with a U.S. Person or U.S. Guaranteed Entity in its SD de minimis registration threshold. The Commission believes that few, if any, additional Other Non-U.S. Persons would be required to register as an SD as a result of changes made by the proposed rule (as compared to the Guidance) with respect to either U.S. persons or U.S. Guaranteed Entities.
In addition, as explained in the preamble, the Commission believes that there are few U.S. Guaranteed Entities at this time.
As noted above, the Commission requests comment regarding its estimates of the scope and number of market participants potentially affected by the proposed rule, including its methodology for arriving at the estimates included in this Appendix.
Counterparties, Cross-border, Major swap participants, Swap dealers, Swaps.
Business conduct standards, Counterparties, Cross-border, Major swap participants, Swap dealers, Swaps.
For the reasons discussed in the preamble, the Commodity Futures Trading Commission proposes to amend 17 CFR chapter I as follows:
7 U.S.C. 1a, 2, 5, 6, 6a, 6b, 6c, 6d, 6e, 6f, 6g, 6h, 6i, 6k, 6l, 6m, 6n, 6o, 6p, 6r, 6s, 7, 7a-1, 7a-2, 7b, 7b-3, 8, 9, 10a, 12, 12a, 12c, 13a, 13a-1, 16, 16a, 19, 21, 23, and 24 (2012).
The additions to read as follows:
(ggg) * * *
(7)
(i) For purposes of determining whether an entity engages in more than a de minimis quantity of swap dealing activity under § 1.3(ggg)(4)(i), a person shall include the following swaps (subject to § 1.3(ggg)(6)):
(A) If such person is a U.S. person, all swaps connected with the dealing activity in which such person engages;
(B) If such person is a Foreign Consolidated Subsidiary, all swaps connected with the dealing activity in which such person engages;
(C) If such person is a non-U.S. person that is not a Foreign Consolidated Subsidiary, and its obligations under the relevant swap(s) are guaranteed by a U.S. person, all swaps connected with the dealing activity in which such person engages as to which its obligations under the relevant swap(s) are guaranteed by a U.S. person (in addition to any swaps that it is required to include pursuant to paragraph (ggg)(7)(i)(D) of this section);
(D) If such person is a non-U.S. person that is not a Foreign Consolidated Subsidiary, and its obligations under the relevant swap(s) are not guaranteed by a U.S. person, all of the following swaps connected with the dealing activity in which such person engages (in addition to any swaps that it is required to include pursuant to paragraph (ggg)(7)(i)(C) of this section) (unless the swap is entered into anonymously on a registered designated contract market, registered swap execution facility, or registered foreign board of trade and cleared through a registered or exempt derivatives clearing organization):
(
(
(
(ii) [Reserved]
(nnn)
(1) For purposes of determining a person's status as a major swap participant as defined in section 1a(33) of the Act, 7 U.S.C. 1(a)(33) and the rules and regulations thereunder, a person shall include the following swap positions:
(i) If such person is a U.S. person, all swap positions that are entered into by the person;
(ii) If such person is a Foreign Consolidated Subsidiary, all swap positions that are entered into by the person; and
(iii) If such person is a non-U.S. person that is not a Foreign Consolidated Subsidiary, and its obligations under the relevant swap(s) are guaranteed by a U.S. person, all swap positions that are entered into by the person as to which its obligations under the relevant swap(s) are guaranteed by a U.S. person (in addition to any swap positions that it is required to include pursuant to paragraph (nnn)(1)(iv) of this section);
(iv) If such person is a non-U.S. person that is not a Foreign Consolidated Subsidiary, and its obligations under the relevant swap(s) are not guaranteed by a U.S. person, all of the following swap positions that are entered into by the person (in addition to any swap positions that it is required to include pursuant to paragraph (nnn)(1)(iii) of this section) (unless the swap position is entered into anonymously on a registered designated contract market, registered swap execution facility, or registered foreign board of trade and cleared through a registered or exempt derivatives clearing organization):
(A) Swap positions with a counterparty that is a U.S. person;
(B) Swap positions with a counterparty that is a Foreign Consolidated Subsidiary; and
(C) Swap positions with a counterparty that is a non-U.S. person that is not a Foreign Consolidated Subsidiary and whose obligations under the relevant swap are guaranteed by a U.S. person.
(2) [Reserved]
(ooo)-(www) [Reserved]
(tttt)-(zzzz) [Reserved]
(aaaaa)
(1)
(2)
(3)
(4)
(5)
(i) A natural person who is a resident of the United States;
(ii) An estate of a decedent who was a resident of the United States at the time of death;
(iii) A corporation, partnership, limited liability company, business or other trust, association, joint-stock company, fund or any form of entity similar to any of the foregoing (other than an entity described in paragraph (aaaaa)(5)(iv) or (v) of this section) (“legal entity”), in each case that is organized or incorporated under the laws of the United States or that has its principal place of business in the United States, including any branch of the legal entity;
(iv) A pension plan for the employees, officers or principals of a legal entity described in paragraph (aaaaa)(5)(iii) of this section, unless the pension plan is primarily for foreign employees of such entity;
(v) A trust governed by the laws of a state or other jurisdiction in the United States, if a court within the United States is able to exercise primary supervision over the administration of the trust;
(vi) A legal entity (other than a limited liability company, limited liability partnership or similar entity where all of the owners of the entity have limited liability) that is owned by one or more persons described in paragraphs (aaaaa)(5)(i) through (v) of this section and for which such person(s) bears unlimited responsibility for the obligations and liabilities of the legal entity, including any branch of the legal entity; or
(vii) An individual account or joint account (discretionary or not) where the beneficial owner (or one of the beneficial owners in the case of a joint account) is a person described in paragraphs (aaaaa)(5)(i) through (vi) of this section.
7 U.S.C. 1a, 2, 6, 6a, 6b, 6b-1, 6c, 6p, 6r, 6s, 6t, 9, 9a, 12, 12a, 13b, 13c, 16a, 18, 19, 21.
Section 23.160 also issued under 7 U.S.C. 2(i); Sec. 721(b), Public Law 111-203, 124 Stat. 1641 (2010).
(a) Except as provided in paragraph (b) of this section, anything else to the contrary in this subpart notwithstanding, a swap dealer or major swap participant that is a non-U.S. person or a foreign branch of a U.S. person shall not be subject to the requirements of this subpart with respect to any transaction in swaps (or any swap that is offered but not entered into) where its counterparty is a foreign branch of a U.S. person that is a swap dealer or major swap participant or is a non-U.S. person.
(b) Notwithstanding paragraph (a) of this section, a swap dealer that is a non-U.S. person or a foreign branch of a U.S. person shall be subject to the requirements set forth in §§ 23.410 and 23.433 if the swap dealer uses personnel located in the United States to arrange, negotiate, or execute a transaction in swaps or a swap that is offered but not entered into.
On this matter, Chairman Massad and Commissioners Bowen and Giancarlo voted in the affirmative. No Commissioner voted in the negative.
I am pleased to support this proposal, which addresses several important aspects of the cross-border application of our swaps rules.
First, it seeks to enhance clarity and consistency in the application of our rules by proposing to define certain key terms, including the terms “U.S. person” and “Foreign Consolidated Subsidiary” (FCS), consistent with how they are defined in the Commission's cross-border margin rule.
Second, the proposal provides a clear standard for determining whether a swap dealing transaction should be included in an entity's calculation of whether it must register as a swap dealer. The proposal states that for U.S. persons, as well as those non-U.S. persons whose swaps are guaranteed by a U.S. person or that are a financially consolidated subsidiary of a U.S. ultimate parent (FCS), all swap dealing transactions must be included. All other persons would include swap dealing transactions with counterparties that are U.S. persons or FCSs, as well as swaps that have a U.S. guarantee, unless the swap is executed anonymously on a registered platform and cleared. The Proposed Rule provides a similar counting framework for the major swap participant registration threshold.
We are also proposing the application of external business conduct (EBC) standards for cross-border transactions, including those transactions that are arranged, negotiated, or executed by personnel in the U.S. Specifically, U.S. swap dealers would be required to comply with applicable standards, with the exception of their foreign branches. Non-U.S. swap dealers and foreign branches of U.S. swap dealers would be required to comply with applicable EBC standards for transactions with a U.S. counterparty—other than the foreign branch of a U.S. entity. For all other transactions, these dealers would not be subject to EBC standards, unless they use personnel located in the United States to arrange, negotiate, or execute such transactions. In that case, they would be required to comply with those EBC standards prohibiting fraud and other abusive conduct.
This aspect of our proposal follows up on a staff advisory and a Commission request for comment relating to non-U.S. swap dealers using personnel located in the United States to arrange, negotiate, or execute swap transactions. We will address whether other requirements should apply to such transactions at a later date.
This is just the latest in a number of steps we have taken to address cross-border issues in swaps rules. We have harmonized clearinghouse regulation through our accord with the European Commission—as well as through our work to address recovery and resolution internationally. We have given exemptions from registration to several foreign clearinghouses, and granted “foreign board of trade” status to several exchanges. We are actively working on harmonizing data reporting standards, and we are looking at whether we can do the same regarding trading requirements. And we harmonized requirements on margin for uncleared swaps, adopted a cross-border approach to that rule, and recently issued our first comparability determination for margin.
I wish to express my appreciation for the hard work of the CFTC staff in putting together these important rules. I thank Commissioner Bowen and Giancarlo for their support. And I encourage market participants to give us their comments on this proposed rule.
The rule proposal we have before us is significant. It addresses a number of important issues including: (i) The “US Person” definition; (ii) the treatment of foreign affiliates of US Persons (“Foreign Consolidated Subsidiaries” or “FCS”); (iii) the application of the de minimis threshold and business conduct standards to non-US registered dealers; and (iv) the treatment of swap trades that are “arranged, negotiated, or executed” in the US by foreign-based dealers but booked elsewhere.
I intend to vote “yes” for this proposed rule. Although I do not agree with every part of the proposal, I believe the proposal and questions lay out the key issues to allow for meaningful comments from the public. In that vein, I strongly urge market participants and members of the general public to comment on this rule proposal before the Commission makes a final decision. Its importance to our overall effort to regulate the swaps market requires us to take special care in considering how average investors and interested citizens feel about this proposal before we decide to finalize it.
I like many aspects of this rule. First, I am happy to see that it largely adopts the US Person and FCS definitions from the cross border margin rule. Whenever possible, we should try to make our rules consistent with each other; so this is a move in the right direction.
Second, it proposes that three important groups: US-based dealers, non-US entities guaranteed by US persons, and FCS—each count
However, I especially invite robust comment on certain aspects of the proposal:
For these reasons, and others, I would strongly encourage the public and market participants, particularly our US dealers, to comment on this proposal. Thank you.
I support issuing today's proposed rule in order to hear commenters' considered views, especially with respect to the Commission's approach on the issue of U.S. personnel arranging, negotiating or executing transactions for two non-U.S. persons.
I have been a critic of the Commission's 2013 over-expansive cross-border interpretative guidance
The proposed rule provides that these ANE Transactions fall within the scope of the Dodd-Frank Act and that it may be appropriate to apply specific swap requirements to such transactions to advance Dodd-Frank's regulatory objectives. Yet, it also preliminarily determines that applying registration thresholds and external business conduct standards to such ANE Transactions would not further Dodd-Frank's regulatory objectives, except for certain abusive practices and fair dealing rules with respect to external business conduct standards. While this limited application seems appropriate, I am interested to hear commenters' thoughts about the Commission's approach and rationale before reaching a decision.
Since this proposal only addresses registration thresholds and external business conduct standards, the Commission says it intends to address the application of other Dodd-Frank swap requirements to ANE Transactions in subsequent rulemakings as necessary and appropriate. Until that happens, I urge the staff to commit to extend no-action letter 16-64
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
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