Federal Register Vol. 83, No.221,
Federal Register Volume 83, Issue 221 (November 15, 2018)
Federal Register Volume 83, Issue 221 (November 15, 2018)
| Page Range | 57307-57670 | |
| FR Document |
Document Created: 2018-10-26 09:29:50
Document Modified: 2018-10-26 09:29:50
| Page and Subject | |
|---|---|
| 83 FR 57669 - Veterans Day, 2018 | |
| 83 FR 57667 - National Apprenticeship Week, 2018 | |
| 83 FR 57665 - American Education Week, 2018 | |
| 83 FR 57661 - Addressing Mass Migration Through the Southern Border of the United States | |
| 83 FR 57507 - Sunshine Act Meeting | |
| 83 FR 57511 - Sunshine Act Meetings | |
| 83 FR 57456 - List of Borrowers Who Have Defaulted on Their Health Education Assistance Loans | |
| 83 FR 57526 - Request for Comments on Negotiating Objectives for a U.S.-European Union Trade Agreement | |
| 83 FR 57319 - Safety Zone; Delaware River; Camden, NJ; Fireworks Display | |
| 83 FR 57432 - Takes of Marine Mammals Incidental to Specified Activities; Taking Marine Mammals Incidental to Boost-Back and Landing of Falcon 9 Rockets | |
| 83 FR 57476 - Notice of Public Meeting of the Interagency Steering Committee on Radiation Standards (ISCORS) | |
| 83 FR 57395 - Magnuson-Stevens Act Provisions; Fisheries of the Northeastern United States; Northeast Multispecies Fishery; Approval of New Gear Under Small-Mesh Fisheries Accountability Measures | |
| 83 FR 57333 - Azoxystrobin; Pesticide Tolerances | |
| 83 FR 57473 - Draft TSCA Risk Evaluation for Colour Index (C. I.) Pigment Violet 29 (PV29); Notice of Availability | |
| 83 FR 57475 - Pesticide Product Registration; Receipt of Applications for New Uses | |
| 83 FR 57477 - Product Cancellation Order for Certain Pesticide Registrations and Amendments To Terminate Uses | |
| 83 FR 57488 - Proposed Data Collection Submitted for Public Comment and Recommendations | |
| 83 FR 57485 - Agency Forms Undergoing Paperwork Reduction Act Review | |
| 83 FR 57484 - Agency Forms Undergoing Paperwork Reduction Act Review | |
| 83 FR 57486 - Proposed Data Collection Submitted for Public Comment and Recommendations | |
| 83 FR 57387 - Adopting Subpart Ba Requirements in Emission Guidelines for Municipal Solid Waste Landfills; Notice of Public Hearing | |
| 83 FR 57500 - Endangered and Threatened Species; Receipt of Recovery Permit Applications | |
| 83 FR 57490 - Evaluating the Pressor Effects of Drugs; Public Workshop | |
| 83 FR 57408 - Submission for OMB Review; Comment Request | |
| 83 FR 57525 - Notice of Meeting: U.S. Advisory Commission on Public Diplomacy | |
| 83 FR 57523 - Notice of Determinations; Culturally Significant Objects Imported for Exhibition-Determinations: “Vija Celmins: To Fix the Image in Memory” Exhibition | |
| 83 FR 57431 - Northeast Regional Stock Assessment Workshop and Stock Assessment Review Committee Public Meeting | |
| 83 FR 57506 - Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public Interest | |
| 83 FR 57340 - Atlantic Highly Migratory Species; Atlantic Bluefin Tuna Fisheries | |
| 83 FR 57490 - Agency Information Collection Activities: Proposed Collection; Comment Request | |
| 83 FR 57493 - Family Self-Sufficiency Performance Measurement System (“Composite Score”) | |
| 83 FR 57424 - Export Trade Certificate of Review | |
| 83 FR 57389 - Fisheries of the Northeastern United States; Summer Flounder, Scup, and Black Sea Bass Fisheries; 2019 Specifications | |
| 83 FR 57386 - Expanding Employment, Training, and Apprenticeship Opportunities for 16- and 17-Year-Olds in Health Care Occupations Under the Fair Labor Standards Act, Comment Extension Period | |
| 83 FR 57411 - Initiation of Antidumping and Countervailing Duty Administrative Reviews | |
| 83 FR 57429 - Certain Steel Threaded Rod From the People's Republic of China: Final Results of Antidumping Duty Administrative Review and Final Determination of No Shipments; 2016-2017 | |
| 83 FR 57419 - Certain Quartz Surface Products From the People's Republic of China: Preliminary Affirmative Determination of Critical Circumstances, in Part, in the Countervailing Duty Investigation | |
| 83 FR 57425 - Diamond Sawblades and Parts Thereof From the People's Republic of China: Preliminary Affirmative Determination of Circumvention | |
| 83 FR 57401 - Notice of Solicitation of Applications for Inviting Applications for the Rural Economic Development Loan and Grant Programs for Fiscal Year 2019 | |
| 83 FR 57408 - Reorganization of Foreign-Trade Zone 283; (Expansion of Service Area) Under Alternative Site Framework; West Tennessee Area | |
| 83 FR 57409 - Reorganization of Foreign-Trade Zone 81 Under Alternative Site Framework; Portsmouth, New Hampshire | |
| 83 FR 57410 - Reorganization of Foreign-Trade Zone 9 Under Alternative Site Framework; Honolulu, Hawaii | |
| 83 FR 57410 - Production Authority Not Approved; Gildan Yarns, LLC; Foreign-Trade Zone 57; (Cotton and Cotton/Polyester Yarns); Salisbury, North Carolina | |
| 83 FR 57409 - Foreign-Trade Zone (FTZ) 230-Greensboro, North Carolina; Notification of Proposed Production Activity; Patheon Softgels; (Pharmaceutical Products); High Point, North Carolina | |
| 83 FR 57410 - Foreign-Trade Zone (FTZ) 41-Milwaukee, Wisconsin; Authorization of Production Activity; CNH Industrial America LLC; (Tractors, Component Parts, and Axle Subassemblies); Sturtevant, Wisconsin | |
| 83 FR 57482 - Submission for OMB Review; Subcontracting Plans | |
| 83 FR 57401 - Notice of Revision of a Currently Approved Information Collection | |
| 83 FR 57509 - Notice of Intent To Seek Approval To Extend an Information Collection | |
| 83 FR 57482 - Formations of, Acquisitions by, and Mergers of Bank Holding Companies | |
| 83 FR 57453 - Proposed Information Collection; Comment Request; International Billfish Angler Survey | |
| 83 FR 57454 - Proposed Information Collection; Comment Request; Designation of Fishery Management Council Members and Application for Reinstatement of State Authority | |
| 83 FR 57527 - Results of the 2017/2018 Annual Generalized System of Preferences Review | |
| 83 FR 57399 - Notice of Intent To Request To Conduct a New Information Collection | |
| 83 FR 57400 - Notice of Intent To Request Revision and Extension of a Currently Approved Information Collection | |
| 83 FR 57510 - New Postal Product | |
| 83 FR 57339 - Snapper-Grouper Fishery of the South Atlantic; 2018 Commercial Closure for Hogfish in the Florida Keys/East Florida Area of the South Atlantic | |
| 83 FR 57341 - Fisheries of the Exclusive Economic Zone off Alaska; Shortraker Rockfish in the Central Regulatory Area of the Gulf of Alaska | |
| 83 FR 57508 - Petitions for Modification of Application of Existing Mandatory Safety Standard | |
| 83 FR 57509 - Petition for Modification | |
| 83 FR 57511 - Product Change-Priority Mail Negotiated Service Agreement | |
| 83 FR 57455 - Notice of Intent To Grant Co-Exclusive License | |
| 83 FR 57455 - Notice of Public Meetings for the Draft Environmental Impact Statement for the Modernization of the Fallon Range Training Complex, Nevada | |
| 83 FR 57517 - Privacy Act of 1974; System of Records | |
| 83 FR 57491 - First Responders Community of Practice (FRCoP) | |
| 83 FR 57492 - Science and Technology Collection of Qualitative Feedback | |
| 83 FR 57523 - Updating the State Department's List of Entities and Subentities Associated With Cuba (Cuba Restricted List) | |
| 83 FR 57456 - Notice of Availability of Government-Owned Inventions; Available for Licensing | |
| 83 FR 57408 - Agenda and Notice of Public Meeting of the North Dakota Advisory Committee | |
| 83 FR 57321 - Safety Zone; Santa Spectacular, Ohio River, Monongahela River, Allegheny River, Pittsburgh, PA | |
| 83 FR 57322 - Safety Zone; The Gut, South Bristol, ME | |
| 83 FR 57516 - Meeting of the Advisory Committee on Veterans Business Affairs | |
| 83 FR 57517 - Meeting of the Interagency Task Force on Veterans Small Business Development | |
| 83 FR 57517 - Presidential Declaration Amendment of a Major Disaster for the State of South Carolina | |
| 83 FR 57516 - Presidential Declaration Amendment of a Major Disaster for Public Assistance Only for the State of Georgia | |
| 83 FR 57502 - Agency Information Collection Activities; Navajo Partitioned Lands Grazing Permits | |
| 83 FR 57532 - Notice of OFAC Sanctions Actions | |
| 83 FR 57470 - Notice of Request Under Blanket Authorization Florida Gas Transmission Company, LLC | |
| 83 FR 57472 - Notice of Application Ready for Environmental Analysis and Soliciting Comments, Recommendations, Terms and Conditions, and Prescriptions; Goose River Hydro, Inc. | |
| 83 FR 57469 - Notice of Availability of Draft Environmental Assessment: California Department of Water Resources | |
| 83 FR 57471 - Notice of Petition for Declaratory Order; Blue Marmot V LLC, Blue Marmot VI LLC, Blue Marmot VII LLC, Blue Marmot VIII LLC, and Blue Marmot IX LLC | |
| 83 FR 57472 - Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization; NTE Southeast Electric Company, LLC | |
| 83 FR 57470 - Combined Notice of Filings #1 | |
| 83 FR 57468 - Combined Notice of Filings | |
| 83 FR 57481 - Radio Broadcasting Services; AM or FM Proposals To Change the Community of License | |
| 83 FR 57534 - Open Meeting of the Taxpayer Advocacy Panel Notices and Correspondence Project Committee | |
| 83 FR 57502 - Notice of Request for Nominees for the Advisory Committee on Water Information | |
| 83 FR 57505 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Accounts Receivable Confirmations Reporting | |
| 83 FR 57407 - Notice of Public Meeting of the Florida Advisory Committee | |
| 83 FR 57528 - Notice of Intent To Rule on Request To Release Airport Property | |
| 83 FR 57467 - Sabine Pass LNG, L.P.; Notice of Application | |
| 83 FR 57513 - Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Relating to Amendments to the F&O Guaranty Fund Policy (the “Policy”), Clearing Rules (the “Rules”) and Finance Procedures (“Finance Procedures”) | |
| 83 FR 57421 - Antidumping Duty Investigation of Common Alloy Aluminum Sheet From the People's Republic of China: Affirmative Final Determination of Sales at Less-Than-Fair Value | |
| 83 FR 57511 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend the NYSE Arca Equities Fees and Charges To Remove Certain Obsolete Text That References Pillar Phase I Protocols | |
| 83 FR 57427 - Countervailing Duty Investigation of Common Alloy Aluminum Sheet From the People's Republic of China: Final Affirmative Determination | |
| 83 FR 57503 - Exxon Valdez Oil Spill Public Advisory Committee; Call for Nominations | |
| 83 FR 57504 - Request for Nominations for the Acadia National Park Advisory Commission | |
| 83 FR 57503 - Notice of a Teleconference Meeting of the Made in America Outdoor Recreation Advisory Committee on Friday, November 30, 2018 | |
| 83 FR 57406 - Rural Broadband Access Loans and Loan Guarantees Program | |
| 83 FR 57507 - Agency Information Collection Activities: Proposed Collection; Comments Requested | |
| 83 FR 57364 - Airworthiness Directives; Dassault Aviation Airplanes | |
| 83 FR 57520 - Privacy Act of 1974; System of Records | |
| 83 FR 57366 - Security and Suitability Files | |
| 83 FR 57386 - Noncommercial Use of Pre-1972 Sound Recordings That Are Not Being Commercially Exploited: Extension of Comment Period | |
| 83 FR 57318 - Safety Zone; Columbia River, Cascade Locks, OR | |
| 83 FR 57378 - Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations | |
| 83 FR 57324 - Prevention of Significant Deterioration (PSD) and Nonattainment New Source Review (NNSR): Aggregation; Reconsideration | |
| 83 FR 57388 - Pipeline Safety: Guidance on the Extension of the 7-year Integrity Management Reassessment Interval by 6 Months | |
| 83 FR 57307 - Benefits Payable in Terminated Single-Employer Plans; Interest Assumptions for Paying Benefits | |
| 83 FR 57368 - Setting the Manner for the Appearance of Parties and Witnesses at a Hearing | |
| 83 FR 57308 - Democratic Republic of the Congo Sanctions Regulations | |
| 83 FR 57351 - Potential Federal Reserve Actions To Support Interbank Settlement of Faster Payments, Request for Comments | |
| 83 FR 57343 - Rules Regarding Equal Opportunity | |
| 83 FR 57592 - Moral Exemptions and Accommodations for Coverage of Certain Preventive Services Under the Affordable Care Act | |
| 83 FR 57536 - Religious Exemptions and Accommodations for Coverage of Certain Preventive Services Under the Affordable Care Act | |
| 83 FR 57634 - Significant New Use Rules on Certain Chemical Substances | |
| 83 FR 57529 - Notice of OFAC Sanctions Actions | |
| 83 FR 57531 - Notice of OFAC Sanctions Action |
Issue
National Agricultural Statistics Service
Rural Business-Cooperative Service
Rural Utilities Service
Foreign-Trade Zones Board
International Trade Administration
National Oceanic and Atmospheric Administration
Navy Department
Federal Energy Regulatory Commission
Agency for Toxic Substances and Disease Registry
Centers for Disease Control and Prevention
Centers for Medicare & Medicaid Services
Food and Drug Administration
Coast Guard
Fish and Wildlife Service
Geological Survey
Indian Affairs Bureau
National Park Service
Office of Natural Resources Revenue
Foreign Claims Settlement Commission
Employee Benefits Security Administration
Mine Safety and Health Administration
Wage and Hour Division
Copyright Office, Library of Congress
Federal Aviation Administration
Pipeline and Hazardous Materials Safety Administration
Foreign Assets Control Office
Internal Revenue Service
Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws.
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Pension Benefit Guaranty Corporation.
Final rule.
This final rule amends the Pension Benefit Guaranty Corporation's regulation on Benefits Payable in Terminated Single-Employer Plans to prescribe interest assumptions under the regulation for valuation dates in December 2018. The interest assumptions are used for paying benefits under terminating single-employer plans covered by the pension insurance system administered by PBGC.
Effective December 1, 2018.
Melissa Rifkin (
PBGC's regulation on Benefits Payable in Terminated Single-Employer Plans (29 CFR part 4022) prescribes actuarial assumptions—including interest assumptions—for paying plan benefits under terminated single-employer plans covered by title IV of the Employee Retirement Income Security Act of 1974. The interest assumptions in the regulation are also published on PBGC's website (
PBGC uses the interest assumptions in appendix B to part 4022 to determine whether a benefit is payable as a lump sum and to determine the amount to pay. Appendix C to part 4022 contains interest assumptions for private-sector pension practitioners to refer to if they wish to use lump-sum interest rates determined using PBGC's historical methodology. Currently, the rates in appendices B and C of the benefit payment regulation are the same.
The interest assumptions are intended to reflect current conditions in the financial and annuity markets. Assumptions under the benefit payments regulation are updated monthly. This final rule updates the benefit payments interest assumptions for December 2018.
The December 2018 interest assumptions under the benefit payments regulation will be 1.50 percent for the period during which a benefit is in pay status and 4.00 percent during any years preceding the benefit's placement in pay status. In comparison with the interest assumptions in effect for November 2018, these assumptions represent an increase of 0.25% in the immediate rate and are otherwise unchanged.
PBGC has determined that notice and public comment on this amendment are impracticable and contrary to the public interest. This finding is based on the need to determine and issue new interest assumptions promptly so that the assumptions can reflect current market conditions as accurately as possible.
Because of the need to provide immediate guidance for the payment of benefits under plans with valuation dates during December 2018, PBGC finds that good cause exists for making the assumptions set forth in this amendment effective less than 30 days after publication.
PBGC has determined that this action is not a “significant regulatory action” under the criteria set forth in Executive Order 12866.
Because no general notice of proposed rulemaking is required for this amendment, the Regulatory Flexibility Act of 1980 does not apply. See 5 U.S.C. 601(2).
Employee benefit plans, Pension insurance, Pensions, Reporting and recordkeeping requirements.
In consideration of the foregoing, 29 CFR part 4022 is amended as follows:
29 U.S.C. 1302, 1322, 1322b, 1341(c)(3)(D), and 1344.
Issued in Washington, DC.
Office of Foreign Assets Control, Treasury.
Final rule.
The Department of the Treasury's Office of Foreign Assets Control (OFAC) is adopting a final rule amending the Democratic Republic of the Congo Sanctions Regulations to implement Executive Order 13671 of July 8, 2014 (“Taking Additional Steps to Address the National Emergency With Respect to the Conflict in the Democratic Republic of the Congo”). This rule also incorporates other technical and conforming changes.
The Department of the Treasury's Office of Foreign Assets Control: Assistant Director for Licensing, tel.: 202-622-2480; Assistant Director for Regulatory Affairs, tel: 202-622-4855; Assistant Director for Sanctions Compliance & Evaluation, tel.: 202-622-2490; or the Department of the Treasury's Office of the Chief Counsel (Foreign Assets Control), Office of the General Counsel, tel.: 202-622-2410.
This document and additional information concerning OFAC are available from OFAC's website (
On May 28, 2009, OFAC issued the Democratic Republic of the Congo Sanctions Regulations, 31 CFR part 547 (the “Regulations”) (74 FR 25439, May 28, 2009) to implement Executive Order 13413 of October 27, 2006 (71 FR 64105, October 31, 2006) (E.O. 13413).
On July 8, 2014, the President, invoking the authority of,
E.O. 13671 amends several sections of E.O. 13413 but does not amend the Annex to E.O. 13413 as originally issued. Section 1 of E.O. 13671 amends E.O. 13413 by replacing subsection 1(a) of E.O. 13413 in its entirety. New subsection 1(a) of E.O. 13413 as amended by E.O. 13671 (“amended E.O. 13413”)
(A) To be a political or military leader of a foreign armed group operating in the Democratic Republic of the Congo that impedes the disarmament, demobilization, voluntary repatriation, resettlement, or reintegration of combatants;
(B) to be a political or military leader of a Congolese armed group that impedes the disarmament, demobilization, voluntary repatriation, resettlement, or reintegration of combatants;
(C) to be responsible for or complicit in, or to have engaged in, directly or indirectly, any of the following in or in relation to the Democratic Republic of the Congo: (1) Actions or policies that threaten the peace, security, or stability of the Democratic Republic of the Congo; (2) actions or policies that undermine democratic processes or institutions in the Democratic Republic of the Congo; (3) the targeting of women, children, or any civilians through the commission of acts of violence (including killing, maiming, torture, or rape or other sexual violence), abduction, forced displacement, or attacks on schools, hospitals, religious sites, or locations where civilians are seeking refuge, or through conduct that would constitute a serious abuse or violation of human rights or a violation of international humanitarian law; (4) the use or recruitment of children by armed groups or armed forces in the context of the conflict in the Democratic Republic of the Congo; (5) the obstruction of the delivery or distribution of, or access to, humanitarian assistance; (6) attacks
(D) except where intended for the authorized support of humanitarian activities or the authorized use by or support of peacekeeping, international, or government forces, to have directly or indirectly supplied, sold, or transferred to the Democratic Republic of the Congo, or been the recipient in the territory of the Democratic Republic of the Congo, of arms and related materiel, including military aircraft and equipment, or advice, training, or assistance, including financing and financial assistance, related to military activities;
(E) to be a leader of (i) an entity, including any armed group, that has, or whose members have, engaged in any of the activities described in paragraphs (A) through (D) above or (ii) an entity whose property and interests in property are blocked pursuant to amended E.O. 13413;
(F) to have materially assisted, sponsored, or provided financial, material, logistical, or technological support for, or goods or services in support of: (i) Any of the activities described in (A) through (D) above; or (ii) any person whose property and interests in property are blocked pursuant to amended E.O. 13413; or
(G) to be owned or controlled by, or to have acted or purported to act for or on behalf of, directly or indirectly, any person whose property and interests in property are blocked pursuant to amended E.O. 13413.
The property and interests in property of the persons described above may not be transferred, paid, exported, withdrawn, or otherwise dealt in.
Section 2 of E.O. 13671 adds new subsection (d) to section 1 of E.O. 13413. This new subsection provides that the prohibitions in subsection 1(a) of amended E.O. 13413 apply except to the extent provided by statutes, or in regulations, orders, directives, or licenses that may be issued pursuant to amended E.O. 13413, and notwithstanding any contract entered into or any license or permit granted prior to the effective date of the order.
Section 3 of E.O. 13671 amends section 2 of E.O. 13413 by adding a prohibition. Section 2 of E.O. 13413 prohibited any transaction by a U.S. person or within the United States that evades or avoids, has the purpose of evading or avoiding, or attempts to violate any of the prohibitions set forth in E.O. 13413, as well as any conspiracy formed to violate such prohibitions. Section 3 of E.O. 13671 adds a prohibition on causing a violation of any prohibitions set forth in amended E.O. 13413 to the existing prohibitions.
Section 4 of E.O. 13671 authorizes the Secretary of the Treasury, in consultation with the Secretary of State, to take such actions, including the promulgation of rules and regulations, and to employ all powers granted to the President by IEEPA and the UNPA as may be necessary to carry out the purposes of E.O. 13671 and amended E.O. 13413. Section 4 of E.O. 13671 also provides that the Secretary of the Treasury may redelegate any of these functions to other officers and agencies of the U.S. government.
This rule amends the Regulations to implement the relevant provisions of E.O. 13671, as well as to update certain provisions and to make other technical and conforming changes. OFAC is revising and republishing in its entirety subpart B of the Regulations, which sets forth the prohibitions contained in sections 1 and 2 of amended E.O. 13413.
This rule also amends several sections in subpart C, which defines key terms used throughout the Regulations. New § 547.300 is being added to clarify that the definitions contained in subpart C apply throughout the entire part, and §§ 547.314 and 547.315 are being added to define key terms used in the Regulations. Also, certain existing definitions in subpart C are being updated or revised to take account of new provisions and to provide greater clarity with respect to the terms being used.
This rule also revises and republishes in its entirety subpart D, which contains interpretive sections regarding the Regulations. Section 547.411 of subpart D is being amended to clarify that the property and interests in property of an entity are blocked if the entity is directly or indirectly owned, whether individually or in the aggregate, 50 percent or more by one or more persons whose property and interests in property are blocked, whether or not the entity itself is listed in or designated pursuant to amended E.O. 13413 or incorporated into OFAC's Specially Designated Nationals and Blocked Persons List (SDN List). Other sections within subpart D are being amended to reflect current OFAC interpretations.
Transactions otherwise prohibited by the Regulations but found to be consistent with U.S. policy may be authorized by one of the general licenses contained in subpart E of the Regulations or by a specific license issued pursuant to the procedures described in subpart E of 31 CFR part 501. This rule also amends subpart E of the Regulations. In particular, a general license is being added in § 547.508, authorizing payments from outside the United States for the provision of legal services authorized in § 547.507. The general license authorizing certain emergency medical services that was formerly at § 547.508 has been moved to § 547.509 and updated to reflect current licensing policies. Updates to reflect current licensing policies have also been made to several other general licenses. General licenses and statements of licensing policy relating to this part also may be available through the Democratic Republic of the Congo sanctions page on OFAC's website:
This rule revises subpart G of the Regulations and republishes it in its entirety. Subpart G of the Regulations describes the civil and criminal penalties applicable to violations of the Regulations, as well as the procedures governing the potential imposition of a civil monetary penalty or issuance of a Finding of Violation. Subpart G also refers to appendix A of part 501 for a more complete description of these procedures. Finally, this rule updates the delegation of authority by the Secretary of the Treasury in subpart H of the Regulations.
Because the Regulations involve a foreign affairs function, the provisions of Executive Order 12866 and the Administrative Procedure Act (5 U.S.C. 553) requiring notice of proposed rulemaking, opportunity for public participation, and delay in effective date, as well as the provisions of Executive Order 13771 are inapplicable. Because no notice of proposed rulemaking is required for this rule, the Regulatory Flexibility Act (5 U.S.C. 601-612) does not apply.
The collections of information related to the Regulations are contained in 31
Administrative practice and procedure, Banks, Banking, Blocking of assets, Credit, Democratic Republic of the Congo, Foreign trade, Penalties, Reporting and recordkeeping requirements, Securities, Services.
For the reasons set forth in the preamble, the Department of the Treasury's Office of Foreign Assets Control amends 31 CFR part 547 as follows:
3 U.S.C. 301; 31 U.S.C. 321(b); 50 U.S.C. 1601-1651, 1701-1706; 22 U.S.C. 287c; Pub. L. 101-410, 104 Stat. 890 (28 U.S.C. 2461 note); Pub. L. 110-96, 121 Stat. 1011 (50 U.S.C. 1705 note); E.O. 13413, 71 FR 64105, 3 CFR, 2006 Comp., p. 247; E.O. 13671, 79 FR 39949, 3 CFR, 2015 Comp., p. 280.
(a) All property and interests in property that are in the United States, that come within the United States, or that are or come within the possession or control of any U.S. person of the following persons are blocked and may not be transferred, paid, exported, withdrawn, or otherwise dealt in:
(1) The persons listed in the Annex to Executive Order 13413 of October 27, 2006; and
(2) Any person determined by the Secretary of the Treasury, in consultation with the Secretary of State:
(i) To be a political or military leader of a foreign armed group operating in the Democratic Republic of the Congo that impedes the disarmament, demobilization, voluntary repatriation, resettlement, or reintegration of combatants;
(ii) To be a political or military leader of a Congolese armed group that impedes the disarmament, demobilization, voluntary repatriation, resettlement, or reintegration of combatants;
(iii) To be responsible for or complicit in, or to have engaged in, directly or indirectly, any of the following in or in relation to the Democratic Republic of the Congo:
(A) Actions or policies that threaten the peace, security, or stability of the Democratic Republic of the Congo;
(B) Actions or policies that undermine democratic processes or institutions in the Democratic Republic of the Congo;
(C) The targeting of women, children, or any civilians through the commission of acts of violence (including killing, maiming, torture, or rape or other sexual violence), abduction, forced displacement, or attacks on schools, hospitals, religious sites, or locations where civilians are seeking refuge, or through conduct that would constitute a serious abuse or violation of human rights or a violation of international humanitarian law;
(D) The use or recruitment of children by armed groups or armed forces in the context of the conflict in the Democratic Republic of the Congo;
(E) The obstruction of the delivery or distribution of, or access to, humanitarian assistance;
(F) Attacks against United Nations missions, international security presences, or other peacekeeping operations; or
(G) Support to persons, including armed groups, involved in activities that threaten the peace, security, or stability of the Democratic Republic of the Congo or that undermine democratic processes or institutions in the Democratic Republic of the Congo, through the illicit trade in natural resources of the Democratic Republic of the Congo;
(iv) Except where intended for the authorized support of humanitarian activities or the authorized use by or support of peacekeeping, international, or government forces, to have directly or indirectly supplied, sold, or transferred to the Democratic Republic of the Congo, or been the recipient in the territory of the Democratic Republic of the Congo of, arms and related materiel, including military aircraft and equipment, or advice, training, or assistance, including financing and financial assistance, related to military activities;
(v) To be a leader of:
(A) An entity, including any armed group, that has, or whose members have, engaged in any of the activities described in paragraphs (a)(2)(i) through (iv) of this section; or
(B) An entity whose property and interests in property are blocked pursuant to paragraph (a) of this section;
(vi) To have materially assisted, sponsored, or provided financial, material, logistical, or technological support for, or goods or services in support of any of the activities described in paragraphs (a)(2)(i) through (iv) of this section or any person whose property and interests in property are blocked pursuant to paragraph (a) of this section; or
(vii) To be owned or controlled by, or to have acted or purported to act for or on behalf of, directly or indirectly, any person whose property and interests in property are blocked pursuant to paragraph (a) of this section.
The names of persons listed in or designated pursuant to Executive Order 13413, both as originally issued and as amended by Executive Order 13671, whose property and interests in property therefore are blocked pursuant to paragraph (a) of this section, are published in the
The International Emergency Economic Powers Act (50 U.S.C. 1701-1706), in Section 203 (50 U.S.C. 1702), authorizes the blocking of property and interests in property of a person during the pendency of an investigation. The names of persons whose property and interests in property are blocked pending investigation pursuant to paragraph (a) of this section also are published in the
Sections 501.806 and 501.807 of this chapter describe the procedures to be followed by persons seeking, respectively, the unblocking of funds that they believe were blocked due to mistaken identity, and administrative reconsideration of their status as persons whose property and interests in property are
(b) The prohibitions in paragraph (a) of this section include prohibitions on the following transactions:
(1) The making of any contribution or provision of funds, goods, or services by, to, or for the benefit of any person whose property and interests in property are blocked pursuant to paragraph (a) of this section; and
(2) The receipt of any contribution or provision of funds, goods, or services from any person whose property and interests in property are blocked pursuant to paragraph (a) of this section.
(c) Unless authorized by this part or by a specific license expressly referring to this part, any dealing in securities (or evidence thereof) held within the possession or control of a U.S. person and either registered or inscribed in the name of, or known to be held for the benefit of, or issued by, any person whose property and interests in property are blocked pursuant to paragraph (a) of this section is prohibited. This prohibition includes the transfer (including the transfer on the books of any issuer or agent thereof), disposition, transportation, importation, exportation, or withdrawal of, or the endorsement or guaranty of signatures on, any securities on or after the effective date. This prohibition applies irrespective of the fact that at any time (whether prior to, on, or subsequent to the effective date) the registered or inscribed owner of any such securities may have or might appear to have assigned, transferred, or otherwise disposed of the securities.
(d) The prohibitions in paragraph (a) of this section apply except to the extent provided by regulations, orders, directives, or licenses that may be issued pursuant to this part, and notwithstanding any contract entered into or any license or permit granted prior to the effective date.
(a) Any transfer after the effective date that is in violation of any provision of this part or of any regulation, order, directive, ruling, instruction, or license issued pursuant to this part, and that involves any property or interest in property blocked pursuant to § 547.201(a), is null and void and shall not be the basis for the assertion or recognition of any interest in or right, remedy, power, or privilege with respect to such property or interests in property.
(b) No transfer before the effective date shall be the basis for the assertion or recognition of any right, remedy, power, or privilege with respect to, or any interest in, any property or interests in property blocked pursuant to § 547.201(a), unless the person who holds or maintains such property, prior to that date, had written notice of the transfer or by any written evidence had recognized such transfer.
(c) Unless otherwise provided, a license or other authorization issued by OFAC before, during, or after a transfer shall validate such transfer or make it enforceable to the same extent that it would be valid or enforceable but for the provisions of this part and any regulation, order, directive, ruling, instruction, or license issued pursuant to this part.
(d) Transfers of property that otherwise would be null and void or unenforceable by virtue of the provisions of this section shall not be deemed to be null and void or unenforceable as to any person with whom such property is or was held or maintained (and as to such person only) in cases in which such person is able to establish to the satisfaction of OFAC each of the following:
(1) Such transfer did not represent a willful violation of the provisions of this part by the person with whom such property is or was held or maintained (and as to such person only);
(2) The person with whom such property is or was held or maintained did not have reasonable cause to know or suspect, in view of all the facts and circumstances known or available to such person, that such transfer required a license or authorization issued pursuant to this part and was not so licensed or authorized, or, if a license or authorization did purport to cover the transfer, that such license or authorization had been obtained by misrepresentation of a third party or withholding of material facts or was otherwise fraudulently obtained; and
(3) The person with whom such property is or was held or maintained filed with OFAC a report setting forth in full the circumstances relating to such transfer promptly upon discovery that:
(i) Such transfer was in violation of the provisions of this part or any regulation, ruling, instruction, license, or other directive or authorization issued pursuant to this part;
(ii) Such transfer was not licensed or authorized by OFAC; or
(iii) If a license did purport to cover the transfer, such license had been obtained by misrepresentation of a third party or withholding of material facts or was otherwise fraudulently obtained.
The filing of a report in accordance with the provisions of paragraph (d)(3) of this section shall not be deemed evidence that the terms of paragraphs (d)(1) and (2) of this section have been satisfied.
(e) Unless licensed pursuant to this part, any attachment, judgment, decree, lien, execution, garnishment, or other judicial process is null and void with respect to any property and interests in property blocked pursuant to § 547.201(a).
(a) Except as provided in paragraph (e) or (f) of this section, or as otherwise directed or authorized by OFAC, any U.S. person holding funds, such as currency, bank deposits, or liquidated financial obligations, subject to § 547.201(a) shall hold or place such funds in a blocked interest-bearing account located in the United States.
(b)(1) For purposes of this section, the term
(i) In a federally-insured U.S. bank, thrift institution, or credit union, provided the funds are earning interest at rates that are commercially reasonable; or
(ii) With a broker or dealer registered with the Securities and Exchange Commission under the Securities Exchange Act of 1934 (15 U.S.C. 78a
(2) Funds held or placed in a blocked account pursuant to paragraph (a) of this section may not be invested in instruments the maturity of which exceeds 180 days.
(c) For purposes of this section, a rate is commercially reasonable if it is the rate currently offered to other depositors on deposits or instruments of comparable size and maturity.
(d) For purposes of this section, if interest is credited to a separate blocked account or subaccount, the name of the account party on each account must be the same.
(e) Blocked funds held in instruments the maturity of which exceeds 180 days at the time the funds become subject to § 547.201(a) may continue to be held until maturity in the original instrument, provided any interest, earnings, or other proceeds derived therefrom are paid into a blocked interest-bearing account in accordance with paragraph (a) or (f) of this section.
(f) Blocked funds held in accounts or instruments outside the United States at the time the funds become subject to § 547.201(a) may continue to be held in the same type of accounts or instruments, provided the funds earn
(g) This section does not create an affirmative obligation for the holder of blocked tangible property, such as real or personal property, or of other blocked property, such as debt or equity securities, to sell or liquidate such property. However, OFAC may issue licenses permitting or directing such sales or liquidation in appropriate cases.
(h) Funds subject to this section may not be held, invested, or reinvested in a manner that provides immediate financial or economic benefit or access to any person whose property and interests in property are blocked pursuant to § 547.201(a), nor may their holder cooperate in or facilitate the pledging or other attempted use as collateral of blocked funds or other assets.
(a) Except as otherwise authorized, and notwithstanding the existence of any rights or obligations conferred or imposed by any international agreement or contract entered into or any license or permit granted prior to the effective date, all expenses incident to the maintenance of tangible property blocked pursuant to § 547.201(a) shall be the responsibility of the owners or operators of such property, which expenses shall not be met from blocked funds.
(b) Property blocked pursuant to § 547.201(a) may, in the discretion of OFAC, be sold or liquidated and the net proceeds placed in a blocked interest-bearing account in the name of the owner of the property.
(a) Any transaction on or after the effective date that evades or avoids, has the purpose of evading or avoiding, causes a violation of, or attempts to violate any of the prohibitions set forth in this part is prohibited.
(b) Any conspiracy formed to violate the prohibitions set forth in this part is prohibited.
(a)
Persons whose property and interests in property are blocked pursuant to the authority of the UNPA include those listed on
(b)
(c)
(2) This section does not exempt from regulation transactions related to information or informational materials not fully created and in existence at the date of the transactions, or to the substantive or artistic alteration or enhancement of information or informational materials, or to the provision of marketing and business consulting services. Such prohibited transactions include payment of advances for information or informational materials not yet created and completed (with the exception of prepaid subscriptions for widely circulated magazines and other periodical publications); provision of services to market, produce or co-produce, create, or assist in the creation of information or informational materials; and payment of royalties with respect to income received for enhancements or alterations made by U.S. persons to such information or informational materials.
(3) This section does not exempt transactions incident to the exportation of software subject to the Export Administration Regulations, 15 CFR parts 730 through 774, or to the exportation of goods (including software) or technology for use in the transmission of any data, or to the provision, sale, or leasing of capacity on telecommunications transmission facilities (such as satellite or terrestrial network connectivity) for use in the transmission of any data. The exportation of such items or services and the provision, sale, or leasing of such capacity or facilities to a person whose property and interests in property are blocked pursuant to § 547.201(a) are prohibited.
(d)
The definitions in this subpart apply throughout the entire part.
The terms
See § 547.411 concerning the blocked status of property and interests in property of an entity that is directly or indirectly owned, whether individually or in the aggregate, 50 percent or more by one or more persons whose property and interests in property are blocked pursuant to § 547.201(a).
(a) The term
(1) With respect to a person whose property and interests in property are blocked pursuant to § 547.201(a)(1), 12:01 a.m. eastern standard time on October 30, 2006; and
(2) With respect to a person whose property and interests in property are otherwise blocked pursuant to § 547.201(a), the earlier of the date of actual or constructive notice that such person's property and interests in property are blocked.
(b) For the purposes of this section,
(a) Except as otherwise provided in this part, the term
(b) The term
(c) The term
See § 501.801 of this chapter on licensing procedures.
The term
The term
(a)(1) The term
(2) To be considered information or informational materials, artworks must be classified under heading 9701, 9702, or 9703 of the Harmonized Tariff Schedule of the United States.
(b) The term
(1) That were, as of April 30, 1994, or that thereafter become, controlled for export pursuant to section 5 of the Export Administration Act of 1979, 50 U.S.C. App. 2401-2420 (1979) (EAA), or section 6 of the EAA to the extent that such controls promote the nonproliferation or antiterrorism policies of the United States; or
(2) With respect to which acts are prohibited by 18 U.S.C. chapter 37.
The term
(a) Reference to any section in this part is a reference to the same as currently amended, unless the reference includes a specific date.
(b) Reference to any ruling, order, instruction, direction, or license issued pursuant to this part is a reference to the same as currently amended unless otherwise so specified.
Unless otherwise specifically provided, any amendment, modification, or revocation of any provision in or appendix to this part or chapter or of any order, regulation, ruling, instruction, or license issued by OFAC does not affect any act done or omitted, or any civil or criminal proceeding commenced or pending, prior to such amendment, modification, or revocation. All penalties, forfeitures, and liabilities under any such order, regulation, ruling, instruction, or license continue and may be enforced as if such amendment, modification, or revocation had not been made.
(a) Whenever a transaction licensed or authorized by or pursuant to this part results in the transfer of property (including any property interest) away from a person whose property and interests in property are blocked pursuant to § 547.201(a), such property shall no longer be deemed to be property blocked pursuant to § 547.201(a), unless there exists in the property another interest that is blocked pursuant to § 547.201(a), the transfer of which has not been effected pursuant to license or other authorization.
(b) Unless otherwise specifically provided in a license or authorization issued pursuant to this part, if property (including any property interest) is transferred or attempted to be transferred to a person whose property and interests in property are blocked pursuant to § 547.201(a), such property shall be deemed to be property in which such person has an interest and therefore blocked.
(a) Any transaction ordinarily incident to a licensed transaction and
(1) An ordinarily incident transaction, not explicitly authorized within the terms of the license, by or with a person whose property and interests in property are blocked pursuant to § 547.201(a); or
(2) An ordinarily incident transaction, not explicitly authorized within the terms of the license, involving a debit to a blocked account or a transfer of blocked property.
(b) For example, a license authorizing a person to complete a securities sale involving Company A, whose property and interests in property are blocked pursuant to § 547.201(a), also authorizes other persons to engage in activities that are ordinarily incident and necessary to complete the sale, including transactions by the buyer, broker, transfer agents, and banks, provided that such other persons are not themselves persons whose property and interests in property are blocked pursuant to § 547.201(a).
(a) The prohibitions on transactions contained in § 547.201 apply to services performed in the United States or by U.S. persons, wherever located, including by a foreign branch of an entity located in the United States:
(1) On behalf of or for the benefit of a person whose property and interests in property are blocked pursuant to § 547.201(a); or
(2) With respect to property interests of any person whose property and interests in property are blocked pursuant to § 547.201(a).
(b) For example, U.S. persons may not, except as authorized by or pursuant to this part, provide legal, accounting, financial, brokering, freight forwarding, transportation, public relations, or other services to a person whose property and interests in property are blocked pursuant to § 547.201(a).
See §§ 547.507 and 547.509 on licensing policy with regard to the provision of certain legal and emergency medical services.
The prohibitions in § 547.201 on transactions or dealings involving blocked property, as defined in § 547.302, apply to transactions by any U.S. person in a location outside the United States.
Pursuant to § 547.201, no debits may be made to a blocked account to pay obligations to U.S. persons or other persons, except as authorized by or pursuant to this part.
Unless specifically authorized by OFAC pursuant to this part, no charitable contribution of funds, goods, services, or technology, including contributions to relieve human suffering, such as food, clothing, or medicine, may be made by, to, or for the benefit of, or received from, a person whose property and interests in property are blocked pursuant to § 547.201(a). For the purposes of this part, a contribution is made by, to, or for the benefit of, or received from, a person whose property and interests in property are blocked pursuant to § 547.201(a) if made by, to, or in the name of, or received from or in the name of, such a person; if made by, to, or in the name of, or received from or in the name of, an entity or individual acting for or on behalf of, or owned or controlled by, such a person; or if made in an attempt to violate, to evade, or to avoid the bar on the provision of contributions by, to, or for the benefit of such a person, or the receipt of contributions from such a person.
The prohibition in § 547.201 on dealing in property subject to that section prohibits U.S. financial institutions from performing under any existing credit agreements, including charge cards, debit cards, or other credit facilities issued by a financial institution to a person whose property and interests in property are blocked pursuant to § 547.201(a).
A setoff against blocked property (including a blocked account), whether by a U.S. bank or other U.S. person, is a prohibited transfer under § 547.201 if effected after the effective date.
Persons whose property and interests in property are blocked pursuant to § 547.201(a) have an interest in all property and interests in property of an entity in which such persons directly or indirectly own, whether individually or in the aggregate, a 50 percent or greater interest. The property and interests in property of such an entity, therefore, are blocked, and such an entity is a person whose property and interests in property are blocked pursuant to § 547.201(a), regardless of whether the name of the entity is incorporated into OFAC's Specially Designated Nationals and Blocked Persons List (SDN List).
For provisions relating to licensing procedures, see part 501, subpart E, of this chapter. Licensing actions taken pursuant to part 501 of this chapter with respect to the prohibitions contained in this part are considered actions taken pursuant to this part. General licenses and statements of licensing policy relating to this part also may be available through the Democratic Republic of the Congo sanctions page on OFAC's website:
(a) No license or other authorization contained in this part, or otherwise issued by OFAC, authorizes or validates any transaction effected prior to the issuance of such license or other authorization, unless specifically provided in such license or authorization.
(b) No regulation, ruling, instruction, or license authorizes any transaction prohibited under this part unless the regulation, ruling, instruction, or license is issued by OFAC and specifically refers to this part. No regulation, ruling, instruction, or license referring to this part shall be deemed to authorize any transaction prohibited by any other part of this chapter unless the regulation, ruling, instruction, or license specifically refers to such part.
(c) Any regulation, ruling, instruction, or license authorizing any transaction otherwise prohibited under this part has the effect of removing a prohibition contained in this part from the transaction, but only to the extent specifically stated by its terms. Unless the regulation, ruling, instruction, or license otherwise specifies, such an authorization does not create any right,
(d) Nothing contained in this part shall be construed to supersede the requirements established under any other provision of law or to relieve a person from any requirement to obtain a license or other authorization from another department or agency of the U.S. Government in compliance with applicable laws and regulations subject to the jurisdiction of that department or agency. For example, exports of goods, services, or technical data that are not prohibited by this part or that do not require a license by OFAC nevertheless may require authorization by the U.S. Department of Commerce, the U.S. Department of State, or other agencies of the U.S. Government.
(e) No license or other authorization contained in or issued pursuant to this part authorizes transfers of or payments from blocked property or debits to blocked accounts unless the license or other authorization explicitly authorizes the transfer of or payment from blocked property or the debit to a blocked account.
(f) Any payment relating to a transaction authorized in or pursuant to this part that is routed through the U.S. financial system should reference the relevant OFAC general or specific license authorizing the payment to avoid the blocking or rejection of the transfer.
OFAC reserves the right to exclude any person, property, transaction, or class thereof from the operation of any license or from the privileges conferred by any license. OFAC also reserves the right to restrict the applicability of any license to particular persons, property, transactions, or classes thereof. Such actions are binding upon actual or constructive notice of the exclusions or restrictions.
(a) The provision of the following legal services to or on behalf of persons whose property and interests in property are blocked pursuant to § 547.201(a) or any further Executive orders relating to the national emergency declared in E.O. 13413 of October 27, 2006, is authorized, provided that receipt of payment of professional fees and reimbursement of incurred expenses must be authorized: Pursuant to § 547.508, which authorizes certain payments for legal services from funds originating outside the United States; via specific license; or otherwise pursuant to this part:
(1) Provision of legal advice and counseling on the requirements of and compliance with the laws of the United States or any jurisdiction within the United States, provided that such advice and counseling are not provided to facilitate transactions in violation of this part;
(2) Representation of persons named as defendants in or otherwise made parties to legal, arbitration, or administrative proceedings before any U.S. federal, state, or local court or agency;
(3) Initiation and conduct of legal, arbitration, or administrative proceedings before any U.S. federal, state, or local court or agency;
(4) Representation of persons before any U.S. federal, state, or local court or agency with respect to the imposition, administration, or enforcement of U.S. sanctions against such persons; and
(5) Provision of legal services in any other context in which prevailing U.S. law requires access to legal counsel at public expense.
(b) The provision of any other legal services to or on behalf of persons whose property and interests in property are blocked pursuant to § 547.201(a) or any further Executive orders relating to the national emergency declared in E.O. 13413 of October 27, 2006, not otherwise authorized in this part, requires the issuance of a specific license.
(c) U.S. persons do not need to obtain specific authorization to provide related services, such as making filings and providing other administrative services, that are ordinarily incident to the provision of services authorized by paragraph (a) of this section. Additionally, U.S. persons who provide services authorized by paragraph (a) of this section do not need to obtain specific authorization to contract for related services that are ordinarily incident to the provision of those legal services, such as those provided by private investigators or expert witnesses, or to pay for such services. See § 510.404.
(d) Entry into a settlement agreement or the enforcement of any lien, judgment, arbitral award, decree, or other order through execution, garnishment, or other judicial process purporting to transfer or otherwise alter or affect property or interests in property blocked pursuant to § 547.201(a) or any further Executive orders relating to the national emergency declared in E.O. 13413 of October 27, 2006, is prohibited unless licensed pursuant to this part.
Pursuant to part 501, subpart E, of this chapter, U.S. persons seeking administrative reconsideration or judicial review of their designation or the blocking of their property and interests in property may apply for a specific license from OFAC to authorize the release of certain blocked funds for the payment of professional fees and reimbursement of incurred expenses for the provision of such legal services where alternative funding sources are not available. For more information, see OFAC's
(a)
(i) A source within the United States;
(ii) Any source, wherever located, within the possession or control of a U.S. person; or
(iii) Any individual or entity, other than the person on whose behalf the legal services authorized pursuant to § 547.507(a) are to be provided, whose property and interests in property are blocked pursuant to any part of this chapter or any Executive order or statute.
(2) Nothing in this paragraph (a) authorizes payments for legal services using funds in which any other person whose property and interests in property are blocked pursuant to § 547.201(a), any other part of this chapter, or any Executive order has an interest.
(b)
(i) The individual or entity from whom the funds originated and the amount of funds received; and
(ii) If applicable:
(A) The names of any individuals or entities providing related services to the U.S. person receiving payment in connection with authorized legal services, such as private investigators or expert witnesses;
(B) A general description of the services provided; and
(C) The amount of funds paid in connection with such services.
(2) The reports, which must reference this section, are to be submitted to OFAC using one of the following methods:
(i)
(ii)
The provision and receipt of nonscheduled emergency medical services that are otherwise prohibited by this part or any further Executive orders relating to the national emergency declared in Executive Order 13413 of October 27, 2006 are authorized.
(a) Section 206 of the International Emergency Economic Powers Act (50 U.S.C. 1705) (IEEPA) is applicable to violations of the provisions of any license, ruling, regulation, order, directive, or instruction issued by or pursuant to the direction or authorization of the Secretary of the Treasury pursuant to this part or otherwise under IEEPA.
(1) A civil penalty not to exceed the amount set forth in section 206 of IEEPA may be imposed on any person who violates, attempts to violate, conspires to violate, or causes a violation of any license, order, regulation, or prohibition issued under IEEPA.
IEEPA provides for a maximum civil penalty not to exceed the greater of $295,141 or an amount that is twice the amount of the transaction that is the basis of the violation with respect to which the penalty is imposed.
(2) A person who willfully commits, willfully attempts to commit, willfully conspires to commit, or aids or abets in the commission of a violation of any license, order, regulation, or prohibition may, upon conviction, be fined not more than $1,000,000, or if a natural person, be imprisoned for not more than 20 years, or both.
(b)(1) The civil penalties provided in IEEPA are subject to adjustment pursuant to the Federal Civil Penalties Inflation Adjustment Act of 1990 (Pub. L. 101-410, as amended, 28 U.S.C. 2461 note).
(2) The criminal penalties provided in IEEPA are subject to adjustment pursuant to 18 U.S.C. 3571.
(c) Pursuant to 18 U.S.C. 1001, whoever, in any matter within the jurisdiction of the executive, legislative, or judicial branch of the Government of the United States, knowingly and willfully falsifies, conceals, or covers up by any trick, scheme, or device a material fact; or makes any materially false, fictitious, or fraudulent statement or representation; or makes or uses any false writing or document knowing the same to contain any materially false, fictitious, or fraudulent statement or entry shall be fined under title 18, United States Code, imprisoned, or both.
(d) Section 5 of the United Nations Participation Act, as amended (22 U.S.C. 287c(b)) (UNPA) provides that any person who willfully violates or evades or attempts to violate or evade any order, rule, or regulation issued by the President pursuant to the authority granted in that section, upon conviction, shall be fined not more than $10,000 and, if a natural person, may also be imprisoned for not more than 10 years; and the officer, director, or agent of any corporation who knowingly participates in such violation or evasion shall be punished by a like fine, imprisonment, or both and any property, funds, securities, papers, or other articles or documents, or any vessel, together with her tackle, apparel, furniture, and equipment, or vehicle, or aircraft, concerned in such violation shall be forfeited to the United States.
(e) Violations involving transactions described at section 203(b)(1), (3), and (4) of IEEPA shall be subject only to the penalties set forth in paragraph (d) of this section.
(f) Violations of this part may also be subject to other applicable laws.
(a)
(b)
(2)
(i)
(ii)
(3)
(c)
(d)
(e)
If, after considering any written response to the Pre-Penalty Notice and any relevant facts, OFAC determines that there was a violation by the alleged violator named in the Pre-Penalty Notice and that a civil monetary penalty is appropriate, OFAC may issue a Penalty Notice to the violator containing a determination of the violation and the imposition of the monetary penalty. For additional details concerning issuance of a Penalty Notice, see appendix A to part 501 of this chapter. The issuance of the Penalty Notice shall constitute final agency action. The violator has the right to seek judicial review of that final agency action in federal district court.
In the event that the violator does not pay the penalty imposed pursuant to this part or make payment arrangements acceptable to OFAC, the matter may be referred for administrative collection measures by the Department of the Treasury or to the United States Department of Justice for appropriate action to recover the penalty in a civil suit in a federal district court.
(a)
(i) Determines that there has occurred a violation of any provision of this part, or a violation of the provisions of any license, ruling, regulation, order, directive, or instruction issued by or pursuant to the direction or authorization of the Secretary of the Treasury pursuant to this part or otherwise under the International Emergency Economic Powers Act (50 U.S.C. 1701-1706);
(ii) Considers it important to document the occurrence of a violation; and
(iii) Based on the Guidelines contained in appendix A to part 501 of this chapter, concludes that an administrative response is warranted but that a civil monetary penalty is not the most appropriate response.
(2) An initial Finding of Violation shall be in writing and may be issued whether or not another agency has taken any action with respect to the matter. For additional details concerning issuance of a Finding of Violation, see appendix A to part 501 of this chapter.
(b)
(2)
(i)
(ii)
(3)
(4)
(c)
(2)
A determination by OFAC that a final Finding of Violation is not warranted does not preclude OFAC from pursuing other enforcement actions consistent with the Guidelines contained in appendix A to part 501 of this chapter.
(d)
Any action that the Secretary of the Treasury is authorized to take pursuant to Executive Order 13413 of October 27, 2006 (E.O. 13413), Executive Order 13671 of July 8, 2014, and any further Executive orders relating to the national emergency declared in E.O. 13413, may be taken by the Director of OFAC or by any other person to whom the Secretary of the Treasury has delegated authority so to act.
Coast Guard, DHS.
Final rule; termination of existing safety zone.
The Coast Guard is removing the temporary safety zone for navigable waters of the Columbia River between river mile 142 and 143 in vicinity of Cascade Locks, Oregon. The safety zone was necessary to protect personnel, vessels, and the marine environment from potential hazards created by salvage operations of the tug DIANE. The safety zone is no longer needed and the Coast Guard is removing the regulation.
The rule is effective November 15, 2018.
To view documents mentioned in this preamble as being available in the docket, go to
If you have questions on this rule, call or email LCDR Dixon Whitley, Waterways Management Division, Marine Safety Unit Portland, U.S. Coast Guard; telephone 503-240-9319, email
The Coast Guard is issuing this rule to remove a regulation without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to removing the safety zone regulation around the salvage operations for the tug DIANE because to do so would be unnecessary since the salvage operations concluded and the safety zone that is no longer needed.
Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the
The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The Captain of the Port Columbia River (COTP) has determined that potential hazards associated with pile driving, cofferdam installation, diving, and vessel recovery operations are no longer present between Columbia River Mile 142 and 143 in vicinity of Cascade Locks, Oregon.
On November 2, 2018, the Coast Guard published a temporary final rule “Safety Zone; Columbia River, Cascade Locks, OR” in the
We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders, and we discuss First Amendment rights of protestors.
Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13771 directs agencies to control regulatory costs through a budgeting process. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.
This regulatory action determination is based on the removal of an obsolete safety zone.
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.
Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this rule under Department of Homeland Security Directive 023-01 and Commandant Instruction M16475.1D, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. It is categorically excluded from further review under paragraph L60(b) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A Record of Environmental Consideration is not required for this rule because we are disestablishing a safety zone.
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:
33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 0170.1.
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing a temporary safety zone on a portion of the Delaware River in Camden, NJ. This action is necessary to protect the surrounding public and vessels on these navigable waters adjacent to the Battleship New Jersey Museum and Memorial, Camden, NJ, during a fireworks display on November 14, 2018. This regulation prohibits persons and vessels from entering, transiting, or remaining within the safety zone unless authorized by the Captain of the Port Delaware Bay or a designated representative.
This rule is effective from 8:15 p.m. through 9:15 p.m. on November 14, 2018.
To view documents mentioned in this preamble as being available in the docket, go to
If you have questions on this rule, call or email Petty Officer Thomas Welker, U.S. Coast Guard, Sector Delaware Bay, Waterways Management Division; telephone 215-271-4814, email
On September 14, 2018, Rexel, Inc. notified the Coast Guard that it will be conducting a fireworks display from 8:35 p.m. to 8:55 p.m. on November 14, 2018. The fireworks are to be launched from a barge on the Delaware River adjacent the Battleship New Jersey
Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the
The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The Captain of the Port Delaware Bay (COTP) has determined that potential hazards associated with the fireworks display on November 14, 2018, will be a safety concern for anyone within a 600-foot radius of the fireworks barge, which will be anchored in approximate position 39°56′20″ N Latitude, 075°08′08″ W Longitude. This rule is needed to protect persons, vessels and the public near the fireworks barge during the fireworks display.
As noted above, we received one comment on our NPRM published October 22, 2018. The comment was generally supportive of the proposed rulemaking. The comment did express concern with public notification of the rule. The comment suggested the Coast Guard notify the public more than once. The Coast Guard agrees that notification to the public of the existence of this rule is a key component to ensuring safety. In addition to publication of the NPRM and final rule in the
This rule establishes a temporary safety zone from approximately 8:15 p.m. through 9:15 p.m. on November 14, 2018, for the navigable waters in the vicinity of the Battleship New Jersey Museum and Memorial, Camden, NJ, during a fireworks display from a barge. The event is scheduled to take place at approximately 8:35 p.m. on November 14, 2018. The safety zone will extend 600 feet around the barge, which will be anchored at approximate position 39°56′20″ N Latitude, 075°08′08″ W Longitude. Persons or vessels will not be permitted to enter, transit through, or remain within the safety zone without obtaining permission from the COTP or a designated representative.
If authorization to enter, transit through, or remain within the safety zone is granted by the COTP or a designated representative, all persons and vessels receiving such authorization must comply with the instructions of the COTP or a designated representative. The Coast Guard will provide public notice of the safety zone by Broadcast Notice to Mariners and by on-scene actual notice.
We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders, and we discuss First Amendment rights of protestors.
Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13771 directs agencies to control regulatory costs through a budgeting process. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.
This regulatory action determination is based on the size, location, duration, and time-of-day of the safety zone. Vessel traffic will be able to safely transit around this safety zone which will impact a small designated area of the Delaware River for 1 hour during the evening when vessel traffic is normally low. Moreover, the Coast Guard will issue a Broadcast Notice to Mariners via VHF-FM marine channel 16 about the zone, and the rule will allow vessels to seek permission to enter the zone.
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard received no comments from the Small Business Administration on this rulemaking. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.
While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this proposed rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism
Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this rule under Department of Homeland Security Directive 023-01 and Commandant Instruction M16475.1D, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made a preliminary determination that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone lasting 1 hour that will prohibit entry within 600 feet of a fireworks barge. Normally such actions are categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A preliminary Record of Environmental Consideration supporting this determination is available in the docket where indicated under
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:
33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 0170.1.
(a)
(b)
(c)
(2) To request permission to enter the safety zone, contact the COTP or the COTP's representative on marine band radio VHF-FM channel 16 (156.8 MHz) or 215-271-4807.
(3) No vessel may take on bunkers or conduct lightering operations within the safety zone during the enforcement period.
(4) This section applies to all vessels except those engaged in law enforcement, aids to navigation servicing, and emergency response operations.
(d)
(e)
Coast Guard, DHS.
Notice of enforcement of regulation.
The Coast Guard will enforce the safety zone for the Santa Spectacular Fireworks to provide for the safety of persons, vessels, and the marine environment on the navigable waters of the Ohio River, Monongahela River and Allegheny River during this event. Our regulation for marine events within the Eighth Coast Guard District identifies the regulated area for this event in Pittsburgh, PA. During the enforcement period, entry into this zone is prohibited unless authorized by the Captain of the Port Marine Safety Unit Pittsburgh or a designated representative.
The regulations in 33 CFR 165.801, Table 1, Line 64 will be enforced from 8 p.m. through 9:30 p.m. on November 16, 2018.
If you have questions about this notice of enforcement, call or email Petty Officer Jennifer Haggins, Marine Safety Unit Pittsburgh, U.S. Coast Guard; telephone 412-221-0807, email
The Coast Guard will enforce a temporary safety zone for the Santa Spectacular Fireworks Race in 33 CFR 165.801, Table 1, titled “Sector Ohio Valley Annual and Recurring Safety Zones,” line 64, from 8 p.m. through 9:30 p.m. on November 16, 2018. This action is being taken to provide for the safety of persons, vessels, and the marine environment on the navigable waters of the Ohio River, Monongahela River and Allegheny River during this event. Our regulation for marine events within the Eighth Coast Guard District, § 165.801
In addition to this notice of enforcement in the
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing a temporary safety zone for the navigable waters within a 50 yard radius from the center point of The Gut Bridge in South Bristol, ME between Rutherford Island and Bristol Neck. The safety zone is necessary to protect personnel, vessels, and the marine environment from potential hazards created during bedrock removal operations. When enforced, this regulation prohibits entry of vessels or persons into the safety zone unless authorized by the Captain of the Port Northern New England or a designated representative.
This rule is effective without actual notice from November 15, 2018 through March 31, 2019. For the purposes of enforcement, actual notice will be used from November 8, 2018 through November 15, 2018.
To view documents mentioned in this preamble as being available in the docket, go to
If you have questions on this rule, call or email LT Matthew Odom, Waterways Management Division, U.S. Coast Guard Sector Northern New England, telephone 207-347-5015, email
On August 21, 2018, the Maine Department of Transportation (MEDOT) notified the Coast Guard that it will be removing bedrock in the areas between Rutherford Island and Bristol Neck underneath The Gut Bridge. The removal operations include removing bedrock from between the bridge abutments and areas near the navigation channel both upstream and downstream of The Gut Bridge. To remove the bedrock workers will need to utilize the waterway underneath the bridge span and prohibit people and vessels from entering the safety zone at various times. Removal operations are expected to take place between 8 November 2018 and 31 March 2019. However, we only anticipate a continuous 35 day full closure of the waterway. The COTP Northern New England has determined that the potential hazards associated with the removal operations will be a safety concern for anyone transiting within a 50-yard radius of the center point of The Gut Bridge.
In response, on September 27, 2018, the Coast Guard published a notice of proposed rulemaking (NPRM) titled “Safety Zone; The Gut, South Bristol, ME” (83 FR 48748). There we stated why we issued the NPRM, and invited comments on our proposed regulatory action related to this safety zone. During the comment period that ended on October 29, 2018, we received no comments.
Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the
The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The COTP Northern New England has determined that potential hazards associated with the bedrock removal operations will be a safety concern for anyone transiting within a 50-yard radius of the center point of the bridge. The purpose of this rule is to ensure the safety of vessels and personnel within a 50-yard radius of the center point of The Gut Bridge before, during, and after the bedrock removal operations.
As noted above, we received no comments on our NPRM published September 27, 2018. There are no changes in the regulatory text of this rule from the proposed rule in the NPRM.
This rule establishes a safety zone from 12:01 a.m. on November 8, 2018 to 11:59 on March 31, 2019. While the safety zone would be effective throughout this period, it would only be enforced during periods of active bedrock removal operations. The safety zone would include all navigable waters from surface to bottom within a 50 yard radius from the center point of The Gut Bridge between Rutherford Island and Bristol Neck in South Bristol, ME. During times of enforcement, no vessel or person would be permitted to enter the safety zone without obtaining permission from the COTP Northern New England or a designated representative. The Coast Guard will notify the public and local mariners of this safety zone through appropriate means, which may include, but are not limited to, publication in the
We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and
Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13771 directs agencies to control regulatory costs through a budgeting process. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, the rule has not been reviewed by the Office of Management and Budget (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.
This regulatory action determination is based on the size, location, duration, and selective enforcement of the safety zone. The safety zone impacts only a small designated portion on The Gut waterway for 143 days. This waterway is typically transited by small recreational craft on an infrequent basis after Labor Day Weekend and prior to Memorial Day Weekend. Vessel traffic is able to safely transit around this safety zone with a slight delay (approximately 20-60 minutes) by transiting around Rutherford Island to reach any destination on the other side of The Gut. Additionally, the safety zone will only be enforced during active bedrock removal operations necessitating closure of the waterway or during an emergency. Moreover, the rule allows vessels to seek permission to enter the zone. The Coast Guard will notify the public of enforcement of this rule via appropriate means, such as via Local Notice to Mariners and Broadcast Notice to Mariners via marine Channel 16 (VHF-FM).
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard received no comments from the Small Business Administration on this rulemaking. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule would not have a significant economic impact on a substantial number of small entities.
While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section IV.A above, this rule would not have a significant economic impact on any vessel owner or operator.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule would not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.
Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it would not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule would not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this rule under Department of Homeland Security Directive 023-01 and Commandant Instruction M16475.1D, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone that would prohibit entry within a 50-yard radius of the center point of a bridge. It is categorically excluded from further review under paragraph L60 (a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A Record of Environmental Consideration supporting this determination is available in the docket where indicated under
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard to amend 33 CFR part 165 as follows:
33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 0170.1.
(a)
(b)
(c)
(d)
(1) No person or vessel may enter or remain in the safety zone described in paragraph (a) of this section unless authorized by the COTP or the COTP's designated representative.
(2) To obtain permission required by this regulation, individuals may reach the COTP or the COTP's designated representative via Channel 16 (VHF-FM) or (207) 767-0303 (Sector Northern New England Command Center).
(3) During periods of enforcement, any person or vessel permitted to enter the safety zone must comply with all lawful orders or directions given to them by the COTP or the COTP's designated representative.
(e)
(f)
Environmental Protection Agency (EPA).
Final action; lifting of administrative stay and announcement of effective date.
In this action, the Environmental Protection Agency (EPA) is concluding the reconsideration of an earlier action that the EPA published on January 15, 2009, titled “Prevention of Significant Deterioration (PSD) and Nonattainment New Source Review (NSR): Aggregation and Project Netting.” The 2009 action—hereafter referred to as “2009 NSR Aggregation Action”—clarified implementation of the New Source Review (NSR) permitting program under the Clean Air Act (CAA or Act) with respect to treating related physical or operational changes as a single “modification” for the purpose of determining NSR applicability at a stationary source. On April 15, 2010, the EPA proposed to revoke the 2009 NSR Aggregation Action. After a review of the public comments received on that proposal, the EPA has now decided to not revoke the 2009 NSR Aggregation Action. The EPA is, therefore, retaining the interpretation set forth in the 2009 NSR Aggregation Action, while not adopting any changes to the relevant rule text. At the same time, the EPA is using this present action to clarify the implications of the 2009 NSR Aggregation Action for EPA-approved permitting programs. This action also lifts the administrative stay and announces the effective date of the 2009 NSR Aggregation Action.
This action is effective on November 15, 2018.
The EPA has established a docket for this action, identified by Docket ID No. EPA-HQ-OAR-2003-0064. All documents in the docket are listed in the
For further general information on this action, contact Mr. Dave Svendsgaard, Office of Air Quality Planning and Standards (OAQPS), Air Quality Policy Division, U.S. EPA, Mail Code 504-03, 109 T.W. Alexander Drive, Research Triangle Park, NC 27711; by telephone at (919) 541-2380; or by email at
Entities potentially affected directly by this action include sources in all industry categories. Entities potentially affected by this action also include state, local and tribal air pollution control agencies (air agencies) responsible for permitting sources pursuant to the NSR program.
In addition to being available in the docket, an electronic copy of this
The information presented in this document is organized as follows:
The NSR program is a preconstruction permitting program that requires certain stationary sources of air pollution to obtain permits prior to beginning construction. The NSR permitting program applies both to new construction and to modifications of existing sources, regardless of whether the source is in an area where the national ambient air quality standards (NAAQS) have been exceeded (nonattainment area) or if the source is in an area where the NAAQS have not been exceeded (attainment or unclassifiable area). New construction and modifications that emit “regulated NSR pollutants”
Major NSR permits for sources that are located in attainment or unclassifiable areas are referred to as Prevention of Significant Deterioration (PSD) permits. These permits can also cover pollutants for which there are no NAAQS. Major NSR permits for sources located in nonattainment areas and that emit pollutants above the specified thresholds for which the area is in nonattainment are referred to as nonattainment NSR (NNSR) permits. The pollutant(s) at issue and the air quality designation of the area where the facility is located or proposed to be built determine the specific permitting requirements. The CAA requires sources subject to PSD to meet emission limits based on Best Available Control Technology (BACT) as specified by CAA section 165(a)(4), and sources subject to NNSR to meet Lowest Achievable Emissions Rate (LAER) pursuant to CAA section 173(a)(2). Other requirements to obtain a major NSR permit vary depending on whether it is a PSD or NNSR permit.
A new stationary source is subject to major NSR requirements if its potential to emit (PTE) a regulated NSR pollutant exceeds statutory emission thresholds.
In many cases, these requirements of the major NSR program (or equivalent requirements) are formally adopted by a state or local air agency, and the agency submits a revised state implementation plan (SIP) to the EPA for approval. The EPA's regulations provide for the minimum requirements of these programs. Upon EPA approving the SIP, the air agency becomes the “permitting authority” for major NSR permits for sources within its boundaries. When a state or local air agency is not the permitting authority, either the EPA issues the major NSR permits or a state or local air agency issues the major NSR permits on behalf of the EPA by way of a delegation agreement. For sources located in Indian country, the EPA is currently the only permitting authority for major NSR. Currently, state and local air agencies issue the vast majority of major NSR permits each year.
New sources and modifications that do not require a major NSR permit may instead require a minor NSR permit prior to construction. Minor NSR permits are almost exclusively issued by state and local air agencies, although the EPA issues minor NSR permits in some areas of Indian country. Minor NSR requirements are approved into a SIP in order to achieve and maintain the NAAQS.
As described in the preceding section, the EPA's implementing regulations for NSR establish a two-step process for determining major NSR applicability for projects at stationary sources. To be subject to major NSR requirements, the project must result in both (1) a significant emissions increase from the project (the determination of which is called “Step 1” of the NSR applicability analysis, or “project emissions accounting”); and (2) a significant
As with certain other aspects of the NSR program, determining what constitutes the “project” is a case-by-case decision that is both site-specific and fact-driven. There is no pre-determined list of activities that should be aggregated for a given industry or industries. It is, therefore, necessary to establish criteria for determining when nominally-separate activities are considered one project under NSR. The EPA has specifically sought to develop principles for aggregating changes such that a project is appropriately defined by the source, so that the emission increases attributable to the project are accurately quantified for purposes of analyzing NSR applicability. Over the years, the EPA articulated its policy on project aggregation through a series of statutory and regulatory interpretations contained in EPA letters and memoranda, the most commonly cited being a 1993 EPA memorandum regarding NSR applicability for activities that had occurred at a 3M facility in Minnesota.
To date, the EPA's focus in formulating criteria for project aggregation has been to ensure that NSR is not circumvented through some artificial separation of activities at Step 1 of the NSR applicability analysis where it would be unreasonable for the source to consider them to be separate projects. However, in a March 13, 2018, memorandum
On January 15, 2009, the EPA published a final action—which we are calling the “2009 NSR Aggregation Action”—that described the principles of project aggregation that we would apply when determining whether a source had unreasonably segregated a single project into multiple projects, thereby circumventing the NSR permitting requirements.
The 2009 NSR Aggregation Action called for sources and reviewing authorities to aggregate emissions from nominally-separate activities when they are “substantially related” for the purpose of determining whether they are a single modification resulting in a significant emissions increase under NSR at Step 1.
The 2009 NSR Aggregation Action retained the existing rule text defining the term “project”—
The 2009 NSR Aggregation Action specifically addressed the timing element of project aggregation decisions in multiple ways. It affirmed that timing alone should not be a basis for aggregating projects because the appropriate basis for aggregation is whether there is a substantial technical or economic relationship. It further explained that activities that occur simultaneously should not be presumed to be substantially related, although it is reasonable to presume that activities
The 2009 NSR Aggregation Action also expressed that the farther apart projects are timed, the less likely they are to be substantially related, since the activities would likely be part of distinct planning and capital-funding cycles. It stated “the passage of time provides a fairly objective indicator of nonrelatedness between physical or operational changes. Specifically, the greater the time period between activities, the less likely that a deliberate decision was made by the source to split an otherwise `significant' activity into two or more smaller, non-major activities.” 74 FR 2380.
To this end, the 2009 NSR Aggregation Action affirmed that timing could be a basis to not aggregate separate projects, and it established a policy of applying a rebuttable presumption against aggregating projects that occur 3 or more years apart. The EPA justified its selection of 3 years as the presumptive timeframe in part by reasoning that it “is long enough to ensure a reasonable likelihood that the presumption of independence will be valid, but is short enough to maintain a useful separation between relevant construction cycles, consistent with industry practice. For example, in the case of electric utilities, a commenter explained that companies plan and schedule major turbine outages every four to five years.”
With regard to implementing the 3-year presumption, the EPA stated “the time period separating physical or operational changes should be calculated based on time of approval (
The EPA also explained that a statement within the 3M Memorandum was potentially vulnerable to misapplication and did not properly reflect the “substantially related” criterion. The 3M Memorandum stated the following:
Some minimum level of research activity and commensurate emissions, source-wide, perhaps could be expected from year to year, as would be expected to keep the 3M plant productive or operable. These emissions and thereby modifications cannot be presumed to be independent given the plant's
In the 2009 NSR Aggregation Action, the EPA expressed concern with this statement from the 3M Memorandum, saying “it could be interpreted to imply that almost any activity is related to any other activity at that source simply because they are both capital investments and support the company's goal to make a profit.” 74 FR 2376, 2379. The suggestion that all changes consistent with the “overall basic purpose” of the plant can and should be aggregated is inconsistent with the interpretation of “project” to include only those changes that have a substantial relationship. While the EPA did not, in the 2009 NSR Aggregation Action, find such a broad approach to project aggregation was often applied after the 3M determination, we nevertheless had concerns that it did not represent an appropriate criterion for aggregating projects for NSR purposes and could be misapplied. Thus, in the 2009 NSR Aggregation Action, we maintained that two nominally separate projects are not substantially related if they are only related to the extent that they both support the source's “overall basic purpose.”
In summarizing what it means for projects to be substantially related, the 2009 NSR Aggregation Action provided that “in most cases, activities occurring in unrelated portions of a major stationary source (
On January 30, 2009, the Natural Resources Defense Council (NRDC) submitted a petition for reconsideration of the 2009 NSR Aggregation Action (the “NRDC Petition”). In response to the NRDC Petition, on February 13, 2009, the EPA convened a proceeding for reconsideration as provided for under the CAA section 307(d)(7)(B), finding that the petitioner had raised objections to the action that arose after the comment period and that were of central relevance to the action.
To allow time to complete the reconsideration prior to the 2009 NSR Aggregation Action becoming effective, the EPA announced a 90-day administrative stay of the action.
As part of the reconsideration proceeding, on April 15, 2010, the EPA published a proposed reconsideration of the 2009 NSR Aggregation Action (the “2010 Reconsideration Proposal”).
The EPA received a total of 27 comments on our 2010 Reconsideration Proposal. Of those commenters, 20 represented industry parties, three represented state and local air agencies, one represented a tribal government agency, one represented a federal agency, one represented an environmental advocacy group, and one was a private citizen.
In the history of actions that the EPA has taken regarding its project aggregation policy since 2006, the EPA has variously described the 2009 NSR Aggregation Action as a “rule,” “interpretation,” and “policy.” However, we are now mindful that these terms may be used to refer to three distinct types of agency action that have varying degrees of legal effect and can be changed through different types of procedures.
We begin by defining what we understand each of these terms to mean when they are used in the discussion that follows. We use the term “rule” to describe a “legislative rule,” which is “[a]n agency action that purports to impose legally binding obligations or prohibitions on regulated parties—and that would be the basis for an enforcement action for violations of those obligations or requirements.”
In 2006, we proposed a rule (meaning a
In 2009, we took “final action” in the matter. That is, we completed the action begun in 2006, while not changing the regulatory text itself. 74 FR 2376. In retaining the existing regulatory text defining the term “project,” we said that the action we were taking “interprets that rule text.”
In 2009, we also discussed our intention to apply a rebuttable presumption that activities separated by more than 3 years would not be considered substantially related. This section of the action is best understood as a statement of policy, as we were describing how we intended to exercise our discretion under the NSR regulations, as we interpreted them. We justified the 3-year presumption as a commonsense approach, in that we believed that in practice once 3 years had passed, “it is difficult to argue that th[e activities] are
The 2009 action, thus, contained both an interpretation of the existing regulations and a statement of policy on how we intended to implement that interpretation. It is for this reason that we refer to it as the 2009 NSR Aggregation Action. However, when reconsidering that 2009 action, we were not sufficiently clear in the 2010 Reconsideration Proposal regarding the nature of the action we were reconsidering. At times, we described the 2009 action as a “final rule,” and called it the “NSR Aggregation Amendments,” which could be read to suggest that we considered the 2009 NSR Aggregation Action, despite the lack of regulatory text changes, to somehow be a
Much of the confusion stemmed from the fact that at the time we took these actions, judicial precedent in the United States Court of Appeals for District of Columbia Circuit (D.C. Circuit) provided that, where an agency had given a definitive interpretation to one of its own legislative rules, the agency could not thereafter change that interpretation without providing notice and an opportunity to comment.
The United States Supreme Court has since abrogated the
In this action, we are taking final action on reconsideration of the issues for which we asked for comment in the 2010 Reconsideration Proposal. The proposal invited comment on all issues alleged in the petition for reconsideration, including the following: Lack of adequate opportunity for notice and comment on the final action; legal inconsistency with a prior court decision; lack of demonstrated need for a policy change; and lack of clarity over state plan adoption of the action.
This action addresses all of the petitioner's issues. Moreover, to the extent that commenters lacked an adequate notice-and-comment opportunity in the development of the 2009 NSR Aggregation Action, the reconsideration process has addressed this deficiency by inviting comment in 2010 on the issues raised by the petitioner. This action (1) takes final action on the 2010 Reconsideration Proposal and retains the 2009 NSR Aggregation Action without adopting any changes to the rule text or the interpretation and statement of policy contained therein; (2) completes the CAA section 307 reconsideration proceeding on the 2009 NSR Aggregation Action to address any potential notice-and-comment deficiency; and (3) lifts the APA section 705 stay of the 2009 NSR Aggregation Action. The conclusions reached and expressed in this final action are based on careful review of the public comments on the 2010 Reconsideration Proposal.
This final decision on reconsideration of the 2009 NSR Aggregation Action does not finalize the 2010 Reconsideration Proposal's preferred option to revoke the 2009 NSR Aggregation Action's interpretation and policy. Upon reviewing public comments, after further deliberation, and taking account of the Administration's priorities and policy goals, the EPA has concluded that the interpretation and policy in the 2009 NSR Aggregation Action should be retained.
With regard to the petitioner's concern about how the 2009 NSR Aggregation Action applies to EPA-approved permitting programs, we affirm our decision in 2009 not to revise the current rule text, and instead to conclude that the terms “project” and “a physical change in, or change in method of operation of” in the existing NSR regulations can be reasonably interpreted as already incorporating the “substantially related” test set forth in the 2009 preamble. Because the 2009 NSR Aggregation Action did not amend the rule text, state and local air agencies with approved state implementation plans (SIPs) are not required to amend those plans to adopt this interpretation that projects should be aggregated when “substantially related.” If state and local agencies want to adopt this interpretation, we believe that in most cases this interpretation can be applied without formal adoption into their rules. We encourage state and local air agencies to follow this interpretation to ensure greater national consistency in making NSR applicability determinations, though state and local air agencies with approved SIPs can continue to apply their own interpretation of the scope of a “project.”
Consistent with comments received on the EPA's 2006 proposed rule, commenters on the 2010 Reconsideration Proposal raised concerns with the clarity of our prior policy on project aggregation, which was developed over time through a number of
As this action officially completes our reconsideration proceeding, we are also lifting the APA section 705 stay and announcing the effective date of the 2009 NSR Aggregation.
As explained earlier in this document, the EPA's past position on project aggregation—prior to the 2009 NSR Aggregation Action—was not established through a rule or through a single, comprehensive policy statement. Rather, the policy had been articulated by the EPA through a number of site-specific determinations, many of which were issued after the activities subject to the determination had already occurred. Navigating this collection of EPA statements, capturing their salient points, and determining whether and how to apply their rationale to new determinations with different fact patterns was arguably a challenge for sources and permitting authorities over the years. Such an approach lacked clarity for sources and permitting authorities, making it sometimes difficult to understand the overall policy so they could effectively apply it prospectively.
There is a substantive distinction between making case-by-case determinations after-the-fact and making case-by-case determinations prospectively—
Previous agency statements can be taken out of context or misunderstood when reviewing projects having a different set of facts. For example, while the 3M Memorandum was considered by some as the EPA's guiding policy on project aggregation, parties could certainly misconstrue portions of that statement to suggest that all projects occurring within the same timeframe should be aggregated, or that all projects occurring at a facility should be aggregated as long as they contribute to the source's “overall basic purpose.” Such an approach—
We noted in the 2010 Reconsideration Proposal that “in reviewing the record for the NSR Aggregation Amendments, we find that the only factual support for the contention that our historic approach caused confusion was anecdotal,” and that the “parties supporting a change in policy failed to provide us with any characterization of the overall level of uncertainty or other problems resulting from the existing policy on aggregation.” 75 FR 19572. However, after further consideration, the EPA finds this to be an insufficient basis for changing or revoking the 2009 NSR Aggregation Action. So-called “anecdotal” evidence is nevertheless still evidence of which the agency can properly take account if, in its judgment, it finds it to be meaningful. Indeed, the criticism of relying on “anecdotes” suggests that examples of problems offered in public comments should be ignored. The EPA is required to take into account the comments submitted. Furthermore, merely because the overall level of uncertainty demonstrated by public comments cannot be characterized—a given entity would not necessarily know whether others were as uncertain as they were—does not serve to demonstrate that the 2009 NSR Aggregation Action was unwarranted. We believe that the evidence before the EPA in 2009 and the agency's own extensive permitting experience, coupled with statements from public commenters in this reconsideration proceeding, clearly indicates that the EPA's prior policy on project aggregation lacked clarity and promoted confusion. The 2009 NSR Aggregation Action provides a more concise formulation for how to interpret the scope of a project and provides clarity for permitting authorities, regulated entities, and the public.
Finally, the 2010 Reconsideration Proposal states that “[w]hile the [2009 NSR Aggregation Action] may, in some respects, appear clearer than our previous policy, we are not convinced that it achieved enough additional clarity to improve the process of making aggregation assessments by sources and reviewing authorities. . . .” 75 FR 19573. After further consideration, we now believe that providing clarity in a single document is a better approach than continuing the previous policy that was based on a host of EPA letters and memoranda, which collectively provided less clarity. We recognize there will continue to be “gray areas” that sources and permitting authorities will ultimately have to work through in deciding whether or not to aggregate a set of changes at a facility. But this is attributable to the inherent nature of such decisions, not to some deficiency in the 2009 NSR Aggregation Action. That does not mean that the EPA should abandon the clarity it attempted to provide in that action.
As noted above, the EPA continues to believe that there is a need for
As explained elsewhere in this document, the nature of the project aggregation determination is case-specific, which means it is inherently difficult to establish a bright line standard: Such a standard may be reasonable when conducting an evaluation of project scope in one situation, but could prove to be unreasonable or unworkable when applied in other situations. This case-by-case aspect necessitates that the EPA establish a reasonable general principle to apply, and we believe the “substantially related” criterion is an appropriate principle for concluding that claimed separate projects are a single project for NSR applicability purposes. We believe the substantially related criterion is sound from a policy and implementation perspective.
The 2009 NSR Aggregation Action effectively addresses certain past EPA statements in relation to implementing the “substantially related” test for future project aggregation determinations. The 2009 NSR Aggregation Action outlined the role of timing—specifically, that timing alone is not determinative of whether activities are substantially related and that, as a policy matter, activities separated in time by three or more years may be presumed to be not substantially related. The 2009 NSR Aggregation Action also rejected the use of an “overall basic purpose” criterion for aggregating physical or operational changes, since it could have been read to constitute an open-ended standard, resulting in the unreasonable or improper aggregation of unrelated activities.
Importantly, we do not believe the 2009 NSR Aggregation Action reflects a major shift in policy from EPA's prior policy on project aggregation. To the contrary, we believe that in many ways the 2009 NSR Aggregation Action clarifies and supplements previous statements of policy. For example, in the case of timing, the 3M Memorandum suggested that when minor NSR permit applications occur “over a short time period (
In addition, the “substantially related” criterion is not materially different from the factors the agency has considered in previous project aggregation decisions. Over time, the EPA has used various terms and phrases—
Finally, the matter of defining the scope of a project was raised, in a different context, in the Project Emissions Accounting Memorandum issued on March 13, 2018. There, we observed that, as general matter, the source itself is responsible for defining the scope of its own project, subject to the limitation that the source cannot seek to circumvent NSR by characterizing the proposed project in a way that would separate a single project into multiple projects. We further pointed out that, “[s]ubject to the equivalent understanding that it might be possible [for a source] to circumvent NSR through some wholly artificial
In the Project Emissions Accounting Memorandum, we noted that EPA was then evaluating whether to undertake a future notice-and-comment rulemaking to implement, through changes to the regulatory text itself, the interpretation of the NSR applicability provisions set forth in the memorandum. At such time as we proceed with that rulemaking, we will look to provide further guidance with respect to properly accounting for the scope of a project in which a source is seeking to take account of emission decreases at Step 1 of the NSR applicability analysis. Meanwhile, in advance of that rulemaking, we take the opportunity here to clarify that, as a general matter, it is neither necessary nor appropriate to take into consideration such matters as whether emission decreases attributable to a particular activity are “integral” to the overall project, as had once been proposed by a petroleum refinery to the EPA.
We believe the 2009 NSR Aggregation Action is legally supportable and makes sense for sometimes difficult case-by-
Drawing on arguments made by NRDC in its petition, in 2010 we had postulated, while “[m]uch of the emphasis” of
In the 2010 Reconsideration Proposal, we said we then read the D.C. Circuit's opinion as “requir[ing] EPA to aggregate any group of small changes” that were “sufficiently related to `fit[] within one of the ordinary meanings of `physical change.' ” 75 FR 19571. In this regard, we said that we “agree[d] with [NRDC's] contention that, to the extent that our `substantially related' interpretation,” as set forth in the 2009 NSR Aggregation Action, would “exclude meanings that fit within a reasonable understanding of the ordinary meaning of `any physical change,' ” that interpretation would “impermissibly narrow the scope of CAA section 111(a)(4).”
Upon further consideration and after reviewing the public comments on this reconsideration proposal, the agency does not read
With NRDC's arguments in mind, the agency at one point read
We now believe that such concerns were unwarranted. Upon further consideration, we do not view
Finally, to the extent that NRDC argues that the aggregation of activities that are not substantially related into one activity that fits within the ordinary meaning of a physical change—and not aggregating those changes to compare to the significance level would violate
We acknowledge that, by not making any changes to the regulatory text, as had been proposed, it may have been somewhat unclear to some whether state and local air agencies have to adopt or implement the elements of the 2009 NSR Aggregation Action, and, if so, how they should do so. In the 2010 Reconsideration Proposal, we expressed our agreement with “NRDC's assertion that the state and local implementation requirements of the NSR Aggregation Amendments are unclear,” and that the “question of whether a SIP amendment is required when the CFR remains unchanged is likely to cause confusion for reviewing authorities and other stakeholders.” 75 FR 19572. Taking account of this confusion, the agency considered that it “added support for our preferred position in this notice, which is to revoke” the 2009 NSR Aggregation Action.
We now find such concerns over potential “confusion” to have been overstated. In the Response to Comments document for the 2009 NSR Aggregation Action (2009 RTC), the agency had specifically noted that “[s]ince we are not promulgating the proposed rule regulatory changes, we are not adding NSR minimum program elements that would require states to modify their SIP.” 2009 RTC at 56. The agency continued that it would “begin applying the interpretations laid out in the final action to activities that postdate actions after the effective date of the final rulemaking notice.”
Further, as previously discussed, determining whether a source has sought to circumvent NSR by failing to treat nominally-separate activities as a single project is inherently case-specific and fact-dependent. Given this, it is not reasonable to imagine that perfect clarity could ever be achieved. To the extent, however, that the 2009 NSR Aggregation Action, in setting forth both the “substantially related” interpretation and the EPA's policy for applying that interpretation, provides some meaningful guidance to sources and to state and local permitting authorities, we fail to understand how revoking the 2009 NSR Aggregation Action would serve to promote clarity.
Indeed, in this regard, we believe in most cases that sources and state and local air agencies already implement a standard that is similar to the substantially related standard. To the extent that a state or local air agency desires to formally adopt the 2009 NSR Aggregation Action, the EPA will provide support to those agencies to process SIP submittals and issue approvals, as warranted. In most cases, however, we do not think changes in state plans would be needed to implement this interpretation.
We believe that this final action addresses the concerns raised by the petitioner with respect to the 2009 NSR Aggregation Action—
On May 18, 2010, after a series of temporary administrative stays of the 2009 NSR Aggregation Action, the EPA exercised the provisions of the APA section 705 to postpone the effectiveness of the action “until judicial review is no longer pending or the EPA completes the reconsideration process.” 75 FR 27644. Since this action concludes the reconsideration proceeding, and we have affirmed the legal consistency and policy appropriateness of the 2009 NSR Aggregation Action, we are hereby lifting the indefinite administrative stay and announcing the effective date of the action. The effective date of the 2009 NSR Aggregation Action, published in the
We believe that this action does not have any effect on environmental justice communities. Through this action, the EPA is affirming its interpretation that its current NSR regulations allow for the 2009 NSR Aggregation Action and, as such, no increased burden is expected for source owners, permitting authorities, or environmental justice communities.
This action is a significant action that was submitted to the Office of Management and Budget (OMB) for review. Any changes made in response to OMB recommendations have been documented in the docket.
Section 307(b)(1) of the CAA indicates which Federal Courts of Appeal have venue for petitions of review of final agency actions by the EPA under the CAA. This section provides, in part, that petitions for review must be filed in the U.S. Court of Appeals for the District of Columbia Circuit (i) when the agency action consists of “nationally applicable regulations promulgated, or final actions taken, by the Administrator” or (ii) when such action is locally or regionally applicable, if “such action is based on a determination of nationwide scope or effect and if in taking such action the Administrator finds and publishes that such action is based on such a determination.”
This action completes the reconsideration proceeding and makes effective the 2009 NSR Aggregation Action. The 2009 NSR Aggregation Action is an interpretation of NSR rule language that applies in every state and territory in the United States where EPA is the permitting authority. Therefore, to the extent that this action is a “final action,” it is “nationally applicable” within the meaning of CAA section 307(b)(1).
Under section 307(b)(1) of the Act, to the extent that this action is judicially reviewable, petitions for judicial review of this action must be filed in the United States Court of Appeals for the District of Columbia Circuit by January 14, 2019.
The statutory authority for this action is provided by section 301(a) of the CAA as amended (42 U.S.C. 7601(a)). This document is also subject to section 307(d) of the CAA (42 U.S.C. 7407(d)).
Environmental Protection Agency (EPA).
Final rule.
This regulation establishes tolerances for residues of azoxystrobin in or on beet, sugar, roots and vegetable, root, except sugar beet, subgroup 1B. Syngenta Crop Protection, LLC requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
This regulation is effective November 15, 2018. Objections and requests for hearings must be received on or before January 14, 2019, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2017-0744, is available at
Michael Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address:
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).
You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2017-0744 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 January 14, 2019. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2017-0744, by one of the following methods:
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In the
Based upon review of the data supporting the petition, EPA is establishing the tolerance level for vegetable, root, subgroup 1B at 1.0 ppm instead of 0.5 ppm. Additionally, the Agency has revised the commodity name to vegetable, root, except sugar beet, subgroup 1B. The reason for these changes are explained in Unit IV.D.
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .”
Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for azoxystrobin including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with azoxystrobin follows.
EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.
With repeated dosing by the oral route, the liver and bile ducts were consistently affected by azoxystrobin. Liver and biliary effects were seen in rats (increased liver weights, gross and histopathological lesions of the bile duct and liver), and in dogs (increased liver weights, clinical observations including fluid feces and salivation) and clinical chemistry alterations (including increased serum levels of alkaline phosphatase, and gamma-glutamyl transferase; and decreases in serum albumin). The effects seen are indicative of changes to liver/biliary function. Decreased body weight (rats and mice)
No developmental effects were seen in the rabbit and rat developmental toxicity studies and no reproductive or offspring effects were seen in the 2-generation rat reproduction study. In the reproduction study, decreased body weights and increased adjusted liver weights were observed at the same dose in both offspring and parental animals. Therefore, the toxicity data showed no increased susceptibility in the young.
In the acute and subchronic neurotoxicity studies, there were no consistent indications of treatment-related neurotoxicity. There was no evidence of neurotoxicity seen in the acute neurotoxicity study in rats from a single gavage dose up to 2,000 mg/kg. There was also no evidence of neurotoxicity seen in the subchronic neurotoxicity study in rats up to the highest dose tested (201 mg/kg/day). Based on the toxicity profile of azoxystrobin, a developmental neurotoxicity study in rats is not needed.
Although azoxystrobin induced a weak mutagenic response in the mouse lymphoma assay (non-linear, slight but significant increases in the mutation frequency of mouse lymphoma cells), the activity expressed
Azoxystrobin has a low order of acute toxicity via oral, dermal and inhalation routes of exposure. Azoxystrobin is not an eye or skin irritant and is not a skin sensitizer.
Specific information on the studies received and the nature of the adverse effects caused by azoxystrobin as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at
Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see
A summary of the toxicological endpoints for azoxystrobin used for human risk assessment is shown in Table 1 of this unit.
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i.
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iv.
Section 408(b)(2)(F) of FFDCA states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if:
• Condition a: The data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain the pesticide residue.
• Condition b: The exposure estimate does not underestimate exposure for any significant subpopulation group.
• Condition c: Data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area.
In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by FFDCA section 408(b)(2)(F), EPA may require registrants to submit data on PCT.
The Agency estimated the PCT for existing uses for the chronic dietary exposure assessment as follows: Almonds, 20%; apricots, 10%; artichokes, 20%; asparagus, <2.5%; barley, <2.5%; green beans, 15%; blueberries, 15%; broccoli, 10%; cabbage, 10%; caneberries, 5%; cantaloupes, 20%; carrots, 10%; cauliflower, <2.5%; celery, 10%; corn, <2.5%; cotton, <2.5%; cotton (seed treatment), 25%; cucumbers, 20%; dry beans/peas, <2.5%; eggplant, 30%; garlic, 70%; grapefruit, 20%; grapes, 5%; hazelnuts, 5%; lemons, <2.5%; lettuce, <2.5%; nectarines, <2.5%; onions, 5%; oranges, 5%; peaches, 5%; peanuts, 20%; peanuts (seed treatment), 30%; green peas, <2.5%; pecans, 5%; peppers, 20%; pistachios, 5%; plums/prunes, <2.5%; potatoes, 40%; potatoes (seed treatment), <1%; pumpkins, 20%; rice, 40%; soybeans, 5%; soybeans (seed treatment), <1%; spinach, 10%; squash, 20%; strawberries, 25%; sugar beets, 10%; sugar beets (seed treatment), <2.5%; sweet corn, 15%; tangelos, 25%; tangerines, 10%; tobacco, 15%; tomatoes, 25%; walnuts, <2.5%; watermelons, 15%; wheat, 5%; wheat seed (seed treatment), <1%. For crops not specified, 100 PCT was used.
In most cases, EPA uses available data from United States Department of Agriculture/National Agricultural Statistics Service (USDA/NASS), proprietary market surveys, and California Department of Pesticide Regulation (CalDPR) Pesticide Use Reporting (PUR) for the chemical/crop combination for the most recent 10 years. EPA uses an average PCT for chronic dietary risk analysis and a maximum PCT for acute dietary risk analysis. The average PCT figures for each existing use is derived by combining available public and private market survey data for that use, averaging across all observations, and rounding up to the nearest 5%, except for those situations in which the average PCT is less than 1% or less than 2.5%. In those cases, the Agency would use less than 1% or less than 2.5% as the average PCT value, respectively. The maximum PCT figure is the highest observed maximum value reported within the most recent 10 years of available public and private market survey data for the existing use and rounded up to the nearest multiple of 5%, except where the maximum PCT is less than 2.5%, in which case, the Agency uses less than 2.5% as the maximum PCT.
The Agency believes that the three conditions discussed in Unit III.C.1.iv. have been met. With respect to Condition a, PCT estimates are derived from Federal and private market survey data, which are reliable and have a valid basis. The Agency is reasonably certain that the percentage of the food treated is not likely to be an underestimation. As to Conditions b and c, regional consumption information and consumption information for significant subpopulations is taken into account through EPA's computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available reliable information on the regional consumption of food to which azoxystrobin may be applied in a particular area.
2.
Based on the Surface Water Concentration Calculator (SWCC) and Screening Concentration in Ground Water (SCI-GROW) models, the estimated drinking water concentrations (EDWCs) of azoxystrobin for acute exposures are estimated to be 70.2 parts per billion (ppb) for surface water and 3.1 ppb for ground water. For chronic exposures for non-cancer assessments the EDWCs of azoxystrobin are estimated to be 48.5 ppb for surface water and 3.1 ppb for ground water.
Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 70.2 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 48.5 ppb was used to assess the contribution to drinking water.
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Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at
4.
EPA has not found azoxystrobin to share a common mechanism of toxicity with any other substances, and azoxystrobin does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that azoxystrobin does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at
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• The LOAEL is based on a transient effect (diarrhea in rats) expected to be relatively insignificant in nature. This effect is also seen in other chemicals of the same class.
• The diarrhea was only seen in studies using gavage dosing in the rat, but not in studies using repeat dosing through dietary administration in rats or mice, and not through gavage dosing in rabbits.
• The very high dose level needed to reach the acute oral lethal dose (LD)
The decision to reduce the FQPA safety factor to 1X for the assessment of the remaining exposure scenarios is based on the following findings:
i. The toxicity database for azoxystrobin is considered sufficient for selecting toxicity endpoints and PODs for risk assessment.
ii. There is no indication that azoxystrobin is a neurotoxic chemical. There was no evidence of neurotoxicity seen in the acute neurotoxicity study in rats from a single gavage dose up to 2,000 mg/kg. There was also no evidence of neurotoxicity seen in the subchronic neurotoxicity study in rats up to the highest dose tested (201 mg/kg/day). Therefore, there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.
iii. There is no evidence that azoxystrobin results in increased susceptibility in
iv. There are no residual uncertainties identified in the exposure databases. The acute dietary (food) exposure assessments utilized conservative upper-bound inputs including assuming 100% CT and tolerance-level residues for all commodities except citrus fruits where the highest field trial residue was
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.
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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 390 for children 1 to <2 years old. Because EPA's level of concern for azoxystrobin is a MOE of 100 or below, these MOEs are not of concern.
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Adequate enforcement methodology (gas chromatography with nitrogen-phosphorus detector (GC/NPD) method, RAM 243/04) is available to enforce the tolerance expression for residues of azoxystrobin and its
The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address:
In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.
The Codex has established MRLs for azoxystrobin in or on root and tuber vegetables (except potato) at 1.0 ppm. This MRL is the same as the tolerance being established for azoxystrobin in the United States.
EPA received ten comments to the docket EPA-HQ-OPP-2017-0744. However, only three comments were in response to the petition filed by Syngenta Crop Protection. One comment (ID: EPA-HQ-OPP-2017-0744-0007) among the three, is inclusive of the other two comments (ID: EPA-HQ-OPP-2017-0744-0008 and EPA-HQ-OPP-2017-0744-0009), and describes portions of the content of the
The Agency recommends increasing the tolerance for vegetable, root, except sugar beet, subgroup 1B from the proposed 0.5 ppm to 1.0 ppm to harmonize with the existing Codex MRL. Additionally, the Agency is revising the significant figure on root vegetables subgroup 1B based on current policy and revising the commodity definition to reflect the common commodity vocabulary currently used by the Agency. The commodity definition was revised from vegetable, root, subgroup 1B to vegetable, root, except sugar beet, subgroup 1B.
Therefore, tolerances are established for residues of azoxystrobin, in or on beet, sugar, roots at 5.0 ppm and vegetable, root, except sugar beet, subgroup 1B at 1.0 ppm.
This action establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and
Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501
This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).
Pursuant to the Congressional Review Act (5 U.S.C. 801
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
Therefore, 40 CFR chapter I is amended as follows:
21 U.S.C. 321(q), 346a and 371.
The additions read as follows:
(a) * * *
(1) * * *
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; closure.
NMFS implements accountability measures (AMs) for the hogfish commercial sector in the exclusive economic zone (EEZ) of the South Atlantic for the Florida Keys/East Florida (FLK/EFL) stock for the 2018 fishing year through this temporary rule. NMFS estimates commercial hogfish landings for the FLK/EFL hogfish stock for the 2018 fishing year will reach the annual catch limit (ACL) on November 16, 2018. Therefore, NMFS closes the commercial sector for the FLK/EFL hogfish stock in the South Atlantic EEZ on November 16, 2018, through the remainder of the 2018 fishing year. This closure is necessary to protect the hogfish resource in the FLK/EFL region of the South Atlantic.
This rule is effective 12:01 a.m., local time, November 16, 2018, until 12:01 a.m., local time, January 1, 2019.
Mary Vara, NMFS Southeast Regional Office, telephone: 727-824-5305, email:
The snapper-grouper fishery of the South Atlantic includes hogfish and is managed under the Fishery Management Plan for the Snapper-Grouper Fishery of the South Atlantic Region (FMP). The FMP was prepared by the South Atlantic Fishery Management Council and is implemented by NMFS under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) by regulations at 50 CFR part 622.
The final rule for Amendment 37 to the FMP established two stocks of hogfish in Federal waters of the South Atlantic and new stock boundaries under the jurisdiction of the South Atlantic Fishery Management Council (82 FR 34584; July 25, 2017). One stock is the Georgia through North Carolina
In accordance with regulations at 50 CFR 622.193(u)(2)(i), the commercial AMs for the FLK/EFL hogfish stock include an in-season closure if the commercial ACL is met or is projected to be met. NMFS is required to close the commercial sector for hogfish when the ACL has been met, or is projected to be met, by filing a notification to that effect with the Office of the Federal Register.
NMFS has determined that the 2018 commercial ACL for the EFL/FLK hogfish stock established by Amendment 37 will be met on November 16, 2018. Therefore, this temporary rule implements the AM to close the commercial sector for EFL/FLK hogfish stock in the South Atlantic for the remainder of the 2018 fishing year. Accordingly, the commercial sector for the EFL/FLK hogfish stock in the South Atlantic EEZ will be closed effective 12:01 a.m. local time, November 16, 2018, until January 1, 2019, the start of the next fishing year.
During the commercial closure, all sale or purchase of hogfish in or from the EEZ off the Florida Keys and east coast of Florida, and south of 25°09′ N lat. off the west coast of Florida is prohibited, and harvest or possession of this species is limited to the bag and possession limits. These bag and possession limits apply for this hogfish stock on board a vessel for which a valid Federal commercial or charter vessel/headboat permit for South Atlantic snapper-grouper has been issued, without regard to where such species were harvested,
The Regional Administrator, Southeast Region, NMFS, has determined this temporary rule is necessary for the conservation and management of hogfish in the South Atlantic snapper-grouper fishery and is consistent with the Magnuson-Stevens Act and other applicable laws.
This action is taken under 50 CFR 622.193(u)(2)(i) and is exempt from review under Executive Order 12866.
These measures are exempt from the procedures of the Regulatory Flexibility Act because the temporary rule is issued without opportunity for prior notice and public comment.
This action responds to the best scientific information available. The Assistant Administrator for NOAA Fisheries (AA) finds that the need to immediately implement this action to close the commercial sector for this stock constitutes good cause to waive the requirements to provide prior notice and opportunity for public comment on this temporary rule pursuant to 5 U.S.C. 553(b)(B), because such procedures are unnecessary and contrary to the public interest. Such procedures are unnecessary because the AMs established by Amendment 37 (82 FR 34584; July 25, 2017) and located at 50 CFR 622.193(u)(2)(i) have already been subject to notice and public comment. All that remains is to notify the public of the commercial closure for the EFL/FLK hogfish stock in the South Atlantic EEZ for the remainder of the 2018 fishing year. Such procedures are contrary to the public interest because of the need to immediately implement this action to protect the EFL/FLK hogfish stock, since time for notice and public comment will allow for continued commercial harvest and further exceedance of the commercial ACLs.
For the aforementioned reasons, the AA also finds good cause to waive the 30-day delay in the effectiveness of this action under 5 U.S.C. 553(d)(3).
16 U.S.C. 1801
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; General category October-November fishery for 2018; fishery reopening.
NMFS has determined that a reopening of the Atlantic bluefin tuna (BFT) General category fishery is warranted. This action is intended to provide a reasonable opportunity to harvest the full annual U.S. BFT quota without exceeding it, while maintaining an equitable distribution of fishing opportunities across time periods; help achieve optimum yield in the BFT fishery; and optimize the ability of all permit categories to harvest their full BFT quota allocations. This action applies to Atlantic tunas General category (commercial) permitted vessels and Atlantic Highly Migratory Species (HMS) Charter/Headboat category permitted vessels with a commercial sale endorsement when fishing commercially for BFT.
Effective 12:30 a.m., local time, November 12, 2018, through 11:30 p.m., local time, November 16, 2018.
Uriah Forest-Bulley, 978-675-2154, or Larry Redd, 301-427-8503.
Regulations implemented under the authority of the Atlantic Tunas Convention Act (ATCA; 16 U.S.C. 971
NMFS recently published a final rule (
As of November 6, 2018, reports show that the October through November landings are still less than the available subquota of 127.2 mt. Based on landings rates, NMFS has determined that reopening the General category fishery for five days is appropriate.
Therefore, the General category fishery will reopen at 12:30 a.m., November 12, 2018, and close at 11:30 p.m., November 16, 2018. The General category daily retention limit during this reopening is one large medium or giant BFT per vessel per day/trip. This action applies to those vessels permitted in the General category, as well as to those HMS Charter/Headboat permitted vessels with a commercial sale endorsement when fishing commercially for BFT. Retaining, possessing, or landing large medium or giant BFT by persons aboard vessels permitted in the General and HMS Charter/Headboat categories must cease at 11:30 p.m. local time on November 16, 2018.
The General category will reopen automatically on December 1, 2018, for the December 2018 subquota period at the default retention limit of one fish. In December 2017, NMFS adjusted the General category base subquota for the December 2018 period to 10 mt (82 FR 60680, December 22, 2017), although this amount increased to 14.6 mt with finalization of the quota rule. Based on quota availability in the Reserve, NMFS may consider transferring additional quota to the December subquota period, as appropriate.
Fishermen may catch and release (or tag and release) BFT of all sizes, subject to the requirements of the catch-and-release and tag-and-release programs at § 635.26. All BFT that are released must be handled in a manner that will maximize their survival, and without removing the fish from the water, consistent with requirements at § 635.21(a)(1). For additional information on safe handling, see the “Careful Catch and Release” brochure available at
NMFS will continue to monitor the BFT fishery closely. Dealers are required to submit landing reports within 24 hours of a dealer receiving BFT. Late reporting by dealers compromises NMFS' ability to timely implement actions such as quota and retention limit adjustment, as well as closures, and may result in enforcement actions. Additionally, and separate from the dealer reporting requirement, General and HMS Charter/Headboat 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
Depending on the level of fishing effort and catch rates of BFT, NMFS may determine that additional adjustments are necessary to ensure available subquotas are not exceeded or to enhance scientific data collection from, and fishing opportunities in, all geographic areas. If needed, subsequent adjustments will be published in the
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 actions 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 opportunity for public comment to implement the fishery reopening is impracticable and contrary to the public interest. The General category recently closed, but based on available BFT quotas, recent fishery performance, and the availability of BFT on the fishing grounds, responsive reopening of the fishery is warranted to allow fishermen to take advantage of availability of fish and of quota. NMFS could not have proposed this action earlier, as it needed to consider and respond to updated data and information about fishery conditions and this year's landings. If NMFS was to offer a public comment period now, after having appropriately considered that data, it would preclude fishermen from harvesting BFT that are legally available. 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 all of the above reasons, there also is good cause under 5 U.S.C. 553(d) to waive the 30-day delay in effectiveness.
This action is being taken under § 635.27(a)(1), 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; closure.
NMFS is prohibiting retention of shortraker rockfish in the Central Regulatory Area of the Gulf of Alaska (GOA). This action is necessary because the 2018 total allowable catch of shortraker rockfish in the Central Regulatory Area of the GOA will be reached.
Effective 1200 hours, Alaska local time (A.l.t.), November 9, 2018, through 2400 hours, A.l.t., December 31, 2018.
Obren Davis, 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
The 2018 total allowable catch (TAC) of shortraker rockfish in the Central Regulatory Area of the GOA is 305 metric tons (mt) as established by the final 2018 and 2019 harvest specifications for groundfish of the GOA (83 FR 8768, March 1, 2018).
In accordance with § 679.20(d)(2), the Administrator, Alaska Region, NMFS (Regional Administrator), has determined that the 2018 TAC of shortraker rockfish in the Central Regulatory Area of the GOA will be reached. Therefore, NMFS is requiring that shortraker rockfish in the Central Regulatory Area of the GOA be treated as prohibited species in accordance with § 679.21(b). This action does not apply to fishing by trawl catcher/processors in the cooperative fishery in 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 the retention of shortraker rockfish 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 November 8, 2018.
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
Board of Governors of the Federal Reserve System.
Notice of proposed rulemaking.
The Board of Governors of the Federal Reserve System (the Board) is proposing to revise and expand its equal employment opportunity regulation to adopt recent changes the Equal Employment Opportunity Commission (EEOC) had made to its rules. The Board's proposed rule is intended to provide Board employees, applicants for employment, and others with the same substantive and procedural rights generally guaranteed to others under Title VII of the Civil Rights Act of 1964, the Equal Pay Act, the Age Discrimination in Employment Act, and the Rehabilitation Act and thus to comply with the spirit of those laws. The Board's proposed rule also clarifies provisions related to Board employees' right to bring a claim before the Merit System Protection Board and the Federal Labor Relations Board.
Comments on the notice of proposed rulemaking must be received on or before December 17, 2018.
You may submit comments, identified by Docket No. R-[1630 and RIN 7100-AF 23], by any of the following methods:
•
•
•
•
All public comments will be made available on the Board's website at
Sheila Clark, Program Director, Office of Diversity and Inclusion, Board of Governors of the Federal Reserve System, (202) 452-2883. For the hearing impaired only, Telecommunications Device for the Deaf (TDD) users may contact 202-263-4869.
The terms of Board employment are established by the Federal Reserve Act and rules established by the Board. 12 U.S.C. 244 (Section 244 provides that the “employment, compensation, leave, and expenses” of Board employees “shall be governed solely by the provisions of this chapter and rules and regulations of the Board not inconsistent therewith.”) Although the Board has broad discretion to establish the terms of Board employment and can establish terms that deviate from the rights afforded to other government employees, the Board, as a matter of policy, has long aligned its employment practices with federal laws that provide for equal employment opportunity. Pursuant to this policy, Part 268 was issued by the Board to provide equal opportunity in employment in compliance with the spirit of Title VII of the Civil Rights Act of 1964 (Title VII), the Equal Pay Act, the Age Discrimination in Employment Act, and the Rehabilitation Act. Part 268 has not been updated in several years, and the Board is now proposing to amend it in order to better align its practices with those of the Equal Employment Opportunity Commission's (EEOC's) rules. The proposed revisions to Part 268 would:
1. Amend section 268.101 to prohibit discrimination on the basis of genetic information to ensure compliance with the Genetic Information Nondiscrimination Act of 2008 (GINA) and to make conforming changes throughout to reflect this proposed change.
2. Amend section 268.102(b)(3) to clarify that the Board follows Commission guidance and management directives relating to advice for ensuring compliance with Title VII, the Equal Pay Act, the Age Discrimination in Employment Act, GINA, and the Rehabilitation Act.
3. Amend section 268.1 to remove references to hiring and granting information access since those rules will be incorporated into internal Board policies;
4. Amend section 268.106(a)(5) to adopt the EEOC's rule requiring dismissal of complaints that allege discrimination on the basis of proposed personnel actions or other preliminary steps unless the complainant has alleged that the proposal or preliminary step is retaliatory;
5. Amend section 268.107(e) to require Board staff, EEO investigators, and complainants to comply with the Board's program for the security of Federal Open Market Committee (FOMC) information when investigating and processing complaints that require access to FOMC information;
6. Amend section 268.107(g) to adopt the EEOC's rule on investigating complaints which requires agencies that have not completed an investigation within EEOC's time limits to send a notice to the complainant indicating the investigation is not complete, providing the date by which it will be completed, and explaining that the complainant has the right to request a hearing or file a lawsuit;
7. Amend section 268.201 to reflect updated address information for the EEOC;
8. Amend section 268.203 to more closely reflect the EEOC's approach to designing an affirmative action plan for individuals with disabilities;
9. Amend section 268.204 and section 268.401 to reflect the EEOC's rules for processing class complaints;
10. Remove section 268.205 since its subject is not related to equal employment opportunity rules and since rules for hiring and granting access to information will be incorporated into the Board's internal policies;
11. Remove section 268.302 to eliminate procedures for handling mixed case complaints since mixed case complaints cannot be brought against the Board;
12. Amend section 268.403 to update address information and to incorporate the EEOC's rule that agencies submit appellate records and complaint files to the EEOC in a digital format that is acceptable to the EEOC;
13. Add a new section 268.405(b) to adopt the EEOC's procedures for class complaints which provide that an administrative judge's decision on the merits of a class complaint is a final decision which the Board can fully implement or appeal in its final action and to provide for expedited processing of appeals of decisions to accept or dismiss class complaints;
14. Amend section 268.502(c) to adopt the EEOC's rule which permits agencies up to 120 days to provide the particular relief the EEOC ordered; and
15. Amend section 268.710 to make changes to headings and titles to conform to the EEOC's rules and to the Board's functional titles.
Except as described below, the above changes are necessary to align the Board's employment practices and complaint processing with the EEOC's rules. The proposed revisions to Part 268 are designed to align the Board's practices with changes the EEOC has made to its rules on Federal Sector Equal Employment Opportunity found at 29 CFR part 1614. In addition, the amendment to section 268.102(b)(3) is proposed in order to clarify that the Board follows Commission guidance and management directives relating to advice for ensuring compliance with Title VII, the Equal Pay Act, the Age Discrimination in Employment Act, GINA, and the Rehabilitation Act.
Currently part 268 requires Board staff, EEO investigators, and complainants to protect confidential information of the Board but does not expressly address confidential FOMC information. Because it is conceivable that a complaint could require access to FOMC information, and because FOMC information is not solely Board information, the Board proposes amending section 268.107(e)(2) to expressly require those seeking access to FOMC information to agree to abide by the Program for Security of FOMC Information before being granted access to such information. This will ensure that FOMC information is protected in the same manner as other confidential Board information.
The revisions also eliminate section 268.205, which discusses the Board's rules for hiring non-citizens and for allowing access to confidential supervisory information (CSI) and FOMC information. The subject matter of this section is not relevant to the Board's equal employment opportunity rules. Thus, the proposed revisions would remove this section from the Board's equal employment opportunity regulation. Going forward, rules relating to the hiring of non-citizens and governing access to CSI and FOMC information will be incorporated in the Board's internal management policies.
The revisions would eliminate section 268.302, which addresses procedures that apply to “mixed case complaints.” A mixed case complaint is an employment complaint which raises violations of both EEO laws (over which the EEOC retains jurisdiction) and merit system principles, created by certain civil service laws over which the Merit Systems Protection Board (MSPB) retains jurisdiction. The Board is not subject to the MSPB's jurisdiction in light of its employment authorities under the Federal Reserve Act. Thus, the revisions would remove this provision of the regulation.
The revisions proposed to Subpart H reflect changes to the Board's organizational structure since the last time the Board updated its EEO Regulation. Subpart H prohibits discrimination on the basis of disability in programs or activities conducted by the Board and describes how to file complaints alleging such discrimination. The complaint process described in Subpart H incorporates references to position titles that are no longer in use at the Board. For example, Subpart H refers to the Equal Employment Opportunity Office, which has since been replaced by the Office of Diversity and Inclusion; to an EEO Program Director, which has since been replaced by the Office of Diversity and Inclusion Program Director; and to a Staff Director for Management, which has been replaced by the Chief Operating Officer. The amendments to Subpart H replace the out-of-date titles with up-to-date information each place the rule refers to such titles.
Certain provisions of the proposed rule contain “collection of information” requirements within the meaning of the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3521). In accordance with the requirements of the PRA, the Board may not conduct or sponsor, and the respondent is not required to respond to, an information collection unless it displays a currently valid Office of Management and Budget (OMB) control number. The OMB control number for the Board is 7100-0313. The Board will address the information collection requirements associated with this proposed rule under a separate
The Regulatory Flexibility Act, 5 U.S.C. 601
Section 722 of the Gramm-Leach-Bliley Act requires each federal banking agency to use plain language in all rules published after January 1, 2000. In light of this requirement, the Board believes this rule is presented in a simple and straightforward manner and is consistent with this “plain language” directive.
Administrative practice and procedure, Aged, Civil rights, Equal employment opportunity, Federal buildings and facilities, Genetic information, Government employees, Individuals with disabilities, Religious discrimination, Sex discrimination, Wages.
For the reasons set forth in the preamble, the Board proposes to amend 12 CFR part 268 as set forth below:
12 U.S.C. 244 and 248(i), (k) and (l).
(b) Purpose and scope. This part sets forth the Board's policy, program and procedures for providing equal opportunity to Board employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, or genetic information. It also sets forth the Board's policy, program and procedures for prohibiting discrimination on the basis of disability in programs and activities conducted by the Board.
(a) It is the policy of the Board to provide equal opportunity in employment for all persons, to prohibit discrimination in employment because of race, color, religion, sex, national origin, age, disability, or genetic information and to promote the full realization of equal opportunity in employment through a continuing affirmative program.
(b) No person shall be subject to retaliation for opposing any practice made unlawful by Title VII of the Civil Rights Act (title VII) (42 U.S.C. 2000e
(a) * * *
(4) Communicate the Board's equal employment opportunity policy and program and its employment needs to all sources of job candidates without regard to race, color, religion, sex, national origin, age disability, or genetic information, and solicit their recruitment assistance on a continuing basis;
(b) * * *
(3) Appraise its personnel operations at regular intervals to assure their conformity with the Board's program, this part 268 and the instructions contained in the Commission's management directives relating to advice for ensuring compliance with the provisions of title VII, the Equal Pay Act, the Age Discrimination in Employment Act, GINA, and the Rehabilitation Act.
(4) Designate a Director for Equal Employment Opportunity (EEO Programs Director), EEO Officer(s), and such Special Emphasis Program Managers/Coordinators (
(a) Individual and class complaints of employment discrimination and retaliation prohibited by title VII (discrimination on the basis of race, color, religion, sex and national origin), the ADEA (discrimination on the basis of age when the aggrieved person is at least 40 years of age), the Rehabilitation Act (discrimination on the basis of disability), the Equal Pay Act (sex-based wage discrimination), or GINA (discrimination on the basis of genetic information) shall be processed in accordance with this part. Complaints alleging retaliation prohibited by these statutes are considered to be complaints of discrimination for purposes of this part.
(a) Aggrieved persons who believe they have been discriminated against on the basis of race, color, religion, sex, national origin, age disability, or genetic information must consult a Counselor prior to filing a complaint in order to try to informally resolve the matter.
* * *
(d) Unless the aggrieved person agrees to a longer counseling period under paragraph (e) of this section, or the aggrieved person chooses an alternative dispute resolution procedure in accordance with paragraph (b)(2) of this section, the Counselor shall conduct the final interview with the aggrieved person within 30 days of the date the aggrieved person contacted the Board's Office of Diversity and Inclusion to request counseling. If the matter has not been resolved, the aggrieved person shall be informed in writing by the Counselor, not later than the thirtieth day after contacting the Counselor, of the right to file a discrimination complaint with the Board. This notice shall inform the complainant of the right to file a discrimination complaint within 15 days of receipt of the notice, of the appropriate official with whom to file a complaint and of the complainant's duty to assure that the Programs Director is informed immediately if the complainant retains counsel or a representative.
(a) * * *
(4) Reserved.
(5) That is moot or alleges that a proposal to take a personnel action, or other preliminary step to taking a personnel action, is discriminatory, unless the complaint alleges that the proposal or preliminary step is retaliatory;
The additions and redesignation read as follows.
(e) (1) * * *
(2) * * * Confidential supervisory information, as defined in 12 CFR 261.2(c), and other confidential information of the Board may be included in the investigative file by the investigator, the EEO Programs Director, or another appropriate officer of the Board, where such information is relevant to the complaint. Neither the complainant nor the complainant's personal representative may make further disclosure of such information, however, except in compliance with the Board's Rules Regarding Availability of
(g) If the Board does not send the notice required in paragraph (f) of this section within the applicable time limits, it shall, within those same time limits, issue a written notice to the complainant informing the complainant that it has been unable to complete its investigation within the time limits required by § 268.107(f) and estimating a date by which the investigation will be completed. Further, the notice must explain that if the complainant does not want to wait until the agency completes the investigation, he or she may request a hearing in accordance with paragraph (h) of this section, or file a civil action in an appropriate United States District Court in accordance with § 268.406(b). Such notice shall contain information about the hearing procedures.
(g) Summary Judgement. * * *
(a) As an alternative to filing a complaint under this part, an aggrieved individual may file a civil action in a United States district court under the ADEA against the agency after giving the Commission not less than 30 days' notice of the intent to file such an action. Such notice must be filed in writing with EEOC, at P.O. Box 77960, Washington, DC 20013, or by personal delivery or facsimile within 180 days of the occurrence of the alleged unlawful practice.
* * *
(c) When an individual has filed an administrative complaint alleging age discrimination, administrative remedies will be considered to be exhausted for purposes of filing a civil action:
* * *
(a)
(1) The term
(2) The term
(3) The term
(4) The term
(5) The term
(6) The term
(7) Reserved.
(8) The term
(9) The term
(10) The term
(b)
(c)
(d)
(1)
(i)
(A) Use of programs and resources that identify job applicants with disabilities, including individuals with targeted disabilities, who are eligible to be appointed under a hiring authority that takes disability into account, examples of which could include programs that provide the qualifications necessary for particular positions within the Board to individuals with disabilities, databases of individuals with disabilities who previously applied to the Board but were not hired for the positions they applied for, and training and internship programs that lead directly to employment for individuals with disabilities; and
(B) Establishment and maintenance of contacts (which may include formal agreements) with organizations that specialize in providing assistance to individuals with disabilities, including individuals with targeted disabilities, in securing and maintaining employment, such as American Job Centers, State Vocational Rehabilitation Agencies, the Veterans' Vocational Rehabilitation and Employment Program, Centers for Independent Living, and Employment Network service providers.
(ii)
(A) Ensuring that disability-related questions from members of the public regarding the agency's application and selection processes are answered promptly and correctly, including questions about reasonable accommodations needed by job applicants during the application and selection processes and questions about how individuals may apply for appointment under hiring authorities that take disability into account;
(B) Processing requests for reasonable accommodations needed by job applicants during the application and placement processes, and ensuring that the Board provides such accommodations when required to do so under the standards set forth in 29 CFR part 1630;
(C) Accepting applications for appointment under hiring authorities that take disability into account, if permitted under written Board policy;
(D) If an individual has applied for appointment to a particular position under a hiring authority that takes disability into account, determining whether the individual is eligible for appointment under such authority, and, if so, forwarding the individual's application to the relevant hiring officials with an explanation of how and when the individual may be appointed, consistent with all applicable laws;
(E) Overseeing any other Board programs designed to increase hiring of individuals with disabilities.
(iii)
(A) Efforts to ensure that employees with disabilities are informed of and have opportunities to enroll in relevant training, including management training when eligible;
(B) Development or maintenance of a mentoring program for employees with disabilities; and
(C) Administration of exit interviews that include questions on how the Board could improve the recruitment, hiring, inclusion, and advancement of individuals with disabilities.
(2)
(3)
(i)
(A) Explain relevant terms such as “reasonable accommodation,” “disability,” “interactive process,” “qualified,” and “undue hardship,” consistent with applicable statutory and regulatory definitions, using examples where appropriate;
(B) Explain that reassignment to a vacant position for which an employee is qualified, and not just permission to compete for such position, is a reasonable accommodation, and that the Board must consider providing reassignment to a vacant position as a reasonable accommodation when it determines that no other reasonable accommodation will permit an employee with a disability to perform the essential functions of his or her current position;
(C) Notify supervisors and other relevant Board employees how and where they are to conduct searches for available vacancies when considering reassignment as a reasonable accommodation;
(D) Explain that an individual may request a reasonable accommodation orally or in writing at any time, need not fill out any specific form in order for the interactive process to begin, and need not have a particular accommodation in mind before making a request, and that the request may be made to a supervisor or manager in the individual's chain of command, the office designated by the Board to oversee the reasonable accommodation process, any Board employee connected with the application process, or any other individual designated by the Board to accept such requests;
(E) Include any forms the Board uses in connection with a reasonable accommodation request as attachments, and indicate that such forms are available in alternative formats that are accessible to people with disabilities;
(F) Describe the Board's process for determining whether to provide a reasonable accommodation, including the interactive process, and provide contact information for the individual or program office from whom requesters will receive a final decision;
(G) Provide guidance to supervisors on how to recognize requests for reasonable accommodation;
(H) Require that decision makers communicate, early in the interactive process and periodically throughout the process, with individuals who have requested a reasonable accommodation;
(I) Explain when the Board may require an individual who requests a reasonable accommodation to provide medical information that is sufficient to explain the nature of the individual's disability, his or her need for reasonable accommodation, and how the requested accommodation, if any, will assist the individual to apply for a job, perform the essential functions of a job, or enjoy the benefits and privileges of the workplace;
(J) Explain the Board's right to request relevant supplemental medical information if the information submitted by the requester is insufficient for the purposes specified in paragraph (d)(3)(i)(I) of this section;
(K) Explain the Board's right to have medical information reviewed by a medical expert of the Board's choosing at the Board's expense;
(L) Explain the Board's obligation to keep medical information confidential, in accordance with applicable laws and regulations, and the limited circumstances under which such information may be disclosed;
(M) Designate the maximum amount of time the Board has, absent extenuating circumstances, to either provide a requested accommodation or deny the request, and explain that the time limit begins to run when the accommodation is first requested;
(N) Explain that the Board will not be expected to adhere to its usual timelines if an individual's health professional fails to provide needed documentation in a timely manner;
(O) Explain that, where a particular reasonable accommodation can be provided in less than the maximum amount of time permitted under paragraph (d)(3)(i)(M) of this section, failure to provide the accommodation in a prompt manner may result in a violation of the Rehabilitation Act;
(P) Provide for expedited processing of requests for reasonable accommodations that are needed sooner than the maximum allowable time frame permitted under paragraph (d)(3)(i)(M) of this section;
(Q) Explain that, when all the facts and circumstances known to the Board make it reasonably likely that an individual will be entitled to a reasonable accommodation, but the accommodation cannot be provided immediately, the Board shall provide an interim accommodation that allows the individual to perform some or all of the essential functions of his or her job, if
(R) Inform applicants and employees how they may track the processing of requests for reasonable accommodation;
(S) Explain that, where there is a delay in either processing a request for or providing a reasonable accommodation, the Board must notify the individual of the reason for the delay, including any extenuating circumstances that justify the delay;
(T) Explain that individuals who have been denied reasonable accommodations have the right to file complaints pursuant to 12 CFR 268.105;
(U) Encourage the use of voluntary informal dispute resolution processes that individuals may use to obtain prompt reconsideration of denied requests for reasonable accommodation;
(V) Provide that the Board shall give the requester a notice consistent with the requirements of paragraph (d)(3)(iii) of this section at the time a request for reasonable accommodation is denied; and
(W) Provide information on how to access additional information regarding reasonable accommodation, including, at a minimum, Commission guidance and technical assistance documents.
(ii)
(A) Ensure that anyone who is authorized to grant or deny requests for reasonable accommodation or to make hiring decisions is aware that, pursuant to the regulations implementing the undue hardship defense at 29 CFR part 1630, all resources available to the agency as a whole, excluding those designated by statute for a specific purpose that does not include reasonable accommodation, are considered when determining whether a denial of reasonable accommodation based on cost is lawful; and
(B) Ensure that anyone authorized to grant or deny requests for reasonable accommodation or to make hiring decisions is aware of, and knows how to arrange for the use of, Board resources available to provide the accommodation, including any centralized fund the Board may have for that purpose.
(iii)
(A) Explains the reasons for the denial and notifies the job applicant or employee of any available internal appeal or informal dispute resolution processes;
(B) Informs the job applicant or employee of the right to challenge the denial by filing a complaint of discrimination under this part;
(C) Provides instructions on how to file such a complaint; and
(D) Explains that, pursuant to 12 CFR 268.105, the right to file a complaint will be lost unless the job applicant or employee initiates contact with an EEO Counselor within 45 days of the denial, regardless of whether the applicant or employee participates in an informal dispute resolution process.
(4)
(i)
(A) Explains their rights under Section 508 of the Rehabilitation Act of 1973, 29 U.S.C. 794d, concerning the accessibility of agency technology, and the Architectural Barriers Act, 42 U.S.C. 4151 through 4157, concerning the accessibility of agency building and facilities;
(B) Provides contact information for a Board employee who is responsible for ensuring the physical accessibility of the Board's facilities under the Architectural Barriers Act of 1968, and a Board employee who is responsible for ensuring that the electronic and information technology purchased, maintained, or used by the agency is readily accessible to, and usable by, individuals with disabilities, as required by Section 508 of the Rehabilitation Act of 1973; and
(C) Provides instructions on how to file complaints alleging violations of the accessibility requirements of the Architectural Barriers Act of 1968 and Section 508 of the Rehabilitation Act of 1973.
(ii)
(5)
(i)
(A) The employee requires such services because of a targeted disability;
(B) Provision of such services would, together with any reasonable accommodations required under the standards set forth in 29 CFR part 1630, enable the employee to perform the essential functions of his or her position; and
(C) Provision of such services would not impose undue hardship on the Board.
(ii)
(iii)
(iv)
(v)
(6)
(i)
(ii)
(A) The individual's self-identification as an individual with a disability or an individual with a targeted disability on a form, including but not limited to the Office of Personnel Management's Standard Form 256, which states that the information collected will be kept confidential and used only for statistical purposes, and that completion of the form is voluntary;
(B) Records relating to the individual's appointment under a hiring authority that takes disability into account, if applicable; and
(C) Records relating to the individual's requests for reasonable accommodation, if any.
(iii)
(7)
(i)
(A) No less than 12% of employees who have salaries equal to or greater than employees at the GS-11, step 1 level in the Washington, DC locality, are individuals with disabilities;
(B) No less than 12% of employees who have salaries less than employees at the GS-11, step 1 level in the Washington, DC locality, are individuals with disabilities;
(C) No less than 2% of employees who have salaries equal to or greater than employees at the GS-11, step 1 level in the Washington, DC locality, are individuals with targeted disabilities; and
(D) No less than 2% of employees who have salaries less than employees at the GS-11, step 1 level in the Washington, DC locality, are individuals with targeted disabilities.
(ii)
(A) Increased use of hiring authorities that take disability into account to hire or promote individuals with disabilities or targeted disabilities, as applicable;
(B) To the extent permitted by applicable laws, consideration of disability or targeted disability status as a positive factor in hiring, promotion, or assignment decisions;
(C) Disability-related training and education campaigns for all employees in the Board;
(D) Additional outreach or recruitment efforts;
(E) Increased efforts to hire and retain individuals who require supported employment because of a disability, who have retained the services of a job coach at their own expense or at the expense of a third party, and who may be given permission to use the job coach during work hours as a reasonable accommodation without imposing undue hardship on the Board; and
(F) Adoption of training, mentoring, or internship programs for individuals with disabilities.
(8)
(i) The number of job applications received from individuals with disabilities, and the number of individuals with disabilities who were hired by the Board;
(ii) The number of job applications received from individuals with targeted disabilities, and the number of individuals with targeted disabilities who were hired by the Board;
(iii) All rescissions of conditional job offers, demotions, and terminations taken against applicants or employees as a result of medical examinations or inquiries;
(iv) All Board employees hired under special hiring authority for person with certain disabilities, and each such employee's date of hire, entering grade level, probationary status, and current grade level;
(v) The number of employees appointed under special hiring authority for persons with certain disabilities who successfully completed the Board's Provisional Employment period and the number of such employees who were terminate prior to the end of their Provisional Employment period; and
(vi) Details about each request for reasonable accommodation including, at a minimum—
(A) The specific reasonable accommodation requested, if any;
(B) The job sought by the requesting applicant or held by the requesting employee;
(C) Whether the accommodation was needed to apply for a job, perform the essential functions of a job, or enjoy the benefits and privileges of employment;
(D) Whether the request was granted (which may include an accommodation different from the one requested) or denied;
(E) The identity of the deciding official;
(F) If denied, the basis for such denial; and
(G) The number of days taken to process the request.
(e)
(1)
(i) A copy of its current Plan;
(ii) The results of the two most recent workforce analyses performed pursuant to paragraph (d)(6) of this section showing the percentage of employees with disabilities and employees with targeted disabilities in each of the designated pay groups;
(iii) The number of individuals appointed to positions within the Board under special hiring authority for persons with certain disabilities during the previous year, and the total number of employees whose employment at the Board began by appointment under special hiring authority for persons with certain disabilities; and
(iv) A list of changes made to the Plan since the prior submission, if any, and an explanation of why those changes were made.
(2)
(i)
(j)
(2) If the Board does not issue a final order within 60 days of receipt of the administrative judge's decision, then the decision of the administrative judge shall become the final action of the Board.
(3) A final order on a class complaint shall, subject to subpart E of this part, be binding on all members of the class and the Board.
(k)
(l) * * *
(3) * * * The claim must include a specific detailed showing that the claimant is a class member who was affected by the discriminatory policy or practice, and that this discriminatory action took place within the period of time for which class-wide discrimination was found in the final order. * * *
(c) A class agent or the Board may appeal an administrative judge's decision accepting or dismissing all or part of a class complaint; a class agent may appeal the Board's final action or the Board may appeal an administrative judge's decision on a class complaint; a class member may appeal a final decision on a claim for individual relief under a class complaint; and a class member, a class agent or the Board may appeal a final decision on a petition pursuant to § 268.204(g)(4).
(a) The complainant, the Board, agent or individual class claimant (hereinafter appellant) must file an appeal with the Director, Office of Federal Operations, Equal Employment Opportunity Commission, at P.O. Box 77960, Washington, DC 20013, or electronically, or by personal delivery or facsimile. The appellant should use EEOC Form 573, Notice of Appeal/Petition, and should indicate what is being appealed.
(g) The Board will submit appeals, complaint files, and other filings to the Commission's Office of Federal Operations in a digital format acceptable to the Commission, absent a showing of good cause why the Board cannot submit digital records. Appellants are encouraged, but not required, to submit digital appeals and supporting documentation to the Commission's Office of Federal Operations in a format acceptable to the Commission.
The addition and revisions read as follows:
(a) * * * The Office of Federal Operations, on behalf of the Commission, shall issue a written decision setting forth its reasons for the decision. The Commission shall dismiss appeals in accordance with §§ 268.106, 268.403(c) and 268.408. The decision shall be based on the preponderance of the evidence. The decision on an appeal from the Board's final action shall be based on a de novo review, except that the review of the factual findings in a decision by an administrative judge issued pursuant to § 268.108(i) shall be based on a substantial evidence standard of review. If the decision contains a finding of discrimination, appropriate remedy(ies) shall be included and, where appropriate, the entitlement to interest, attorney's fees or costs shall be indicated. The decision shall reflect the date of its issuance, inform the complainant of his or her civil action rights, and be transmitted to the complainant and the Board by first class mail. * * *
(b) The Office of Federal Operations, on behalf of the Commission, shall issue decisions on appeals of decisions to accept or dismiss a class complaint issued pursuant to § 268.204(d)(7) within 90 days of receipt of the appeal.
(c) A decision issued under paragraph (a) of this section is final within the meaning of § 268.406 unless the Board issues a final decision under paragraph (d) of this section or unless a timely request for reconsideration is filed by a party to the case. A party may request reconsideration within 30 days of receipt of a decision of the Commission, which the Commission in its discretion may grant, if the party demonstrates that:
(1) The appellate decision involved a clearly erroneous interpretation of material fact or law; or
(2) The decision will have a substantial impact on the policies, practices, or operations of the Board.
(d) The Board, within 30 days of receiving a decision of the Commission, may issue a final decision based upon that decision, which shall be final within the meaning of § 268.406.
(b) * * *
(2) When the Board requests reconsideration, it may delay the payment of any amounts ordered to be paid to the complainant until after the request for reconsideration is resolved. If the Board delays payment of any
(c) When no request for reconsideration or final decision under § 268.405(d) is filed or when a request for reconsideration is denied, the Board shall provide the relief ordered and there is no further right to delay implementation of the ordered relief. The relief shall be provided in full not later than 120 days after receipt of the final decision unless otherwise ordered in the decision.
(c) Prior to rendering its determination, the Commission may request that the parties submit whatever additional information or documentation it deems necessary or may direct that an investigation or hearing on the matter be conducted. If the Commission determines that the Board is not in compliance with a decision or a settlement agreement, and the noncompliance is not attributable to acts or conduct of the complainant, it may order such compliance with the decision or settlement agreement, or, alternatively, for a settlement agreement, it may order that the complaint be reinstated for further processing from the point processing ceased. Allegations that subsequent acts of discrimination violate a settlement agreement shall be processed as separate complaints under §§ 268.105 or 268.204, as appropriate, rather than under this section.
The revisions read as follows:
(c)
(d) * * *
(4) * * *
As part of its overall mission, the Federal Reserve has a fundamental interest in ensuring there is a safe and robust U.S. payment system, including a settlement infrastructure on which the private sector can provide innovative faster payment services that serve the broad public interest. Accordingly, the Board of Governors of the Federal Reserve System (Board) is seeking input on potential actions that the Federal Reserve could take to promote ubiquitous, safe, and efficient faster payments in the United States by facilitating real-time interbank settlement of faster payments. While the Board is not committing to any specific actions, potential actions include the Federal Reserve Banks developing a service for 24x7x365 real-time interbank settlement of faster payments; and a liquidity management tool that would enable transfers between Federal Reserve accounts on a 24x7x365 basis to support services for real-time interbank settlement of faster payments, whether those services are provided by the private sector or the Federal Reserve Banks. The Board is seeking input on whether these actions, separately or in combination, or alternative approaches, would help achieve ubiquitous, nationwide access to safe and efficient faster payments.
Comments on the potential actions must be received on or before December 14, 2018.
You may submit comments, identified by Docket No. OP-1625, by any of the following methods:
•
•
•
•
All public comments will be made available on the Board's website at
Kirstin Wells, Principal Economist (202-452-2962), Mark Manuszak, Manager (202-721-4509), Susan V. Foley, Senior Associate Director (202-452-3596), Division of Reserve Bank Operations and Payment Systems, or Gavin Smith, Senior Counsel, Legal Division (202-452-3474), Board of Governors of the Federal Reserve System; for the hearing impaired and users of Telecommunications Device for the Deaf (TDD) only, contact 202-263-4869.
Broad trends in society based on technological advancements have changed the ways that people interact
Traditional payment methods, such as checks, automated clearinghouse (ACH) payments, and debit and credit cards, form a retail payment infrastructure that is safe, reliable, and ubiquitous, albeit not necessarily quick.
Over the past two decades, however, a gap has emerged between the capabilities of traditional payment methods and end-user expectations for enhanced payment speed, convenience, and accessibility. A new method of faster payment has emerged to address this gap, with several nonbank payment service providers entering the payment market alongside—and sometimes in lieu of—banks. Faster payments allow end users to initiate and receive payments at any time of the day, any day of the year, and to complete those payments in near-real time (from the end users' perspective), such that, within seconds, the recipient has access to final funds that can be used to make other payments.
The term “faster payments” is broadly used in the payment industry to indicate simply that increased speed, convenience, and accessibility are essential features for the future of the payment and settlement system. However, faster payments provide more to individuals and businesses than just the ability to make payments quickly from a mobile device. For example, when funds move in and out of end-user bank accounts in real time, end users have more flexibility in managing their money. Faster payments eliminate the need to schedule bill or vendor payments well in advance and, more broadly, allow end users to make time-sensitive payments whenever needed. By increasing flexibility and accessibility, end users may also have greater scope to avoid penalties such as late fees.
The development of payment and settlement services that are essentially real time and always available is a worldwide phenomenon. Both advanced and emerging economies have undertaken efforts to develop faster payment services, and those services are now broadly accessible to the general public in an increasing number of countries.
Efforts to implement faster payments in other countries often reflect a collaborative, strategic endeavor that involves the payment industry, central banks, and other authorities. The deployment of accessible faster payment services generally requires extensive upgrades to a country's or region's payment and settlement infrastructure, involving significant coordination among all stakeholders. As part of these upgrades, central banks in various jurisdictions have implemented or planned changes to their settlement services in support of faster payments, reflecting the foundational role that central banks play worldwide in the settlement of obligations between financial institutions. The ability to reliably settle interbank obligations using balances at the central bank (also referred to as central bank money) is vital not only to the smooth functioning of the payment system but also to financial stability more broadly.
As the U.S. central bank, the Federal Reserve initiated a broadly collaborative effort with the payment industry and other stakeholders in 2013, to support development of ubiquitous, nationwide access to safe and efficient faster payments in the United States. While the private sector has to date implemented certain faster payment services for the public, there are still challenges related to achieving these broader goals. As part of its central mission, the Federal Reserve has a fundamental responsibility to ensure that there is a flexible and robust infrastructure supporting the U.S. payment system on which the private sector can develop innovative payment services that serve the broadest public interests.
A safe and efficient payment and settlement system that works in the interest of the public is vital to the U.S. economy, and the Federal Reserve plays important roles in helping maintain the integrity of that system.
One of the Federal Reserve's most significant roles in that system involves providing mechanisms for the settlement of payment obligations between and among banks. Banks process payments on their own behalf as well as on behalf of their end-user customers, including individuals, households, businesses, and other parties. Banks—small, medium, and large—settle payments at the Federal Reserve through their accounts and balances at the Federal Reserve Banks (Reserve Banks).
Through the services that it provides to the banking industry and the U.S. government, the Federal Reserve seeks to foster the safety and efficiency of the payment and settlement system. In doing so, the Federal Reserve provides payment and settlement services on an equitable basis and maintains a fundamental commitment to competitive fairness, which is essential to fostering end-user choice and innovation across the financial services sector as a whole.
When evaluating the potential introduction of a new payment service or major enhancements to an existing service, the Federal Reserve looks to its statutory obligations as well as long-standing principles and criteria.
In addition to providing payment and settlement services, the Federal Reserve plays other roles, including serving as a convener of industry stakeholders, in support of its mission to foster safety and efficiency of the payment and settlement system. The next section discusses the broad initiative that the Federal Reserve launched five years ago to collaborate with the payment industry to foster payment system improvements.
Beginning in 2013, the Federal Reserve established a new initiative—Strategies for Improving the U.S. Payment System (SIPS)—with the objective of engaging with the payment industry and other stakeholders to upgrade and enhance the nation's payment system. The collaborative work began with a consultation paper that requested public views on gaps, opportunities, and desired outcomes related to the goal of improving the speed and efficiency of the U.S. payment and settlement system from end-to-end while maintaining a high level of safety and efficiency.
Based on responses to the initial consultation paper, the Federal Reserve published in 2015 a set of strategies that it would pursue in collaborative engagement with payment industry stakeholders to improve the safety and efficiency of the U.S. payment and settlement system.
In 2015, the Federal Reserve also convened the Faster Payments Task Force (FPTF), a 320-member group comprised of banks of varying sizes, nonbank providers of payment services, business and government end users, consumer interest organizations, governmental organizations, and other industry participants.
The FPTF's effectiveness criteria provide important benchmarks for both end-user capabilities of faster payments and interbank settlement arrangements. With respect to service availability and payment speed for end users, the FPTF viewed service availability on any day, at any time of the day (that is, 24x7x365 service availability), and final funds provided to the recipient within one minute as characteristics of a “very effective” faster payment service.
In its final report, released in 2017, the FPTF published a set of consensus recommendations for achieving its vision of ubiquitous, safe, and efficient faster payment capabilities for the United States.
The Board has worked with the Reserve Banks to identify the potential actions described in this notice. The Board believes it is important to present these conceptual approaches for supporting interbank settlement of faster payments to the public and to gather initial public comments while faster payment services are still in the early stages of their development. The Board is not committing to any further actions at this time or in the future, but is committed to transparent communication with the public after analyzing the responses to this notice and determining further steps, should any be taken. As outlined earlier, any new services or service enhancements proposed by the Board would be expected to meet longstanding principles and criteria established under Federal Reserve policy as part of meeting its statutory requirements and would also be subject to request for public comment.
First, the Board is seeking comment on whether the Reserve Banks should consider developing a service for real-time gross settlement (RTGS) of faster payments that is available to conduct settlement on a 24x7x365 basis (24x7x365 RTGS settlement service). Such a service would involve interbank settlement of faster payments using banks' balances in accounts at the Reserve Banks. Reflecting the characteristics of faster payments, the service would provide payment-by-payment interbank settlement in real time and at any time, on any day, including weekends and holidays. A 24x7x365 RTGS settlement service could be similar, in certain respects, to the Fedwire® Funds Service, the RTGS service that the Reserve Banks currently provide for banks to clear and settle payments on behalf of their customers and for their own purposes.
Second, the Board is seeking comment on whether the Reserve Banks should consider developing a liquidity management tool that would operate on a 24x7x365 basis in support of services for real-time interbank settlement of faster payments, whether those services are provided by the private sector or the Reserve Banks (liquidity management tool). Such a tool would enable movement of funds during hours when traditional settlement systems are not open (nonstandard business hours) between banks' master accounts at the Reserve Banks and an account (or accounts) at the Reserve Banks used to conduct or support 24x7x365 real-time settlement of faster payments.
Later sections of this notice expand on these possible actions to support interbank settlement of faster payments, as well as the general concepts that underlie them. The Board is seeking input on the proposition that RTGS is the appropriate strategic foundation for interbank settlement of faster payments. The Board is also seeking input on whether the provision of a 24x7x365 RTGS settlement service and a liquidity management tool, separately or in combination, would help achieve the goals of ubiquitous, nationwide access to safe and efficient faster payments in the long run. The Board is further interested in receiving comment about whether other approaches, not explicitly considered in this notice, might help achieve those goals.
Payments are essential to the conduct of economic activity. When a good is purchased, a service is rendered, or a debt is repaid, a payment is typically involved. For example, an individual's purchase of a product from a business involves the business providing something of value, namely the product itself, to the buyer. As compensation for the product, the business needs to receive something of financial value from the buyer in return. This act of transferring financial value from the buyer to the seller, or, more generally, from one party in a transaction to another, constitutes a payment.
In the United States, as in other modern economies, the value transferred in a payment typically involves monetary assets. Individuals, households, businesses, and other parties in the economy (for example, governments and nonprofit organizations) hold these monetary assets in various forms. For example, some monetary assets may be held as currency and coin. Other monetary assets may involve funds held with specialized financial institutions. In the United States, deposits in accounts with banks comprise the monetary asset that is most widely held by the general public to conduct payments.
In broad terms, the function of the payment and settlement system is to enable the transfer of these monetary assets between their holders for the purposes of exchanging value to pay for goods and services, remitting funds to pay bills and meet other obligations, managing business balance sheets, and conducting other activities. This transfer can occur in various ways. For example, in a face-to-face payment, the handover of currency serves to transfer a monetary asset from the individual to the business and, hence, to complete a payment between them. When the monetary asset used for payment is deposits held in accounts with banks or other institutions, transfers require adjustments to the amount of funds in the respective accounts of each party in a payment. Thus, the balance in the individual's account with their bank must be decreased by the amount of the purchase, and the balance in the business's account with its bank must be increased by the same amount.
To make these adjustments, the banks involved in a payment must have a way to receive and exchange payment messages. A payment message typically contains information related to the payment, such as the identities of the parties involved, relevant account information, and the payment amount. Without a payment message and a method to exchange it, the banks involved in a payment would not know the details of a payment or even be aware of an end user's need to conduct it.
The payment between end users and associated payment message generates an obligation between the respective banks. The banks must have a mechanism to conduct a transfer of assets between one another to settle the payment. Without a mechanism to settle the interbank obligation, the banks would not have transferred the underlying funds to complete the payment.
These activities, which are known as clearing and interbank settlement, involve processes, infrastructure, rules, agreements, and law that ultimately allow end users, such as an individual and a business, to conduct payments using accounts held with banks or other institutions.
To complete a payment between two bank accounts, three key levels of the payment process are necessary: End-user services, clearing services, and interbank settlement services.
An end-user service includes the tools that an individual or business uses to conduct a payment. For example, an individual wishing to pay a bill to a utility company or send money to a friend may be able to do so through a mobile phone application. Similarly, a business may be able to initiate a payment to a vendor through a bank's website. Such services allow an end user to communicate with their bank about the need to make a payment and the details of that payment. In other words, end-user services support the exchange of payment messages and other information between a bank and its end-user customers. End-user services also include other critical aspects of the overall payment experience for an individual or business, such as error resolution procedures and security measures to mitigate fraud.
Clearing services and interbank settlement services constitute the infrastructure underlying payment
In clearing services, the sending and receiving banks interact, possibly through an intermediary such as a clearing house, based on the payment information received from end users and the protocols associated with a payment service. A key element of this interaction is the exchange of the payment message between the sending and receiving banks.
Finally, in interbank settlement services, the sending and receiving banks transfer assets to each other to satisfy the interbank obligations that arise from end-user payments. Settlement takes place by adjusting the balances in banks' settlement accounts on the books of a settlement institution. For example, interbank settlement can be performed by directly adjusting balances in accounts that banks hold with the central bank or a commercial bank.
In a faster payment, the three levels of the payment process are structured so that senders can immediately initiate, and recipients can immediately receive, payments at any time.
At the clearing level, certain activities must similarly happen in real time and
Although the previous discussion focused on activities related to faster payment services involving banks, several established services in the United States that allow end users to conduct faster payments are provided by nonbank entities. These nonbank payment services usually combine all three levels of the payment process. These services often focus on enabling impromptu payments between individuals, such as friends or family members, although some also handle a wider array of payment situations, such as payments between individuals and businesses. Such a service typically provides an online portal or mobile application that allows parties who have signed up with the service to send payments to each other. The service executes payments through adjustments to balances of the sender's and recipient's service-specific accounts, which are located on the service's internal books.
Recently, other faster payment services have emerged in the United States that are based on transfers between bank accounts. These include services that allow end users to send or receive faster payments using the debit card infrastructure of certain payment card networks and services that allow faster payments over newer proprietary payment networks owned by groups of banks. The end-user service can involve a service-specific website or mobile application or may be integrated into a participating bank's website or mobile application, similar to many existing online bill payment services. For business customers, the end-user service may be integrated into a bank's back-end payment processing infrastructure. To use these services, end users must typically sign up with a specific service through their banks or, in some cases, may sign up directly with the service itself. Because the sending and receiving end users may hold their accounts at different banks, their banks must exchange payment messages as part of clearing. These interbank clearing activities can occur through existing payment card networks or proprietary communication networks of the bank-owned services. To enable their customers to make payments through a specific faster payment service, banks must participate in the service or otherwise be capable of receiving payment messages initiated through the service. Interbank settlement must also occur, allowing the banks to transfer assets reflecting their customers' faster payments. At present, interbank settlement for these services is largely conducted through existing services provided by the Reserve Banks and, in one case, is performed using a private sector-owned settlement ledger that is backed by funds in a “joint account.” A joint account is a recently announced type of account held at a Reserve Bank that holds balances for the joint benefit of settling banks in a private-sector settlement service.
The interbank settlement models discussed in this notice specifically focus on faster payment services that involve transfers between bank accounts and do not directly address services provided by nonbank entities. At the same time, many nonbank faster payment services ultimately use deposit accounts at banks to hold funds associated with their customers' balances and further rely on established interbank payment systems for the movement of money between their customers' bank accounts and service-specific accounts. Nonbank faster payment services may also have access to Reserve Bank services when acting as agents on behalf of banks that participate in their services. As a result, interbank clearing and settlement capabilities may have implications for both bank and nonbank faster payment services.
As defined above, faster payment services involving transfers between bank accounts must conduct certain activities in real time on a 24x7x365 basis. In particular, such services must accept payment messages from end users, exchange payment messages between banks, and make final funds available to recipients in real time and at any time. However, interbank settlement can be performed in two ways: On a deferred basis or in real time. These two models have important distinguishing features with risk, liquidity management, and other implications.
In a deferred settlement arrangement for faster payments, final funds are made available to the end-user recipient
The Board understands that, at present, most faster payment services in the United States that involve transfers between bank accounts are based on a DNS model for interbank settlement. In these services, interbank settlement of net obligations is conducted using traditional payment and settlement systems, namely the Fedwire Funds Service or the ACH system, with the timing and frequency of settlement depending on, among other things, the operating hours of those systems.
A number of factors may contribute to the current prevalence of DNS-based arrangements for faster payment services in the United States. First, traditional payment and settlement systems, which can be leveraged for settlement of faster payments, already have widespread participation by banks. In addition, by using the Fedwire Funds Service or the ACH system, banks can treat settlement payments for faster payment services much like other interbank payments, without the need to implement new faster payment settlement capabilities and operational procedures. As a result, it may be easier for banks to become participants in these faster payment services. Finally, DNS-based faster payment services can be attractive from a liquidity management perspective because netting reduces balances that banks need to set aside to settle obligations related to faster payments.
At the same time, DNS arrangements for faster payments involve inherent risks that need to be managed. Because the recipient's bank makes final funds available to the recipient before interbank settlement occurs, DNS arrangements for faster payments inherently generate interbank credit risk for the recipient's bank. If a sending bank in the arrangement fails to pay a net obligation, receiving banks are at risk of losing the full value of funds that they have already made available to recipients.
The interbank settlement risks created in a DNS-based faster payment service may be mitigated with appropriate risk management tools. Potential tools include (i) transaction limits on individual payments or frequent settlement cycles to help prevent the emergence of large net interbank exposures, (ii) loss-sharing agreements among participants in a system to help spread the risk of a settlement failure, (iii) limits on the net negative position of each participating bank to prevent interbank exposures from becoming too large, and (iv) collateralization to back settlement activity if one or more participants were not able to meet their obligations. Credit and liquidity risk exposures can be fully mitigated by requiring participants in a DNS-based faster payment service to prefund potential exposures fully with cash held at a custodial institution, with an enforceable limit on payment transactions to prevent interbank settlement exposures from exceeding the covering funds or, potentially, a mechanism to augment prefunded cash collateral when needed. Under this risk-management structure, if a participant in a DNS system is unable to fund its settlement obligations, the obligations could be covered with prefunded cash, allowing the settlement payments to be completed and avoiding the need to recalculate settlement obligations.
In other countries, every faster payment service based on a DNS model employs measures to mitigate the resulting interbank settlement risk.
In addition to risk management, DNS-based faster payment services may have liquidity management implications. On the one hand, liquidity management may be simplified for banks in a DNS arrangement because netting reduces the funds that banks need to have available for settlement obligations related to faster payments. In addition, because settlement is conducted periodically, often at pre-defined times, banks in a DNS arrangement do not need to provide sufficient funds on a real-time basis to settle faster payments that are otherwise taking place in real time. On the other hand, if a DNS-based service were to use frequent settlement cycles to manage credit risk exposures, banks would need to ensure that they have adequate liquidity whenever a settlement cycle occurs. For example, if it were possible to conduct the 30-minute settlement cycles that would be applied in a DNS arrangement satisfying the FPTF's effectiveness criterion related to settlement speed, that settlement frequency would require banks to monitor and manage their liquidity over the weekend and on holidays.
Furthermore, collateral management may have implications for banks participating in a DNS-based faster payment service that employs collateral to mitigate interbank credit risk. The availability of adequate collateral to cover a bank's net obligation would need to be verified in real time for each individual faster payment, with
Another consideration for DNS-based faster payment services is that interoperability between services that use different risk and liquidity management arrangements may be challenging, which can be a barrier to faster payment ubiquity if end users are not able to send payments across services. For faster payment services to be interoperable, each service should have the ability to receive transactions originated from the other service and to manage the associated cross-service settlement risks.
In an RTGS arrangement for faster payments, final funds are made available to the recipient only after interbank settlement has occurred between the banks that are party to the transaction. To ensure this outcome, RTGS-based faster payments involve both completion of end-user payments and settlement of interbank obligations on a payment-by-payment basis in real time and at any time. RTGS for faster payments thus aligns the speed and 24x7x365 availability of interbank settlement with the speed and 24x7x365 availability of faster payments for end users. In such an arrangement, because the speed and timing of interbank messaging activities needed to support faster payments for end users coincide with the speed and timing of interbank settlement activities, it can be possible to avoid duplicative activities by combining interbank messaging and settlement.
RTGS arrangements inherently avoid interbank settlement risk because funds are made available to the recipient only after interbank settlement has occurred. This key feature enhances the safety of faster payment services based on the RTGS model, both for individual banks and in the aggregate, particularly during times of financial stress. The lack of inherent interbank settlement risk eliminates the need for measures to mitigate such risk, as would be needed in a DNS arrangement. In addition, by aligning interbank settlement with interbank messaging, the RTGS model can avoid activities, such as storing, netting, and submitting groups of payments for settlement, that are not generally relevant for the provision of faster payments to end users, but would be necessary in DNS-based faster payment services because of the timing mismatch between settlement and the underlying payments. In the process, the RTGS model also avoids the unanticipated liquidity effects that can occur in the event of a settlement failure when interbank settlement positions have been netted by a centralized entity. Finally, when considering interoperability between RTGS-based faster payment services, the lack of interbank settlement risk in such services may facilitate interoperability by avoiding the need to reconcile measures to mitigate cross-system settlement risk, in particular, as may be necessary with DNS-based faster payment services.
At the same time, real-time settlement for faster payments may have liquidity management implications. Because RTGS-based faster payment services process and settle each payment separately, with continuous updates to settlement accounts on a 24x7x365 basis, participants in an RTGS-based service may need to monitor and manage their settlement accounts outside standard business hours to ensure that balances are available to settle each payment. Further, even for retail payment systems, gross settlement may be more liquidity intensive than net settlement.
Based on the design, liquidity management may require tools to reallocate liquidity to support settlement of faster payments. For example, if settlement for an RTGS-based service is conducted in an account that is separate from a bank's primary settlement account (that is, a Federal Reserve master account), a liquidity management tool could allow for banks or an agent acting on their behalf, such as the provider of an RTGS service, to move liquidity to the faster payment settlement account when needed. Alternatively, liquidity management could involve automatic replenishment of the faster payment settlement account from the primary account, based on certain parameters or at certain times of the day. Liquidity management tools are discussed later in the notice.
Another consideration for RTGS-based faster payments is that faster payment services to end users are dependent on uninterrupted availability of the RTGS service to conduct faster payments. Although faster payments based on deferred settlement would require certain clearing activities to occur in real time and at any time, necessitating a high level of resiliency for those activities, end-user payments could still be completed even if the interbank settlement service is temporarily unavailable. In contrast, an RTGS service supporting faster payments would require advanced throughput capabilities and high resiliency of both the settlement service and messaging activities. In addition, to avoid failed end-user payments, enhanced contingency arrangements may be necessary to deal with situations when a primary RTGS processing service is temporarily unavailable to process transactions.
One example of an RTGS service for faster payments is the system being developed by the European Central Bank (ECB) to support “instant payments” in the European Union. Like faster payments in the United States, instant payments in the European Union are expected to involve services for real-time payments between end users that can be conducted on a 24x7x365 basis. To facilitate ubiquity of instant payment services across national jurisdictions,
Another example, albeit with a different approach, of an RTGS service for faster payments involves a system launched domestically in the United States in late 2017. This system, operated by a private-sector entity, performs immediate, round-the-clock settlement of payments on its private ledger, rather than using central bank money. Each participant in this arrangement relies on the presence of balances stored in a single joint account at a Reserve Bank that is held for the benefit of the joint account-holding banks as a method of backing the private-sector service.
Although both DNS and RTGS arrangements have benefits and drawbacks for settling faster payments, on balance, the Board views RTGS as offering clear benefits from a risk and efficiency perspective, making it the preferable basis for interbank settlement of faster payments over the long term in the United States. Given the round-the-clock availability of end-user faster payment services, real-time interbank settlement should likewise be possible at any time and on any day. While DNS-based faster payment services with measures to mitigate risk may be appropriate for a nascent faster payment market in the short term, the Board believes that, as the volume and value of faster payments grow in the future, an RTGS infrastructure would provide the safest and most efficient foundation for interbank settlement for the next generation of payment services. Through this notice, the Board is seeking views regarding this perspective on interbank settlement.
In addition, the Board is requesting comment about potential actions that the Federal Reserve could take to support a ubiquitous, nationwide infrastructure for 24x7x365 real-time settlement of faster payments. These actions, which could be taken separately or in combination, include the Reserve Banks' developing (i) a 24x7x365 RTGS settlement service and (ii) a liquidity management tool. In addition to seeking comment on whether the Reserve Banks should consider developing either or both of these services, the Board is interested in receiving comment about whether other approaches would help achieve the long run goals of ubiquitous, nationwide access to safe and efficient settlement services for faster payments.
As one potential action, the Reserve Banks could provide a 24x7x365 RTGS settlement service for banks that would carry out the interbank settlement of individual payments immediately, on any day, and at any time of the day. Such a service would reflect the real-time speed and 24x7x365 nature of faster payments. The service would settle interbank obligations through debits and credits to balances in banks' accounts at the Reserve Banks, constituting settlement in central bank money.
A 24x7x365 RTGS settlement service could involve messaging functionality, which traditionally is considered part of the clearing level, and may function much like the Fedwire Funds Service. As with the Fedwire Funds Service, a 24x7x365 RTGS settlement service could receive and deliver the entire payment message, including bank routing information needed for interbank settlement and customer information needed by receiving banks to update their customers' accounts.
The proposed 24x7x365 RTGS settlement service could make use of the existing electronic access connections and payment services network that the Reserve Banks provide to banks to enable secure payment processing for transactions involving Reserve Bank payment services. In addition, interbank settlement of faster payments could occur in Federal Reserve master accounts, similar to the way that settlement for other types of Reserve Bank payment services occurs, and could use the same account-monitoring regime that is in place for other payment services provided by the Reserve Banks. Alternatively, interbank settlement of faster payments could occur in separate, dedicated faster payment settlement accounts for each participating bank with balances that could be treated as reserves, earning interest and satisfying reserve balance requirements. With separate accounts, an approach would be needed for moving funds between a bank's master account and its faster payment settlement account during standard business hours and potentially outside those hours. In either account structure, the service would record end-of-day balances in the account and provide balance reports for each calendar day of the week (that is, a seven-day accounting regime). The Board is requesting comment on the advantages and disadvantages of these design options and features.
Additionally, a 24x7x365 RTGS settlement service might need to incorporate some auxiliary services or other service options in order to support an effective nationwide system. One example of an auxiliary service is a proxy database or directory that allows banks to route end-user payments using the recipient's alias, such as an email address or phone number, rather than
A 24x7x365 RTGS settlement service provided by the Reserve Banks would rely on banks and other parties, such as processors and other providers of payment services, to develop end-user services and, ideally, the full suite of auxiliary services, such as a proxy database or directory, that build upon the basic functionality of the settlement service.
The Federal Reserve's longstanding public policy objectives for the payment system are that payment systems are safe, efficient, and accessible to all eligible banks on an equitable basis and, through them, to the public nationwide.
A 24x7x365 RTGS settlement service provided by the Reserve Banks could significantly improve the long-term prospect of all banks having access to a real-time interbank settlement infrastructure for faster payments. Today, the Reserve Banks provide payment services to more than 11,000 banks—the vast majority of banks in the United States. By capitalizing on its electronic access network and customer relationships, the Reserve Banks are in a position to offer equitable access to real-time interbank settlement to all eligible banks in the country, regardless of type or size.
It may be difficult for the private sector to create an infrastructure that, on its own, could provide equitable access to enough banks to achieve ubiquity. Practically, a private-sector RTGS service that does not have existing relationships with a large number of banks may have difficulties establishing those relationships for a new service. Likewise, banks without an existing relationship to the provider of a private-sector RTGS service may find it cumbersome and time-consuming to establish connections with a new provider of settlement services. However, accessibility could be greatly enhanced if existing and potential future private-sector RTGS services were able to interoperate with a Reserve Bank service, such that end-user customers of any bank could send faster payments to end-user customers of any other bank, regardless of the faster payment RTGS service used by the banks. In such a scenario, private-sector and Reserve Bank RTGS services would work in tandem to provide ubiquitous, nationwide access to real-time interbank settlement for faster payments.
As noted above, real-time settlement for faster payments avoids interbank settlement risk by aligning the speed of interbank settlement with the speed of the underlying payments. If a 24x7x365 RTGS settlement service developed by the Reserve Banks were to significantly improve the prospect that banks nationwide would use real-time settlement for faster payments, the overall safety of the faster payment market in the United States could be enhanced. In addition, a service provided by the Federal Reserve, with its focus on the stability of the overall payment system, could also contribute to the real and perceived resiliency of faster payment settlement. This would be especially true if a 24x7x365 RTGS settlement service provided by the Reserve Banks were available alongside private-sector RTGS services, giving banks an option to connect to multiple operators for resiliency, as they often do with traditional payment systems. Finally, a 24x7x365 RTGS settlement service could further support the Federal Reserve's ability to provide payment system stability in moments of financial crisis or natural disaster, as it has done in the past with its cash, check, ACH, and wire transfer services.
Payment system efficiency has multiple facets, including resource costs, the value of broad networks, and competition between and innovation by faster payment services. While a 24x7x365 RTGS settlement service provided by the Reserve Banks would consume societal resources and could duplicate certain costs that may already have been incurred to set up other settlement arrangements for faster payments, its net effect on the efficiency of the faster payment environment would depend on the extent to which it generates societal benefits by improving bank participation in a real-time interbank settlement infrastructure and, ultimately, public access to safe and secure faster payment services. Specifically, the value of a payment system increases as more banks join the system because all participants and end users can send payments to more recipients. As a result, incremental societal benefits realized through nationwide bank participation in a real-time interbank settlement infrastructure could outweigh the societal costs of the Reserve Banks developing a 24x7x365 RTGS settlement service.
Additional efficiency benefits could be realized through enhanced competition between and innovation by faster payment services. The development of a nationwide real-time interbank settlement infrastructure could play a strategic role in persuading more banks to develop faster payment services, creating more competition among bank-provided services and with existing nonbank services. Bank and nonbank providers of faster payment services may also be able to develop new or enhance existing services by capitalizing on the underlying interbank infrastructure. The resulting competition and innovation could ultimately benefit end users because competition typically generates lower costs and innovation advances feature-rich services.
The Board recognizes the possibility that introduction of a Reserve Bank-provided 24x7x365 RTGS settlement service could have the opposite effect and disrupt the existing faster payment market. Industry stakeholders have already made certain initial investments in faster payment services and would need to assess how, or if, to connect to a new settlement service.
The Board also recognizes that the cost of investing in new technology for the banking industry, its customers, and
RTGS for faster payments can raise liquidity management issues for banks, particularly given the 24x7x365 nature of faster payments. RTGS-based faster payments require banks to have sufficient liquidity to perform interbank settlement of individual payments. Absent sufficient liquidity, banks, and by extension their customers, would experience failed faster payments because interbank settlement, which must occur prior to the provision of final funds to the recipient in an RTGS arrangement, could not take place. Moreover, because faster payments can occur on a 24x7x365 basis, RTGS for faster payments requires banks to have sufficient liquidity to settle individual payments at any time of the day, any day of the year.
The risk of failed payments caused by insufficient liquidity in an RTGS-based faster payment service implies a general need for banks to manage their liquidity related to settlement. The nature of this liquidity management will depend on the design of a particular RTGS arrangement for faster payments. For example, a private-sector RTGS arrangement for faster payments may rely on a joint account at a Reserve Bank that backs settlement conducted on a private ledger maintained by the arrangement's operator. In such an arrangement, banks would need to ensure sufficient liquidity by making contributions to the joint account that are adequate to cover obligations recorded in the operator's ledger. In another example, depending on the design of a 24x7x365 RTGS settlement service provided by the Reserve Banks, participating banks may have individual accounts at the Reserve Banks, separate from their master accounts, that are dedicated to the interbank settlement of faster payments.
In either of these examples, liquidity management by banks requires methods to transfer liquidity between accounts at the Reserve Banks. Because RTGS arrangements for faster payments require liquidity management outside standard business hours, these methods for liquidity transfers may need to be available during nonstandard business hours.
At present, the Reserve Banks do not offer a service that would allow banks to move liquidity as needed to support 24x7x365 real-time settlement of faster payments. Various Reserve Bank services enable transfer of funds between accounts at the Reserve Banks, including the Fedwire Funds Service and the National Settlement Service; however, none of them fulfill the around-the-clock requirement. Over time, the Reserve Banks have extended operating hours for these services.
As a result of the potential need for liquidity management outside standard business hours in certain RTGS-based systems for faster payments, and the limitations of existing Federal Reserve services to support such liquidity management, the Board is requesting comment on whether the Reserve Banks should consider providing a liquidity management tool that would enable movement of funds during nonstandard business hours between banks' master accounts at the Reserve Banks and an account (or accounts) at the Reserve Banks used to conduct or support 24x7x365 real-time settlement of faster payments.
To determine how the Reserve Banks could best provide a liquidity management tool that meets industry needs, the Board is further seeking input on the characteristics and capabilities that such a tool might have. A key area of interest to the Board is the level of involvement that individual banks would wish to have in establishing the timing of liquidity transfers and in initiating specific transfers. For example, a tool could allow a designated agent to coordinate liquidity transfers simultaneously across a large number of participants in a settlement
The Board believes a liquidity management tool could improve the level of participation by banks in real-time settlement infrastructure for faster payments. Such a tool could be an efficient and economical way to close potential gaps in account funding times for existing and potential future private-sector 24x7x365 real-time interbank settlement systems. Thus, the tool might make private-sector systems more attractive to a broader range of banks and boost the prospect of more banks joining private-sector systems. It could similarly increase participation in a 24x7x365 RTGS settlement service provided by the Reserve Banks. The end result might be a combination of RTGS arrangements for faster payments, enabling broader access to real-time interbank settlement infrastructure in the long term with similar safety, resiliency, and efficiency benefits discussed in relation to a Reserve Bank-provided RTGS settlement service. In addition, the liquidity management functionality itself would mitigate liquidity risk that can arise for banks in 24x7x365 real-time settlement of faster payments and the concomitant possibility that end users will experience individually rejected payments and broader scale payment interruptions.
The Board is seeking feedback on all aspects of the discussion presented in this notice and the specific questions posed below. The Board will use this feedback to assess what steps, if any, it should take related to the actions discussed or alternative approaches offered by the payment industry or other stakeholders. As previously mentioned, these actions are subject to the longstanding principles and criteria on new services or major service enhancements as part of the Federal Reserve's statutory requirements. As part of assessing these actions, the Board would continue its due diligence related to those requirements.
The Board intends to publish the results of this request for comment and, as appropriate, to seek further comment on any specific actions that the Board determines that the Federal Reserve might pursue. The Board recognizes that a decision to undertake these actions, in particular the development of a 24x7x365 RTGS settlement service, will require close partnership and collaboration with industry stakeholders. The Federal Reserve would work with stakeholders to implement new infrastructure within a sensible timeline that provides stakeholders enough advance information to calibrate resource planning and operational readiness. The Board also seeks feedback on specific areas, such as liquidity management, interoperability, accounting processes, or payment routing, that stakeholders believe may require joint Federal Reserve and industry teams to identify approaches for implementation in a 24x7x365 RTGS settlement service.
1. Is RTGS the appropriate strategic foundation for interbank settlement of faster payments? Why or why not?
2. Should the Reserve Banks develop a 24x7x365 RTGS settlement service? Why or why not?
3. If the Reserve Banks develop a 24x7x365 RTGS settlement service,
a. Will there be sufficient demand for faster payments in the United States in the next ten years to support the development of a 24x7x365 RTGS settlement service? What will be the sources of demand? What types of transactions are most likely to generate demand for faster payments?
b. What adjustments would the financial services industry and its customers be required to make to operate in a 24x7x365 settlement environment? Are these adjustments incremental or substantial? What would be the time frame required to make these adjustments? Are the costs of adjustment and potential disruption outweighed by the benefits of creating a 24x7x365 RTGS settlement service? Why or why not?
c. What is the ideal timeline for implementing a 24x7x365 RTGS settlement service? Would any potential timeline be too late from an industry adoption perspective? Would Federal Reserve action in faster payment settlement hasten or inhibit financial services industry adoption of faster payment services? Please explain.
d. What adjustments (for example, accounting, operations, and agreements) would banks and bank customers be required to make under a seven-day accounting regime where Reserve Banks record and report end-of-day balances for each calendar day during which payment activity occurs, including weekends and holidays? What time frame would be required to these changes? Would banks want the option to defer receipt of such information for nonbusiness days to the next business day? If necessary changes by banks represent a significant constraint to timely adoption of seven-day accounting for a 24x7x365 RTGS settlement service, are there alternative accounting or operational solutions that banks could implement?
e. What incremental operational burden would banks face if a 24x7x365 RTGS settlement service were designed using accounts separate from banks' master accounts? How would the treatment of balances in separate accounts (for example, ability to earn interest and satisfy reserve balance requirements) affect demand for faster payment settlement?
f. Regarding auxiliary services or other service options,
i. Is a proxy database or directory that allows faster payment services to route end-user payments using the recipient's alias, such as email address or phone number, rather than their bank routing and account information, needed for a 24x7x365 RTGS settlement service? How should such a database be provided to best facilitate nationwide adoption? Who should provide this service?
ii. Are fraud prevention services that provide tools to detect fraudulent transfers needed for a 24x7x365 RTGS settlement service? How should such tools be provided? Who should provide them?
iii. How important are these auxiliary services for adoption of faster payment settlement services by the financial services industry? How important are other service options such as transaction limits for risk management and offsetting mechanisms to conserve liquidity? Are there other auxiliary services or service options that are needed for the settlement service to be adopted?
g. How critical is interoperability between RTGS services for faster payments to achieving ubiquity?
h. Could a 24x7x365 RTGS settlement service be used for purposes other than interbank settlement of retail faster payments? If so, for what other purposes could the service be used? Should its use be restricted and, if so, how?
i. Are there specific areas, such as liquidity management, interoperability, accounting processes, or payment routing, for which stakeholders believe the Board should establish joint Federal Reserve and industry teams to identify approaches for implementation of a 24x7x365 RTGS settlement service?
4. Should the Federal Reserve develop a liquidity management tool that would enable transfers between Federal Reserve accounts on a 24x7x365 basis to support services for real-time interbank settlement of faster payments, whether those services are provided by the private sector or the Reserve Banks? Why or why not?
5. If the Reserve Banks develop a liquidity management tool,
a. What type of tool would be preferable and why?
i. A tool that requires a bank to originate a transfer from one account to another
ii. A tool that allows an agent to originate a transfer on behalf of one or more banks
iii. A tool that allows an automatic transfer of balances (or “sweep”) based on pre-established thresholds and limits
iv. A combination of the above
v. An alternative approach
b. Would a liquidity management tool need to be available 24x7x365, or alternatively, during certain defined hours on weekends and holidays? During what hours should a liquidity management tool be available?
c. Could a liquidity management tool be used for purposes other than to support real-time settlement of retail faster payments? If so, for what other purposes could the tool be used? Should its use be restricted and, if so, how?
6. Should a 24x7x365 RTGS settlement service and liquidity management tool be developed in tandem or should the Federal Reserve pursue only one, or neither, of these initiatives? Why?
7. If the Federal Reserve pursues one or both of these actions, do they help achieve ubiquitous, nationwide access to safe and efficient faster payments in the long run? If so, which of the potential actions, or both, and in what ways?
8. What other approaches, not explicitly considered in this notice, might help achieve the broader goals of ubiquitous, nationwide access to faster payments in the United States?
9. Beyond the provision of payment and settlement services, are there other actions, under its existing authority, the Federal Reserve should consider that might help its broader goals with respect to the U.S. payment system?
Federal Aviation Administration (FAA), DOT.
Supplemental notice of proposed rulemaking (SNPRM); reopening of comment period.
We are revising an earlier proposal for certain Dassault Aviation Model FALCON 7X airplanes. This action revises the notice of proposed rulemaking (NPRM) by proposing to require the incorporation of revised and more restrictive airworthiness limitations. We are proposing this airworthiness directive (AD) to address the unsafe condition on these products. Since these actions would impose an additional burden over those in the NPRM, we are reopening the comment period to allow the public the chance to comment on these changes.
The comment period for the NPRM published in the
We must receive comments on this SNPRM by December 31, 2018.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
For service information identified in this NPRM, contact Dassault Falcon Jet Corporation, Teterboro Airport, P.O. Box 2000, South Hackensack, NJ 07606; telephone 201-440-6700; internet
You may examine the AD docket on the internet at
Tom Rodriguez, Aerospace Engineer, International Section, Transport Standards Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone and fax 206-231-3226.
We invite you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under the
We will post all comments we receive, without change, to
We issued an NPRM to amend 14 CFR part 39 by adding an AD that would apply to certain Dassault Aviation Model FALCON 7X airplanes. The NPRM published in the
Since we issued the NPRM, additional airworthiness limitations have been issued, and we have determined that it is necessary to revise the existing maintenance or inspection program to incorporate the new and more restrictive requirements in the revised service information. We have changed paragraph (g) of this proposed AD to require revising the existing maintenance or inspection program to incorporate the information specified in Chapter 5-40-00, Airworthiness Limitations, DGT 107838, Revision 7, dated August 24, 2018, of the Dassault Falcon 7X Maintenance Manual (MM).
The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2018-0101, dated May 3, 2018 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Dassault Aviation Model FALCON 7X airplanes. The MCAI states:
The airworthiness limitations and certification maintenance instructions for Dassault Falcon 7X aeroplanes, which are approved by EASA, are currently defined and published in Dassault Falcon 7X AMM [airplane maintenance manual], Chapter 5-40. These instructions have been identified as mandatory for continued airworthiness.
Failure to accomplish these instructions could result in an unsafe condition [
Previously, EASA issued AD 2015-0095 [which corresponds to FAA AD 2016-16-09, Amendment 39-18607 (81 FR 52752, August 10, 2016) (“AD 2016-16-09”)] to require accomplishment of the maintenance tasks, and implementation of the airworthiness limitations, as specified in Dassault Falcon 7X AMM, Chapter 5-40, at Revision 4.
Since that [EASA] AD was issued, Dassault issued the ALS [airworthiness limitations section], which introduces new and more restrictive maintenance requirements and/or airworthiness limitations.
For the reason described above, this [EASA] AD retains the requirements of EASA AD 2015-0095, which is superseded, and requires accomplishment of the actions specified in the ALS.
You may examine the MCAI in the AD docket on the internet at
Dassault Aviation has issued Chapter 5-40-00, Airworthiness Limitations, DGT 107838, Revision 7, dated August 24, 2018, of the Dassault Falcon 7X MM. This service information introduces new and more restrictive maintenance requirements and airworthiness limitations for airplane structures and systems. 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 gave the public the opportunity to participate in developing this proposed AD. We received no comments on the NPRM or on the determination of the cost to the public.
This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all pertinent information and determined an unsafe condition exists and is likely to exist or develop on other products of the same type design.
Certain changes described above expand the scope of the NPRM. As a result, we have determined that it is necessary to reopen the comment period to provide additional opportunity for the public to comment on this SNPRM.
We estimate that this proposed AD affects 67 airplanes of U.S. registry. We estimate the following costs to comply with this proposed AD:
We have determined that revising the existing maintenance or inspection program takes an average of 90 work-hours per operator, although we recognize that this number may vary from operator to operator. In the past, we have estimated that this action takes 1 work-hour per airplane. Since operators incorporate maintenance or inspection program changes for their affected fleet(s), we have determined that a per-operator estimate is more accurate than a per-airplane estimate. Therefore, we estimate the total cost per operator to be $7,650 (90 work-hours × $85 per work-hour).
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
This proposed AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to transport category airplanes and associated appliances to the Director of the System Oversight Division.
We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify this proposed regulation:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);
3. Will not affect intrastate aviation in Alaska; and
4. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
We must receive comments by December 31, 2018.
This AD affects AD 2014-16-23, Amendment 39-17947 (79 FR 52545, September 4, 2014) (“AD 2014-16-23”) and AD 2016-16-09, Amendment 39-18607 (81 FR 52752, August 10, 2016) (“AD 2016-16-09”).
This AD applies to Dassault Aviation Model FALCON 7X airplanes, certificated in any category, with an original certificate of airworthiness or original export certificate of airworthiness issued on or before August 24, 2018.
Dassault Aviation Model FALCON 7X airplanes with modifications M1000 and M1254 incorporated are commonly referred to as “Model FALCON 8X” airplanes as a marketing designation.
Air Transport Association (ATA) of America Code 05, Time limits/maintenance checks.
This AD was prompted by a determination that more restrictive maintenance requirements and airworthiness limitations are necessary. We are issuing this AD to address reduced structural integrity and reduced control of airplanes due to the failure of system components.
Comply with this AD within the compliance times specified, unless already done.
Within 90 days after the effective date of this AD, revise the existing maintenance or inspection program, as applicable, by incorporating the information specified in Chapter 5-40-00, Airworthiness Limitations, DGT 107838, Revision 7, dated August 24, 2018, of the Dassault Falcon 7X Maintenance Manual (MM). The initial compliance times for the tasks specified in Chapter 5-40-00, Airworthiness Limitations, DGT 107838, Revision 7, dated August 24, 2018, of the Dassault Falcon 7X MM are at the applicable compliance times specified in Chapter 5-40-00, Airworthiness Limitations, DGT 107838, Revision 7, dated August 24, 2018, of the Dassault Falcon 7X MM, or within 90 days after the effective date of this AD, whichever occurs later.
(1) Accomplishing the actions required by paragraph (g) of this AD terminates the requirements of paragraph (q) of AD 2014-16-23.
(2) Accomplishing the actions required by paragraph (g) of this AD terminates all requirements of AD 2016-16-09.
After the existing maintenance or inspection program, as applicable, has been revised as required by paragraph (g) of this AD, no alternative actions (
The following provisions also apply to this AD:
(1)
(2)
(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA AD 2018-0101, dated May 3, 2018, for related information. This MCAI may be found in the AD docket on the internet at
(2) For more information about this AD, contact Tom Rodriguez, Aerospace Engineer, International Section, Transport Standards Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; phone and fax: 206-231-3226.
(3) For service information identified in this AD, contact Dassault Falcon Jet Corporation, Teterboro Airport, P.O. Box 2000, South Hackensack, NJ 07606; phone: 201-440-6700; internet:
Social Security Administration.
Notice of proposed rulemaking.
The Social Security Administration (SSA) separately published, in today's
To ensure that your comments are considered, we must receive them no later than December 17, 2018.
You may submit comments by any one of three methods—internet,
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Comments are available for public viewing on the Federal eRulemaking portal at
Jasson Seiden, Government Information Specialist, Privacy Implementation Division, Office of Privacy and Disclosure, Office of the General Counsel, SSA, Room G-401 West High Rise, 6401 Security Boulevard, Baltimore, Maryland 21235-6401, telephone: (410) 597-4307, email:
In accordance with the Privacy Act (5 U.S.C. 552a) we are issuing public notice of our intent to establish a new system of records entitled, Security and Suitability Files (60-0377).
We are establishing the Security and Suitability Files to govern the information we generate in conducting personnel security and suitability background investigations. With limited exceptions, persons appointed to, and under consideration for, Federal service or contract employment are required to submit to a suitability background investigation. The Deputy Commissioner for Human Resources, Office of Personnel, Center for Suitability and Personnel Security (CSPS) oversees and is responsible for adjudicating these investigations. Information collected as part of the agency's suitability and background investigations process that is sent to the Office of Personnel Management (OPM) is covered by OPM/Central-9, Personnel Investigations Records. The Security and Suitability Files we are creating covers any additional security and suitability related information generated by SSA that is not sent to OPM. We will use the information we collect to conduct background investigations to establish that individuals employed by SSA, working for SSA under contract, or otherwise granted access to agency facilities and records are suitable for such employment or access.
Due to the investigatory nature of information that will be maintained in this system of records, this rule would add the Security and Suitability Files to the list of SSA systems that are exempt from specific provisions of the Privacy Act pursuant to 5 U.S.C. 552a(k)(5).
All comments received on or before the close of business on the comment closing date indicated above will be considered and will be available for examination in the docket at the above address. Comments received after the comment closing date will be filed in the docket and will be considered to the extent practicable. A final rule may be published at any time after close of the comment period.
Executive Order 12866, as supplemented by Executive Order 13563, requires each agency to write all rules in plain language. In addition to your substantive comments on this interim final rule, we invite your comments on how to make the rule easier to understand.
For example:
• Would more, but shorter, sections be better?
• Are the requirements in the rule clearly stated?
• Have we organized the material to suit your needs?
• Could we improve clarity by adding tables, lists, or diagrams?
• What else could we do to make the rule easier to understand?
• Does the rule contain technical language or jargon that is not clear?
• Would a different format make the rule easier to understand,
SSA will publish a final rule responding to any comments received and, if appropriate, will amend provisions of the rule.
We consulted with the Office of Management and Budget (OMB) and determined that this proposed rule does not meet the criteria for a significant regulatory action under Executive Order 12866, as supplemented by Executive Order 13563.
We also determined that this proposed rule meets the plain language requirement of Executive Order 12866.
This proposed rule was analyzed in accordance with the principles and criteria established by Executive Order 13132, and SSA determined that the proposed rule will not have sufficient Federalism implications to warrant the preparation of a Federalism assessment. SSA also determined that this proposed rule will not preempt any State law or State regulation or affect the States' abilities to discharge traditional State governmental functions.
The regulations effectuating Executive Order 12372 regarding intergovernmental consultation on Federal programs and activities apply to this proposed rule.
We certify that this proposed rule will not have a significant economic impact on a substantial number of small entities because it affects individuals only. Therefore, the Regulatory Flexibility Act, as amended, does not require us to prepare a regulatory flexibility analysis.
These rules do not create any new or affect any existing collections and, therefore, do not require Office of Management and Budget approval under the Paperwork Reduction Act.
Privacy and disclosure of official records and information.
For the reasons stated in the preamble, we propose to amend part 401 of title 20 of the Code of Federal Regulations as set forth below:
Secs. 205, 702(a)(5), 1106, and 1141 of the Social Security Act (42 U.S.C. 405, 902(a)(5), 1306, and 1320b-11); 5 U.S.C. 552 and 552a; 8 U.S.C. 1360; 26 U.S.C. 6103; 30 U.S.C. 923.
(b) * * *
(2) * * *
(iii) * * *
(A) Security and Suitability Files.
Social Security Administration.
Notice of proposed rule making.
We propose to revise our rules to explain that the agency retains the right to determine how parties and witnesses will appear at a hearing before an administrative law judge (ALJ) at the hearing level of our administrative review process, and we will set the time and place for the hearing accordingly. We also propose to revise our rules to explain the State agency or the Associate Commissioner for Disability Determinations, or his or her delegate, will determine how parties and witnesses will appear, and will set the time and place for a hearing, before a disability hearing officer (DHO) at the reconsideration level in continuing disability review (CDR) cases. At both levels, we propose to schedule the parties to a hearing to appear by video teleconference (VTC), in person, or, in limited circumstances, by telephone. We propose that parties to a hearing will not have the option to opt out of appearing by the manner of hearing we choose. We also propose rules that explain how we will determine the manner of a party's or a witness's appearance. We expect these proposed changes would improve our service to the public by increasing the efficiency of our hearings processes and reducing the amount of time it takes us to schedule and hold hearings.
To ensure that your comments are considered, we must receive them no later than January 14, 2019.
You may submit comments by any one of three methods—internet, fax, or mail. Do not submit the same comments multiple times or by more than one method. Regardless of which method you choose, please state that your comments refer to Docket No. SSA-2017-0015 so that we may associate your comments with the correct rule.
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2.
3.
Comments are available for public viewing on the Federal eRulemaking portal at
Susan Swansiger, Office of Hearings Operations, Social Security Administration, 5107 Leesburg Pike, Falls Church, VA 22041, (703) 605-8500. For information on eligibility or filing for benefits, call our national toll-free number, 1-800-772-1213 or TTY 1-800-325-0778, or visit our internet site, Social Security Online, at
When we determine whether you are disabled under the old-age, survivors, and disability insurance program under title II of the Social Security Act (Act) or the Supplemental Security Income (SSI) program under title XVI of the Act, we follow an administrative review process that usually consists of the following steps:
Once you are receiving benefits under title II or XVI of the Act, we are required to conduct CDRs periodically to determine whether your disability continues.
Since Congress established Social Security in 1935, the size and scope of the programs we administer have grown tremendously. During the 1940s and 1950s, Congress extended coverage under title II to nearly the entire American workforce. In the 1950s, Congress revised the Act and created the disability insurance program, and in the 1970s, Congress created the Supplemental Security Income (SSI) program, both of which greatly expanded the size and scope of our programs. The aging of the baby boomers and the changing demographics of our nation have also significantly affected the size and scope of our workloads. The Supreme Court has aptly observed that we are “probably the largest adjudicative agency in the western world,” where “[t]he need for efficiency is self-evident.”
When we began our hearings process in 1940, we handled a comparatively small number of claims involving retirement and survivors insurance, and received only about 16,000 hearing requests in our first decade.
We face the same workload challenges with regard to the reconsideration disability hearings before a DHO for CDRs. According to our internal data sources, from 2007 to 2018 the number of requests for a disability hearing at the reconsideration level increased from 19,898 to 82,604.
Our Office of the Inspector General (OIG) evaluated the financial impact of individuals continuing to receive benefit payments during CDR appeals. In 2006, OIG found that individuals waited an average of 648 days (in title II cases) and 694 days (in title XVI cases) from the time they requested reconsideration of an initial medical cessation determination and the time they received an ALJ decision.
Efficiently managing these workloads while preserving the accuracy and fundamental fairness of our hearings has required, and continues to require, creative thinking and strategic planning. Since the mid-1990s, we have recognized that electronic service delivery, based on proven secure technology, can provide our customers with new ways to conduct business with us. These new ways of conducting business with us are both convenient for claimants and efficient for claimants and us. We have continuously explored expanding the service options available to our customers in new and innovative ways as technological advances allow.
For about 20 years we have explored the use of VTC to conduct fair and accurate hearings more efficiently. In the late 1990s, we tested our capacity to conduct ALJ hearings by VTC in Iowa. We received positive feedback from participants, and test data showed that processing times for VTC hearings were substantially lower than the processing time for in-person hearings held by ALJs at remote locations during the same
As we gained experience with VTC for hearings before an ALJ, we and others have studied the efficacy of these hearings; those studies have found that the use of VTC provides us a number of benefits, including additional flexibility, especially with respect to aged and backlogged hearing requests, improved case processing times, and reduced ALJ travel.
The Administrative Conference of the United States (ACUS), an independent, nonpartisan Federal agency that studies and recommends improvements to administrative process and procedures, also has noted a number of advantages to the use of VTC hearings before an ALJ.
As we continue to seek ways to improve the efficiency of our hearings process, we also are mindful of recommendations from our Inspector General. For example, in 2012, our OIG studied the operation of our National Hearing Centers (NHC), which primarily use VTC to conduct hearings, and raised concerns that claimants were opting out of VTC hearings after they had already been scheduled, sometimes even on the day of the hearing, and that representatives were opting out to avoid appearing before certain ALJs.
At the reconsideration level at CDR, our rules state we will set the time and place of a disability hearing,
When an individual objects to appearing by VTC at an ALJ hearing or does not elect to appear by VTC at a reconsideration hearing before a DHO at CDR, the efficiency of our hearings process is set back without any corresponding increase in the fairness of the process, and the individual may wait longer for an in person hearing. At the ALJ hearing level, the number of ALJs available to conduct an in person hearing is generally limited to those ALJs stationed at, or geographically close to, the assigned hearing office or within travel distance to one of our permanent remote sites. Requiring an ALJ to travel to a remote hearing site for an in person hearing reduces the amount of time the ALJ can devote to holding other hearings and issuing decisions from his or her assigned hearing office. We expect the ten-year savings due to decreased reimbursements for all ALJ hearings
We expect that expanding our use of VTC technology will help us in two ways. First, increased use of VTC technology will reduce these discrepancies in the wait time among the hearing offices. Second, increased use of VTC will allow us to decrease the total number of cases pending at the ALJ hearing level by allowing us to shift cases from overburdened hearing offices to hearing offices with fewer requests for hearing pending per ALJ. Balancing our workloads by using VTC has been key to addressing our oldest pending cases, and it has allowed us to act quickly as service needs arise from unanticipated emergencies,
As documented in ACUS's studies and in feedback from multiple other sources, our use of VTC has been widely accepted as an important tool that increases our ability to hold hearings and improve public service. For example, in 2006, the Social Security Advisory Board (SSAB), a bipartisan, independent body that advises the President, Congress, and the Commissioner of Social Security on matters of policy and administration of the disability insurance and Supplemental Security Income programs,
Moreover, there is no evidence that the use of VTC technology adversely affects the outcome of the decision making process. An internal report prepared in FY 2017 by our Office of Quality Review (OQR) showed there was not a significant difference in outcome or policy compliance for VTC and in person hearings. OQR found a high degree of policy compliance and quality for both types of hearings. We included this report as part of the rulemaking docket, which is publicly available at
We also have made great strides in increasing our video capabilities in order to improve our business processes. Since 2016, we have refreshed all VTC equipment and infrastructure, which has resulted in better technological quality of video hearings. Additionally, the dramatic reduction in the number of cases that involve paper claims folders over the past ten years has allowed for smoother workload balancing, ensuring consistent service on a national level. With the infrastructure and equipment we have in place, the use of VTC technology ensures that we can deliver service in a modern, seamless, and flexible manner. All video hearings rooms are section 504 compliant based on the capacity for individuals attending a hearing, providing equal access to hearings for claimants with disabilities.
We expect that this proposed rule will ensure that as we expand our ability to conduct appearances by VTC, we are able to schedule hearings more fairly and efficiently. The preferred methods for conducting hearings are by VTC and in person. However, an ALJ or DHO may conduct a hearing by telephone under two circumstances: (1) When it is physically impossible to conduct the hearing by VTC or in person, such as incarceration in a facility without VTC ability; and (2) extraordinary circumstances, such as when a natural disaster occurs and our VTC facilities are unavailable.
To increase our ability to schedule hearings more fairly, flexibly, and efficiently and address the unprecedented service challenges we face at the reconsideration and ALJ hearing levels of our administrative review process, we propose the following changes to our rules:
• We propose to revise and unify some of the rules that govern how, where, and when individuals appear for hearings before an ALJ at the hearings level and before a DHO at the reconsideration level of our administrative review process.
• At the hearings level, we will determine the time and place of a hearing before an ALJ and determine how parties and witnesses will appear at the hearing.
• At the reconsideration level for CDRs, the State agency or the Associate Commissioner for Disability Determinations, or his or her delegate, will determine the time and place of a hearing before a DHO and determine how parties and witnesses will appear at the hearing. Under the proposed rules, while we will evaluate the specific circumstances of each claimant's or beneficiary's case to determine what is the most efficient and appropriate manner of hearing, we would not permit individuals to object to appearing by the manner of hearing we choose.
• At both the CDR reconsideration and ALJ levels of our administrative review process, when we schedule a hearing, we propose that we will determine the manner in which the parties to the hearing will appear: By VTC, in person, or, under the limited circumstances specified here, by telephone. In determining whether a party will appear by VTC or in person, we would consider whether VTC technology is available; whether it would be more efficient for an individual to appear by VTC or in person; and whether there are circumstances in the case that provide a good reason to schedule an individual to appear by VTC or in person. Under the proposed rules, we would not permit individuals to opt out of or objecting to appearing by the manner of hearing we chose.
• We also propose that we would determine the manner in which witnesses to a hearing will appear. In general, we would schedule witnesses to appear at hearings by VTC or telephone, unless VTC or telephone equipment are not available; we determine that it would be more efficient for a witness to appear in
• We also propose that an ALJ may continue to identify case-specific facts that affect which manner of appearance is most efficient. However, the agency will have the final responsibility to determine in which manner the individual must appear.
• At the Appeals Council level, if the Appeals Council grants an individual's request to appear to present oral argument, the individual will appear before the Appeals Council by VTC or in person, or, when the circumstances described in § 404.936(c)(2) exist, by telephone.
We believe that we can best serve individuals involved in our disability program by maximizing the case processing efficiencies and flexibility allowed by VTC hearings. Supporting this, OIG and ACUS have repeatedly recommended that we increase use of VTC hearings for greater efficiency. The SSAB has also recommended we eliminate the ability to object to appearing by VTC.
The changes we propose will provide us with the flexibility we need to address the ongoing service challenges we face by balancing our hearing workloads in a way that we expect will reduce overall wait and processing times across the country and reduce the processing time disparities that exist from region to region.
In addition to the changes we propose for setting the manner for appearing at a hearing, we also propose to make one clarification to our rules regarding the notice of hearing at the ALJ hearings level. Under our current rules, we send a notice of hearing at least 75 days prior to the date of the scheduled hearing to all parties and their representatives, if any.
If we need to change the date of a hearing, the date we choose will always be at least 75 days from the date we first sent the claimant a notice of hearing, unless the claimant has waived his or her right to advance notice. We believe sending an amended notice of hearing at least 20 days prior to the hearing would give the individual ample time to fully prepare for the hearing because the individual would have already received the initial notice of hearing, sent at least 75 days before the hearing. In many cases, sending an amended notice of hearing at least 75 days before the date of the hearing would require us to reschedule and unnecessarily delay the hearing, which would inhibit us from providing better public service by having a hearing as soon as we can do so. Therefore, we propose to send an amended notice of hearing at least 20 days prior to the hearing, which is the same amount of advance notice we used to provide most claimants before we implemented the 75-day notice period. Similarly, if we schedule a supplemental hearing, after the initial hearing was continued by the assigned ALJ, we will send a notice of hearing at least 20 days before the date of the hearing.
Executive Order 12866 as supplemented by Executive Order 13563 requires each agency to write all rules in plain language. In addition to your substantive comments on this NPRM, we invite your comments on how to make rules easier to understand.
For example:
• Would more, but shorter, sections be better?
• Are the requirements in the rule clearly stated?
• Have we organized the material to suit your needs?
• Could we improve clarity by adding tables, lists, or diagrams?
• What else could we do to make the rule easier to understand?
• Does the rule contain technical language or jargon that is not clear?
• Would a different format make the rule easier to understand,
We consulted with the Office of Management and Budget (OMB) and determined that these proposed rules meet the requirements for a significant regulatory action under Executive Order 12866 as supplemented by Executive Order 13563. Thus, OMB reviewed these proposed rules.
This proposed rule is not subject to the requirements of Executive Order 13771 because it is administrative in nature.
SSA's Office of the Chief Actuary estimates that the actuarial impact of the rule will be de minimis.
SSA's Office of Budget estimates that the proposal, if implemented, will result in administrative savings of $118 million over a 10-year period. These savings stem from reduced costs of claimant and representative travel, a reduced number of workyears needed, and fewer forms processed.
We certify that these proposed rules will not have a significant economic impact on a substantial number of small entities because they only affect individuals. Accordingly, a regulatory flexibility analysis as provided in the Regulatory Flexibility Act, as amended, is not required.
These proposed rules do not create any new or affect any existing collections and, therefore, do not require Office of Management and Budget approval under the Paperwork Reduction Act.
Administrative practice and procedure, Blind, Disability benefits, Old-Age, Survivors, and Disability Insurance, Reporting and recordkeeping requirements, Social Security.
Administrative practice and procedure, Aged, Blind, Disability benefits, Public Assistance programs, Reporting and recordkeeping requirements, Supplemental Security Income (SSI).
For the reasons set out in the preamble, we propose to amend 20 CFR
Secs. 201(j), 204(f), 205(a)-(b), (d)-(h), and (j), 221, 223(i), 225, and 702(a)(5) of the Social Security Act (42 U.S.C. 401(j), 404(f), 405(a)-(b), (d)-(h), and (j), 421, 423(i), 425, and 902(a)(5)); sec. 5, Pub. L. 97-455, 96 Stat. 2500 (42 U.S.C. 405 note); secs. 5, 6(c)-(e), and 15, Pub. L. 98-460, 98 Stat. 1802 (42 U.S.C. 421 note); sec. 202, Pub. L. 108-203, 118 Stat. 509 (42 U.S.C. 902 note).
(c)
(d)
(e)
(f)
(2)
(3)
(i) The availability of video teleconferencing equipment to conduct the appearance;
(ii) Whether use of video teleconferencing to conduct the appearance would be less efficient than conducting the appearance in person; and
(iii) Any facts in your particular case that provide a good reason to schedule your appearance by video teleconferencing or in person.
(4)
(5)
(6)
(i) Telephone or video teleconferencing equipment is not available to conduct the appearance;
(ii) We determine that use of telephone or video teleconferencing equipment would be less efficient than conducting the appearance in person; or
(iii) We find that there are facts in your particular case that provide a good reason to schedule this individual's appearance in person.
(g)
(1)
(i) Notify us in writing at the earliest possible opportunity, but not later than 5 days before the date set for the hearing; and
(ii) State the reason(s) for your objection to the time of the hearing and state the time you want the hearing to be held.
(2) If you notify us that you object to the time of the hearing less than 5 days before the date set for the hearing, we will consider this objection only if you show you had good cause for missing the deadline. To determine whether good cause exists for missing the deadline, we use the standards explained in § 404.911.
(h)
(1) Determining good cause for changing the time of the hearing. We will find good cause to change the time of your hearing if we determine that, based on the evidence:
(i) A serious physical or mental condition or incapacitating injury makes it impossible for you or your representative to travel to the hearing, or a death in the family occurs; or
(ii) Severe weather conditions make it impossible for you or your representative to travel to the hearing.
(2)
(3) Examples of such other circumstances that you might give for requesting a change in the time of the hearing include, but are not limited to the following:
(i) You unsuccessfully attempted to obtain a representative and need additional time to secure representation;
(ii) Your representative was appointed within 20 days of the scheduled hearing and needs additional time to prepare for the hearing;
(iii) Your representative has a prior commitment to be in court or at another administrative hearing on the date scheduled for the hearing;
(iv) A witness who will testify to facts material to your case would be unavailable to attend the scheduled hearing and the evidence cannot be otherwise obtained;
(v) Transportation is not readily available for you to travel to the hearing; or
(vi) You are unrepresented, and you are unable to respond to the notice of hearing because of any physical, mental, educational, or linguistic limitations (including any lack of facility with the English language) which you may have.
If you are dissatisfied with one of the determinations or decisions listed in § 404.930, you may request a hearing. The Deputy Commissioner for Hearings Operations, or his or her delegate, will appoint an administrative law judge to conduct the hearing. If circumstances warrant, the Deputy Commissioner for Hearings Operations, or his or her delegate, may assign your case to another administrative law judge. In general, we will schedule you to appear by video teleconferencing or in person. When we determine whether you will appear by video teleconferencing or in person, we consider the factors described in § 404.936(c)(1)(i) through (iii), and in the limited circumstances described in § 404.936(c)(2), we will schedule you to appear by telephone. You may submit new evidence (subject to the provisions of § 404.935), examine the evidence used in making the determination or decision under review, and present and question witnesses. The administrative law judge who conducts the hearing may ask you questions. He or she will issue a decision based on the preponderance of the evidence in the hearing record. If you waive your right to appear at the hearing, the administrative law judge will make a decision based on the preponderance of the evidence that is in the file and, subject to the provisions of § 404.935, any new evidence that may have been submitted for consideration.
(a)
(b)
(c) We will generally schedule you or any other party to the hearing to appear either by video teleconferencing or in person.
(1) When we determine whether you will appear by video teleconferencing or in person, we consider the following factors:
(i) The availability of video teleconferencing equipment to conduct the appearance;
(ii) Whether use of video teleconferencing to conduct the appearance would be less efficient than conducting the appearance in person; and
(iii) Any facts in your particular case that provide a good reason to schedule your appearance by video teleconferencing or in person.
(2) Subject to paragraph (c)(3) of this section, we will schedule you or any other party to the hearing to appear by telephone when we find an appearance by video teleconferencing or in person is not possible or other extraordinary circumstances prevent you from appearing by video teleconferencing or in person.
(3) If you are incarcerated and video teleconferencing is not available, we will schedule your appearance by telephone, unless we find that there are facts in your particular case that provide a good reason to schedule your appearance in person, if allowed by the place of confinement, or by video teleconferencing or in person upon your release.
(4) We will generally direct any person we call as a witness, other than you or any other party to the hearing, including a medical expert or a vocational expert, to appear by telephone or by video teleconferencing. Witnesses you call will appear at the hearing pursuant to § 404.950(e). If they are unable to appear with you in the same manner as you, we will generally direct them to appear by video teleconferencing or by telephone. We will consider directing them to appear in person only when:
(i) Telephone or video teleconferencing equipment is not available to conduct the appearance;
(ii) We determine that use of telephone or video teleconferencing equipment would be less efficient than conducting the appearance in person; or
(iii) We find that there are facts in your particular case that provide a good reason to schedule this individual's appearance in person.
(d)
(i) Notify us in writing at the earliest possible opportunity, but not later than 5 days before the date set for the hearing or 30 days after receiving notice of the hearing, whichever is earlier; and
(ii) State the reason(s) for your objection and state the time you want the hearing to be held. If the administrative law judge finds you have good cause, as determined under paragraph (e) of this section, we will change the time of the hearing.
(2) If you notify us that you object to the time of hearing less than 5 days before the date set for the hearing or, if earlier, more than 30 days after receiving notice of the hearing, we will consider this objection only if you show you had good cause for missing the deadline. To determine whether good cause exists for missing this deadline, we use the standards explained in § 404.911.
(e)
(1) The administrative law judge will find good cause to change the time of your hearing if he or she determines that, based on the evidence:
(i) A serious physical or mental condition or incapacitating injury makes it impossible for you or your representative to travel to the hearing, or a death in the family occurs; or
(ii) Severe weather conditions make it impossible for you or your representative to travel to the hearing.
(2) In determining whether good cause exists in circumstances other than those set out in paragraph (e)(1) of this section, the administrative law judge will consider your reason(s) for requesting the change, the facts supporting it, and the impact of the proposed change on the efficient administration of the hearing process. Factors affecting the impact of the change include, but are not limited to, the effect on the processing of other scheduled hearings, delays that might occur in rescheduling your hearing, and whether we previously granted you any changes in the time of your hearing. Examples of such other circumstances that you might give for requesting a change in the time of the hearing include, but are not limited to, the following:
(i) You unsuccessfully attempted to obtain a representative and need additional time to secure representation;
(ii) Your representative was appointed within 30 days of the scheduled hearing and needs additional time to prepare for the hearing;
(iii) Your representative has a prior commitment to be in court or at another administrative hearing on the date scheduled for the hearing;
(iv) A witness who will testify to facts material to your case would be unavailable to attend the scheduled hearing and the evidence cannot be otherwise obtained;
(v) Transportation is not readily available for you to travel to the hearing; or
(vi) You are unrepresented, and you are unable to respond to the notice of hearing because of any physical, mental, educational, or linguistic limitations (including any lack of facility with the English language) which you may have.
(b) * * *
(3) How to request that we change the time of your hearing;
* * *
(5) Whether your appearance or that of any other party or witness is scheduled to be made by video teleconferencing, in person, or, when the circumstances described in § 404.936(c)(2) exist, by telephone. If we have scheduled you to appear by video teleconferencing, the notice of hearing will tell you that the scheduled place for the hearing is a video teleconferencing site and explain what it means to appear at your hearing by video teleconferencing;
(c)
(d)
(a)
(e)
(b)
Secs. 702(a)(5), 1631, and 1633 of the Social Security Act (42 U.S.C. 902(a)(5), 1383, and 1383b); sec. 202, Pub. L. 108-203, 118 Stat. 509 (42 U.S.C. 902 note).
(c)
(d)
(e)
(f)
(2)
(3)
(i) The availability of video teleconferencing equipment to conduct the appearance;
(ii) Whether use of video teleconferencing to conduct the appearance would be less efficient than conducting the appearance in person; and
(iii) Any facts in your particular case that provide a good reason to schedule your appearance by video teleconferencing or in person.
(4)
(5)
(6)
(i) Telephone or video teleconferencing equipment is not available to conduct the appearance;
(ii) We determine that use of telephone or video teleconferencing equipment would be less efficient than conducting the appearance in person; or
(iii) We find that there are facts in your particular case that provide a good reason to schedule this individual's appearance in person.
(g)
(i) Notify us in writing at the earliest possible opportunity, but not later than 5 days before the date set for the hearing; and
(ii) State the reason(s) for your objection to the time of the hearing and state the time you want the hearing to be held.
(2) If you notify us that you object to the time of the hearing less than 5 days before the date set for the hearing, we will consider this objection only if you show you had good cause for missing the deadline. To determine whether good cause exists for missing the deadline, we use the standards explained in § 416.1411.
(h)
(1)
(i) A serious physical or mental condition or incapacitating injury makes it impossible for you or your representative to travel to the hearing, or a death in the family occurs; or
(ii) Severe weather conditions make it impossible for you or your representative to travel to the hearing.
(2)
(i) You unsuccessfully attempted to obtain a representative and need additional time to secure representation;
(ii) Your representative was appointed within 20 days of the scheduled hearing and needs additional time to prepare for the hearing;
(iii) Your representative has a prior commitment to be in court or at another administrative hearing on the date scheduled for the hearing;
(iv) A witness who will testify to facts material to your case would be unavailable to attend the scheduled hearing and the evidence cannot be otherwise obtained;
(v) Transportation is not readily available for you to travel to the hearing; or
(vi) You are unrepresented, and you are unable to respond to the notice of hearing because of any physical, mental, educational, or linguistic limitations (including any lack of facility with the English language) which you may have.
If you are dissatisfied with one of the determinations or decisions listed in § 416.1430, you may request a hearing.
(a)
(b)
(c) We will generally schedule you or any other party to the hearing to appear either by video teleconferencing or in person.
(1) When we determine whether you will appear by video teleconferencing or in person, we consider the following factors:
(i) The availability of video teleconferencing equipment to conduct the appearance;
(ii) Whether use of video teleconferencing to conduct the appearance would be less efficient than conducting the appearance in person; and
(iii) Any facts in your particular case that provide a good reason to schedule your appearance by video teleconferencing or in person.
(2) Subject to paragraph (c)(3) of this section, we will schedule you or any other party to the hearing to appear by telephone when we find an appearance by video teleconferencing or in person is not possible or other extraordinary circumstances prevent you from appearing by video teleconferencing or in person.
(3) If you are incarcerated and video teleconferencing is not available, we will schedule your appearance by telephone, unless we find that there are facts in your particular case that provide a good reason to schedule your appearance in person, if allowed by the place of confinement, or by video teleconferencing or in person upon your release.
(4) We will generally direct any person we call as a witness, other than you or any other party to the hearing, including a medical expert or a vocational expert, to appear by telephone or by video teleconferencing. Witnesses you call will appear at the hearing pursuant to § 416.1450(e). If they are unable to appear with you in the same manner as you, we will generally direct them to appear by video teleconferencing or by telephone. We will consider directing them to appear in person only when:
(i) Telephone or video teleconferencing equipment is not available to conduct the appearance;
(ii) We determine that use of telephone or video teleconferencing equipment would be less efficient than conducting the appearance in person; or
(iii) We find that there are facts in your particular case that provide a good reason to schedule this individual's appearance in person.
(d)
(i) Notify us in writing at the earliest possible opportunity, but not later than 5 days before the date set for the hearing or 30 days after receiving notice of the hearing, whichever is earlier; and
(ii) State the reason(s) for your objection and state the time you want the hearing to be held. If the administrative law judge finds you have good cause, as determined under paragraph (e) of this section, we will change the time of the hearing.
(2) If you notify us that you object to the time of hearing less than 5 days before the date set for the hearing or, if earlier, more than 30 days after receiving notice of the hearing, we will consider this objection only if you show you had good cause for missing the deadline. To determine whether good cause exists for missing this deadline, we use the standards explained in § 416.1411.
(e)
(1) The administrative law judge will find good cause to change the time of your hearing if he or she determines that, based on the evidence:
(i) A serious physical or mental condition or incapacitating injury makes it impossible for you or your representative to travel to the hearing, or a death in the family occurs; or
(ii) Severe weather conditions make it impossible for you or your representative to travel to the hearing.
(2) In determining whether good cause exists in circumstances other than those set out in paragraph (e)(1) of this section, the administrative law judge will consider your reason(s) for requesting the change, the facts supporting it, and the impact of the proposed change on the efficient administration of the hearing process. Factors affecting the impact of the change include, but are not limited to, the effect on the processing of other scheduled hearings, delays that might occur in rescheduling your hearing, and whether we previously granted you any changes in the time of your hearing. Examples of such other circumstances that you might give for requesting a change in the time of the hearing include, but are not limited to, the following:
(i) You unsuccessfully attempted to obtain a representative and need additional time to secure representation;
(ii) Your representative was appointed within 30 days of the scheduled hearing
(iii) Your representative has a prior commitment to be in court or at another administrative hearing on the date scheduled for the hearing;
(iv) A witness who will testify to facts material to your case would be unavailable to attend the scheduled hearing and the evidence cannot be otherwise obtained;
(v) Transportation is not readily available for you to travel to the hearing; or
(vi) You are unrepresented, and you are unable to respond to the notice of hearing because of any physical, mental, educational, or linguistic limitations (including any lack of facility with the English language) which you may have.
(b) * * *
(3) How to request that we change the time of your hearing;
(5) Whether your appearance or that of any other party or witness is scheduled to be made by video teleconferencing, in person, or, when the circumstances described in § 416.1436(c)(2) exist, by telephone. If we have scheduled you to appear by video teleconferencing, the notice of hearing will tell you that the scheduled place for the hearing is a video teleconferencing site and explain what it means to appear at your hearing by video teleconferencing;
(c)
(d)
(a)
(e)
(b)
Food and Drug Administration, HHS.
Proposed rule.
The Food and Drug Administration (FDA or Agency) is proposing to amend its regulations to implement a provision of the 21st Century Cures Act (Cures Act). This proposed rule, if finalized, would allow an exception from the requirement to obtain informed consent when a clinical investigation poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of human subjects. The proposed rule, if finalized, would permit an Institutional Review Board (IRB) to waive or alter certain informed consent elements or to waive the requirement to obtain informed consent, under limited conditions, for certain FDA-regulated minimal risk clinical investigations.
Submit either electronic or written comments on this proposed rule by January 14, 2019.
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before January 14, 2019. The
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions.”)
Submit written/paper submissions in the following ways:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
•
The purpose of this proposed rule is to implement the statutory changes made to the Federal Food, Drug, and Cosmetic Act (FD&C Act) by section 3024 of the Cures Act (Pub. L. 114-255) to allow for a waiver or alteration of informed consent when a clinical investigation poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of human subjects. The proposed rule, if finalized, would permit an IRB to waive or alter certain informed consent elements or to waive the requirement to obtain informed consent, under limited conditions, for certain minimal risk clinical investigations.
The major provisions of the proposed rule would add § 50.22 to part 50 (21 CFR part 50) to allow IRBs responsible for the review, approval, and continuing review of clinical investigations to approve an informed consent procedure that waives or alters certain informed consent elements or that waives the requirement to obtain informed consent for certain minimal risk clinical investigations. In order for an IRB to approve a waiver or alteration of informed consent requirements for minimal risk clinical investigations, the proposed rule would require an IRB to find and document four criteria that are consistent with the “Federal Policy for the Protection of Human Subjects” (the Common Rule) (56 FR 28001, June 18, 1991). FDA believes proposed § 50.22 would provide appropriate safeguards to protect the rights, safety, and welfare of the human subjects participating in such clinical investigations. We are also proposing conforming amendments to FDA's regulations, including § 50.20, 21 CFR 312.60, and 21 CFR 812.2.
Sections 505(i)(4) and 520(g)(3) of the FD&C Act (21 U.S.C. 355(i)(4) and 360j(g)(3)), as amended by section 3024 of the Cures Act, in conjunction with FDA's general rulemaking authority in section 701(a) of the FD&C Act (21 U.S.C. 371(a)), serve as FDA's principal legal authority for this proposed rule.
We do not anticipate additional costs associated with this rulemaking. This proposed rule would help enable the conduct of certain minimal risk clinical investigations for which the requirement to obtain informed consent is waived or for which certain elements of informed consent are waived or altered. We expect benefits in the form of healthcare advances from such minimal risk clinical investigations and from harmonization of FDA's informed consent regulations with the Common
On December 13, 2016, the Cures Act was signed into law, amending certain provisions of the FD&C Act. FDA is proposing to update its regulations to reflect some of those changes that are now in effect. Specifically, section 3024 of the Cures Act amended sections 520(g)(3) and 505(i)(4) of the FD&C Act to provide FDA with the authority to permit an exception from informed consent requirements when the proposed clinical testing poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of the human subject. This proposed rule, if finalized, would implement this statutory change.
Sections 505(i) and 520(g) of the FD&C Act require FDA to publish regulations governing the use in human subjects of drugs and devices in clinical investigations. In 1962, amendments to section 505(i) of the FD&C Act provided that FDA regulations must ensure that informed consent for investigational use of drugs (including biological products) in human beings is obtained except where it is not feasible or it is contrary to the best interests of such human beings. The Medical Device Amendments of 1976 subsequently added section 520(g) to the FD&C Act. Among other requirements, section 520(g)(3)(D) of the FD&C Act directed that FDA regulations governing investigational use of devices require that informed consent be obtained except where the investigator determines in writing that there exists a life-threatening situation involving the human subject of such testing that necessitates the use of such device and it is not feasible to get the consent of the subject and there is not sufficient time to obtain such consent from the subject's representative. Section 520(g)(3)(D) of the FD&C Act further provided that a licensed physician not involved in the research must also concur in this determination, unless immediate use is necessary to save the subject's life and there is not time to get concurrence.
In 1979, FDA proposed revisions to its regulations governing informed consent (44 FR 47713, August 14, 1979). The Agency recognized in the preamble to its proposed rule that the statutory language regarding exceptions from informed consent for investigational drugs differed from that regarding investigational devices. However, the Agency explained that its prior regulations implementing the statutory exception from informed consent for investigational drugs “carefully limited” the exception to certain situations that assume “the patient subject is seriously ill” and did not differ greatly from the new statutory exceptions from informed consent for devices (see 44 FR 47713 at 47718). When FDA issued final revisions to its informed consent regulations in 1981, it adopted a single set of requirements for informed consent for all FDA-regulated clinical investigations, which reflected the device standard in section 520(g)(3)(D) of the FD&C Act (see 46 FR 8942, January 27, 1981). FDA explained its intent to adopt a single standard that reflected the most current congressional thinking on informed consent (see 44 FR 47713 at 44718; 46 FR 8942 to 8944).
Currently, FDA's regulations governing the protection of human subjects (21 CFR parts 50 and 56) allow exception from the general requirements of informed consent only in life-threatening situations when certain conditions are met (§ 50.23) or when the requirements for emergency research are met (§ 50.24). In all other cases, FDA regulations require that a human subject provide informed consent before participating in a clinical investigation. At this time, FDA's regulations do not allow an exception from the general requirements of informed consent for minimal risk clinical investigations.
In contrast, the Common Rule has included waiver of informed consent provisions for minimal risk research since it was originally issued in 1991 (56 FR 28001). The Common Rule sets forth requirements for the protection of human subjects involved in research that is conducted or supported by the Department of Health and Human Services (HHS) (see 45 CFR 46, Subpart A) and 15 other Federal departments and agencies. The purpose of the Common Rule is to promote uniformity, understanding, and compliance with human subject protections as well as to create a uniform body of regulations across the Federal departments and agencies.
FDA amended its regulations in parts 50 and 56 to conform them to the Common Rule in 1991 (56 FR 28001 at 28025) but diverged from the Common Rule's provision for waiver or alteration of informed consent for minimal risk research at 45 CFR 46.116(d). In explaining the reason for this departure, FDA cited sections 505(i) and 520(g)(3)(D) of the FD&C Act
The Common Rule provision recognizes that there may be proposed research that cannot practicably be conducted without a waiver or alteration of informed consent, but the research would contribute valuable medical or scientific knowledge and would present no more than minimal risk to subjects. FDA believes this is also true for some minimal risk FDA-regulated clinical investigations. On March 13, 2014, the Secretary's Advisory Committee on Human Research Protections (SACHRP) considered whether the Common Rule standard for waiver of informed consent for minimal risk research would be appropriate and helpful for FDA-regulated clinical investigations. SACHRP recommended to the Secretary of HHS that FDA adopt the provisions for waiver of informed consent that existed under the Common Rule at that time at 45 CFR 46.116(d). On October 26, 2016, SACHRP reiterated that recommendation to the Secretary.
FDA believes that the Common Rule provision has provided appropriate safeguards to protect the rights, safety, and welfare of human subjects participating in certain minimal risk research for over 25 years. Consistent with SACHRP's recommendations, FDA also believes that this standard is appropriate for FDA-regulated clinical investigations posing no more than minimal risk to human subjects. The Cures Act statutory revision authorizes FDA to permit an exception from informed consent requirements when the proposed clinical testing poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of the human subject. This enables FDA to harmonize with the Common Rule's well-established waiver provision for certain minimal risk research, thereby facilitating investigators' ability to conduct minimal risk clinical investigations that could contribute substantially to the development of products to diagnose or treat diseases or other conditions, without compromising subjects' rights, safety, or welfare. Because some clinical research is subject to both FDA and HHS requirements, harmonization of this waiver provision should also reduce burden on the research community.
The Common Rule was recently revised (82 FR 7149, January 19, 2017), introducing new terminology and regulatory provisions. Although it retains the same criteria for IRB waiver or alteration of informed consent as were included in the 1991 version of the Common Rule, it adds a fifth criterion,
Subsequent to the Cures Act amendment to the FD&C Act, FDA issued a guidance document for immediate implementation, entitled “Institutional Review Board Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects” (82 FR 34535, July 25, 2017). This guidance informed sponsors, investigators, and IRBs that FDA does not intend to object to an IRB waiving or altering informed consent requirements, as described in the guidance, for certain minimal risk clinical investigations. In addition, the guidance informed sponsors, investigators, and IRBs that FDA does not intend to object to a sponsor initiating, or an investigator conducting, a minimal risk clinical investigation for which an IRB waives or alters the informed consent requirements as described in the guidance. FDA intends to withdraw the guidance after regulations to implement section 3024 of the Cures Act become effective.
Obtaining informed consent from those who volunteer to participate in research is a fundamentally important principle of human subject protection. FDA is issuing this proposed rule to permit IRB waiver or alteration of informed consent in limited circumstances, consistent with the Cures Act. Given the variety and complexity of clinical investigations being conducted in today's research environment, FDA is soliciting additional stakeholder input on the types of FDA-regulated minimal risk clinical investigations for which sponsors would anticipate requesting a waiver or alteration of informed consent from the IRB.
FDA proposes to add § 50.22, “Exception from informed consent requirements for minimal risk clinical investigations” to part 50. The proposed exception would allow the IRB responsible for the review, approval, and continuing review of the clinical investigation to approve an informed consent procedure that does not include or that alters some or all of the elements of informed consent in § 50.25(a) and (b) of FDA's current regulations, or that waives the requirement to obtain informed consent, provided that the IRB finds and documents that:
• The clinical investigation involves no more than minimal risk to the subjects;
• the waiver or alteration of informed consent will not adversely affect the rights and welfare of the subjects;
• the clinical investigation could not practicably be carried out without the waiver or alteration of informed consent; and
• whenever appropriate, the subjects will be provided with additional pertinent information after participation.
Consistent with the amendments made by section 3024 of the Cures Act, § 50.22(a) would limit the application of a waiver or alteration of informed consent under proposed § 50.22 to clinical investigations that involve no more than minimal risk. FDA regulations and the Common Rule have shared the same definition of “minimal risk” since 1991 (see 56 FR 28025, June 18, 1991; § 50.3(k); 45 CFR 46.102(i)).
Proposed § 50.22 also provides for appropriate safeguards to protect the rights, safety, and welfare of human subjects. Proposed § 50.22(b) requires the reviewing IRB to find that the waiver or alteration will not adversely affect the rights and welfare of the subjects. To make this finding, IRBs may consider, for example, whether the waiver or alteration has the potential to negatively affect the subjects' well-being or whether the subject population in
Proposed § 50.22(c) requires the reviewing IRB to find that the clinical investigation could not practicably be carried out without the waiver or alteration. If scientifically sound research can be practicably carried out using only consenting subjects, FDA believes it should be carried out without involving nonconsenting subjects. By practicable, FDA means, for example: (1) That recruitment of consenting subjects does not bias the science and the science is no less rigorous as a result of restricting it to consenting subjects or (2) that the research is not unduly delayed by restricting it to consenting subjects. The emphasis is on situations where it is impracticable to carry out the clinical investigation, as designed, without the waiver or alteration, rather than on situations where it is not feasible to obtain informed consent from human subjects.
Finally, proposed § 50.22(d) requires the reviewing IRB to find that, whenever appropriate, the subjects will be provided with additional pertinent information after participation. For example, an IRB may determine that information that had been previously withheld about the clinical investigation to prevent bias must be provided to subjects following their participation.
If an IRB finds and documents the criteria set forth in proposed § 50.22(a) to (d), the proposed rule would provide for the IRB to approve an informed consent procedure that does not include or that alters some or all of the elements of informed consent in § 50.25(a) and (b), or that waives the requirement to obtain informed consent. This means that an IRB may waive entirely, under proposed § 50.22, the requirement to obtain informed consent, which would constitute a waiver of all elements under § 50.25(a), (b), and (c). However, regarding an alteration to the informed consent document, the proposed rule would not permit an IRB to approve an informed consent document with an omission or alteration of the specific informed consent element set forth in § 50.25(c), which requires that a statement regarding the inclusion of clinical trial information at
FDA revised its informed consent regulations to add § 50.25(c) in response to section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) (Pub. L. 110-85, September 27, 2007). Section 801 of FDAAA amended section 505(i)(4) of the FD&C Act to direct the Secretary of HHS “to require inclusion in the informed consent documents and process a statement that clinical trial information for such clinical investigation has been or will be submitted for inclusion in the registry data bank pursuant to subsection (j) of section 402 of the Public Health Service Act.” Under proposed new § 50.22, if an IRB approved the use of a consent procedure that omitted or altered certain elements in § 50.25(a) and (b), the informed consent document and/or oral presentation provided to subjects would still need to include the statement at § 50.25(c) without alteration. As FDA has previously explained, requiring a uniform statement that cannot be altered helps to ensure that potential clinical trial participants receive a consistent and accurate message that is consistent with the intent of the statutory requirement and are directed to the specific website that contains the clinical trial databank (see 76 FR 256 at 261, January 4, 2011).
Proposed § 50.22 should not be confused with the provision of the current regulations that allows for a waiver of
We are also proposing three conforming amendments to §§ 50.20, 312.60, and 812.2 of our current regulations to reflect the proposed exception from informed consent for minimal risk clinical investigations. FDA is proposing to revise the introductory clause of § 50.20, General requirements of informed consent, to include reference to proposed § 50.22 as one of the limited exceptions to the general requirements for informed consent. Thus, the introductory clause to § 50.20 is proposed to read, “Except as provided in §§ 50.22, 50.23, and 50.24. . . .”
In addition, we are proposing a conforming amendment to the second sentence in § 312.60, General responsibilities of investigators, of our current regulations on investigational new drug applications to reference part 50 generally rather than list each specific exception to the informed consent requirements in part 50. This would simplify the regulatory text and make it clear that the investigator is responsible for obtaining the informed consent of each human subject to whom the drug is administered in accordance with part 50, which includes proposed § 50.22.
The remaining conforming amendment we are proposing in part 812, Investigational Device Exemptions (IDEs), § 812.2(b)(1)(iii), would make it clear that the investigator must obtain informed consent in accordance with part 50, which includes proposed § 50.22. To simplify the current regulatory text, we are proposing to remove the reference to documentation being waived under § 56.109(c), as the relevant section of the regulations in part 50 (
FDA proposes that any final rule that may issue based on this proposal become effective 30 days after its date of publication in the
Title III, section 3024 of the Cures Act amended sections 520(g)(3) and 505(i)(4) of the FD&C Act to provide FDA with the authority to permit an exception from informed consent requirements when the proposed clinical testing poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of the human subject. This statutory amendment was signed into law and became effective on December 13, 2016. We are proposing these regulations to reflect these statutory changes to the FD&C Act, including appropriate human subject protection safeguards. Thus, sections 520(g)(3) and 505(i)(4) of the FD&C Act, as amended by section 3024 of the Cures Act, in conjunction with FDA's general rulemaking authority in section 701(a) of the FD&C Act, serve as our principal legal authority for this proposed rule.
We have examined the impacts of the proposed rule under Executive Order 12866, Executive Order 13563, Executive Order 13771, the Regulatory
The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because this proposed rule would not impose new requirements on any entity and therefore has no associated compliance costs, we propose to certify that the proposed rule will not have a significant economic impact on a substantial number of small entities.
The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to prepare a written statement, which includes an assessment of anticipated costs and benefits, before 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 $150 million, using the most current (2017) Implicit Price Deflator for the Gross Domestic Product. This proposed rule would not result in an expenditure in any year that meets or exceeds this amount.
The proposed rule would amend FDA's current informed consent regulations to harmonize with the 1991 version of the Common Rule's provision for waiver of the requirement to obtain informed consent for certain minimal risk research. We expect benefits in the form of healthcare advances stemming from additional minimal risk clinical investigations that would proceed using a waiver or alteration of informed consent, and from harmonization with the Common Rule's provision for waiver of the requirement to obtain informed consent for certain minimal risk research. The Common Rule provision is currently used by numerous other Federal departments and agencies. Some clinical research is subject to both FDA's regulations and the Common Rule, so harmonization of this specific waiver provision would benefit those entities that conduct, sponsor, or review certain minimal risk clinical investigations by reducing confusion and burden created by the need to comply with differing requirements.
The proposed rule would harmonize FDA's informed consent regulations with the 1991 version of the Common Rule's provision for waiver of the requirement to obtain informed consent for certain minimal risk clinical investigations. As in a previous economic analysis of the 2017 revisions to the Common Rule (Ref. 1), we attempt to quantify the effects of the proposed rule where possible. We conducted a search for active IRBs regulated by both FDA and the Office for Human Research Protections (OHRP) in HHS in the “Office for Human Research Protections (OHRP) Database for Registered IORGs & IRBs, Approved FWAs, and Documents Received in the Last 60 Days” (Ref. 2). Using this data, we are able to determine whether an IRB is active or inactive, and whether it is regulated by FDA, OHRP, or both. We multiply the number of active IRBs by the percentage of IRBs regulated by both FDA and OHRP to yield an estimate of 2,442 active IRBs that are regulated by both FDA and OHRP (= 3,507 × 0.696). We expect that some of these IRBs would be affected by the proposed rule, and would experience a reduction in the time burden of determining whether to approve a waiver of the requirement to obtain informed consent for a minimal risk clinical investigation by reviewing it under a harmonized standard.
We draw from Bureau of Labor Statistics data to estimate hourly wage rates for IRB chairs, IRB voting members, and IRB administrative staff in 2016 dollars. Based on an economic analysis of impacts of revisions to the Common Rule (Ref. 1), we use wages for postsecondary education administrators to proxy for IRB administrator wages (Ref. 4), wages for office and administrative support workers to proxy for IRB administrative staff wages (Ref. 5), and wages for postsecondary health teachers to proxy for the wages of IRB chairs and IRB voting members (Ref. 6). We double each hourly wage to account for benefits and overhead, yielding wage rates of $134.50 for IRB administrators (= $67.25 × 2), $35.94 for IRB administrative staff (= $17.97 × 2), $109.40 for IRB chairs (= $54.70 × 2), and $109.40 for IRB voting members (= $54.70 × 2). We estimate that each of these forms of labor would experience time savings as a result of the proposed rule ranging from 15 to 60 minutes, with a central estimate of 30 minutes. We also estimate that time savings would be incurred by one IRB administrator, one IRB administrative staff, one IRB chair, and one IRB voting member. We multiply the number of active IRBs regulated by the percentage of IRBs affected by the proposed rule, the estimated reduced time burden of the proposed rule, and the sum of each IRB wage rate to yield a total estimated cost savings of approximately $237,631 (= 2,442 × 0.50 × 0.50 × [$134.50 + $109.40 + $109.40 + $35.94]), with lower bound estimated cost savings of approximately $59,408 (= 2,442 × 0.25 × 0.25 × [$134.50 + $109.40 + $109.40 + $35.94]) and upper bound estimated cost savings of approximately $950,524 (= 2,442 × 1 × 1 × [$134.50 + $109.40 + $109.40 + $35.94]). The net present value of the cost savings of the proposed rule is approximately $230.7 thousand, discounted at 3 percent, with a lower bound of approximately $57.7 thousand and an upper bound of approximately
We do not anticipate additional costs associated with this rulemaking. This proposed rule would help enable the conduct of certain minimal risk clinical investigations for which the requirement to obtain informed consent is waived or for which certain elements of informed consent are waived or altered.
Executive Order 13771 requires that the costs associated with significant new regulations “shall, to the extent permitted by law, be offset by the elimination of existing costs associated with at least two prior regulations.” We believe that the proposed rule, if finalized, is deregulatory under Executive Order 13771 and does not require us to identify cost offsets.
The net present value of the cost savings of the proposed rule are approximately $222.1 thousand, discounted at 7 percent, with a lower bound of approximately $55.5 thousand and an upper bound of approximately $888.3 thousand. The annualized cost savings of the proposed rule are approximately $15,546, discounted at 7 percent on an infinite time horizon, with a lower bound of approximately $3,886 and an upper bound of approximately $62,184. Discounted at 3 percent, the net present value of the cost savings of the proposed rule are approximately $230.7 thousand, with a lower bound of approximately $57.7 thousand and an upper bound of approximately $922.8 thousand. The annualized cost savings of the proposed rule are approximately $6,921, discounted at 3 percent on an infinite time horizon, with a lower bound of approximately $1,730 and an upper bound of approximately $27,685. The estimated net cost savings under Executive Order 13771 are summarized in table 2.
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.
This proposed rule refers to previously approved collections of information found in 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). IRB actions related to the waiver or alteration of informed consent requirements are currently approved under OMB control numbers 0910-0014, 0910-0078, 0910-0130, and 0910-0755. Therefore, FDA tentatively concludes the requirements in this document are not subject to additional review by OMB.
We have analyzed this proposed rule in accordance with the principles set forth in Executive Order 13175. We
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 Dockets Management Staff (see
Human research subjects, Prisoners, Reporting and recordkeeping requirements, Safety.
Drugs, Exports, Imports, Investigations, Labeling, Medical research, Reporting and recordkeeping requirements, Safety.
Health records, Medical devices, Medical research, Reporting and recordkeeping requirements.
Therefore under the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, and under authority delegated to the Commissioner of Food and Drugs, it is proposed that 21 CFR parts 50, 312, and 812 be amended as follows:
21 U.S.C. 321, 343, 346, 346a, 348, 350a, 350b, 352, 353, 355, 360, 360c-360f, 360h-360j, 371, 379e, 381; 42 U.S.C. 216, 241, 262, 263b-263n.
Except as provided in §§ 50.22, 50.23, and 50.24, no investigator may involve a human being as a subject in research covered by these regulations unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative. * * *
The IRB responsible for the review, approval, and continuing review of the clinical investigation described in this section may approve an informed consent procedure that does not include or that alters some or all of the elements of informed consent set forth in § 50.25(a) and (b), or that waives the requirement to obtain informed consent, provided the IRB finds and documents the following:
(a) The clinical investigation involves no more than minimal risk to the subjects;
(b) The waiver or alteration will not adversely affect the rights and welfare of the subjects;
(c) The clinical investigation could not practicably be carried out without the waiver or alteration; and
(d) Whenever appropriate, the subjects will be provided with additional pertinent information after participation.
21 U.S.C. 321, 331, 351, 352, 353, 355, 360bbb, 371; 42 U.S.C. 262.
An investigator is responsible for ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under the investigator's care; and for the control of drugs under investigation. An investigator shall obtain the informed consent of each human subject to whom the drug is administered, in accordance with part 50 of this chapter. Additional specific responsibilities of clinical investigators are set forth in this part and in parts 50 and 56 of this chapter.
21 U.S.C. 331, 351, 352, 353, 355, 360, 360c-360f, 360h-360j, 360bbb-8b, 371, 372, 374, 379e, 381, 382, 383; 42 U.S.C. 216, 241, 262, 263b-263n.
(b) * * *
(1) * * *
(iii) Ensures that each investigator participating in an investigation of the
Wage and Hour Division, Department of Labor.
Proposed rule; extension of comment period.
This document extends the period for submitting written comments on the Notice of Proposed Rulemaking (NPRM) entitled “Expanding Employment, Training, and Apprenticeship Opportunities for 16- and 17-Year-Olds in Health Care Occupations Under the Fair Labor Standards Act.” The comment period now ends on December 11, 2018. The Department of Labor (Department) is taking this action to provide interested parties additional time to submit comments in response to a request for extension, as some supporting documents for the proposal may not have been originally fully visible in the docket.
The comment period for the proposed rule published September 27, 2018, at 83 FR 48737, is extended. Comments should be received on or before December 11, 2018.
To facilitate the receipt and processing of written comments on this NPRM, the Department encourages interested persons to submit their comments electronically. You may submit comments, identified by Regulatory Information Number (RIN) 1235-AA22, by either of the following methods:
Melissa Smith, Director of the 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 NPRM may be obtained in alternative formats (Large Print, Braille, Audio Tape or Disc), upon request, by calling (202) 693-0675 (this is not a toll-free number). TTY/TDD callers may dial toll-free 1 (877) 889-5627 to obtain information or request materials in alternative formats.
Questions of interpretation and/or enforcement of the agency's regulations may be directed to the nearest WHD district office. Locate the nearest office by calling the WHD's toll-free help line at (866) 4US-WAGE ((866) 487-9243) between 8 a.m. and 5 p.m. in your local time zone, or log onto WHD's website at
On September 27, 2018, the Department published an NPRM and request for comments in the
U.S. Copyright Office, Library of Congress.
Notice of inquiry; extension of comment period.
The Copyright Office is extending the deadline for the submission of written comments in response to its October 16, 2018 notice of inquiry regarding the Classics Protection and Access Act, title II of the recently enacted Orrin G. Hatch-Bob Goodlatte Music Modernization Act.
The initial comment period for the notice of inquiry, published on October 16, 2018, is extended by an additional ten days. Initial comments must be made in writing and must be received in the U.S. Copyright Office no later than 11:59 p.m. Eastern Time on November 26, 2018. Written reply comments must be received no later
For reasons of government efficiency, the Copyright Office is using the regulations.gov system for the submission and posting of public comments in this proceeding. All comments are therefore to be submitted electronically through
Regan A. Smith, General Counsel and Associate Register of Copyrights, by email at
On October 16, 2018, the U.S. Copyright Office issued a notice of inquiry (“NOI”) regarding the Classics Protection and Access Act, title II of the recently enacted Orrin G. Hatch-Bob Goodlatte Music Modernization Act.
To ensure that members of the public have sufficient time to respond, and to ensure that the Office has the benefit of a complete record, the Office is extending the deadline for the submission of initial written comments to 11:59 p.m. Eastern Time on November 26, 2018. Written reply comments must be received no later than 11:59 p.m. Eastern Time on December 11, 2018. So that the Office is able to meet the statutory deadlines described in the NOI, no further extensions of time will be granted in this rulemaking.
Environmental Protection Agency (EPA).
Notice of public hearing.
On October 30, 2018, the Environmental Protection Agency (EPA) published in the
The EPA will hold a public hearing on November 27, 2018, in Washington, DC. Please refer to the
The hearing will be held at the EPA WJC East Building, 1201 Constitution Avenue NW, Room #1117A & B, Washington, DC 20004. The hearing will convene at 9:00 a.m. local time and will conclude at 5:00 p.m. local time. There will be a lunch break from 12:00 p.m. to 1:00 p.m. The EPA will end the hearing 2 hours after the last registered speaker has concluded their comments.
Because this hearing is being held at a U.S. government facility, individuals planning to attend the hearing should be prepared to show valid picture identification to the security staff in order to gain access to the meeting room. Please note that the REAL ID Act, passed by Congress in 2005, established new requirements for entering federal facilities. For purposes of the REAL ID Act, the EPA will accept government-issued IDs, including driver's licenses from the District of Columbia and all states and territories. Acceptable alternative forms of identification include: Federal employee badges, passports, enhanced driver's licenses, and military identification cards. For additional information for the status of your state regarding REAL ID, go to:
The EPA will begin pre-registering speakers for the hearing upon publication of this document in the
Each commenter will have 5 minutes to provide oral testimony. The EPA encourages commenters to provide the EPA with a copy of their oral testimony electronically (via email) or in hard copy form.
The EPA may ask clarifying questions during the oral presentations but will not respond to the presentations at that time. Written statements and supporting information submitted during the comment period will be considered with the same weight as oral comments and supporting information presented at the public hearing. Commenters should notify Virginia Hunt if there are special needs related to providing comments at the hearing. Verbatim transcripts of the hearing and written statements will be included in the docket for the rulemaking.
Please note that any updates made to any aspect of the hearing will be posted online at
The EPA will not provide audiovisual equipment for presentations unless we receive special requests in advance. Commenters should notify Virginia Hunt when they pre-register to speak that they will need specific equipment. If you require the service of a translator or special accommodations such as audio description, please pre-register for the hearing and describe your needs by November 21, 2018. We may not be able to arrange accommodations without advanced notice.
Pipeline and Hazardous Materials Safety Administration (PHMSA); DOT.
Request for comments.
PHMSA is publishing this document to seek public comments on frequently asked questions (FAQs) developed to provide guidance on what constitutes sufficient justification for an operator to request a 6-month extension to a gas pipeline's 7-year integrity management reassessment interval. This guidance, which consists of one revised and two new FAQs, will implement authority granted by Congress in Section 5(e) of the Pipeline Safety, Regulatory Certainty, and Job Creation Act of 2011 (2011 Act).
Interested persons are invited to submit comments on or before December 17, 2018.
Comments should reference Docket No. PHMSA-2018-0073 and may be submitted in the following ways:
Congress made several amendments to the pipeline safety statutes in the Pipeline Safety, Regulatory Certainty, and Job Creation Act of 2011 (the 2011 Act). The Secretary of Transportation (the Secretary) has delegated to PHMSA the responsibility for implementing the changes resulting from the 2011 Act. Section 5, “Integrity Management,” paragraph (e), of the 2011 Act made a technical correction to the Federal pipeline safety statutes regarding the performance of integrity management assessments. As part of an operator's integrity management program, operators must assess pipelines in high-consequence areas for defects and anomalies at a minimum of once every 7 years. The technical correction clarified that the Secretary may extend such deadlines by an additional 6 months if the operator submits written notice to the Secretary with sufficient
To implement this authority, PHMSA is issuing guidance on what constitutes sufficient justification to extend a gas pipeline operator's 7-year integrity management reassessment interval by up to 6 months if the operator submits written notice. PHMSA invites interested individuals to participate by reviewing the FAQs provided below and submitting written comments, data, or other information. Please include any comments on potential safety and environmental impacts that may result from issuance of the FAQs. Before finalizing the FAQs, PHMSA will evaluate all comments received on or before the comment closing date. PHMSA will consider all relevant comments we receive prior to the deadline when making changes to the final FAQs. Comments received after the closing date will be evaluated to the extent practicable.
Once finalized, PHMSA's FAQs will be posted on PHMSA's public website at
Guidance on the Extension of the 7-year Integrity Management Reassessment Interval by 6 Months (FAQs):
•
Notify PHMSA, in accordance with 49 CFR 192.949, of the need for an extension, which may not exceed 6 months. The notification must be made 180 days prior to end of the 7-year assessment date and include sufficient information to justify the extension.
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Documentation is required to comply with 49 CFR 192.943 and include:
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Section 192.939(a)(1) specifies requirements for establishing reassessment intervals. Two options are allowed: (i) Basing the interval on identified threats, assessment results, data integration, and risk analysis, or (ii) using the intervals specified in Table 3 of ASME/ANSI B31.8S. An operator using the former option (§ 192.939(a)(1)(i)) could establish intervals longer than those in Table 3. The intervals that can be established by either method are limited to the maximum intervals in the table in § 192.939.
Pressure tests used as integrity management assessments must meet the requirements of Subpart J, including required test pressures. Higher test pressures must be used to justify extended reassessment intervals (§ 192.937(c)(2)). As used here “extended reassessment intervals” refers to any interval longer than 7 years as required by §§ 192.937(a) and 192.939(a) and (b).
Operators conducting assessments by pressure testing and who use test pressures meeting Subpart J requirements may establish a reassessment interval of 7 years, unless their analysis under § 192.939(a)(i) indicates a need for a shorter interval. This is true even if Table 3 would lead to a shorter interval.
Operators who use Table 3 test pressures may establish reassessment intervals in accordance with Table 3 up to the maximums listed in the table in § 192.939, again unless their analysis under § 192.939(a)(i) indicates a need for a shorter interval. Operators who establish intervals longer than 7 years must conduct a confirmatory direct assessment within the 7-year period. (For segments operating at less than 30% specified maximum yield strength, a low-stress reassessment per § 192.941 may be conducted in lieu of confirmatory direct assessment—see § 192.939(b)(1)).
PHMSA may extend the 7-year interval for an additional 6 months if the operator submits written notice that includes sufficient justification regarding the need for an extension (Reference FAQ-281 and 282).
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Proposed rule; request for comments.
NMFS proposes 2019 specifications for the summer flounder and black sea bass fisheries and maintains previously established 2019 specifications for the scup fishery. Additionally, this action proposes to reopen the February 2018 black sea bass recreational fishery and to adjust to the current commercial incidental possession limit for scup. The implementing regulations for the Summer Flounder, Scup, and Black Sea Bass Fishery Management Plan require us to publish specifications for the upcoming fishing year for each of these species and to provide an opportunity for public comment. This action is intended to inform the public of the proposed specifications and management measures for the start of the 2019 fishing year for these three species.
Comments must be received on or before November 30, 2018.
An environmental assessment (EA) was prepared for this action that describes the proposed measures and other considered alternatives, and provides an analysis of the impacts of the proposed measures and alternatives. Copies of the Summer Flounder, Scup, and Black Sea Bass 2019 Specifications, including the EA, are available on request from Dr. Christopher M. Moore, Executive Director, Mid-Atlantic Fishery Management Council, Suite 201, 800 North State Street, Dover, DE 19901. These documents are also accessible via the internet at
You may submit comments on this document, identified by NOAA-NMFS-2018-0110, by either of the following methods:
1. Go to
2. Click the “Comment Now!” icon, complete the required fields, and
3. Enter or attach your comments.
Emily Gilbert, Fishery Policy Analyst, (978) 281-9244.
The Mid-Atlantic Fishery Management Council (Council) and the Atlantic States Marine Fisheries Commission (Commission) cooperatively manage the summer flounder, scup, and black sea bass fisheries. The Summer Flounder, Scup, and Black Sea Bass Fishery Management Plan (FMP) and its implementing regulations outline the Council's process for establishing specifications. Specifications in these fisheries include various catch and landing subdivisions, such as the commercial and recreational sector annual catch limits (ACL), annual catch targets (ACT), and sector-specific landing limits (
This action proposes 2019 specifications for summer flounder and black sea bass. The previously approved 2019 scup specifications (82 FR 60682; December 22, 2017) remain unchanged from the current two year specifications and are maintained through this action. The Council's Science and Statistical Committee (SSC) and Summer Flounder, Scup, and Black Sea Bass Monitoring Committee met in July 2018 to develop specification recommendations, including new acceptable biological catch limits (ABC) for summer flounder and black sea bass. The Council and the Commission's Summer Flounder, Scup, and Black Sea Bass Management Board (Board) met jointly August 14-15, 2018, to consider the SSC and Monitoring Committee's recommendations, receive public comments on those recommendations, and to formalize recommendations to the NMFS for catch limit specifications and commercial management measures. Recreational fishery management measures will be developed in early 2019. A summer flounder benchmark assessment, which will incorporate updated Marine Recreational Information Program (MRIP) data, is expected to be completed by early 2019. Operational assessments for black sea bass and scup that will also incorporate updated MRIP information will be completed in spring 2019. Because of this, the Council and Board have only recommended specifications for 2019. As explained below, the Council and Board are considering the specifications here as interim measures and will likely develop mid-year changes to the summer flounder specifications, if not also black sea bass, to address the updated assessment information, if necessary.
In June, the Northeast Fisheries Science Center (Center) provided the Council with a summer flounder data update. The data update provided a projection for stock biomass for 2019. Most state and Federal survey indices of abundance, with the exception of Massachusetts and Delaware, remain below their most recent peaks (generally 2009-2012) in the update. Recruitment indices in 2017 were highly variable. Based on the best available scientific information, the summer flounder stock is subject to overfishing but is not overfished. After reviewing the update, the SSC and Monitoring Committee recommended an interim ABC of 15.41 million lb (6,990 mt).
At the joint August meeting, the Council and Board made recommendations for interim summer flounder specifications for the start of the 2019 fishing year (Table 1). Compared to 2018, the proposed interim 2019 ABC is a 16-percent increase. The results from the benchmark stock assessment are expected to be available in early 2019 following peer review in November 2018. The Council and Board intend to consider revising the 2019 summer flounder specifications at a joint meeting in February 2019 taking into account the benchmark stock assessment. If revisions are recommended at this meeting, we anticipate updated catch limits could be in place by early May 2019.
Our final 2017 catch accounting shows that the 2017 commercial fishery exceeded its ACL by 21 percent and the 2017 ABC was exceeded by 7 percent, due to higher than expected discards in the commercial fishery. Currently, the regulations require a pound-for-pound accountability measure (AM) that is applied to the commercial ACT when the ACL has been exceeded and the overage is caused by higher discards than those estimated prior to the fishing year. A final rule for a framework adjustment (Framework 13) that would modify this AM published on October 25, 2018 (83 FR 53825), and will be effective on November 26, 2018. That action adjusts this non-landings based AM to help account for the variability in commercial discard estimates and provide additional flexibility based on stock status and the biological consequences, if any, of estimated discard overages. In terms of impacts of the 2017 discard overage for 2019, the AM as modified by the pending framework would result in a scaled payback against the commercial fishery's ACT, based on the amount of the overage and the status of the summer flounder stock, using the most recent biological reference points.
Based on the 2016 assessment update, this scaled payback would be 1.04 million lb (472 mt). This overage, when applied to the proposed 2019 commercial ACT of 9.18 million lb (3,502 mt), would result in a commercial quota of 6.67 million lb (3,030 mt), after subtracting the 2019 projected estimated discards. The resulting quota is less than one percent higher than the 2018 quota.
Table 2 presents the proposed state summer flounder allocations for 2019 using the commercial state quota allocations described in the FMP. Any commercial quota adjustments to account for commercial landings overages will be published in the final specification rule prior to the start of the respective fishing year.
The Council and Board recommended no adjustment to the commercial minimum fish size (14-inch (35.6 cm) total length), gear requirements, and possession limits. The Council and Board will develop recreational management measures (
At the August meeting, the Council and Board made recommendations for the 2019 black sea bass specifications, but for reasons outlined below, we propose maintaining status quo measures currently in place for 2018.
In June 2018, the Center provided the Council with a black sea bass data update, including updated catch, landings, and survey indices through 2017. Black sea bass biomass continues to be high and the 2015 year class appears to be above average in both the northern and southern surveys. Updated stock status information and biomass projections incorporating data on the 2015 year class are not available, but will be once the operational assessment is completed in April 2019.
The SSC recommended a 2019 ABC of 7.97 million lb (3,615 mt), which was based on biomass projections from the 2016 benchmark stock assessment. This ABC would be an 11-percent reduction
Following the Council and Board meeting, the Center performed a sensitivity analysis of the 2019 projection derived from the 2016 benchmark stock assessment. As previously described, that projection did not include the 2015 year class because those fish were too small to be widely captured in the surveys at the time of the 2016 assessment. This sensitivity analysis used various recruitment scenarios applied to the original projection and compared them to the most recent survey indices. The objective of this analysis was to see if that projection would have supported different specifications for 2019 had we been able to incorporate what we know now about the strength of the 2015 year class. The results suggest that the 2015 year class would only have to be about 50 percent above average to allow for 2019 catch limits to be the same as what they were in 2018. Based on a comparison between the Center's 2018 spring survey results and average recruitment from 2003-2018, the 2015 year class appears to be well more than 50 percent above average. Based on this information, we propose maintaining status quo black sea bass specifications for 2019 (Table 3).
Maintaining status quo would allow for stability in the black sea bass commercial and recreational fisheries while we wait for the results of the MRIP operational assessment to be completed in April 2019. Once that information is available, the Council and Board may recommend adjusting black sea bass measures mid-year.
The Council and Board recommended no adjustment to the commercial minimum fish size (11-inch (27.9 cm) total length), gear requirements, and possession limits.
This action also proposes reopening the black sea bass recreational fishery for the month of February (during MRIP Wave 1). The current Federal black sea bass recreational management measures (
There are currently no MRIP survey estimates collected for Wave 1, but catch from this time period must be accounted for, and count against the recreational harvest limit. Similar to last year, to account for the harvest during this 28-day season, the Council and Board recommended a catch estimate of 100,000 lb (45.3 mt). States that decide to participate in the Wave 1 fishery must account for this catch when developing their management measures for the remainder of the fishing year. Only two states participated in the 2018 February recreational fishery. The estimated catch was nominal. Measures for the rest of the 2019 recreational fishery will be developed through the winter for implementation in spring 2019.
The scup fishery is currently operating under multi-year specifications projected through 2019. The Council received a data update indicating that biomass continues to be high, and the 2015 year class appears to be above average. In response, the Council and Board made no adjustments to the previously implemented multi-year specifications set in August 2017. This action reaffirms the Council's and Board's previous recommendation for scup 2019 specifications. Those specifications result in the same commercial quota and recreational harvest limit as implemented in 2018 (Table 4).
The 2019 scup commercial quota is divided into three commercial fishery quota periods, as outlined in Table 5.
The current quota period possession limits are not changed by this action, and are outlined in Table 6. The Winter I possession limit will drop to 1,000 lb (454 kg) upon attainment of 80 percent of that period's allocation. If the Winter I quota is not fully harvested, the remaining quota is transferred to Winter II. The Winter II possession limit may be adjusted (in association with a transfer of unused Winter I quota to the Winter II period) via notice in the
This action proposes adjustments to the gear-based incidental possession limit for the commercial fishery. The incidental possession limit applies to vessels with commercial moratorium scup permits fishing with nets with diamond mesh smaller than 5 inches (12.7 cm) in diameter. The incidental possession limit is currently 1,000 lb (454 kg) during October 1-April 30 and 200 lb (91 kg) during May 1-September 30. The action would add another threshold period from April 15-June 15 to allow for higher retention in the small-mesh squid fishery that operates during that time and occasionally catches larger amounts of scup than the current limits allow to be landed (Table 8). During that time, vessels with scup moratorium permits using small mesh
The Council and Board made no adjustments to the current commercial minimum fish size (9-inch (22.9-cm) total length) and winter quota period directed-fishery possession limits.
Pursuant to section 304(b)(1)(A) of the Magnuson-Stevens Act, the NMFS Assistant Administrator has determined that this proposed rule is consistent with the Summer Flounder, Scup, and Black Sea Bass FMP, other provisions of the Magnuson-Stevens Act, 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.
The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration that this proposed rule, if adopted, would not have a significant economic impact on a substantial number of small entities. The Mid-Atlantic Fishery Management Council conducted an evaluation of the potential socioeconomic impacts of the proposed measures in conjunction with an environmental assessment. According to the commercial ownership database, 771 affiliate firms landed summer flounder and/or black sea bass during the 2015-2017 period, with 762 of those business affiliates categorized as small businesses and nine categorized as large businesses. Summer flounder and black sea bass represented approximately 4 percent of the average receipts of the small entities and 1 percent for large entities considered over this time period.
The ownership data for the for-hire fleet indicate that there were 869 for-hire affiliate firms with summer flounder and/or black sea bass permits generating revenues from recreationally fishing, all of which are categorized as small businesses. Although it is not possible to derive what proportion of the overall revenues came from specific fishing activities, given the popularity of these three species as recreational targets it is likely that revenues generated from these species are important for some, if not all, of these firms.
For the summer flounder fishery, the proposed measures would increase both the 2019 commercial quota and the 2019 recreational harvest limit. Even though there will be an AM applied to the commercial summer flounder fishery, the resulting commercial quota will still be a slight increase from 2018. For the black sea bass fishery, the proposed measures would result in a 2019 commercial quota and a 2019 recreational harvest limit that are identical to what was in place for 2018. As a result, this action is not expected to adversely impact revenues for vessels that fish for summer flounder and black sea bass commercially. The increase in the summer flounder recreational harvest limit does not directly impact the party/charter fishery. Future regulatory action may be needed to adjust current summer flounder, black sea bass, and scup recreational management measures (
Because this rule will not have a significant economic impact on a substantial number of small entities, an initial regulatory flexibility analysis is not required and none has been prepared. There are no new reporting or recordkeeping requirements contained in any of the alternatives considered for this action.
Fisheries, Fishing, Recordkeeping and reporting requirements.
For the reasons set out in the preamble, 50 CFR part 648 is proposed to be amended as follows:
16 U.S.C. 1801
(a) * * * (1)
(5)
Vessels that are not eligible for a moratorium permit under § 648.4(a)(7), and fishermen subject to the possession limit specified in § 648.145(a), may only possess black sea bass from February 1 through February 28, May 15 through December 31, unless this time period is adjusted pursuant to the procedures in § 648.142.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Proposed rule; request for comments.
We propose to approve new selective trawl gear for use in several non-groundfish fisheries when subject to the Georges Bank yellowtail flounder accountability measure. The proposed selective gear would reduce bycatch of groundfish species, while allowing the target fisheries to continue operating when selective trawl gear is required. Approving this selective trawl gear would provide the fishing industry with more flexibility because there are limited selective trawl gears currently approved for use. We also propose to disapprove the use of this gear in the southern windowpane accountability measure areas.
Written comments must be received on or before December 17, 2018.
You may submit comments, identified by NOAA-NMFS-2018-0119, by either of the following methods:
•
1. Go to
2. Click the “Comment Now!” icon and complete the required fields; and
3. Enter or attach your comments.
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Emily Keiley, Fishery Management Specialist, phone: (978) 281-9116; email:
The Northeast Multispecies Fishery Management Plan (FMP) requires the use of selective trawl gear in certain times and areas. The FMP specifies the list of selective trawl gear that meet the required selectivity standards. The FMP also authorizes NMFS to approve additional selective gear, at the request of the New England Fishery Management Council, if the gear meets the regulatory requirements for new selective gear. The regulations (§ 648.85(b)(6)(iv)(J)(
The small-mesh trawl fishery (
Southern windowpane flounder is allocated to three fishery components: Groundfish; scallops; and, other non-groundfish fisheries. The other (non-groundfish) component is primarily the scup, fluke, squid, and whiting fisheries. If the AM for the other (non-groundfish) component is triggered, vessels fishing with any trawl gear with a codend mesh size greater than, or equal to 5 in (12.7 cm), are required to use one of the approved selective trawl gears to reduce flatfish bycatch in certain areas in Southern New England in a subsequent year.
The selective trawl gears approved for use under these AMs are: Haddock separator trawl; Ruhle trawl; and rope separator trawl. When we adopted the AMs for the non-groundfish fisheries, many industry members expressed concern that the selective trawl gears currently approved for use were not suitable for their fisheries. To address this concern, Cornell University conducted a series of studies to test the effectiveness of a new selective gear, the large-mesh belly panel, in several non-groundfish fisheries. The experimental gear included a large-mesh panel to replace the first bottom belly of the trawl net that allows flatfish such as windowpane and yellowtail flounder to escape.
Cornell University conducted two studies in 2014 to investigate using a large-mesh belly panel in a small-mesh trawl net typical of those used in the squid and whiting fisheries on Georges Bank. Both experiments demonstrated a statistically significant reduction in catch of more than 50 percent of Georges Bank yellowtail flounder on a trip-by-trip basis, as required by regulations, without a significant reduction in squid and whiting catch. These studies also demonstrated that the large-mesh belly panel reduced catch, by more than 50 percent per trip, of stocks that are overfished or subject to overfishing.
Cornell University conducted an additional study in 2015 to investigate using a large-mesh belly panel in a trawl net typical of those used in the scup fishery in southern New England
Based on the results of the studies described above (copies available from NMFS at the mailing address listed under
This action would define the large-mesh belly panel in the regulations in § 648.80. The proposed gear specifications included in this rule are based on the experimental gear used in the Cornell studies. The experimental selective gear was a 4-seam 3-bridal otter trawl, modified to include a large-mesh panel to replace the first bottom belly that allows escapement of flatfish. The large-mesh panel was made from 5 mm (
Pursuant to section 304(b)(1)(A) of the Magnuson-Stevens Act, the National Marine Fisheries Service (NMFS) Assistant Administrator has made a preliminary determination that this proposed rule is consistent with Framework 51, other provisions of the Magnuson-Stevens Act, and other applicable law. In making the final determination, we will consider the data, views, and comments received during the public comment period.
This proposed rule has been determined to be not significant for purposes of Executive Order (E.O.) 12866.
This proposed rule does not contain policies with Federalism or takings implications as those terms are defined in E.O. 13132 and E.O. 12630, respectively.
The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration that this proposed rule, if adopted, would not have a significant economic impact on a substantial number of small entities. The factual determination for this determination is as follows.
The Council requested that we approve a new selective trawl gear (the large-mesh belly panel) for use in several non-groundfish fisheries to reduce groundfish bycatch. For some stocks, non-groundfish fisheries have an AM that requires the use of selective trawl gear when the ACL has been exceeded. Most of the approved selective trawls are not designed for use in these fisheries, and the large-mesh belly panel would provide these fisheries a better alternative than what is currently available. The requirement to use selective trawl gear was adopted in 2013. This rule would provide vessels an alternative selective gear for meeting that requirement, which would provide additional fishing opportunities, increase operational flexibility, and improve economic efficiency. This action is necessary to allow the fisheries to more effectively harvest its optimum yield, while continuing to reduce bycatch of windowpane and yellowtail flounder. This action seeks to fulfill the purpose and need while meeting the overarching goals and objectives of the Northeast Multispecies FMP.
For purposes of the Regulatory Flexibility Act, NMFS established a small business size standard for businesses, including their affiliates, whose primary industry is commercial fishing (
The small-mesh exempted fishery allows vessels to harvest species in designated areas using mesh sizes smaller than the minimum mesh size required by Regulated Mesh Area regulations. To participate in the small-mesh multispecies exempted fishery, vessels must possess either a limited access multispecies permit (categories A, C, D, E, or F) or an open access multispecies permit (category K). Limited access multispecies permit holders can target small-mesh multispecies with different possession limit requirements depending on fishing region and mesh size used. Open access, Category K permit holders may fish for small-mesh multispecies when participating in an exempted fishing program. Therefore, entities holding one or more multispecies permits (permit type A, C-F, K) are the entities that have the potential to be directly impacted by this action. According to the commercial database, there were 853 distinct ownership entities, based on entities' participation during the 2014-2016 time-period, that could potentially target small-mesh multispecies. This includes entities that could not be classified into a business type because they did not earn revenue from landing and selling fish in 2014-2016 and thus are considered to be small. Of the 853 total firms, 844 are categorized as small business entities and 9 are categorized as large businesses. While 853 commercial entities have the potential to be impacted by the proposed action, not all of these entities actively land small-mesh multispecies for commercial sale. There are 406 distinct entities that commercially sold small-mesh multispecies from 2014-2016 and may be directly affected by the proposed action. Of those, 404 are categorized as small businesses.
The measures proposed are expected to have a positive economic effect on small entities. It could increase catch of target stocks, in a scenario when fishing would otherwise be prohibited. Providing increased fishing opportunities should increase landings and profits. This action is not expected to have a significant or substantial effect on small entities. The effects on the regulated small entities identified in this analysis are expected to be positive relative to the no action alternative, in which this new selective trawl gear would not be added to the list of approved selective gears. Under the proposed action, small entities would not be placed at a competitive disadvantage relative to large entities, and the regulations would not reduce the profit for any small entities. As a result, an initial regulatory flexibility analysis is not required and none has been prepared.
This proposed rule contains a collection-of-information requirement subject to review and approval by OMB under the Paperwork Reduction Act (PRA). This requirement will be submitted to OMB for approval. Public reporting burden for the selection of the gear code is estimated to average one minute per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.
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 NMFS at the
Notwithstanding any other provision of the law, no person is required to respond to, and no person shall be subject to 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.
Fisheries, Fishing, Recordkeeping and reporting requirements.
For the reasons stated in the preamble, 50 CFR part 648 is proposed to be amended as follows:
16 U.S.C. 1801
(f)
(1)
(2)
(a) * * *
(5) * * *
(v)
National Agricultural Statistics Service, USDA.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995 this notice announces the intention of the National Agricultural Statistics Service (NASS) to seek approval to conduct a new information collection to gather data related to what types of technologies are used on farms during a specified reference period. This clearance will allow NASS to conduct surveys in a timely manner for the cooperating institutions providing funding for the surveys.
Comments on this notice must be received by January 14, 2019 to be assured of consideration.
You may submit comments, identified by docket number 0535-NEW, by any of the following methods:
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•
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Kevin L. Barnes, Associate Administrator, National Agricultural Statistics Service, U.S. Department of Agriculture, 202-720-4333. Copies of this information collection and related instructions can be obtained without charge from David Hancock, NASS—OMB Clearance Officer, at 202-690-2388 or at
The Farm Technology Survey will collect information from farmers regarding what types of technologies are used during a specified reference period. These technologies will include both physical and non-physical types such as tablets, applications, automatic sensors, etc. The collected data will be used by State Departments of Agriculture and Land Grant Universities to determine the need for providing assistance to farmers and ranchers to fulfill their technology needs, indicated by the data. These surveys will be conducted through cooperative agreements with State Departments of Agriculture and/or universities; with the cooperators providing the funding.
NASS also complies with OMB Implementation Guidance, “Implementation Guidance for Title V of the E-Government Act, Confidential Information Protection and Statistical Efficiency Act of 2002 (CIPSEA),”
All responses to this notice will become a matter of public record and be summarized in the request for OMB approval.
National Agricultural Statistics Service, USDA.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995, this notice announces the intention of the National Agricultural Statistics Service (NASS) to request revision and extension of a currently approved information collection, the Generic Clearance for Survey Research Studies. Burden hours and number of contacts will be increased to accommodate the proposed testing for the upcoming three year period.
Comments on this notice must be received by January 14, 2019 to be assured of consideration.
You may submit comments, identified by docket number 0535-0248, by any of the following methods:
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•
•
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Kevin L. Barnes, Associate Administrator, National Agricultural Statistics Service, U.S. Department of Agriculture, (202) 720-2707. Copies of this information collection and related instructions can be obtained without charge from David Hancock, NASS—OMB Clearance Officer, at (202) 690-2388 or at
In the last decade, state-of-the art techniques have been increasingly instituted by NASS and other Federal agencies and are now routinely used to improve the quality and timeliness of survey data and analyses, while simultaneously reducing respondents' cognitive workload and burden. The purpose of this generic clearance is to allow NASS to continue to adopt and use these state-of-the-art techniques to improve its current data collections efforts. These tests will also be used to aid in the development of new surveys.
NASS envisions using a variety of survey improvement techniques, as appropriate to the individual project under investigation. These include focus groups, cognitive and usability laboratory and field techniques, exploratory interviews, behavior coding, respondent debriefing, pilot surveys, and split-panel tests. After obtaining participants' permission, NASS plans to audio-record some cognitive interviews and usability interviews, in order to allow for more complete and accurate summaries of these qualitative interviews. This is a standard procedure for cognitive interviews and usability interviews at many other survey organizations, including Federal agencies. The consent form would be used for audio recording some cognitive interviews and usability interviews for research purposes. For these types of interviews, there will be no collection of Personally Identifiable Information (PII) or any identifying information about the operator or operation.
In addition to the testing techniques listed above NASS will be including parallel testing with this renewal request. NASS is investigating methodologies using additional sources of farm operators (including web scraping). These methodologies will be tested against the NASS's current multi-frame methodology.
Following standard OMB requirements NASS will submit a change request to OMB individually for each survey improvement project it undertakes under this generic clearance and provide OMB with a copy of the questionnaire (if one is used), and all other materials describing the project.
NASS also complies with OMB Implementation Guidance, “Implementation Guidance for Title V of the E-Government Act, Confidential Information Protection and Statistical Efficiency Act of 2002 (CIPSEA),”
All responses to this notice will become a matter of public record and be summarized in the request for OMB approval.
Rural Business-Cooperative Service, USDA.
Proposed collection; comments requested.
In accordance with the Paperwork Reduction Act of 1995, this notice announces the Rural Business-Cooperative Service's intention to request an extension for a currently approved information collection.
Comments on this notice must be received by January 14, 2019 to be assured of consideration.
Thomas Dickson, Rural Development Innovation Center—Regulatory Team, U.S. Department of Agriculture, 1400 Independence Avenue SW, STOP 1522, Washington, DC 20250, Telephone: 202-690-4492, email: Thomas
Comments may be sent to Thomas Dickson, Rural Development Innovation Center—Regulatory Team, U.S. Department of Agriculture, Rural Development, STOP 1522, 1400 Independence Avenue SW, Washington, DC 20250-1522.
Copies of this information collection can be obtained from Kimble Brown, Rural Development Innovation Center, Regulations Team, at (202) 692-0043 or email:
All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.
Rural Business-Cooperative Service, USDA.
Notice.
This notice is to invite applications for loans and grants under the Rural Economic Development Loan and Grant (REDLG) Programs for fiscal year (FY) 2019, subject to the availability of funding. This notice is being issued in order to allow applicants sufficient time to leverage financing, prepare and submit their applications, and give the Agency time to process applications within FY 2019. Successful applications will be selected by the Agency for funding and subsequently awarded to the extent that funding may ultimately be made available through appropriations. An announcement on the website at
All applicants are responsible for any expenses incurred in developing their applications.
See under
Submit applications in paper format to the USDA Rural Development State Office for the State where the Project is located. A list of the USDA Rural Development State Office contacts can be found at:
Cindy Mason at (202) 690-1433,
The Agency encourages applications that will support recommendations made in the Rural Prosperity Task Force report to help improve life in rural America,
Key strategies include:
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Awards under the REDLG Programs will be made on a competitive basis using specific selection criteria contained in 7 CFR part 4280, subpart A. Information required to be in the application package includes Standard Form (SF) 424, “Application for Federal Assistance;” a Resolution of the Board of Directors; AD-1047, “Debarment/Suspension Certification;” AD-1049 “Certification Regarding Drug-Free Workplace Requirements;” SF LLL, Restrictions on Lobbying; RD 400-1, “Equal Opportunity Agreement;” RD 400-4, “Assurance Agreement;” Assurance Statement for the Uniform Act; Seismic Certification (if construction); and paperwork required in accordance with 7 CFR part 1970, “Environmental Policies and Procedures.” If the proposal involves new construction; large increases in employment; hazardous waste; a change in use, size, capacity, purpose, or location from an original facility; or is publicly controversial, the following is required: Environmental documentation in accordance with 7 CFR part 1970;” RUS Form 7, “Financial and Statistical Report;” RUS Form 7a, “Investments, Loan Guarantees, and Loans,” or similar information; and written narrative of Project description. Applications will be tentatively scored by the State Offices and submitted to the National Office for review.
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Loans and grants may be made to any entity that is identified by USDA Rural Development as an eligible borrower under the Rural Electrification Act of 1936, as amended (Act). In accordance with 7 CFR 4280.13, applicants that are not delinquent on any Federal debt or otherwise disqualified from participation in these Programs are eligible to apply. An applicant must be eligible under 7 U.S.C. 940c. Notwithstanding any other provision of law, any former Rural Utilities Service borrower that has repaid or prepaid an insured, direct, or guaranteed loan under the Act, or any not-for-profit utility that is eligible to receive an insured or direct loan under such Act shall be eligible for assistance under section 313(b)(2)(B) of such Act in the same manner as a borrower under such Act. All other restrictions in this notice will apply.
The Agency requires the following information to make an eligibility determination. These applications must include, but are not limited to, the following:
(a) An original and one copy of SF 424, “Application for Federal Assistance (for non-construction);”
(b) Copies of applicant's organizational documents showing the applicant's legal existence and authority to perform the activities under the Grant;
(c) A proposed scope of work, including a description of the proposed Project, details of the proposed activities to be accomplished and timeframes for completion of each task, the number of months duration of the Project, and the estimated time it will take from grant approval to beginning of Project implementation;
(d) A written narrative that includes, at a minimum, the following items:
(i) An explanation of why the Project is needed, the benefits of the proposed Project, and how the Project meets the Grant eligible purposes;
(ii) Area to be served, identifying each governmental unit,
(iii) Description of how the Project will coordinate economic development activities with other economic development activities within the Project area;
(iv) Businesses to be assisted, if appropriate, and economic development to be accomplished;
(v) An explanation of how the proposed Project will result in newly created, increased, or supported jobs in the area and the number of projected new and supported jobs within the next 3 years;
(vi) A description of the applicant's demonstrated capability and experience in providing the proposed Project assistance, including experience of key staff members and persons who will be providing the proposed Project activities and managing the Project;
(vii) The method and rationale used to select the areas and businesses that will receive the service;
(viii) A brief description of how the work will be performed, including whether organizational staff or consultants or contractors will be used; and
(ix) Other information the Agency may request to assist it in making a grant award determination.
(e) The last 3 years of financial information to show the applicant's financial capacity to carry out the proposed work. If the applicant is less than 3 years old, at a minimum, the information should include all balance sheet(s), income statement(s), and cash flow statement(s). A current audited report is required if available;
(f) Documentation regarding the availability and amount of other funds to be used in conjunction with the funds from REDLG; and
(g) A budget which includes salaries, fringe benefits, consultant costs, indirect costs, and other appropriate direct costs for the Project.
For loans, either the Ultimate Recipient or the Intermediary must provide supplemental funds for the Project equal to at least 20 percent of the loan to the Intermediary. For grants, the Intermediary must establish a Revolving Loan Fund (or Fund) and contribute an amount equal to at least 20 percent of the Grant. The supplemental contribution must come from Intermediary's funds which may not be from other Federal Grants, unless permitted by law.
Applications will only be accepted for projects that promote rural economic development and job creation.
There are no “responsiveness” or “threshold” eligibility criteria for these loans and grants. There is no limit on the number of applications an applicant may submit under this announcement. In addition to the forms listed under the program description, Form AD 3030 “Representations Regulation Felony Conviction and Tax Delinquent Status for Corporate Applicants,” must be completed in the affirmative.
None of the funds made available by this or any other Act may be used to enter into a contract, memorandum of understanding, or cooperative agreement with, make a grant to, or provide a loan or loan guarantee to, any corporation that has any unpaid Federal tax liability that has been assessed, for which all judicial and administrative remedies have been exhausted or have lapsed, and that is not being paid in a timely manner pursuant to an agreement with the authority responsible for collecting the tax liability, where the awarding agency is aware of the unpaid tax liability, unless a Federal agency has considered suspension or debarment of the corporation and has made a determination that this further action is not necessary to protect the interests of the Government.
None of the funds made available by this or any other Act may be used to enter into a contract, memorandum of understanding, or cooperative agreement with, make a grant to, or provide a loan or loan guarantee to, any corporation that was convicted of a felony criminal violation under any Federal law within the preceding 24 months, where the awarding agency is aware of the conviction, unless a Federal agency has considered suspension or debarment of the corporation and has made a determination that this further action is not necessary to protect the interests of the Government.
Applications will not be considered for funding if they do not provide sufficient information to determine eligibility or are missing required elements.
For further information, entities wishing to apply for assistance should contact the USDA Rural Development State Office provided in the
Prior to official submission of grant applications, applicants may request technical assistance or other application guidance from the Agency, as long as such requests are made by June 15, 2019. Technical assistance is not meant to be an analysis or assessment of the quality of the materials submitted, a substitute for agency review of completed applications, nor a determination of eligibility, if such determination requires in-depth analysis. The Agency will not solicit or consider scoring or eligibility information that is submitted after the application deadline. The Agency reserves the right to contact applicants to seek clarification information on materials contained in the submitted application.
Applications must be submitted in paper format. Applications submitted to a Rural Development State Office must be received by the closing date and local time deadline.
All applicants must have a Dun and Bradstreet Data Universal Numbering System (DUNS) number which can be obtained at no cost via a toll-free request line at (866) 705-5711 or at
Please note that applicants must locate the downloadable application package for this program by the Catalog of Federal Domestic Assistance Number or FedGrants Funding Opportunity Number, which can be found at
An application must contain all of the required elements. Each selection priority criterion outlined in 7 CFR 4280.42(b) must be addressed in the application. Failure to address any of the criterion will result in a zero-point score for that criterion and will impact the overall evaluation of the application. Copies of 7 CFR part 4280, subpart A, will be provided to any interested applicant making a request to a Rural Development State Office. An original copy of the application must be filed with the Rural Development State Office for the State where the Intermediary is located.
The applicant documentation and forms needed for a complete application are located in the Program Description
(a) There are no specific limitations on the number of pages or other formatting requirements other than those described in the Program Description section.
(b) There are no specific limitations on the number of pages, font size and type face, margins, paper size, number of copies, and the sequence or assembly requirements.
(c) The component pieces of this application should contain original signatures on the original application.
(a) Application Deadline Dates: No later than 4:30 p.m. (local time) on:
Second Quarter, December 31, 2018; Third Quarter, March 31, 2019; and Fourth Quarter, June 30, 2019.
Explanation of Dates: Applications must be in the USDA Rural Development State Office by the dates and times as indicated above. If the due date falls on a Saturday, Sunday, or Federal holiday, the application is due the next business day.
(b) The deadline date means that the completed application package must be received in the USDA Rural Development State Office by the deadline date and time established above. All application documents identified in this notice are required.
(c) If completed applications are not received by the deadline established above, the application will neither be reviewed nor considered under any circumstances.
(d) The Agency will determine the application receipt date based on the actual date postmarked.
(e) If the grantee has a previously approved indirect cost rate, it is permissible, otherwise, the applicant may elect to charge the 10 percent indirect cost permitted under 2 CFR 200.414(f). Due to the time required to evaluate Indirect Cost Rates, it is likely that all funds will be awarded by the time the Indirect Cost Rate is determined. No foreign travel is permitted. Pre-Federal award costs will only be permitted with prior written approval by the Agency.
(f) Applicants must submit applications in hard copy format as previously indicated in the Application and Submission Information section of this notice. If the applicant wishes to hand deliver its application, the addresses for these deliveries can be located in the
(g) If you require alternative means of communication for program information (
All eligible and complete applications will be evaluated and scored based on the selection criteria and weights contained in 7 CFR part 4280, subpart A. Failure to address any one of the criteria by the application deadline will result in the application being determined ineligible, and the application will not be considered for funding.
The State Offices will review applications to determine if they are eligible for assistance based on requirements contained in 7 CFR part 4280, subpart A. If determined eligible, your application will be submitted to the National Office. Funding of projects is subject to the Intermediary's satisfactory submission of the additional items required by that subpart and the USDA Rural Development Letter of Conditions. The Agency reserves the right to award additional discretionary points under 7 CFR 4280.43.
In order to distribute funds among the greatest number of projects possible, applications will be reviewed, prioritized, and funded by ranking each State's highest scoring Project in highest to lowest score order. The highest scoring Project from each State will be considered that State's Priority One Project. Priority One projects will be ranked according to score from highest to lowest. The second highest scoring Project from each State will be considered the State's Priority Two Project. Priority Two projects will be ranked according to score from highest to lowest and so forth until all projects have been scored and ranked in priority order. All Priority One projects will be funded before any Priority Two projects and so forth until funds are depleted, so as to ensure broad geographic distribution of funding.
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All successful applicants will be notified by letter which will include a Letter of Conditions, and a Letter of Intent to Meet Conditions. This letter is not an authorization to begin performance. If the applicant wishes to consider beginning performance prior to the loan or grant being officially closed, all pre-award costs must be approved in writing and in advance by the Agency. The loan or grant will be considered officially awarded when all conditions in the Letter of Conditions have been met and the Agency obligates the funding for the Project.
Additional requirements that apply to intermediaries or grantees selected for these Programs can be found in 7 CFR 4280, subpart A; the Grants and Agreements regulations of the U.S. Department of Agriculture codified in 2 CFR 400.1 to 400.2 and 2 CFR part 415 to 422, and successor regulations to these parts.
In addition, all recipients of Federal financial assistance are required to report information about first-tier sub-awards and executive compensation (see 2 CFR part 170). You will be required to have the necessary processes and systems in place to comply with the Federal Funding Accountability and Transparency Act of 2006 (Pub. L. 109-282) reporting requirements (see 2 CFR 170.200(b), unless you are exempt under 2 CFR 170.110(b)).
The following additional requirements apply to intermediaries or grantees selected for these Programs:
(a) Form RD 4280-2 “Rural Business-Cooperative Service Financial Assistance Agreement.”
(b) Letter of Conditions.
(c) Form RD 1940-1, “Request for Obligation of Funds.”
(d) Form RD 1942-46, “Letter of Intent to Meet Conditions.”
(e) Form AD-1047, “Certification Regarding Debarment, Suspension, and Other Responsibility Matters-Primary Covered Transactions.”
(f) Form AD-1048 “Certification Regarding Debarment, Suspension, Ineligibility and Voluntary Exclusion-Lower Tier Covered Transactions.”
(g) Form AD-1049, “Certification Regarding a Drug-Free Workplace Requirement (Grants).”
(h) Form AD-3031, “Assurance Regarding Felony Conviction or Tax Delinquent Status for Corporate Applicants.” Must be signed by corporate applicants who receive an award under this notice.
(i) Form RD 400-4, “Assurance Agreement.” Each prospective recipient must sign Form RD 400-4, “Assurance Agreement,” which assures USDA that the recipient is in compliance with Title VI of the Civil Rights Act of 1964, 7 CFR part 15, and other Agency regulations. That no person will be discriminated against based on race, color, or national origin, in regard to any program or activity for which the recipient receives Federal financial assistance. That nondiscrimination statements are in advertisements and brochures.
Collect and maintain data provided by Ultimate Recipients on race, sex, and national origin and ensure Ultimate Recipients collect and maintain this data. Race and ethnicity data will be collected in accordance with OMB
The applicant and the Ultimate Recipient must comply with Title VI of the Civil Rights Act of 1964, Title IX of the Education Amendments of 1972, Americans with Disabilities Act (ADA), Section 504 of the Rehabilitation Act of 1973, Age Discrimination Act of 1975, Executive Order 12250, Executive Order 13166 Limited English Proficiency (LEP), and 7 CFR part 1901, subpart E.
(j) SF LLL, “Disclosure of Lobbying Activities,” if applicable.
(k) Use Form SF 270, “Request for Advance or Reimbursement.”
(a) A Financial Status Report and a Project performance activity report will be required of all grantees on a quarterly basis until initial funds are expended and yearly thereafter, if applicable, based on the Federal fiscal year. The grantee will complete the Project within the total time available to it in accordance with the Scope of Work and any necessary modifications thereof prepared by the grantee and approved by the Agency. A final Project performance report will be required with the final Financial Status Report. The final report may serve as the last quarterly report. The final report must provide complete information regarding the jobs created and supported as a result of the Grant if applicable. Grantees must continuously monitor performance to ensure that time schedules are being met, projected work by time periods is being accomplished, and other performance objectives are being achieved. Grantees must submit an original of each report to the Agency no later than 30 days after the end of the quarter. The Project performance reports must include, but not be limited to, the following:
(1) A comparison of actual accomplishments to the objectives established for that period;
(2) Problems, delays, or adverse conditions, if any, which have affected or will affect attainment of overall Project objectives, prevent meeting time schedules or objectives, or preclude the attainment of particular Project work elements doing established time periods. This disclosure shall be accompanied by a statement of the action taken or planned to resolve the situation; and
(3) Objectives and timetable established for the next reporting period.
(4) Any special reporting requirements, such as jobs supported and created, businesses assisted, or economic development which results in improvements in median household incomes, and any other specific requirements, should be placed in the reporting section of the Letter of Conditions.
(5) Within 90 days after the conclusion of the Project, the Intermediary will provide a final Project evaluation report. The last quarterly payment will be withheld until the final report is received and approved by the Agency. Even though the Intermediary may request reimbursement on a monthly basis, the last 3 months of reimbursements will be withheld until a final report, Project performance, and financial status report are received and approved by the Agency.
(b) In addition to any reports required by 2 CFR part 200 and 2 CFR 400.1 to 400.2 and 2 CFR part 415 to 422, the Intermediary or grantee must provide reports as required by 7 CFR part 4280, subpart A.
For general questions about this announcement, please contact your USDA Rural Development State Office provided in the
All grants made under this notice are subject to Title VI of the Civil Rights Act of 1964 as required by the USDA (7 CFR part 15, subpart A) and Section 504 of the Rehabilitation Act of 1973, Title VIII of the Civil Rights Act of 1968, Title IX, Executive Order 13166 (Limited English Proficiency), Executive Order 11246, and the Equal Credit Opportunity Act of 1974.
In accordance with the Paperwork Reduction Act of 1995, the information collection requirement contained in this notice is approved by OMB under OMB Control Number 0570-0070.
All applicants, in accordance with 2 CFR part 25, must have a DUNS number, which can be obtained at no cost via a toll-free request line at (866) 705-5711 or online at
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
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USDA is an equal opportunity provider, employer, and lender.
Rural Utilities Service, USDA.
Notice of Solicitation of Applications (NOSA).
The Rural Utilities Service (RUS), an Agency of the United States Department of Agriculture (USDA), announces that it is accepting applications for fiscal year (FY) 2019 for the Rural Broadband Access Loans and Loan Guarantees Program (the Broadband Program). RUS will publish the amount of funding received through the final appropriations act on its website at
RUS is accepting applications on a rolling basis throughout FY 2019. This will give RUS the ability to request additional information and modifications to a submitted application whenever necessary.
Applications will be processed on a first come, first served basis. Every 90 days, RUS will conduct an evaluation of the submitted applications. During the evaluation period, applications will be ranked based on the percentage of unserved households that the applicant proposes to serve. RUS will conduct at least two evaluation periods for FY 2019. Because the Agency will receive applications throughout the fiscal year, subsequent evaluation periods can alter the ranking of applications.
In addition to announcing its acceptance of FY 2019 applications, RUS revises the minimum and maximum amounts for broadband loans for the fiscal year.
Applications under this NOSA will be accepted immediately through September 30, 2019. RUS will process loan applications as they are received.
Applications can only be submitted online through the RD Apply website at
Shawn Arner, Deputy Assistant Administrator, Loan Origination and Approval Division, Rural Utilities Service, Room 2844, STOP 1597, 1400 Independence Avenue SW, Washington, DC 20250-1597; telephone: (202) 720-0800, or email:
The Rural Broadband Access Loan and Loan Guarantee Program (the Broadband Program) is authorized by the Rural Electrification Act (7 U.S.C. 901
During FY 2019, loans will be made available for the construction, improvement, and acquisition of facilities and equipment that will provide service at the Broadband Lending Speed in eligible rural areas. Applications are subject to the requirements of 7 CFR part 1738. No funding for Guaranteed Loans is available in FY 2019 and the agency will not be considering applications for this type of funding.
The Agency encourages applications that will support recommendations made in the Rural Prosperity Task Force report to help improve life in rural America which can be found at
RUS offers pre-application assistance, in which National Office staff and the assigned General Field Representative review the draft application, provide detailed comments, and identify areas where an application is not meeting eligibility requirements for funding. The online application system allows RUS staff to assist an applicant with every part of an application as it is being developed. Once the application is formally submitted, the online system will timestamp the submitted version and establish the application's place in the processing queue.
Based on the order in which the applications are received, RUS will review the application for completeness. The applicant may be asked for additional information to clarify aspects of an otherwise complete application or to assist the Agency in the underwriting process. If the application is determined to be complete, RUS will review the package for eligibility and technical and financial feasibility, in accordance with 7 CFR part 1738. If an application is ultimately found to be incomplete or inadequate, a detailed explanation will be provided to the applicant.
To further assist in the preparation of applications, an application guide is available online at:
Loans under this authority will not be made for less than $100,000. The maximum loan amount that will be considered for FY 2019 is $25,000,000.
The regulation for the Broadband Program requires that certain definitions affecting eligibility be revised and published from time to time by the Agency in the
Applications for FY 2019 will be accepted from the publication date of this NOSA through September 30, 2019. Although review of applications will begin as they are submitted, all applications will be evaluated and ranked every 90 days based on the percentage of unserved households in the proposed funded service area. Subject to available funding, eligible applications that propose to serve a higher percentage of unserved households will receive funding offers before other eligible applications that propose to serve a lower percentage of unserved households. The amount available will be published on the Agency web page once all budgetary allocations have been completed.
Loan offers are limited to the funds available at the time of the Agency's decision to approve an application.
Applications will not be accepted after September 30, 2019, until a new application opportunity has been opened with the publication of an additional NOSA in the
In accordance with the Paperwork Reduction Act of 1995, the information collection requirements associated with Broadband loans, as covered in this NOSA, have been approved by the Office of Management and Budget (OMB) under OMB Control Number 0572-0130.
In accordance with Federal civil rights law and 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 (
Individuals who wish to file a Program Discrimination Complaint must complete the USDA Program Discrimination Complaint Form (PDF). To file a program discrimination complaint, you may obtain a complaint form by sending an email to
Send the completed complaint form or letter by mail to the U.S. Department of Agriculture, Director, Office of Adjudication, 1400 Independence Avenue SW, Washington, DC 20250-9410, or email at
USDA is an equal opportunity provider, employer, and lender.
U.S. Commission on Civil Rights.
Announcement of meeting.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act that the Florida Advisory Committee (Committee) will hold a meeting on Monday, December 3, 2018, at 1:00 p.m. (EST) for the purpose discussing civil rights concerns in the state.
The meeting will be held on Monday, December 3, 2018, at 1:00 p.m. (EST).
Jeff Hinton, DFO, at
Members of the public can listen to the discussion. This meeting is available to the public through the toll-free call-in number dial: 877-260-1479, Conference ID: 5812789. An open comment period will be provided to allow members of the public to make a statement as time allows. The conference call operator will ask callers to identify themselves, the organization they are affiliated with (if any), and an email address prior to placing callers into the conference room. Callers can expect to incur regular charges for calls they initiate over wireless lines, according to their wireless plan. The Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1-800-877-8339 and providing the Service with the conference call number and conference ID number.
Written comments may be mailed to the Regional Program Unit Office, U.S. Commission on Civil Rights, 230 S Dearborn St., Suite 2120, Chicago, IL 60604. They may also be faxed to the Commission at (312) 353-8324 or may be emailed to the Regional Director, Jeff Hinton at
Commission on Civil Rights.
Announcement of meetings.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission), and the Federal Advisory Committee Act (FACA), that a planning meeting of the North Dakota Advisory Committee to the Commission will by teleconference at 12:00 p.m. (CST) on Wednesday, December 5, 2018. The purpose of the meeting is for project and briefing planning.
Wednesday, December 5, 2018, at 12:00 p.m. MDT.
Evelyn Bohor, at
Interested members of the public may listen to the discussion by calling the following toll-free conference call-in number: 1-877-260-1479 and conference call 9602962. Please be advised that before placing them into the conference call, the conference call operator will ask callers to provide their names, their organizational affiliations (if any), and email addresses (so that callers may be notified of future meetings). Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free conference call-in number.
Persons with hearing impairments may also follow the discussion by first calling the Federal Relay Service at 1-800-877-8339 and providing the operator with the toll-free conference call-in number: 1-877-260-1479 and conference call 9602962.
Members of the public are invited to make statements during the open comment period of the meeting or submit written comments. The comments must be received in the regional office approximately 30 days after each scheduled meeting. Written comments may be mailed to the Rocky Mountain Regional Office, U.S. Commission on Civil Rights, 1961 Stout Street, Suite 13-201, Denver, CO 80294, faxed to (303) 866-1040, or emailed to Evelyn Bohor at
Records and documents discussed during the meeting will be available for public viewing as they become available at
The Department of Commerce will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35).
This information collection request may be viewed at
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
The application to reorganize FTZ 283 to expand the service area under the ASF is approved, subject to the FTZ Act and the Board's regulations, including Section 400.13, and to the Board's standard 2,000-acre activation limit for the zone.
The Piedmont Triad Partnership, grantee of FTZ 230, submitted a notification of proposed production activity to the FTZ Board on behalf of Patheon Softgels (Patheon), located in High Point, North Carolina. The notification conforming to the requirements of the regulations of the FTZ Board (15 CFR 400.22) was received on November 7, 2018.
Patheon already has authority to produce certain prescription pharmaceutical products and soft gelatin capsules within Subzone 230C. The current request would add a finished product and a foreign status material/component to the scope of authority. Pursuant to 15 CFR 400.14(b), additional FTZ authority would be limited to the specific foreign-status material/component and specific finished product described in the submitted notification (as described below) and subsequently authorized by the FTZ Board.
Production under FTZ procedures could exempt Patheon from customs duty payments on the foreign-status material/component used in export production. On its domestic sales, for the foreign-status material/component noted below and in the existing scope of authority, Patheon would be able to choose the duty rate during customs entry procedures that applies to gelatin encapsulated mono methyl fumarate capsule (duty-free). Patheon would be able to avoid duty on foreign-status components which become scrap/waste. Customs duties also could possibly be deferred or reduced on foreign-status production equipment.
The material/component sourced from abroad is Mono Methyl Fumarate (duty rate 6.5%). The request indicates the material/component is subject to special duties under Section 301 of the Trade Act of 1974 (Section 301), depending on the country of origin. The applicable Section 301 decisions require subject merchandise to be admitted to FTZs in privileged foreign status (19 CFR 146.41).
Public comment is invited from interested parties. Submissions shall be addressed to the Board's Executive Secretary at the address below. The closing period for their receipt is December 26, 2018.
A copy of the notification will be available for public inspection at the Office of the Executive Secretary, Foreign-Trade Zones Board, Room 21013, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230-0002, and in the “Reading Room” section of the Board's website, which is accessible via
For further information, contact Christopher Wedderburn at
The amended application to reorganize FTZ 81 under the ASF is approved, subject to the FTZ Act and the Board's regulations, including Section 400.13, to the Board's standard 2,000-acre activation limit for the zone, to an ASF sunset provision for magnet sites that would terminate authority for Sites 1, 2, 4 and 5 if not activated within five years from the month of approval, and to an ASF sunset provision for usage-driven sites that would terminate authority for Site 6 if no foreign-status merchandise is admitted for a
The application to reorganize FTZ 9 under the ASF is approved, subject to the FTZ Act and the Board's regulations, including Section 400.13, to the Board's standard 2,000-acre activation limit for the zone, to an ASF sunset provision for magnet sites that would terminate authority for Sites 2, 3, 4 and 9 if not activated within five years from the month of approval and to an ASF sunset provision for usage-driven sites that would terminate authority for Sites 1, 6, 7 and 8 if no foreign-status merchandise is admitted to the sites for a
On July 11, 2018, CNH Industrial America LLC submitted a notification of proposed production activity to the FTZ Board for its facility within Subzone 41I, in Sturtevant, Wisconsin.
The notification was processed in accordance with the regulations of the FTZ Board (15 CFR part 400), including notice in the
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Commerce) has received requests to conduct administrative reviews of various antidumping and countervailing duty orders and findings with September anniversary dates. In accordance with Commerce's regulations, we are initiating those administrative reviews.
Applicable November 15, 2018.
Brenda E. Brown, Office of AD/CVD Operations, Customs Liaison Unit, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230, telephone: (202) 482-4735.
Commerce has received timely requests, in accordance with 19 CFR 351.213(b), for administrative reviews of various antidumping and countervailing duty orders and findings with September anniversary dates.
All deadlines for the submission of various types of information, certifications, or comments or actions by Commerce discussed below refer to the number of calendar days from the applicable starting time.
If a producer or exporter named in this notice of initiation had no exports, sales, or entries during the period of review (POR), it must notify Commerce within 30 days of publication of this notice in the
In the event Commerce limits the number of respondents for individual examination for administrative reviews initiated pursuant to requests made for the orders identified below, Commerce intends to select respondents based on U.S. Customs and Border Protection (CBP) data for U.S. imports during the period of review. We intend to place the CBP data on the record within five days of publication of the initiation notice and to make our decision regarding respondent selection within 30 days of publication of the initiation
In the event Commerce decides it is necessary to limit individual examination of respondents and conduct respondent selection under section 777A(c)(2) of the Act:
In general, Commerce has found that determinations concerning whether particular companies should be “collapsed” (
Pursuant to 19 CFR 351.213(d)(1), a party that has requested a review may withdraw that request within 90 days of the date of publication of the notice of initiation of the requested review. The regulation provides that Commerce may extend this time if it is reasonable to do so. Determinations by Commerce to extend the 90-day deadline will be made on a case-by-case basis.
Section 504 of the Trade Preferences Extension Act of 2015 amended the Act by adding the concept of particular market situation (PMS) for purposes of constructed value under section 773(e) of the Act.
Neither section 773(e) of the Act nor 19 CFR 351.301(c)(v) set a deadline for
In proceedings involving non-market economy (NME) countries, Commerce begins with a rebuttable presumption that all companies within the country are subject to government control and, thus, should be assigned a single antidumping duty deposit rate. It is Commerce's policy to assign all exporters of merchandise subject to an administrative review in an NME country this single rate unless an exporter can demonstrate that it is sufficiently independent so as to be entitled to a separate rate.
To establish whether a firm is sufficiently independent from government control of its export activities to be entitled to a separate rate, Commerce analyzes each entity exporting the subject merchandise. In accordance with the separate rates criteria, Commerce assigns separate rates to companies in NME cases only if respondents can demonstrate the absence of both
All firms listed below that wish to qualify for separate rate status in the administrative reviews involving NME countries must complete, as appropriate, either a separate rate application or certification, as described below. For these administrative reviews, in order to demonstrate separate rate eligibility, Commerce requires entities for whom a review was requested, that were assigned a separate rate in the most recent segment of this proceeding in which they participated, to certify that they continue to meet the criteria for obtaining a separate rate. The Separate Rate Certification form will be available on Commerce's website at
Entities that currently do not have a separate rate from a completed segment of the proceeding
For exporters and producers who submit a separate-rate status application or certification and subsequently are selected as mandatory respondents, these exporters and producers will no longer be eligible for separate rate status unless they respond to all parts of the questionnaire as mandatory respondents.
In accordance with 19 CFR 351.221(c)(1)(i), we are initiating administrative reviews of the following antidumping and countervailing duty orders and findings. We intend to issue the final results of these reviews not later than September 30, 2019.
None
During any administrative review covering all or part of a period falling between the first and second or third and fourth anniversary of the publication of an antidumping duty order under 19 CFR 351.211 or a determination under 19 CFR 351.218(f)(4) to continue an order or suspended investigation (after sunset review), the Secretary, if requested by a domestic interested party within 30 days of the date of publication of the notice of initiation of the review, will determine whether antidumping duties have been absorbed by an exporter or producer subject to the review if the subject merchandise is sold in the United States through an importer that is affiliated with such exporter or producer. The request must include the name(s) of the exporter or producer for which the inquiry is requested.
For the first administrative review of any order, there will be no assessment of antidumping or countervailing duties on entries of subject merchandise entered, or withdrawn from warehouse, for consumption during the relevant provisional-measures “gap” period, of the order, if such a gap period is applicable to the POR.
Interested parties must submit applications for disclosure under administrative protective orders in accordance with the procedures outlined in Commerce's regulations at 19 CFR 351.305. Those procedures apply to administrative reviews included in this notice of initiation. Parties wishing to participate in any of these administrative reviews should ensure that they meet the requirements of these procedures (
Commerce's regulations identify five categories of factual information in 19 CFR 351.102(b)(21), which are summarized as follows: (i) Evidence submitted in response to questionnaires; (ii) evidence submitted in support of allegations; (iii) publicly available information to value factors under 19 CFR 351.408(c) or to measure the adequacy of remuneration under 19 CFR 351.511(a)(2); (iv) evidence placed on the record by Commerce; and (v) evidence other than factual information described in (i)-(iv). These regulations require any party, when submitting factual information, to specify under which subsection of 19 CFR 351.102(b)(21) the information is being submitted and, if the information is submitted to rebut, clarify, or correct factual information already on the record, to provide an explanation identifying the information already on the record that the factual information seeks to rebut, clarify, or correct. The regulations, at 19 CFR 351.301, also provide specific time limits for such factual submissions based on the type of factual information being submitted. Please review the final rule, available at
Any party submitting factual information in an antidumping duty or countervailing duty proceeding must certify to the accuracy and completeness of that information.
Parties may request an extension of time limits before a time limit established under part 351 expires, or as otherwise specified by the Secretary.
These initiations and this notice are in accordance with section 751(a) of the Act (19 U.S.C. 1675(a)) and 19 CFR 351.221(c)(1)(i).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Commerce) preliminarily determines that critical circumstances exist with respect to imports of certain quartz surface products (quartz surface products) from certain producers and
Applicable November 15, 2018.
Darla Brown, AD/CVD Operations, Office II, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone (202) 482-1791.
On April 17, 2018, Commerce received a countervailing duty (CVD) petition concerning imports of quartz surface products from China filed in proper form on behalf of the petitioner, Cambria Company LLC.
Commerce selected Fasa Industrial Corporation, Limited (Fasa Industrial), Foshan Yixin Stone Co., Ltd. (Foshan Yixin), and Foshan Hero Stone Co., Ltd. (Hero Stone) as the individually-examined respondents in this investigation. With respect to Hero Stone and Fasa Industrial, in the
On October 9, 2018, the petitioner alleged that critical circumstances exist with respect to imports of quartz surface products from China, pursuant to section 703(e)(1) of the Act and 19 CFR 351.206.
In accordance with 19 CFR 351.206(c)(1), if the petitioner submits an allegation of critical circumstances 30 days or more before the scheduled date of the final determination,
The POI is January 1, 2017, through December 31, 2017.
The petitioner alleged a massive increase of imports of certain quartz surface products from China and provided monthly import data for the period January 2017 through August 2018.
Section 703(e)(1) of the Act provides that Commerce will preliminarily determine that critical circumstances exist if there is a reasonable basis to believe or suspect that: (A) The alleged countervailable subsidy is inconsistent with the SCM Agreement;
In determining whether there are “massive imports” over a “relatively short period,” pursuant to section 703(e)(1)(B) of the Act and 19 CFR 351.206(h) and (i), Commerce normally compares the import volumes of the subject merchandise for at least three months immediately preceding the filing of the petition (
In the
As explained in our
Because we preliminarily find that the “Export Assistance Grants” program is export contingent, we preliminarily find that the criterion under section 703(e)(1)(A) of the Act has been met. In addition, for the purposes of the “massive imports” analysis, we preliminarily determine, pursuant to section 776(b) of the Act, that Fasa Industrial and Hero Stone shipped quartz surface products in “massive” quantities during the comparison period, thereby fulfilling the criteria under section 703(e)(1)(B) of the Act.
We based the all-others rate applied in the
We will make a final determination concerning critical circumstances in the final determination of this investigation, which is currently scheduled for January 28, 2019.
Case briefs or other written comments may be submitted to the Assistant Secretary for Enforcement and Compliance no later than seven days after the date on which the last verification report is issued in this investigation. Rebuttal briefs, limited to issues raised in case briefs, may be submitted no later than five days after the deadline date for case briefs.
Electronically filed documents must be received successfully in their entirety by 5:00 p.m. Eastern Time on the due dates established above.
In accordance with section 703(e)(2)(A) of the Act, for Fasa Industrial and Hero Stone, we will direct U.S. Customs and Border Protection (CBP) to suspend liquidation of any unliquidated entries of subject merchandise from the China entered, or withdrawn from warehouse for consumption, on or after June 23, 2018, which is 90 days prior to the date of publication of the
In accordance with section 703(f) of the Act, we will notify the ITC of this preliminary determination of critical circumstances.
This determination is issued and published pursuant to sections 703(f) and 777(i)(1) of the Act.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Commerce) determines that common alloy aluminum sheet (common alloy sheet) from the People's Republic of China (China) is being, or is likely to be, sold in the United States at less-than-fair value (LTFV) for the period of investigation (POI) April 1, 2017, through September 30, 2017.
Applicable November 15, 2018.
Scott Hoefke or Julie Geiger, AD/CVD Operations, Office VI, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone (202) 482-4947 and (202) 482-2057, respectively.
On June 6, 2018, Commerce published in the
The Issues and Decision Memorandum is a public document and is on file electronically
We invited parties to comment on Commerce's Scope Comments Preliminary Decision Memorandum.
Commerce conducted this investigation in accordance with section 731 of the Tariff Act of 1930, as amended (the Act). For a full description of the methodology underlying our final determination,
The merchandise covered by this investigation is common alloy sheet from China. For a complete description of the scope of this investigation,
As provided in section 782(i) of the Act, in July, we conducted verification of the questionnaire responses submitted by Henan Mingtai Industrial Co., Ltd. and Zhengzhou Mingtai (collectively, Mingtai). We issued verification reports on August 28, 2018.
The POI is April 1, 2017, through September 30, 2017.
The issues raised in the case and rebuttal briefs that were submitted by parties are discussed in the Issues and Decision Memorandum. A list of the issues that parties raised, and to which we responded in the Issues and Decision Memorandum, is attached to this notice at Appendix II.
In the
For the final determination we continue to rely upon facts otherwise available, with adverse inferences (AFA), for the China-wide entity, the Yongjie Companies, and GKO Aluminium, pursuant to sections 776(a) and (b) of the Act.
Based on our review and analysis of the comments received from parties, and minor corrections presented at verification, we made certain changes to Mingtai's margin calculation since the
• We revised the surrogate value for Mingtai's argon factor of production using data from Bulgaria instead of South Africa.
• We revised the surrogate value for Mingtai's prompt aluminum scrap factor of production.
• We revised Mingtai's normal value calculation by: (1) Disallowing a claimed by-product offset; and (2) treating run-around aluminum scrap as a direct material input, not as a by-product.
For the final determination, we continue to find that the China-wide entity, which includes certain Chinese exporters and/or producers that did not respond to Commerce's requests for information, including mandatory respondents GKO Aluminium and the Yongjie Companies, failed to provide necessary information, failed to provide information in a timely manner, and significantly impeded this proceeding by not submitting the requested information. We also continue to find that the China-wide entity failed to cooperate to the best of its ability. As a result, we continue to rely on AFA in determining the rate for the China-wide entity and, as AFA, we select the highest rate listed in the initiation of the investigation (
Consistent with
The final weighted-average antidumping margins are as follows:
We intend
In accordance with section 735(c)(1)(B) of the Act, for this final determination, we will direct U.S. Customs and Border Protection (CBP) to continue to suspend liquidation of all entries of common alloy sheet from China, as described in Appendix I of this notice, which are entered, or withdrawn from warehouse, for consumption on or after June 6, 2018, the date of publication in the
In accordance with section 735(d) of the Act, we will notify the International Trade Commission (ITC) of the final affirmative determination of sales at LTFV. Because Commerce's final determination is affirmative, in accordance with section 735(b)(2) of the Act, the ITC will make its final determination as to whether the domestic industry in the United States is materially injured, or threatened with material injury, by reason of imports or sales (or the likelihood of sales) for importation of common alloy sheet, no later than 45 days after this final determination. If the ITC determines that such injury does not exist, this proceeding will be terminated and all cash deposits posted will be refunded. If the ITC determines that such injury does exist, Commerce will issue an antidumping duty order directing CBP to assess, upon further instruction by Commerce, antidumping duties on all imports of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the effective date of the suspension of liquidation, as discussed above in the “Suspension of Liquidation” section.
This notice will serve as a reminder to the parties subject to administrative protective order (APO) of their responsibility concerning the disposition of propriety information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of return or destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a sanctionable violation.
In the event the ITC issues a final negative injury determination, this notice serves as the only reminder to parties subject to an APO of their responsibility concerning the destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of the return or destruction of APO materials, or conversion to judicial protective order, is hereby requested. Failure to comply
This determination is issued and published in accordance with sections 735(d) and 777(i)(1) of the Act and 19 CFR 351.210(c).
The merchandise covered by this investigation is aluminum common alloy sheet (common alloy sheet), which is a flat-rolled aluminum product having a thickness of 6.3 mm or less, but greater than 0.2 mm, in coils or cut-to-length, regardless of width. Common alloy sheet within the scope of this investigation includes both not clad aluminum sheet, as well as multi-alloy, clad aluminum sheet. With respect to not clad aluminum sheet, common alloy sheet is manufactured from a 1XXX-, 3XXX-, or 5XXX-series alloy as designated by the Aluminum Association. With respect to multi-alloy, clad aluminum sheet, common alloy sheet is produced from a 3XXX-series core, to which cladding layers are applied to either one or both sides of the core.
Common alloy sheet may be made to ASTM specification B209-14, but can also be made to other specifications. Regardless of specification, however, all common alloy sheet meeting the scope description is included in the scope. Subject merchandise includes common alloy sheet that has been further processed in a third country, including but not limited to annealing, tempering, painting, varnishing, trimming, cutting, punching, and/or slitting, or any other processing that would not otherwise remove the merchandise from the scope of the investigations if performed in the country of manufacture of the common alloy sheet.
Excluded from the scope of this investigation is aluminum can stock, which is suitable for use in the manufacture of aluminum beverage cans, lids of such cans, or tabs used to open such cans. Aluminum can stock is produced to gauges that range from 0.200 mm to 0.292 mm, and has an H-19, H-41, H-48, or H-391 temper. In addition, aluminum can stock has a lubricant applied to the flat surfaces of the can stock to facilitate its movement through machines used in the manufacture of beverage cans. Aluminum can stock is properly classified under Harmonized Tariff Schedule of the United States (HTSUS) subheadings 7606.12.3045 and 7606.12.3055.
Where the nominal and actual measurements vary, a product is within the scope if application of either the nominal or actual measurement would place it within the scope based on the definitions set for the above.
Common alloy sheet is currently classifiable under HTSUS subheadings 7606.11.3060, 7606.11.6000, 7606.12.3090, 7606.12.6000, 7606.91.3090, 7606.91.6080, 7606.92.3090, and 7606.92.6080. Further, merchandise that falls within the scope of this investigation may also be entered into the United States under HTSUS subheadings 7606.11.3030, 7606.12.3030, 7606.91.3060, 7606.91.6040, 7606.92.3060, 7606.92.6040, 7607.11.9090. Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the scope of this investigation is dispositive.
Notice of issuance of an amended Export Trade Certificate of Review to Alaska Longline Cod Commission (“ALCC”), Application No. 10-4A001.
The Secretary of Commerce, through the Office of Trade and Economic Analysis (“OTEA”), issued an amended Export Trade Certificate of Review to ALCC on November 7, 2018.
Joseph Flynn, Director, OTEA, International Trade Administration, by telephone at (202) 482-5131 (this is not a toll-free number) or email at
Title III of the Export Trading Company Act of 1982 (15 U.S.C. 4001-21) (“the Act”) authorizes the Secretary of Commerce to issue Export Trade Certificates of Review. An Export Trade Certificate of Review protects the holder and the members identified in the Certificate from State and Federal government antitrust actions and from private treble damage antitrust actions for the export conduct specified in the Certificate and carried out in compliance with its terms and conditions. The regulations implementing Title III are found at 15 CFR part 325 (2018). OTEA is issuing this notice pursuant to 15 CFR 325.6(b), which requires the Secretary of Commerce to publish a summary of the certification in the
ALCC's Export Trade Certificate of Review has been amended to:
1. Add the following companies as new Members of the Certificate within the meaning of section 325.2(l) of the Regulations (15 CFR 325.2(l)):
2. Delete the following companies as Members of the Certificate:
3. Change/correct the name or location of the following Members of the Certificate:
The effective date of the amended Certificate is August 9, 2018, the date on which ALCC's application to amend was deemed submitted.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Commerce) preliminarily determines that Diamond Tools Technology (Thailand) Co., Ltd. (Diamond Tools) is circumventing the antidumping duty order on diamond sawblades and parts thereof (diamond sawblades) from the People's Republic of China (China).
Applicable November 15, 2018.
Yang Jin Chun, AD/CVD Operations Office I, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-5760.
On December 7, 2017, in response to a request from Diamond Sawblades Manufacturers' Coalition (the petitioner), Commerce published the initiation of the anti-circumvention inquiry to determine whether certain imports of diamond sawblades comprised of cores and segments produced in China and joined into diamond sawblades in, and exported from, Thailand by Diamond Tools are circumventing the antidumping duty order on diamond sawblades from China.
The merchandise subject to the order is diamond sawblades. The diamond sawblades subject to the order are currently classifiable under subheadings 8202 to 8206 of the Harmonized Tariff Schedule of the United States (HTSUS), and may also enter under subheading 6804.21.00. The HTSUS subheadings are provided for convenience and customs purposes. A full description of the scope of the order is contained in the Preliminary Decision Memorandum.
We initiated this anti-circumvention inquiry to cover diamond sawblades produced in Thailand by Diamond Tools with cores and segments produced in China and subsequently exported from Thailand to the United States.
Commerce is conducting this anti-circumvention inquiry in accordance with section 781(b) of the Tariff Act of 1930, as amended (the Act), and 19 CFR 351.225(h). Because China is a non-market economy country within the meaning of section 771(18) of the Act, Commerce relied on surrogate values to value the purchases of Chinese cores and Chinese segments, as discussed in section 773(c) of the Act. For a full description of the methodology underlying our conclusions,
As detailed in the Preliminary Decision Memorandum, Commerce preliminarily determines that diamond sawblades produced by Diamond Tools in Thailand using cores and/or segments from China and exported from Thailand to the United States are circumventing the antidumping duty order on diamond sawblades from China. We therefore preliminarily determine that it is appropriate to include this merchandise within the antidumping duty order on diamond sawblades from China and to instruct U.S. Customs and Border Protection (CBP) to suspend entries of merchandise produced using Chinese cores and/or Chinese segments by Diamond Tools in Thailand and exported to the United States.
As stated above, Commerce has made a preliminary affirmative finding of circumvention of the antidumping duty order on diamond sawblades from China for diamond sawblades assembled or completed using Chinese cores and/or Chinese segments as inputs by Diamond Tools in Thailand and exported to the United States. This preliminary circumvention finding applies to diamond sawblades assembled or completed using Chinese cores and/or Chinese segments as inputs by Diamond Tools in Thailand. In accordance with section 19 CFR 351.225(l)(2), Commerce will direct CBP to suspend liquidation and to require a cash deposit of estimated duties on unliquidated entries of diamond sawblades produced (
Diamond sawblades assembled or completed in Thailand using both non-Chinese origin cores and non-Chinese origin segments are not subject to this anti-circumvention inquiry. However, for the reasons stated in the Preliminary Analysis Memorandum, Commerce finds that Diamond Tools is not currently able to identify diamond sawblades produced with non-Chinese origin cores and non-Chinese origin segments.
Commerce intends to disclose the analysis used in these preliminary findings within five days of publication of this notice. Interested parties are invited to comment on the preliminary determination of this anti-circumvention inquiry. Pursuant to 19 CFR 351.309(b)(2), interested parties may submit case briefs not later than 30 days after the date of publication of this notice. Rebuttal briefs, limited to issues raised in the case briefs, may not be filed later than five days after the time limit for filing case briefs.
Any interested party who wishes to request a hearing, or to participate if one is requested, must submit a written request to the Assistant Secretary for Enforcement and Compliance within 30 days after the day of publication of this notice pursuant to 19 CFR 351.310(c). A request should contain: (1) The party's name, address, and telephone number; (2) the number of participants; (3) whether any participant is a foreign national; and (4) a list of issues to be discussed. If a request for a hearing is made, then Commerce intends to hold the hearing at the U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230, at a time and date to be determined. Parties should confirm by telephone the date, time, and location of the hearing two days before the scheduled date. Issues raised in the hearing will be limited to those raised in case and rebuttal briefs.
Consistent with section 781(e) of the Act, Commerce will notify the International Trade Commission (ITC) of this preliminary determination to include the merchandise subject to this anti-circumvention inquiry within the antidumping duty order on diamond sawblades from China. Pursuant to section 781(e) of the Act, the ITC may request consultations concerning Commerce's proposed inclusion of the subject merchandise. If, after consultations, the ITC believes that a significant injury issue is presented by the proposed inclusion, it will have 60 days from the date of notification by Commerce to provide written advice.
According to section 781(f) of the Act, Commerce shall, to the maximum extent practicable, make its anti-circumvention determination within 300 days from the date of the initiation of the inquiry.
This preliminary affirmative circumvention determination is published in accordance with section 781(b) of the Act and 19 CFR 351.225(f).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Commerce) determines that countervailable subsidies are being provided to producers and exporters of common alloy aluminum sheet (common alloy sheet) from the People's Republic of China (China) for the period of investigation (POI) January 1, 2016, through December 31, 2016.
Applicable November 15, 2018.
Yasmin Bordas, Lana Nigro, or John Anwesen, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-3813, (202) 482-1779, or (202) 482-0131, respectively.
On April 23, 2018, Commerce published in the
The Issues and Decision Memorandum is a public document and is on file electronically
We invited parties to comment on Commerce's Scope Comments Preliminary Decision Memorandum.
Commerce conducted this countervailing duty (CVD) investigation in accordance with section 701 of the Tariff Act of 1930, as amended (Act). For each of the subsidy programs found to be countervailable, we determine that there is a subsidy (
The merchandise covered by this investigation is common alloy sheet from China. For a complete description of the scope of this investigation,
As provided in section 782(i) of the Act, in June 2018, we conducted verification of the questionnaire responses submitted by Henan Mingtai Industrial Co., Ltd. and Zhengzhou Mingtai (collectively, Mingtai); and Yong Jie New Material Co., Ltd. (Yong Jie New Material). We issued verification reports on July 3, 2018.
The POI is January 1, 2016, through December 31, 2016.
The subsidy programs under investigation, and the issues raised in the case and rebuttal briefs submitted by the parties, are discussed in the Issues and Decision Memorandum. A list of the issues that parties raised, and to which we responded in the Issues and Decision Memorandum, is attached to this notice at Appendix II.
In the
For purposes of this final determination, we relied on facts available, and because certain respondents did not act to the best of their ability in responding to Commerce's requests for information, we drew an adverse inference, where appropriate, in selecting from among the facts otherwise available.
Based on our review and analysis of the comments received from parties, and minor corrections presented at verification, we made certain changes to the respondents' subsidy rate calculations since the
In accordance with section 705(c)(1)(B)(i) of the Act, we calculated an individual rate for each producer/exporter of the subject merchandise individually investigated.
In accordance with section 705(c)(5)(A) of the Act, for companies not individually investigated, we apply an “all-others” rate, which is normally calculated by weighting the subsidy rates of the individual companies selected as mandatory respondents by those companies' exports of the subject merchandise to the United States. Under section 705(c)(5)(A)(i) of the Act, the “all-others” rate excludes zero and
Pursuant to section 705(c)(5)(A)(i) of the Act, we calculated the “all-others” rate using the subsidy rates of Mingtai and Yong Jie New Material, the only two mandatory respondents not receiving a subsidy rate based totally on section 776 of the Act. However, we have not calculated the “all-others” rate by weight-averaging these two rates because doing so risks disclosure of proprietary information.
We intend to disclose to parties in this proceeding the calculations performed for this final determination within five days of the date of public announcement of our final determination, in accordance with 19 CFR 351.224(b).
As a result of our
If the U.S. International Trade Commission (the ITC) issues a final affirmative injury determination, we will issue a CVD order, will reinstate the suspension of liquidation under section 706(a) of the Act, and will require a cash deposit of estimated CVDs for such entries of subject merchandise in the amounts indicated above. If the ITC determines that material injury, or threat of material injury, does not exist, this proceeding will be terminated, and all estimated duties deposited or securities posted as a result of the suspension of liquidation will be refunded or canceled.
In accordance with section 705(d) of the Act, we will notify the ITC of our determination. In addition, we are making available to the ITC all non-privileged and non-proprietary information related to this investigation. We will allow the ITC access to all privileged and business proprietary information in our files, provided the ITC confirms that it will not disclose such information, either publicly or under an administrative protective order (APO), without the written consent of the Assistant Secretary for Enforcement and Compliance.
This notice also serves as a reminder to parties subject to administrative protective orders (APOs) of their responsibility concerning the disposition of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of the return or destruction of APO materials or conversion to judicial protective order, is hereby requested. Failure to comply with the regulations and the terms of an APO is a sanctionable violation.
In the event the ITC issues a final negative injury determination, this
This determination is issued and published pursuant to sections 705(d) and 777(i) of the Act.
The merchandise covered by the investigation is aluminum common alloy sheet (common alloy sheet), which is a flat-rolled aluminum product having a thickness of 6.3 mm or less, but greater than 0.2 mm, in coils or cut-to-length, regardless of width. Common alloy sheet within the scope of the investigation includes both not clad aluminum sheet, as well as multi-alloy, clad aluminum sheet. With respect to not clad aluminum sheet, common alloy sheet is manufactured from a 1XXX-, 3XXX-, or 5XXX-series alloy as designated by the Aluminum Association. With respect to multi-alloy, clad aluminum sheet, common alloy sheet is produced from a 3XXX-series core, to which cladding layers are applied to either one or both sides of the core.
Common alloy sheet may be made to ASTM specification B209-14, but can also be made to other specifications. Regardless of specification, however, all common alloy sheet meeting the scope description is included in the scope. Subject merchandise includes common alloy sheet that has been further processed in a third country, including but not limited to annealing, tempering, painting, varnishing, trimming, cutting, punching, and/or slitting, or any other processing that would not otherwise remove the merchandise from the scope of the investigation if performed in the country of manufacture of the common alloy sheet.
Excluded from the scope of the investigation is aluminum can stock, which is suitable for use in the manufacture of aluminum beverage cans, lids of such cans, or tabs used to open such cans. Aluminum can stock is produced to gauges that range from 0.200 mm to 0.292 mm, and has anH-19, H-41, H-48, or H-391 temper. In addition, aluminum can stock has a lubricant applied to the flat surfaces of the can stock to facilitate its movement through machines used in the manufacture of beverage cans. Aluminum can stock is properly classified under Harmonized Tariff Schedule of the United States (HTSUS) subheadings 7606.12.3045 and 7606.12.3055.
Where the nominal and actual measurements vary, a product is within the scope if application of either the nominal or actual measurement would place it within the scope based on the definitions set for the above.
Common alloy sheet is currently classifiable under HTSUS subheadings 7606.11.3060, 7606.11.6000, 7606.12.3090, 7606.12.6000, 7606.91.3090, 7606.91.6080, 7606.92.3090, and 7606.92.6080. Further, merchandise that falls within the scope of these investigation may also be entered into the United States under HTSUS subheadings 7606.11.3030, 7606.12.3030, 7606.91.3060, 7606.91.6040, 7606.92.3060, 7606.92.6040, 7607.11.9090. Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the scope of this investigation is dispositive.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Commerce) finds that Jiaxing Brother Fastener Co., Ltd. (Jiaxing Brother), RMB Fasteners Ltd. (RMB), and IFI & Morgan Ltd. (IFI), collectively RMB/IFI, had no shipments during the period of review (POR), April 1, 2016, through March 31, 2017. We also continue to find that Fastenal Canada Ltd. (Fastenal Canada) did not cooperate to the best of its ability and have based its margin on adverse facts available (AFA) for these final results.
Applicable November 15, 2018.
Paul Walker, AD/CVD Operations, Office V, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: 202.482.0413.
On May 17, 2018, Commerce published the
Commerce conducted this administrative review in accordance with section 751 of the Tariff Act of 1930, as amended (the Act).
The merchandise covered by the order includes steel threaded rod. The subject merchandise is currently classifiable under subheading 7318.15.5051, 7318.15.5056, 7318.15.5090, and 7318.15.2095 of the United States Harmonized Tariff Schedule (HTSUS). Although the HTSUS subheadings are provided for convenience and customs purposes, our written description of the scope of the order, which is contained in the accompanying Issues and Decision Memorandum (I&D Memo), is dispositive.
We addressed the issue raised in RMB/IFI's case brief in the I&D Memo dated concurrently with, and hereby adopted by, this notice. The issue it raised is attached in the Appendix to this notice. The I&D Memo is a public document and is on file in the Central Records Unit (CRU), Room B8024 of the main Commerce building, as well as electronically
In the
No interested party submitted comments on Commerce's preliminary determination to apply AFA to Fastenal Canada. Therefore, we have continued to apply AFA with respect to Fastenal Canada, and have continued to assign it an AFA rate of 206.00 percent. Moreover, we continue to find that Brother Holding Group Co. Ltd, and Zhejiang Morgan Brother Technology Co. Ltd. are a part of the China-wide entity and subject to its rate of 206.00 percent.
Pursuant to section 751(a)(2)(A) of the Act, and 19 CFR 351.212(b), Commerce has determined, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries of subject merchandise in accordance with the final results of this review. Commerce intends to issue appropriate assessment instructions directly to CBP 15 days after publication of the final results of this administrative review. Commerce will assess duties only on entries of subject merchandise (
Pursuant to Commerce's assessment practice, because we found it had no shipments, for all entries claiming RMB/IFI as the exporter or producer, Commerce will direct CBP to liquidate such entries and to assess antidumping duties pursuant to the
The following cash deposit requirements will be effective upon publication of the final results of this
Normally, Commerce discloses to interested parties the calculations performed in connection with the final results within five days of its public announcement, or if there is no public announcement, within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b). However, because Commerce has not calculated a weighted-average dumping margin for any respondent, there are no calculations to disclose.
This notice also serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.
This notice also serves as a reminder to parties subject to administrative protective order (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under the APO in accordance with 19 CFR 351.305(a)(3), which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of the return or destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and the terms of an APO is a violation subject to sanction.
We are issuing and publishing these results in accordance with sections 751(a)(1) and 777(i)(1) of the Act and 19 CFR 351.213(h) and 351.221(b)(5).
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of public meeting.
NMFS and the Northeast Regional Stock Assessment Workshop (SAW) will convene the 66th SAW Stock Assessment Review Committee for the purpose of reviewing stock assessments of Summer Flounder and Striped Bass. The Northeast Regional SAW is a formal scientific peer-review process for evaluating and presenting stock assessment results to managers for fish stocks in the offshore U.S. waters of the northwest Atlantic. Assessments are prepared by SAW working groups and reviewed by an independent panel of stock assessment experts called the Stock Assessment Review Committee, or SARC. The public is invited to attend the presentations and discussions between the review panel and the scientists who have participated in the stock assessment process.
The public portion of the Stock Assessment Review Committee Meeting will be held from November 27, 2018-November 30, 2018. The meeting will commence on November 27, 2018 at 10 a.m. Eastern Standard Time. Please see
The meeting will be held in the S.H. Clark Conference Room in the Aquarium Building of the National Marine Fisheries Service, Northeast Fisheries Science Center (NEFSC), 166 Water Street, Woods Hole, MA 02543.
James Weinberg, 508-495-2352; email:
For further information, please visit the NEFSC website at
The meeting is open to the public; however, during the `SARC Report Writing' session on Friday November 30th the public should not engage in discussion with the SARC.
This meeting is physically accessible to people with disabilities. Special requests should be directed to James Weinberg at the NEFSC, 508-495-2352, at least 5 days prior to the meeting date.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; proposed incidental harassment authorization; request for comments on proposed authorization and possible renewal.
NMFS has received a request from Space Exploration Technology Corporation (SpaceX) for authorization to take marine mammals incidental to boost-back and landing of Falcon 9 rockets at Vandenberg Air Force Base (VAFB) in California, and at contingency landing locations in the Pacific Ocean. Pursuant to the Marine Mammal Protection Act (MMPA), NMFS is requesting comments on its proposal to issue an incidental harassment authorization (IHA) to incidentally take marine mammals during the specified activities. NMFS is also requesting comments on a possible one-year renewal that could be issued under certain circumstances and if all requirements are met, as described in
Comments and information must be received no later than December 17, 2018.
Comments should be addressed to Jolie Harrison, Chief, Permits and Conservation Division, Office of Protected Resources, National Marine Fisheries Service. Physical comments should be sent to 1315 East-West Highway, Silver Spring, MD 20910 and electronic comments should be sent to
Amy Fowler, Office of Protected Resources, NMFS, (301) 427-8401. Electronic copies of the application and supporting documents, as well as a list of the references cited in this document, may be obtained online at:
The MMPA prohibits the “take” of marine mammals, with certain exceptions. Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361
Authorization for incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s) and will not have an unmitigable adverse impact on the availability of the species or stock(s) for taking for subsistence uses (where relevant). Further, NMFS must prescribe the permissible methods of taking and other means of effecting the least practicable adverse impact on the affected species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of such species or stocks for taking for certain subsistence uses (referred to in shorthand as “mitigation”); and requirements pertaining to the mitigation, monitoring and reporting of such takings are set forth.
To comply with the National Environmental Policy Act of 1969 (NEPA; 42 U.S.C. 4321
This action is consistent with categories of activities identified in Categorical Exclusion B4 (incidental harassment authorizations with no anticipated serious injury or mortality) of the Companion Manual for NOAA Administrative Order 216-6A, which do not individually or cumulatively have the potential for significant impacts on the quality of the human environment and for which we have not identified any extraordinary circumstances that would preclude this categorical exclusion. Accordingly, NMFS has preliminarily determined that the issuance of the proposed IHA qualifies to be categorically excluded from further NEPA review.
We will review all comments submitted in response to this notice prior to concluding our NEPA process
On August 30, 2018, NMFS received a request from SpaceX for an IHA to take marine mammals incidental to Falcon 9 First Stage recovery activities, including in-air boost-back maneuvers and landings of the First Stage of the Falcon 9 rocket at VAFB in California, and at contingency landing locations offshore. A revised application was received October 23, 2018. NMFS deemed that request to be adequate and complete. SpaceX's request is for take of a small number of six species by Level B harassment only. Neither SpaceX nor NMFS expects serious injury or mortality to result from this activity and, therefore, an IHA is appropriate.
NMFS has previously issued regulations and Letters of Authorization (LOA) that authorize the take of marine mammals, by Level B harassment, incidental to launches of up to 50 rockets per year (including the Falcon 9) from VAFB (79 FR 18528; April 2, 2014). The regulations, titled
Additionally, NMFS has previously issued two IHAs to SpaceX for similar activities (81 FR 34984, June 1, 2016; 82 FR 60954, December 26, 2017). SpaceX complied with all the requirements (
The Falcon 9 is a two-stage rocket designed and manufactured by SpaceX for transport of satellites and SpaceX's Dragon spacecraft into orbit. SpaceX currently operates the Falcon Launch Vehicle Program at Space Launch Complex 4 East (SLC-4E) at VAFB. SpaceX proposes regular employment of First Stage recovery by returning the Falcon 9 First Stage to SLC-4 West (SLC-4W) at VAFB for potential reuse, up to twelve times per year. This includes performing boost-back maneuvers (in-air) and landings of the Falcon 9 First Stage on the pad at SLC-4W. The reuse of the Falcon 9 First Stage enables SpaceX to efficiently conduct lower cost launch missions from VAFB in support of commercial and government clients.
During descent, a sonic boom (overpressure of high-energy impulsive sound) would be generated when the First Stage reaches a rate of travel that exceeds the speed of sound. Sonic booms would occur in proximity to the landing areas and may be heard during or after the boost-back and landing, depending on the location of the observer. Sound from the sonic boom would have the potential to result in harassment of marine mammals, either on the mainland at or near VAFB or at the Northern Channel Islands (NCI), as described in more detail later in this document.
SpaceX's activities are conducted throughout the year. Up to twelve Falcon 9 First Stage recovery activities would occur per year. Precise dates of Falcon 9 First Stage recovery activities are not known. Falcon 9 First Stage recovery activities may take place at any time of year and at any time of day. The IHA, if issued, would be valid for one year from the date of issuance.
Falcon 9 First Stage recovery activities will originate at VAFB. Areas potentially affected include VAFB, areas on the coastline surrounding VAFB, and the NCI. VAFB operates as a missile test base and aerospace center, supporting west coast space launch activities for the U.S. Air Force (USAF), Department of Defense, National Aeronautics and Space Administration, and commercial contractors. VAFB is the main west coast launch facility for placing commercial government, and military satellites into polar orbit on expendable (unmanned) launch vehicles, and for testing and evaluating intercontinental ballistic missiles and sub-orbital target and interceptor missiles.
VAFB occupies approximately 99,100 acres of central Santa Barbara County, California. VAFB is divided by the Santa Ynez River and State Highway 246 into two distinct parts: North Base and South Base. SLC-4W, the preferred landing location for the Falcon 9 First Stage, is located on South Base, approximately 0.5 miles (mi) (0.8 kilometers (km)) inland from the Pacific Ocean (see Figure 1-2 in the IHA application). SLC-4E, the launch facility for SpaceX's Falcon 9 program, is located approximately 715 feet (ft) (218 meters (m)) to the east of SLC-4W.
Although SLC-4W is the preferred landing location for the Falcon 9 First Stage, SpaceX has identified two contingency landing locations should it not be feasible to land the First Stage at SLC-4W. The first contingency landing location is on a barge located at least 27 nautical miles (nmi) (50 km) offshore of VAFB. The second contingency landing location is on a barge within the Iridium Landing Area, an approximately 12,800 square mile (mi
The Falcon 9 is a two-stage rocket designed and manufactured by SpaceX for transport of satellites into orbit. The First Stage of the Falcon 9 is designed to be reusable, while the second stage is not reusable. The Falcon 9 First Stage is
After launch of the Falcon 9, the boost-back and landing sequence begins when the rocket's First Stage separates from the second stage and the Merlin engines of the First Stage cut off. After First Stage engine cutoff, rather than dropping the First Stage in the Pacific Ocean, exoatmospheric cold gas thrusters would be triggered to flip the First Stage into position for retrograde burn. Three of the nine First Stage Merlin engines would be restarted to conduct the retrograde burn in order to reduce the velocity of the First Stage and to place the First Stage in the correct angle to land. Once the First Stage is in position and approaching its landing target, the three engines would cut off to end the boost-back burn. The First Stage would then perform a controlled descent using atmospheric resistance to slow the stage down and guide it to the landing pad target. The First Stage is outfitted with grid fins that allow cross range corrections as needed. The landing legs on the First Stage would then deploy in preparation for a final single engine burn that would slow the First Stage to a velocity of zero before landing on the landing pad at SLC-4W.
During descent, a sonic boom (overpressure of high-energy impulsive sound) would be generated when the First Stage reaches a rate of travel that exceeds the speed of sound. Sonic booms would occur in proximity to the landing area with the highest sound levels generated from sonic booms generally focused in the direction of the landing area, and may be heard during or briefly after the boost-back and landing, depending on the location of the receiver. Sound from the sonic booms would have the potential to result in harassment of marine mammals, as described in greater detail later in this document. Based on model results, a boost-back and landing of the Falcon 9 First Stage at SLC-4W would produce sonic booms with overpressures that would potentially be as high as 8.5 pounds per square foot (psf) at VAFB and potentially as high as 3.1 psf at the NCI (see Figures 2-2 and 2-5 in the IHA application). Sonic boom modeling indicates that landings that occur at either of the proposed contingency landing locations offshore would result in sonic booms with received overpressures below 1.0 psf at VAFB and the NCI. Take of pinnipeds that are hauled out of the water are expected to occur only when those hauled out pinnipeds experience sonic booms greater than 1.0 psf (discussed in greater detail below in the
As a contingency action to landing the Falcon 9 First Stage on the SLC-4W pad at VAFB, SpaceX proposes to return the Falcon 9 First Stage booster to a barge in the Pacific Ocean (Figure 1-6 in the IHA application). The maneuvering and landing process described above for a pad landing would be the same for a barge landing. Three vessels would be required to support a barge landing, if it were required: A barge/landing platform (300 ft (91 m) long and 150 ft (46 m) wide); a support vessel (165 ft (50 m) long research vessel); and an ocean tug (120 ft (37 m) long open water commercial tug).
Landing noise would be generated during each boost-back event. SpaceX proposes to use a three-engine burn during landing. This engine burn, lasting approximately 17 seconds, would generate noise between 70 and 110 decibels (dB) re 20 micro Pascals (µPa) (non-pulse, in-air noise) centered on SLC-4W, but affecting an area up to 15 nmi (27.8 km) offshore of VAFB (Figure 2-10 in the IHA application). This landing noise event would be of short duration (approximately 17 seconds). Although, during a landing event at SLC-4W, landing noise between 70 and 90 dB would be expected to overlap pinniped haulout areas at and near Point Arguello and Purisima Point, no pinniped haulouts would experience landing noises of 90 dB or greater (see Figure 2-10 in the IHA application).
NMFS's recommended acoustic thresholds for in-air acoustic impacts assume that Level B harassment of harbor seals may occur at 90 dB root mean square (rms) re 20 µPa and Level B harassment of all other pinnipeds may occur at 100 dB rms re 20 µPa. Therefore, harassment of marine mammals hauled out at VAFB from engine noise generated during landings is not expected to occur. Engine noise would also be produced during a contingency barge landing of the Falcon 9 First Stage. Engine noise during a barge landing is expected to be between 70 and 110 dB re 20 µPa affecting a radial area up to 15 nmi (27.8 km) around the contingency landing location (Figure 2-11 in the IHA application) and the Iridium 38 Landing Area (Figure 2-12 in the IHA application). No pinniped haulouts are located within the areas predicted to experience engine noise of 90 dB and above during Falcon 9 First Stage landings at contingency landing locations and the Iridium Landing Area (Figures 2-11 and 2-12 in the IHA application). Therefore, the likelihood of engine noise associated with the landing of the Falcon 9 First Stage resulting in take of marine mammals is considered so low as to be discountable, and landing noise is therefore not discussed further in this document.
In the event of an unsuccessful barge landing, the First Stage would explode upon impact with the barge. The direct sound from an explosion would last less than a second. Furthermore, the proposed activities would be dispersed in time, with maximum of twelve barge landing attempts occurring within a twelve month time period. If an explosion occurred on the barge, as in the case of an unsuccessful barge landing attempt, some amount of the explosive energy would be transferred through the ship's structure and would enter the water and propagate away from the ship.
There is very little published literature on the ratio of explosive energy that is absorbed by a ship's hull versus the amount of energy that is transferred through the ship into the water. However, based on the best available information, we have determined that exceptionally little of the acoustic energy from the explosion would transmit into the water (Yagla and Stiegler, 2003). An explosion on the barge would create an in-air blast that propagates away in all directions, including toward the water's surface; however the barge's deck would act as a barrier that would attenuate the energy directed downward toward the water (Yagla and Stiegler, 2003). Most sound enters the water in a narrow cone beneath the sound source (within 13 degrees of vertical) (National Research Council 2003). Since the explosion
Depending on the amount of fuel remaining in the booster at the time of the explosion, the intensity of the explosion would likely vary. Based on previous Falcon 9 boost-back and landing activities, the explosive equivalence of the First Stage with maximum fuel and oxidizer would be expected to be approximately 500 lb. of trinitrotoluene (TNT). Explosion shock theory has proposed specific relationships for the peak pressure and time constant in terms of the charge weight and range from the detonation position (Pater 1981; Plotkin
As discussed above, in the event of an unsuccessful contingency landing attempt, the First Stage would be expected to explode upon impact with the barge. SpaceX has experience performing recovery operations after water and unsuccessful barge landings for previous Falcon 9 First Stage landing attempts. This experience, in addition to the debris catalog that identifies all floating debris, has revealed that approximately 25 pieces of debris remain floating after an unsuccessful barge landing. The approximately 25 pieces of debris would primarily be made of Carbon Over Pressure Vessels (COPVs), the liquid oxygen fill line, and carbon fiber constructed legs. The vast majority of debris would be recovered. All other debris is expected to sink to the bottom of the ocean. Denser debris that would not float on the surface would sink relatively quickly and is composed of inert materials which would not affect water quality or bottom substrate potentially used by marine mammals. The rate of deposition would vary with the type of debris; however, none of the debris is so dense or large that benthic habitat would be meaningfully degraded.
The surface area potentially impacted with debris would be expected to be less than 0.46 km
In the event that a contingency landing action is required, there is the potential that the Falcon 9 First Stage would miss the barge entirely and land instead in the ocean. However, the likelihood of the First Stage missing the barge entirely and landing in the Pacific Ocean is considered so unlikely as to be discountable. This is supported by several previous attempts by SpaceX at Falcon 9 First Stage barge landings, none of which have missed the barge. Therefore, the likelihood of take of marine mammals associated with a Falcon 9 First Stage landing in the ocean is considered so low as to be discountable, and landing of the Falcon 9 First Stage in the ocean is not considered further in this document.
Proposed mitigation, monitoring, and reporting measures are described in detail later in this document (please see
There are six marine mammal species with expected occurrence in the project area (including at VAFB, on the NCI, and in the waters surrounding VAFB, the NCI and the contingency landing location) that are expected to be affected by the specified activities. These include the Steller sea lion (
There are an additional 28 species of cetaceans with expected or possible occurrence in the project area. However, we have determined that the only potential stressor associated with the activity that could result in take of marine mammals (sonic booms) only has the potential to result in harassment of marine mammals that are hauled out of the water (
Table 1 lists all species with expected potential for occurrence in the vicinity of the project during the project timeframe that are likely to be affected by the specified activities, and summarizes information related to the population or stock, including
Marine mammal abundance estimates presented in this document represent the total number of individuals that make up a given stock or the total number estimated within a particular study or survey area. NMFS's stock abundance estimates for most species represent the total estimate of individuals within the geographic area, if known, that comprises that stock. For some species, this geographic area may extend beyond U.S. waters. All managed stocks in this region are assessed in NMFS's U.S. Pacific and Alaska SARs (
All species that could potentially occur in the proposed survey areas are included in Table 1. As described below, all six species (with six managed stocks) temporally and spatially co-occur with the activity to the degree that take is reasonably likely to occur, and we have proposed authorizing it.
Harbor seals inhabit coastal and estuarine waters and shoreline areas of the northern hemisphere from temperate to polar regions. The eastern North Pacific subspecies is found from Baja California north to the Aleutian Islands and into the Bering Sea. Multiple lines of evidence support the existence of geographic structure among harbor seal populations from California to Alaska (Carretta
Pacific harbor seals are nonmigratory, with local movements associated with such factors as tides, weather, season, food availability, and reproduction (Scheffer and Slipp 1944, Fisher 1952, Bigg 1969, 1981, Hastings
Harbor seals are the most common marine mammal inhabiting VAFB, congregating on multiple rocky haulout sites along the VAFB coastline. Biologists from the Center for Environmental Management of Military Lands (CEMML) and 30 SW, 30th Civil Engineer Squadron (30 CES) survey marine mammal haulout sites on VAFB on a monthly basis (CEMML 2018). There are 12 harbor seal haulout sites on south VAFB; of these, 10 sites represent an almost continuous haulout area which is used by the same animals.
Pups are generally present in the region from March through July. Within the affected area on VAFB, a total of up to 332 adults and 34 pups have been recorded, at all haulouts combined, in monthly counts from 2013 to 2015 (ManTech 2015). Harbor seals also haul out, breed, and pup in isolated beaches and coves throughout the coasts of San Miguel, Santa Rosa, and Santa Cruz Islands (Lowry 2002). During aerial surveys conducted by NMFS in May 2002 and May and June of 2004, between 521 and 1,004 harbors seals were recorded at San Miguel Island, between 605 and 972 at Santa Rosa Island, and between 599 and 1,102 at Santa Cruz Island (M. Lowry, NOAA Fisheries, unpubl. data).
The harbor seal population at VAFB has undergone an apparent decline in recent years (USAF 2013b). This decline has been attributed to a series of natural landslides at south VAFB, resulting in the abandonment of many haulout sites. These slides have also resulted in extensive down-current sediment deposition, making these sites accessible to coyotes, which are now regularly seen in the area. Some of the displaced seals have moved to other sites at south VAFB, while others likely have moved to Point Conception, about 6.5 km south of the southern boundary of VAFB. Additionally, at one haulout, harbor seals have been displaced by elephant seals, who have begun using the haulout for giving birth (CEMML 2018).
Pacific harbor seals frequently use haulout sites on the NCI, including San Miguel, Santa Rosa, Santa Cruz, and Anacapa islands. On San Miguel Island, they occur along the north coast at Tyler Bight and from Crook Point to Cardwell Point. Additionally, they regularly breed on San Miguel Island. On Santa Cruz Island, they inhabit small coves and rocky ledges along much of the coast. Harbor seals are scattered throughout Santa Rosa Island and also are observed in small numbers on Anacapa Island.
California sea lions range from the Gulf of California north to the Gulf of Alaska, with breeding areas located in the Gulf of California, western Baja California, and southern California. Five genetically distinct geographic populations have been identified: (1) Pacific Temperate, (2) Pacific Subtropical, (3) Southern Gulf of California, (4) Central Gulf of California, and (5) Northern Gulf of California (Schramm
Beginning in January 2013, elevated strandings of California sea lion pups were observed in southern California, with live sea lion strandings nearly three times higher than the historical average. Findings to date indicate that a likely contributor to the large number of stranded, malnourished pups was a change in the availability of sea lion prey for nursing mothers, especially sardines. The Working Group on Marine Mammal Unusual Mortality Events determined that the ongoing stranding event meets the criteria for an Unusual Mortality Event (UME) and declared California sea lion strandings from 2013 through 2017 to be one continuous UME. The causes and mechanisms of this event remain under investigation. For more information on the UME, see:
Rookery sites in southern California are limited to San Miguel Island and the southerly Channel Islands of San Nicolas, Santa Barbara, and San Clemente (Carretta
California sea lions are common offshore of VAFB and haul out on rocks and beaches along the coastline of VAFB. At south VAFB, California sea lions haul out on north Rocky Point, with numbers often peaking in spring. They have been reported at Point Arguello and Point Pedernales (both on south VAFB) in the past, although none have been noted there over the past several years. Individual sea lions have been noted hauled out throughout the VAFB coast; these were transient or stranded specimens. They regularly haul out on Lion Rock, north of VAFB and immediately south of Point Sal, and occasionally haul out on Point Conception, south of VAFB. In 2014, counts of California sea lions at haulouts on VAFB ranged from 47 to 416 during monthly counts. Despite their prevalence at haulout sites at VAFB, California sea lions rarely pup on the VAFB coastline (ManTech 2015); no pups were observed in 2013 or 2014 (ManTech 2015) and 1 pup was observed in 2015 (VAFB, unpubl. data).
Pupping occurs in large numbers on San Miguel Island at the rookeries found at Point Bennett on the west end of the island and at Cardwell Point on the east end of the island (Lowry 2002). Sea lions haul out at the west end of Santa Rosa Island at Ford Point and Carrington Point. A few California sea lions have been born on Santa Rosa Island, but no rookery has been established. On Santa Cruz Island, California sea lions haul out from Painted Cave almost to Fraser Point, on the west end. Fair numbers haul out at Gull Island, off the south shore near Punta Arena. Pupping appears to be increasing there. Sea lions also haul out near Potato Harbor, on the northeast end of Santa Cruz. California sea lions haul out by the hundreds on the south side of East Anacapa Island.
During aerial surveys conducted by NMFS in February 2010 of the NCI, 21,192 total California sea lions (14,802 pups) were observed at haulouts on San Miguel Island and 8,237 total (5,712 pups) at Santa Rosa Island (M. Lowry, NOAA Fisheries, unpubl. data). During aerial surveys in July 2012, 65,660 total California sea lions (28,289 pups) were recorded at haulouts on San Miguel Island, 1,584 total (3 pups) at Santa Rosa Island, and 1,571 total (zero pups) at Santa Cruz Island (M. Lowry, NOAA Fisheries, unpubl. data).
Northern elephant seals range in the eastern and central North Pacific Ocean,
Populations of northern elephant seals in the U.S. and Mexico are derived from a few tens or hundreds of individuals surviving in Mexico after being nearly hunted to extinction (Stewart
Northern elephant seals haul out sporadically on rocks and beaches along the coastline of VAFB; monthly counts in 2013 and 2014 recorded between 0 and 191 elephant seals within the affected area (ManTech 2015) and northern elephant seal pupping at VAFB was documented for the first time in January 2017 (Pers. comm., R. Evans, USAF, to J. Carduner, NMFS, February 1, 2017). The nearest regularly used haulout site on the mainland coast is at Point Conception. Eleven northern elephant seals were observed during aerial surveys of the Point Conception area by NMFS in February of 2010 (M. Lowry, NOAA Fisheries, unpubl. data).
Point Bennett on the west end of San Miguel Island is the primary northern elephant seal rookery in the NCI, with another rookery at Cardwell Point on the east end of San Miguel Island (Lowry 2002). They also pup and breed on Santa Rosa Island, mostly on the west end. Northern elephant seals are rarely seen on Santa Cruz and Anacapa Islands. During aerial surveys of the NCI conducted by NMFS in February 2010, 21,192 total northern elephant seals (14,802 pups) were recorded at haulouts on San Miguel Island and 8,237 total (5,712 pups) were observed at Santa Rosa Island (M. Lowry, NOAA Fisheries, unpubl. data). None were observed at Santa Cruz Island (M. Lowry, NOAA Fisheries, unpubl. data).
Steller sea lions are distributed mainly around the coasts to the outer continental shelf along the North Pacific rim from northern Hokkaido, Japan through the Kuril Islands and Okhotsk Sea, Aleutian Islands and central Bering Sea, southern coast of Alaska and south to California (Loughlin
Prior to 2012, there were no records of Steller sea lions observed at VAFB. In April and May 2012, Steller sea lions were observed hauled out at North Rocky Point on VAFB, representing the first time the species had been observed on VAFB during launch monitoring and monthly surveys conducted over the past two decades (Marine Mammal Consulting Group and Science Applications International Corporation 2013). Since 2012, Steller sea lions have been observed frequently in routine monthly surveys, with as many as 16 individuals recorded. In 2014, up to five Steller sea lions were observed in the affected area during monthly marine mammal counts (ManTech 2015) and a maximum of 12 individuals were observed during monthly counts in 2015 (VAFB, unpublished data). However, up to 16 individuals were observed in 2012 (SAIC 2012). Steller sea lions once had two small rookeries on San Miguel Island, but these were abandoned after the 1982-1983 El Niño event (DeLong and Melin 2000; Lowry 2002); these rookeries were once the southernmost colonies of the eastern stock of this species. In recent years, between two to four juvenile and adult males have been observed on a somewhat regular basis on San Miguel Island (pers. comm. Sharon Melin, NMFS Alaska Fisheries Science Center, to J. Carduner, NMFS, Feb 11, 2016). Steller sea lions are not observed on the other NCI.
Northern fur seals occur from southern California north to the Bering Sea and west to the Okhotsk Sea and Honshu Island, Japan. Due to differing requirements during the annual reproductive season, adult males and females typically occur ashore at different, though overlapping, times. Adult males occur ashore and defend reproductive territories during a three month period from June through August, though some may be present until November (well after giving up their territories). Adult females are found ashore for as long as six months (June-November). After their respective times ashore, fur seals of both sexes spend the next seven to eight months at sea (Roppel 1984). Peak pupping is in early July and pups are weaned at three to four months. Some juveniles are present year-round, but most juveniles and adults head for the open ocean and a pelagic existence until the next year. Northern fur seals exhibit high site fidelity to their natal rookeries. Two stocks of northern fur seals are recognized in U.S. waters: An eastern Pacific stock and a California stock (formerly referred to as the San Miguel Island stock). While animals from the eastern Pacific stock are known to travel as far south as Oregon and California (Muto
Northern fur seals have rookeries on San Miguel Island at Point Bennett and on Castle Rock. Comprehensive count data for northern fur seals on San Miguel Island are not available. San Miguel Island is the only island in the NCI on which northern fur seals have been observed. Although the population at San Miguel Island was established by individuals from Alaska and Russian Islands during the late 1960s, most individuals currently found on San Miguel are considered resident to the island. No haulout or rookery sites exist for northern fur seals on the mainland coast. The only individuals that appear on mainland beaches are stranded animals.
Guadalupe fur seals are found along the west coast of the United States. They were abundant prior to seal exploitation, when they were likely the most abundant pinniped species on the Channel Islands, but are considered uncommon in Southern California. They are typically found on shores with abundant large rocks, often at the base of large cliffs (Belcher and Lee 2002).
Comprehensive survey data on Guadalupe fur seals in the NCI is not readily available. On San Miguel Island, one to several male Guadalupe fur seals had been observed annually between 1969 and 2000 (DeLong and Melin 2000) and juvenile animals of both sexes have been seen occasionally over the years (Stewart
Hearing is the most important sensory modality for marine mammals underwater, and exposure to anthropogenic sound can have deleterious effects. To appropriately assess the potential effects of exposure to sound, it is necessary to understand the frequency ranges marine mammals are able to hear. Current data indicate that not all marine mammal species have equal hearing capabilities (
• Pinnipeds in water; Phocidae (true seals): Generalized hearing is estimated to occur between approximately 50 hertz (Hz) to 86 kilohertz (kHz); and
• Pinnipeds in water; Otariidae (eared seals): Generalized hearing is estimated to occur between 60 Hz and 39 kHz.
The pinniped functional hearing group was modified from Southall
For more detail concerning these groups and associated frequency ranges, please see NMFS (2018) for a review of available information. Six species of marine mammal (four otariid and two phocid) species) have the reasonable potential to co-occur with the proposed activities. Please refer to Table 1.
This section includes a summary and discussion of the ways that components of the specified activity may impact marine mammals and their habitat. The
This section contains a brief technical background on sound, the characteristics of certain sound types, and on metrics used in this proposal inasmuch as the information is relevant to the specified activity and to a discussion of the potential effects of the specified activity on marine mammals found later in this document.
Sound travels in waves, the basic components of which are frequency, wavelength, velocity, and amplitude. Frequency is the number of pressure waves that pass by a reference point per unit of time and is measured in Hz or cycles per second. Wavelength is the distance between two peaks or corresponding points of a sound wave (length of one cycle). Higher frequency sounds have shorter wavelengths than lower frequency sounds, and typically attenuate (decrease) more rapidly, except in certain cases in shallower water. Amplitude is the height of the sound pressure wave or the “loudness”
Root mean square is the quadratic mean sound pressure over the duration of an impulse. Root mean square is calculated by squaring all of the sound amplitudes, averaging the squares, and then taking the square root of the average (Urick, 1983). Root mean square accounts for both positive and negative values; squaring the pressures makes all values positive so that they may be accounted for in the summation of pressure levels (Hastings and Popper, 2005). This measurement is often used in the context of discussing behavioral effects, in part because behavioral effects, which often result from auditory cues, may be better expressed through averaged units than by peak pressures.
Sound exposure level (SEL; represented as dB re 1 μPa
A-weighting is applied to instrument-measured sound levels in an effort to account for the relative loudness perceived by the human ear, as the ear is less sensitive to low audio frequencies, and is commonly used in measuring airborne noise. The relative sensitivity of pinnipeds listening in air to different frequencies is more-or-less similar to that of humans (Richardson et al. 1995), so A-weighting may, as a first approximation, be relevant to pinnipeds listening to moderate-level sounds.
The sum of the various natural and anthropogenic sound sources at any given location and time—which comprise “ambient” or “background” sound—depends not only on the source levels (as determined by current weather conditions and levels of biological and human activity) but also on the ability of sound to propagate through the environment. In turn, sound propagation is dependent on the spatially and temporally varying properties of the water column and sea floor, and is frequency-dependent. As a result of the dependence on a large number of varying factors, ambient sound levels can be expected to vary widely over both coarse and fine spatial and temporal scales. Sound levels at a given frequency and location can vary by 10-20 dB from day to day (Richardson
Sounds are often considered as either pulsed or non-pulsed (defined in the following). The distinction between these two sound types is important because they have differing potential to cause physical effects, particularly with regard to hearing (
Pulsed sound sources (
Non-pulsed sounds can be tonal, narrowband, or broadband, brief or prolonged, and may be either continuous or non-continuous (ANSI, 1995; NIOSH, 1998). Some of these non-pulsed sounds can be transient signals of short duration but without the essential properties of pulses (
The effects of sounds on marine mammals are dependent on several factors, including the species, size, behavior (feeding, nursing, resting, etc.), and, if underwater, depth of the animal; the intensity and duration of the sound; and the sound propagation properties of the environment. Impacts to marine species can result from physiological and behavioral responses to both the type and strength of the acoustic signature (Viada
The effects of sounds from the proposed activities are expected to result in behavioral disturbance of marine mammals. Due to the expected sound levels of the activities proposed and the distance of the activity from marine mammal habitat, the effects of sounds from the proposed activities are not expected to result in temporary or permanent hearing impairment (TTS and PTS, respectively), non-auditory physical or physiological effects, or masking in marine mammals. Therefore, TTS, PTS, non-auditory physical or physiological effects, and masking are not discussed further in this section.
Disturbance includes a variety of effects, including subtle changes in behavior, more conspicuous changes in activities, and displacement. Behavioral responses to sound are highly variable and context-specific and reactions, if any, depend on species, state of maturity, experience, current activity, reproductive state, auditory sensitivity, time of day, and many other factors (Richardson
Habituation can occur when an animal's response to a stimulus wanes with repeated exposure, usually in the absence of unpleasant associated events (Wartzok
Controlled experiments with captive marine mammals have shown pronounced behavioral reactions, including avoidance of loud underwater sound sources (Ridgway
The onset of noise can result in temporary, short term changes in an animal's typical behavior and/or avoidance of the affected area. These behavioral changes may include: Reduced/increased vocal activities; changing/cessation of certain behavioral activities (such as socializing or feeding); visible startle response or aggressive behavior; avoidance of areas where sound sources are located; and/or flight responses (Richardson
The biological significance of many of these behavioral disturbances is difficult to predict, especially if the detected disturbances appear minor. However, the consequences of behavioral modification could potentially be biologically significant if the change affects growth, survival, or reproduction. The onset of behavioral disturbance from anthropogenic sound depends on both external factors (characteristics of sound sources and their paths) and the specific characteristics of the receiving animals (hearing, motivation, experience, demography) and is difficult to predict (Southall
Marine mammals that occur in the project area could be exposed to airborne sounds associated with Falcon 9 boost-back and landing activities that have the potential to result in behavioral harassment, depending on an animal's distance from the sound. Airborne sound could potentially affect pinnipeds that are hauled out. Most likely, airborne sound would cause behavioral responses similar to those discussed above in relation to underwater sound. For instance, anthropogenic sound could cause hauled out pinnipeds to exhibit changes in their normal behavior, such as reduction in vocalizations, or cause them to temporarily abandon their habitat and move further from the source. Hauled out pinnipeds may flush from a haulout into the water. Though pup abandonment could theoretically result from these reactions, site-specific monitoring data indicate that pup abandonment is not likely to occur as a result of the specified activity. Not all pinnipeds exposed to a sonic boom and/or launch noise flushed from the haulout, and those that did flush returned to the haulout shortly after the event.
This section includes a discussion of the active acoustic sound sources associated with SpaceX's proposed activity and the likelihood for these sources to result in harassment of marine mammals. Potential acoustic sources associated with SpaceX's proposed activity include sonic booms, Falcon 9 First Stage landings, and potential explosions as a result of unsuccessful Falcon 9 First Stage landing attempts. Sounds produced by the proposed activities may be impulsive, due to sonic booms, and non-pulse (but short-duration) noise, due to combustion effects of the Falcon 9 First Stage. As described above, sounds associated with Falcon 9 First Stage landings and potential explosions as a result of unsuccessful Falcon 9 First Stage landing attempts are not expected to result in take of marine mammals and are therefore not addressed here.
As described above, during descent when the First Stage is supersonic, a sonic boom would be generated. The USAF has monitored pinniped responses to rocket launches from VAFB for nearly 20 years. Though rocket launches are not part of the proposed activities (as described above), the acoustic stimuli (sonic booms) associated with launches is expected to be substantially similar to those expected to occur with Falcon 9 boost-backs and landings; therefore, we rely on observational data on responses of pinnipeds to sonic booms associated with rocket launches from VAFB in making assumptions about expected pinniped responses to sonic booms associated with Falcon 9 boost-backs and landings.
Observed reactions of pinnipeds at the NCI to sonic booms have ranged from no response to heads-up alerts, from startle responses to some movements on land, and from some movements into the water to very occasional stampedes (especially involving California sea lions on the NCI). We therefore assume sonic booms generated during the return flight of the Falcon 9 First Stage may elicit an alerting or other short-term behavioral reaction, including flushing into the water if hauled out.
Data from launch monitoring by the USAF on the NCI has shown that pinniped reactions to sonic booms are correlated with the level of the sonic boom. Low energy sonic booms (<1.0 psf) have typically resulted in little to no behavioral responses, including head raising and briefly alerting but returning to normal behavior shortly after the stimulus (Table 3). More powerful sonic booms have sometimes resulted in some species of pinnipeds flushing from haulouts. No documented pinniped mortalities have been associated with sonic booms. No sustained decreases in numbers of animals observed at haulouts have been observed after the stimulus. Table 3 presents a summary of monitoring efforts at the NCI from 1999 to 2017. These data show that reactions to sonic booms tend to be insignificant below 1.0 psf and that, even above 1.0 psf, only a portion of the animals present have reacted to the sonic boom. Time-lapse video photography during four launch events revealed that harbor seals that reacted to the rocket launch noise but did not leave the haulout were all adults.
Data from previous monitoring also suggests that for those pinnipeds that flush from haulouts in response to sonic booms, the amount of time it takes for those animals to begin returning to the haulout site, and for numbers of animals to return to pre-launch levels, is correlated with sonic boom sound levels. Pinnipeds may begin to return to the haulout site within 2-55 min of the launch disturbance, and the haulout site usually returned to pre-launch levels within 45-120 min. Monitoring data from launches of the Athena IKONOS rocket from VAFB, with 107.3 and 107.8 dB (A-weighted SEL) recorded at the closest haulout site, showed seals that flushed to the water on exposure to the sonic boom began to return to the haulout approximately 16-55 minutes post-launch (Thorson
Monitoring data has consistently shown that reactions among pinnipeds
At the Channel Islands, harbor seals have been observed to react more strongly to sonic booms than other species present there, with some animals startling and fleeing into the water (Table 3). California sea lions have also sometimes shown reactiveness to sonic booms, with pups sometimes reacting more than adults, either because they are more easily frightened or because their hearing is more acute (Table 3). Northern fur seals generally show little or no reaction. Northern elephant seals generally exhibit no reaction at all, except perhaps a heads-up response or some stirring, especially if sea lions in the same area or mingled with the elephant seals react strongly to the boom. Post-launch monitoring generally reveals a return to normal patterns within minutes up to an hour or two of each launch, regardless of species (SAIC 2012).
Table 3 summarizes monitoring efforts at San Miguel Island during which acoustic measurements were successfully recorded and during which pinnipeds were observed. Monitoring was conducted at the haulout closest to the predicted sonic boom. During more recent launches, night vision equipment was used. The table shows only launches during which sonic booms were heard and recorded. Many launches from VAFB do not result in sonic booms that are detectable at the NCI due to the westward trajectory of the rockets. To date, SpaceX has landed only one Falcon 9 First Stage at VAFB and the monitoring results are not yet available. The table shows that little or no reaction from the four species usually occurs when overpressures are below 1.0 psf, and sometimes higher. In general, as described above, elephant seals do not react unless other animals around them react strongly or if the sonic boom is extremely loud, and northern fur seals seem to react similarly.
To determine if harbor seals experience changes in their hearing sensitivity as a result of sounds associated with rocket launches (including sonic booms), Auditory Brainstem Response (ABR) testing was conducted on 14 harbor seals following four launches of the Titan IV rocket, one launch of the Taurus rocket, and two launches of the Delta IV rocket from VAFB. ABR tests have not yet been performed following Falcon 9 rocket landings nor launches, however results of ABR tests that followed launches of other rockets from VAFB are nonetheless informative as the sound source (sonic boom) is expected to be the same as that associated with the activities proposed by SpaceX.
Following standard ABR testing protocol, the ABR was measured from one ear of each seal using sterile, sub-dermal, stainless steel electrodes. A conventional electrode array was used, and low-level white noise was presented to the non-tested ear to reduce any electrical potentials generated by the non-tested ear. A computer was used to produce the click and an eight kHz tone burst stimuli, through standard audiometric headphones. Over 1,000 ABR waveforms were collected and averaged per trial. Initially the stimuli were presented at SPLs loud enough to obtain a clean reliable waveform, and then decreased in 10 dB steps until the response was no longer reliably observed. Once response was no longer reliably observed, the stimuli were then increased in 10 dB steps to the original SPL. By obtaining two ABR waveforms at each SPL, it was possible to quantify the variability in the measurements.
Good replicable responses were measured from most of the seals, with waveforms following the expected pattern of an increase in latency and decrease in amplitude of the peaks, as the stimulus level was lowered. Detailed analysis of the changes in waveform latency and waveform replication of the ABR measurements for the 14 seals showed no detectable changes in the seals' hearing sensitivity as a result of exposure to the launch noise. The delayed start (1.75 to 3.5 hours after the launches) for ABR testing allows for the possibility that the seals may have recovered from a TTS before testing began. However, it can be said with confidence that the post-launch tested animals did not have permanent hearing changes due to exposure to the launch noise from the sonic booms associated with launches of the rockets from VAFB (SAIC 2013).
We also note that stress from long-term cumulative sound exposures can result in physiological effects on reproduction, metabolism, and general health, or on the animals' resistance to disease. However, this is not likely to occur as a result of the proposed activities because of the infrequent nature and short duration of the noise (up to twelve sonic booms annually). Research indicates that population levels at these haulout sites have remained constant in recent years (with decreases only noted in some areas after coastal erosion), giving support to this conclusion.
In conclusion, based on data from numerous years of monitoring of similar activities to the activities proposed by SpaceX, in the same geographic area as the geographic area of the SpaceX's proposed activities, we expect that any behavioral responses by pinnipeds to sonic booms resulting from the proposed activities would range from no response to heads-up alerts, startle responses, some movements on land, and some movements into the water (flushing).
This section includes a discussion of potential effects of SpaceX's proposed activity other than those related to sound.
Visual stimuli resulting from Falcon 9 First Stage landings would have the potential to cause pinnipeds to lift their heads, move towards the water, or enter the water. However, SpaceX has determined that the trajectory of the return flight includes a nearly vertical descent to the SLC-4W landing pad (see Figure 1-7 and 1-8 in the IHA application) and the contingency landing location (see Figure 1-5 in the IHA application). As a result, the descending Falcon 9 First Stage would either be shielded by coastal bluffs (for a SLC-4W landing) or would be too far away from any pinniped haulouts to result in significant stimuli (in the case of a barge landing). Further, the visual stimulus of the Falcon 9 First Stage would not be coupled with the sonic boom, since the First Stage would be at significant altitude when the overpressure is produced, further decreasing the likelihood of a behavioral response. Therefore, the likelihood of takes of marine mammals resulting from visual stimuli associated with the proposed activity is so low as to be considered discountable. As such, visual stimuli associated with the proposed activity is not discussed further in this document.
We do not anticipate that the proposed activities would result in any temporary or permanent effects on the habitats used by the marine mammals in the proposed area, including the food sources they use (
The proposed activities would not result in in-water acoustic stimuli that would cause significant injury or mortality to prey species and would not create barriers to movement for marine mammal prey. As described above, in the event of an unsuccessful barge landing and a resulting explosion of the Falcon 9 First Stage, up to 25 pieces of debris would likely remain floating. SpaceX would recover all floating debris. Denser debris that would not float on the surface is anticipated to sink relatively quickly and would be composed of inert materials. The area of benthic habitat impacted by falling debris would be very small (approximately 0.000706 km
In summary, since the acoustic impacts associated with the proposed activities are of short duration and infrequent (up to twelve events annually), the associated behavioral responses in marine mammals are expected to be temporary. Therefore, the proposed activities are unlikely to result in long term or permanent avoidance of the exposure areas or loss of habitat. The proposed activities are also not expected to result in any reduction in foraging habitat or adverse impacts to marine mammal prey. Thus, any impacts to marine mammal habitat are not expected to cause significant or long-term consequences for individual marine mammals or their populations.
This section provides an estimate of the number of incidental takes proposed for authorization through this IHA, which will inform both NMFS' consideration of “small numbers” and the negligible impact determination.
Harassment is the only type of take expected to result from these activities. Except with respect to certain activities not pertinent here, section 3(18) of the MMPA defines “harassment” as any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild (Level A harassment); or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering (Level B harassment).
Authorized takes would be by Level B harassment only, in the form of potential disruption of behavioral patterns for individual marine mammals resulting from exposure to sounds associated with the planned activities. Based on the nature of the activity, Level A harassment is neither anticipated nor proposed to be authorized.
As described previously, no mortality is anticipated or proposed to be authorized for this activity. Below we describe how the take is estimated.
Generally speaking, we estimate take by considering: (1) Acoustic thresholds above which NMFS believes the best available science indicates marine mammals will be behaviorally harassed or incur some degree of permanent hearing impairment; (2) the area or volume of water that will be ensonified above these levels in a day; (3) the density or occurrence of marine mammals within these ensonified areas; and, (4) and the number of days of activities. We note that while these basic factors can contribute to a basic calculation to provide an initial prediction of takes, additional information that can qualitatively inform take estimates is also sometimes available (
Using the best available science, NMFS has developed acoustic thresholds that identify the received level of underwater sound above which exposed marine mammals would be reasonably expected to be behaviorally harassed (equated to Level B harassment) or to incur PTS of some degree (equated to Level A harassment). Thresholds have also been developed identifying the received level of in-air sound above which exposed pinnipeds would likely be behaviorally harassed.
Typically, NMFS relies on the acoustic criteria described above to estimate take as a result of exposure to airborne sound from a given activity. However, in this case we have the benefit of more than 20 years of observational data on pinniped responses to the stimuli associated with the proposed activity that we expect to result in harassment (sonic booms) in the particular geographic area of the proposed activity (VAFB and the NCI). Therefore, we consider these data to be the best available information in regard to estimating take based on modeled exposures among pinnipeds to sounds associated with the proposed activities. These data suggest that pinniped reactions to sonic booms are dependent on the species and the intensity of the sonic boom (Table 3).
As described above, data from launch monitoring by the USAF on the NCI and at VAFB have shown that pinniped reactions to sonic booms are correlated to the level of the sonic boom. Low energy sonic booms (<1.0 psf) have typically resulted in little to no behavioral responses, including head raising and briefly alerting but returning to normal behavior shortly after the stimulus. More powerful sonic booms have sometimes resulted in animals flushing from haulouts (but not resulted in any mortality or sustained decreased in numbers after the stimulus). Table 3 presents a summary of monitoring efforts at the NCI from 1999 to 2017. These data show that reactions to sonic booms tend to be insignificant below 1.0 psf and that, even above 1.0 psf, only a portion of the animals present react to the sonic boom. Therefore, for the purposes of estimating the extent of take that is likely to occur as a result of the proposed activities, we conservatively assume that Level B harassment may occur when a pinniped (on land) is exposed to a sonic boom at or above 1.0 psf. Thus, the number of expected takes by Level B harassment is based on estimates of the numbers of animals that would be within the areas exposed to sonic booms at levels at or above 1.0 psf.
The data recorded by USAF at VAFB and the NCI over the past 20 years has also shown that pinniped reactions to sonic booms vary between species. As described above, little or no reaction has been observed in northern fur seals and northern elephant seals when overpressures were below 1.0 psf. At the NCI harbor seals have reacted more strongly to sonic booms than most other species. Sea lions also appear to be somewhat more sensitive to sonic booms than some of the other pinniped species, sometimes startling and flushing. Northern fur seals generally show little or no reaction, and northern elephant seals generally exhibit no reaction at all, except perhaps a heads-up response or some stirring, especially if sea lions in the same area mingled with the elephant seals react strongly to the boom. No data is available on Steller sea lion or Guadalupe fur seal responses to sonic booms.
As described above, modeling was performed to estimate overpressure levels that would be created during the return flight of the Falcon 9 First Stage. Previous acoustic modeling underestimated the near-field overpressures from sonic booms so SpaceX used actual observations from past Falcon 9 First Stage boost-back and landing events. SpaceX and the USAF developed new estimates to better predict the potential overpressures from sonic booms resulting from Falcon 9 First Stage boost-back and landing events. The highest modeled overpressure on the mainland (at or near VAFB and Point Conception) was between 1 and 8.5 psf at SLC-4W. However, the overpressure at known pinniped haulout sites on VAFB would likely be closer to 1 to 3 psf (Figure 6-1 in the IHA application). SpaceX used the Wyle model to predict the far-field sonic boom contours from sonic booms
As stated in the “
In this section we provide the information about the presence, density, or group dynamics of marine mammals that will inform the take calculations. Data collected from marine mammal surveys, including monthly marine mammal surveys conducted by the USAF at VAFB (beginning in 1993) as well as data collected by NMFS, represent the best available information on the occurrence of the six pinniped species expected to occur in the project area. The quality and amount of information available on pinnipeds in the project area varies depending on species. California sea lions, Steller sea lions, harbor seals, and northern elephant seals are regularly observed at known haulouts during monthly surveys at VAFB (CEMML 2018). Data on pinniped numbers at the NCI is limited as surveys are not conducted as frequently. However, the best available data was used to estimate take numbers. Take estimates for all species are shown in Table 7.
Here we describe how the information provided above is brought together to produce a quantitative take estimate.
NMFS currently uses a three-tiered scale to determine whether the response of a pinniped on land to acoustic or visual stimuli is considered an alert, a movement, or a flush. NMFS considers the behaviors that meet the definitions of both movements and flushes to qualify as behavioral harassment. Thus a pinniped on land is considered by NMFS to have been behaviorally harassed if it moves greater than two times its body length, or if the animal is already moving and changes direction and/or speed, or if the animal flushes from land into the water. Animals that become alert without such movements are not considered harassed. See Table 4 for a summary of the pinniped disturbance scale.
If issued, this would be the second IHA issued to SpaceX for the proposed activity. SpaceX did not perform any Falcon 9 boost-back and landing activities that resulted in return flights to VAFB nor that generated sonic booms that impacted the NCI. SpaceX did perform boost-back and landing activities at a contingency landing location located offshore during the period of validity for the prior IHA, however the contingency landing location was located so far offshore that there were no impacts predicted to marine mammals by sonic boom modeling, thus marine mammal monitoring was not required. Therefore, we have no activity-specific monitoring data to inform take estimates. NMFS relies on the past monitoring data presented in Table 3 to estimate takes.
Take estimates were calculated by overlaying the modeled acoustic footprints of sonic booms from boost-back and landing events at SLC-4W with known pinniped haulouts on the mainland (including those at VAFB) and the NCI to determine the pinniped haulouts that would potentially be affected by sonic booms with overpressures of 1.0 psf and above. Only haulouts along northeastern San Miguel Island would be expected to experience overpressures greater than 1.0 psf during a boost-back and landing at SLC-4W (Figure 2-5 in the IHA application). Take estimates also account for the likely intensity of the sonic boom as well as the relative sensitivity of the marine mammal species present, based on monitoring data as described above.
As described above, the likelihood of pinnipeds exhibiting responses to sonic booms that would be considered behavioral harassment (based on the levels of pinniped disturbance as shown in Table 4) is dependent on both the species and on the intensity of the sonic boom. Data from rocket launch monitoring by the USAF at VAFB and the NCI show that pinniped reactions to sonic booms are correlated to the level of the sonic boom, with low energy sonic booms (<1.0 psf) typically resulting in little to no behavioral responses, and higher energy sonic booms resulting in responses ranging from no response to heads-up alerts, startle responses, some movements on land, and some movements into the water (flushing). Based on model results, a boost-back and landing of the Falcon 9 First Stage at SLC-4W would produce a sonic boom with greater intensity at VAFB (overpressures potentially as high as 8.5 psf) than at San Miguel Island (overpressures potentially as high as 3.1 psf). Responses of pinnipeds to sonic booms are also highly dependent on species, with harbor seals, California sea lions and Steller sea lions generally displaying greater sensitivity to sonic booms than northern elephant seals and northern fur seals (Table 3). We are not aware of any data on Guadalupe fur seal responses to sonic booms, but we assume responses by Guadalupe fur seal responses to be similar to those observed in northern fur seals as the two species are physiologically and behaviorally very similar.
In their application, SpaceX assumed that all of the California sea lions, harbor seals, northern elephant seals, Steller sea lions, northern fur seals, and Guadalupe fur seals at or near VAFB and Point Conception would be behaviorally harassed by a sonic boom over 1.0 psf resulting from a Falcon 9 First Stage boost-back and landing at SLC-4W. SpaceX also estimated that 5 percent of northern elephant seals, northern fur seals, and Guadalupe fur seals and 100 percent of California sea lions, harbor seals, and Steller sea lions hauled out in the NCI would be behaviorally harassed by a sonic boom over 1.0 psf. However, after reviewing the monitoring information presented in Table 3, NMFS has determined that assuming 100 percent of California sea lions, harbor seals, and Steller sea lions would be behaviorally harassed is an overestimate. Therefore, NMFS has determined that assuming only a fraction of marine mammals exposed to sonic booms over 1.0 psf will be behaviorally harassed represents a more realistic estimate.
NMFS assumes that the minimum sonic boom overpressure with the potential to result in behavioral harassment of pinnipeds is 1.0 psf. However, sonic booms with higher overpressures may result in a higher proportion of exposed animals reacting to the sound. Modeling indicates that the maximum overpressure from a sonic boom resulting from a Falcon 9 First Stage boost-back and landing at SLC-4W is likely to be greater at VAFB and Point Conception than at the NCI (Figures 2-2, 2-4, and 2-5 in the IHA application). Thus, based on previous monitoring data (Table 3), the proportion of animals responding to the sonic boom is likely to be greater at VAFB and Point Conception than at the NCI. Therefore, a boost-back and landing of the Falcon 9 First Stage at SLC-4W that results in a sonic boom of
In their application, SpaceX conservatively assumed 12 landings would occur at SLC-4W. SpaceX modeled sonic booms resulting from rockets with both heavy and light payloads. Modeling of sonic boom contours indicates that light payloads do not create sonic booms with overpressures above 1.0 psf that would impact the NCI. Only heavy payloads have the potential to create sonic booms with overpressures above 1.0 psf along the northern coast of San Miguel Island. SpaceX indicated that of the up to 12 Falcon 9 First Stage boost-back and landing events, up to six would be from a light payload and up to six would be from a heavy payload (pers. comm., M. Thompson, SpaceX, to A. Fowler, NMFS, Oct. 11, 2018). Therefore, to determine the estimated number of marine mammals that could be exposed to a sonic boom over 1.0 psf, the number of boost-back and landing events that could impact each location (12 for the mainland and 6 for the NCI) was multiplied by the number of animals likely to respond.
The take calculations presented in Table 5 are based on the best available information on marine mammal populations in the project location and responses among marine mammals to the stimuli associated with the proposed activities and are considered conservative.
Take estimates are believed to be conservative based on the assumption that all twelve Falcon 9 First Stage recovery actions would result in landings at SLC-4W, with no landings occurring at the contingency barge landing location. However, some or all actual landing events may ultimately occur at the contingency landing location or within the Iridium Landing Area; as described above, landings at the contingency landing location or within the Iridium Landing Area would be expected to result in no takes of marine mammals. However, the number of landings at each location is not known in advance, therefore we assume all landings would occur at SLC-4W. In addition, as described above, it is conservatively assumed that a fraction of marine mammals hauled out at VAFB, Point Conception, and San Miguel Island would be harassed (Level B harassment only) by a Falcon 9 boost-back and landing events at SLC-4W that result in a psf of <1.0. However, it is possible that a smaller number of hauled out pinnipeds will be behaviorally harassed by a Falcon 9 boost-back and landing at SLC-4W. While there may be some limited behavioral harassment of pinnipeds that occurs at psf levels <1.0, we account for that in the overall conservativeness of the total take number, as described above.
Given the many uncertainties in predicting the quantity and types of impacts of sound on marine mammals, it is common practice to estimate how many animals are likely to be present within a particular distance of a given activity, or exposed to a particular level of sound. In practice, depending on the amount of information available to
Take estimates shown in Table 5 are considered reasonable estimates of the number of instances of marine mammal exposures to sound resulting in Level B harassment that are likely to occur as a result of the proposed activities, and not necessarily the number of individual animals exposed.
In order to issue an IHA under Section 101(a)(5)(D) of the MMPA, NMFS must set forth the permissible methods of taking pursuant to such activity, and other means of effecting the least practicable impact on such species or stock and its habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of such species or stock for taking for certain subsistence uses (latter not applicable for this action). NMFS regulations require applicants for incidental take authorizations to include information about the availability and feasibility (economic and technological) of equipment, methods, and manner of conducting such activity or other means of effecting the least practicable adverse impact upon the affected species or stocks and their habitat (50 CFR 216.104(a)(11)).
In evaluating how mitigation may or may not be appropriate to ensure the least practicable adverse impact on species or stocks and their habitat, as well as subsistence uses where applicable, we carefully consider two primary factors:
(1) The manner in which, and the degree to which, the successful implementation of the measure(s) is expected to reduce impacts to marine mammals, marine mammal species or stocks, and their habitat, as well as subsistence uses. This considers the nature of the potential adverse impact being mitigated (likelihood, scope, range). It further considers the likelihood that the measure will be effective if implemented (probability of accomplishing the mitigating result if implemented as planned) the likelihood of effective implementation (probability implemented as planned); and
(2) The practicability of the measures for applicant implementation, which may consider such things as cost, impact on operations, and, in the case of a military readiness activity, personnel safety, practicality of implementation, and impact on the effectiveness of the military readiness activity.
SpaceX's IHA application contains descriptions of the mitigation measures proposed to be implemented during the specified activities in order to effect the least practicable adverse impact on the affected marine mammal species and stocks and their habitats.
It should be noted that it would not be feasible to stop or divert an inbound Falcon 9 First Stage booster. Once the boost-back and landing sequence is underway, there would be no way for SpaceX to change the trajectory of the Falcon 9 First Stage to avoid potential impacts to marine mammals. The proposed mitigation measures include the following:
• Unless constrained by other factors including human safety or national security concerns (as determined by the USAF), launches would be scheduled to avoid boost-backs and landings during the harbor seal pupping season of March through June, when practicable.
Based on our evaluation of SpaceX's proposed mitigation measures, NMFS has preliminarily determined that the proposed mitigation measures provide the means of effecting the least practicable impact on the affected species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance.
In order to issue an IHA for an activity, Section 101(a)(5)(D) of the MMPA states that NMFS must set forth requirements pertaining to the monitoring and reporting of such taking. The MMPA implementing regulations at 50 CFR 216.104(a)(13) indicate that requests for authorizations must include the suggested means of accomplishing the necessary monitoring and reporting that will result in increased knowledge of the species and of the level of taking or impacts on populations of marine mammals that are expected to be present in the proposed action area. Effective reporting is critical both to compliance as well as ensuring that the most value is obtained from the required monitoring.
Monitoring and reporting requirements prescribed by NMFS should contribute to improved understanding of one or more of the following:
• Occurrence of marine mammal species or stocks in the area in which take is anticipated (
• Nature, scope, or context of likely marine mammal exposure to potential stressors/impacts (individual or cumulative, acute or chronic), through better understanding of: (1) Action or environment (
• Individual marine mammal responses (behavioral or physiological) to acoustic stressors (acute, chronic, or cumulative), other stressors, or cumulative impacts from multiple stressors;
• How anticipated responses to stressors impact either: (1) Long-term fitness and survival of individual marine mammals; or (2) populations, species, or stocks;
• Effects on marine mammal habitat (
• Mitigation and monitoring effectiveness.
SpaceX submitted a monitoring plan as part of their IHA application. SpaceX's proposed marine mammal monitoring plan was created with input from NMFS and was based on similar plans that have been successfully implemented by other action proponents under previous authorizations for similar projects, specifically the USAF's monitoring of rocket launches from VAFB. The plan may be modified or supplemented based on comments or new information received from the public during the public comment period.
SpaceX would determine a monitoring location for each boost-back and landing activity, taking into consideration predictions of the areas likely to receive the greatest sonic boom
Marine mammal monitoring protocols would vary based on modeled sonic boom intensity, the location, and the season. As described above, sonic boom modeling would be performed prior to all boost-back and landing activities. Although the same rockets would be used, other parameters specific to each launch would be incorporated into each model. These include direction and trajectory, weight, length, engine thrust, engine plume drag, position versus time from initiating boost-back to additional engine burns, among other aspects. Various weather scenarios would be analyzed from NOAA weather records for the region, then run through the model. Among other factors, these would include the presence or absence of the jet stream, and if present, its direction, altitude and velocity. The type, altitude, and density of clouds would also be considered. From these data, the models would predict peak amplitudes and impact locations. As described above, impacts to pinnipeds on the NCI, including pups, have been shown through more than two decades of monitoring reports to be minimal and temporary (MMCG and SAIC 2012a). Therefore monitoring requirements at the NCI would be dependent on modeled sonic boom intensity and would be based on the harbor seal pupping season, such that monitoring requirements would be greater when pups would be expected to be present. At the height of the pupping season (between March 1 and June 30) monitoring is required if sonic boom model results indicate a peak overpressure of 2.0 psf or greater is likely to impact the NCI. Between July 1 and September 30 monitoring is required if sonic boom model results indicate a peak overpressure of 3.0 psf or greater is likely to impact the NCI. Between October 1 and February 28, monitoring is required if sonic boom model results indicate a peak overpressure of 4.0 psf or greater is likely to impact the NCI.
Marine mammal monitoring procedures would consist of the following:
• To conduct monitoring of Falcon 9 First Stage boost-back and landing activities, SpaceX would designate qualified, on-site observers that would be approved in advance by NMFS;
• If sonic boom model results indicate a peak overpressure of 1.0 psf or greater is likely to impact VAFB, then acoustic and biological monitoring at VAFB would be implemented. Monitoring would be conducted at the haulout site closest to the predicted sonic boom impact area that can be safely accessed by observers;
• If sonic boom model results indicate a peak overpressure of 2.0 psf or greater is likely to impact one of the NCI between March 1 and June 30; a peak overpressure of greater than 3.0 psf is likely to impact one of the NCI between July 1 and September 30, or a peak overpressure of greater than 4.0 psf is likely to impact one of the NCI between October 1 and February 28, then monitoring of haulout sites on the NCI would be implemented. Monitoring would be conducted at the haulout site closest to the predicted sonic boom impact area;
• Monitoring would commence at least 72 hours prior to the boost-back and continue until at least 48 hours after the event;
• Monitoring would include multiple surveys each day that record the species; number of animals; general behavior; presence of pups; age class; gender; and reaction to noise associated with Falcon 9 First Stage recovery activities, sonic booms or other natural or human caused disturbances, in addition to recording environmental conditions such as tide, wind speed, air temperature, and swell;
• If the boost-back and landing is scheduled during daylight, time lapse photography or video recording would be used to document the behavior of marine mammals during Falcon 9 First Stage recovery activities;
• For Falcon 9 First Stage recovery activities scheduled during harbor seal pupping season (March through June), follow-up surveys would be conducted within two weeks of the boost-back and landing; and
• New northern elephant seal pupping location(s) at VAFB would be prioritized for monitoring when landings occur at SLC-4W during northern elephant seal pupping season (January through February) when practicable.
Acoustic measurements of the sonic boom created during boost-back at the monitoring location would be recorded to determine the overpressure level. Typically this would entail use of a digital audio tape (DAT) recorder and a high quality microphone to monitor the sound environment and measure the sonic boom. This system would be specially tailored for recording the low frequency sound associated with rocket launches and sonic booms. The DAT system would record the launch noise and sonic boom digitally to tape, which would allow for detailed post‐analysis of the frequency content, and the calculation of other acoustic metrics, and would record the ambient noise and sonic boom. The DAT recorder would be placed near the marine mammal monitoring site when practicable.
SpaceX would report data collected during marine mammal monitoring and acoustic monitoring as described above. The monitoring report would include a description of project related activities, counts of marine mammals by species, sex and age class, a summary of marine mammal species/count data, and a summary of observed marine mammal responses to project-related activities.
A launch monitoring report would be submitted by SpaceX to the NMFS Office of Protected Resources within 60 days after each Falcon 9 First Stage recovery action. This report would contain information on the date(s) and time(s) of the Falcon 9 First Stage recovery action, the design of the monitoring program; and results of the monitoring program, including, but not necessarily limited to the following:
• Numbers of pinnipeds present on the monitored haulout prior to the Falcon 9 First Stage recovery;
• Numbers of pinnipeds that may have been harassed (based on observations of pinniped responses and the pinniped disturbance scale as shown in Table 3);
• The length of time pinnipeds remained off the haulout or rookery for pinnipeds estimated to have entered the water as a result of Falcon 9 First Stage recovery noise;
• Any other observed behavioral modifications by pinnipeds that were likely the result of Falcon 9 First Stage recovery activities, including sonic boom; and
• Results of acoustic monitoring including comparisons of modeled sonic booms with actual acoustic recordings of sonic booms.
In addition, a final monitoring report would be submitted by SpaceX to the NMFS Office of Protected Resources. A draft of the report would be submitted within 90 days of the expiration of the IHA, or, within 45 days of the requested renewal of the IHA (if applicable). A final version of the report would be submitted within 30 days following resolution of comments on the draft report from NMFS. The report would summarize the information from the 60-day post-activity reports (as described above), including but not necessarily limited to the following:
• Date(s) and time(s) of the Falcon 9 First Stage recovery actions;
• Design of the monitoring program; and
• Results of the monitoring program, including the information components contained in the 60-day launch reports, as well as any documented cumulative impacts on marine mammals as a result of the activities, such as long term reductions in the number of pinnipeds at haulouts as a result of the activities.
In the unanticipated event that the specified activity clearly causes the take of a marine mammal in a manner not authorized by the proposed IHA (if issued), such as a Level A harassment, or a take of a marine mammal species other than those proposed for authorization, SpaceX would immediately cease the specified activities and immediately report the incident to the NMFS Office of Protected Resources. The report would include the following information:
• Time, date, and location (latitude/longitude) of the incident;
• Description of the incident;
• Status of all Falcon 9 First Stage recovery activities in the 48 hours preceding the incident;
• Description of all marine mammal observations in the 48 hours preceding the incident;
• Species identification or description of the animal(s) involved;
• Fate of the animal(s); and
• Photographs or video footage of the animal(s) (if equipment is available).
Activities would not resume until NMFS is able to review the circumstances of the prohibited take. NMFS would work with SpaceX to determine what is necessary to minimize the likelihood of further prohibited take and ensure MMPA compliance. SpaceX would not be able to resume their activities until notified by NMFS via letter, email, or telephone.
In the event that SpaceX discovers an injured or dead marine mammal, and the lead observer determines the cause of the injury or death is unknown and the death is relatively recent (
In the event that SpaceX discovers an injured or dead marine mammal, and the lead MMO determines the injury or death is not associated with or related to the activities authorized in the IHA (
NMFS has defined negligible impact as an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival (50 CFR 216.103). A negligible impact finding is based on the lack of likely adverse effects on annual rates of recruitment or survival (
To avoid repetition, the discussion of our analyses applies to all the species listed in Table 1, given that the anticipated effects of this activity on these different marine mammal species are expected to be similar. Activities associated with the proposed Falcon 9 First Stage recovery activities, as outlined previously, have the potential to disturb or displace marine mammals. Specifically, the specified activities may result in take, in the form of Level B harassment (behavioral disturbance) only, from airborne sounds of sonic booms. Potential takes could occur if marine mammals are hauled out in areas where a sonic boom above 1.0 psf occurs, which is considered likely given the modeled sonic booms of the proposed activities and the occurrence of pinnipeds in the project area. Based on the best available information, including monitoring reports from similar activities that have been authorized by NMFS, behavioral responses will likely be limited to reactions such as alerting to the noise, with some animals possibly moving toward or entering the water, depending on the species and the intensity of the sonic boom. Repeated exposures of individuals to levels of sound that may cause Level B harassment are unlikely to result in hearing impairment or to significantly disrupt foraging behavior. Thus, even repeated Level B harassment of some small subset of an overall stock is unlikely to result in any significant realized decrease in fitness to those individuals, and thus would not result in any adverse impact to the stock as a whole. Level B harassment would be reduced to the level of least practicable impact through use of mitigation measures described above.
If a marine mammal responds to a stimulus by changing its behavior (
Even in the instances of pinnipeds being behaviorally disturbed by sonic booms from rocket launches at VAFB, no evidence has been presented of abnormal behavior, injuries or mortalities, or pup abandonment as a result of sonic booms (SAIC 2013). These findings came as a result of more than two decades of surveys at VAFB and the NCI (MMCG and SAIC, 2012). Post-launch monitoring generally reveals a return to normal behavioral patterns within minutes up to an hour or two of each launch, regardless of species. For instance, a total of eight Delta II and Taurus space vehicle launches occurred from north VAFB, near the Spur Road and Purisima Point haulout sites, from February, 2009 through February, 2014. Of these eight launches, three occurred during the harbor seal pupping season. The continued use by harbor seals of the Spur Road and Purisima Point haulout sites indicates that it is unlikely that these rocket launches (and associated sonic booms) resulted in long-term disturbances of pinnipeds using the haulout sites. San Miguel Island represents the most important pinniped rookery in the continental United States, and as such extensive research has been conducted there for decades. From this research, as well as stock assessment reports, it is clear that VAFB operations (including associated sonic booms) have not had any significant impacts on San Miguel Island rookeries and haulouts (SAIC 2012).
In summary and as described above, the following factors primarily support our preliminary determination that the impacts resulting from this activity are not expected to adversely affect the species or stock through effects on annual rates of recruitment or survival:
• No injury, serious injury, or mortality are anticipated or authorized;
• The anticipated incidences of Level B harassment are expected to consist of, at worst, temporary modifications in behavior (
• The proposed activities are expected to result in no long-term changes in the use by pinnipeds of rookeries and haulouts in the project area, based on over 20 years of monitoring data; and
• The presumed efficacy of planned mitigation measures in reducing the effects of the specified activity to the level of least practicable impact.
Based on the analysis contained herein of the likely effects of the specified activity on marine mammals and their habitat, and taking into consideration the implementation of the proposed monitoring and mitigation measures, NMFS preliminarily finds that the total marine mammal take from the proposed activity will have a negligible impact on all affected marine mammal species or stocks.
As noted above, only small numbers of incidental take may be authorized under Sections 101(a)(5)(A) and (D) of the MMPA for specified activities other than military readiness activities. The MMPA does not define small numbers and so, in practice, where estimated numbers are available, NMFS compares the number of individuals taken to the most appropriate estimation of abundance of the relevant species or stock in our determination of whether an authorization is limited to small numbers of marine mammals. Additionally, other qualitative factors may be considered in the analysis, such as the temporal or spatial scale of the activities.
The numbers of proposed authorized takes are considered small relative to the relevant stocks or populations (less than 11 percent for all species and stocks). It is important to note that the number of expected takes does not necessarily represent the number of individual animals expected to be taken. Our small numbers analysis accounts for this fact. Multiple exposures to Level B harassment can accrue to the same individual animals over the course of an activity that occurs multiple times in the same area (such as SpaceX's proposed activity). This is especially likely in the case of species that have limited ranges and that have site fidelity to a location within the project area, as is the case with Pacific harbor seals.
As described above, harbor seals are non-migratory, rarely traveling more than 50 km from their haulout sites. Thus, while the estimated abundance of the California stock of Pacific harbor seals is 30,968 (Carretta
Based on the analysis contained herein of the proposed activity (including the proposed mitigation and monitoring measures) and the anticipated take of marine mammals, NMFS preliminarily finds that small numbers of marine mammals will be taken relative to the population size of the affected species or stocks.
There are no relevant subsistence uses of the affected marine mammal stocks or species implicated by this action. Therefore, NMFS has determined that the total taking of affected species or stocks would not have an unmitigable adverse impact on the availability of such species or stocks for taking for subsistence purposes.
Section 7(a)(2) of the Endangered Species Act of 1973 (ESA: 16 U.S.C. 1531
There is one marine mammal species (Guadalupe fur seal) listed under the ESA with confirmed occurrence in the area expected to be impacted by the proposed activities. The Permits and Conservation Division has requested initiation of section 7 consultation with the West Coast Region Protected Resources Division Office for the issuance of this IHA. NMFS will conclude the ESA consultation prior to reaching a determination regarding the proposed issuance of the authorization.
As a result of these preliminary determinations, NMFS proposes to issue an IHA to SpaceX for conducting Falcon 9 First Stage recovery activities at Vandenberg Air Force Base, in the Pacific Ocean offshore Vandenberg Air Force Base, and at the Northern Channel Islands, California, for one year from the date of issuance, provided the previously mentioned mitigation, monitoring, and reporting requirements are incorporated. This section contains a draft of the IHA itself. The wording contained in this section is proposed for inclusion in the IHA (if issued).
1. This Incidental Harassment Authorization (IHA) is valid for one year from the date of issuance.
(a) This IHA is valid only for Falcon 9 First Stage recovery activities at Vandenberg Air Force Base, California, and at auxiliary landing sites offshore.
2. General Conditions
(a) A copy of this IHA must be in the possession of SpaceX, its designees, and work crew personnel operating under the authority of this IHA.
(b) The species authorized for taking are the Pacific harbor seal (
(c) The taking, by Level B harassment only, is limited to the species listed in condition 2(b). See Table 5 for numbers of take authorized.
(d) The taking by injury (Level A harassment), serious injury, or death of any of the species listed in condition 2(b) of the Authorization or any taking of any other species of marine mammal is prohibited and may result in the modification, suspension, or revocation of this IHA.
3. Mitigation Measures
The holder of this Authorization must implement the following mitigation measure: Unless constrained by other factors including human safety or national security concerns, launches must be scheduled to avoid, whenever possible, boost-backs and landings during the harbor seal pupping season of March through June.
4. Monitoring
The holder of this Authorization must conduct marine mammal and acoustic monitoring as described below.
(a) To conduct monitoring of Falcon 9 First Stage recovery activities, SpaceX must designate qualified, on-site individuals approved in advance by NMFS;
(b) If sonic boom model results indicate that a peak overpressure of 1.0 psf or greater is likely to impact VAFB, then acoustic and biological monitoring at VAFB must be implemented. Monitoring must be conducted at the haulout site closest to the predicted sonic boom impact area that can be safely accessed by observers;
(c) If sonic boom model results indicate a peak overpressure of 1.0 psf or greater is likely to impact VAFB during January and February, then acoustic and biological monitoring must be implemented at northern elephant seal rookeries at VAFB, when practicable;
(d) If sonic boom model results indicate that a peak overpressure of 2.0 psf or greater is predicted to impact the Channel Islands between March 1 and June 30, greater than 3.0 psf between July 1 and September 30, and greater than 4.0 psf between October 1 and February 28, monitoring of haulout sites on the Channel Islands must be implemented. Monitoring must be conducted at the haulout site closest to the predicted sonic boom impact area that can be safely accessed by observers;
(e) Monitoring must be conducted for at least 72 hours prior to any planned Falcon 9 First Stage recovery and continue until at least 48 hours after the event;
(f) For Falcon 9 First Stage recovery activities that occur during March through June, follow-up surveys of harbor seal haulouts must be conducted within two weeks of the Falcon 9 First Stage recovery;
(g) If Falcon 9 First Stage recovery activities are scheduled during daylight, time-lapse photography or video recording must be used to document the behavior of marine mammals during Falcon 9 First Stage recovery activities;
(h) Monitoring must include multiple surveys each day that record the species, number of animals, general behavior, presence of pups, age class, gender and reaction to noise associated with Falcon 9 First Stage recovery, sonic booms or other natural or human caused disturbances, in addition to recording environmental conditions such as tide, wind speed, air temperature, and swell; and
(i) Acoustic measurements of the sonic boom created during boost-back at the monitoring location must be recorded to determine the overpressure level.
5. Reporting
The holder of this Authorization is required to:
(a) Submit a report to the Office of Protected Resources, NMFS, within 60 days after each Falcon 9 First Stage recovery action. This report must contain the following information:
(1) Date(s) and time(s) of the Falcon 9 First Stage recovery action;
(2) Design of the monitoring program; and
(3) Results of the monitoring program, including, but not necessarily limited to:
(i) Numbers of pinnipeds present on the haulout prior to the Falcon 9 First Stage recovery;
(ii) Numbers of pinnipeds that may have been harassed as a result of Falcon 9 First Stage recovery activities;
(iii) For pinnipeds estimated to have been harassed as a result of Falcon 9 First Stage recovery noise, the length of time pinnipeds remained off the haulout or rookery;
(iv) Any other observed behavioral modifications by pinnipeds that were likely the result of Falcon 9 First Stage recovery activities, including sonic boom; and
(v) Results of acoustic monitoring including comparisons of modeled sonic booms with actual acoustic recordings of sonic booms.
(b) Submit an annual report on all monitoring conducted under the IHA. A draft of the annual report must be submitted within 90 calendar days of the expiration of this IHA, or, within 45 calendar days of the requested renewal of the IHA (if applicable). A final annual report must be prepared and submitted within 30 days following resolution of comments on the draft report from
(1) Date(s) and time(s) of the Falcon 9 First Stage recovery action;
(2) Design of the monitoring program; and
(3) Results of the monitoring program, including, but not necessarily limited to:
(i) Numbers of pinnipeds present on the haulout prior to the Falcon 9 First Stage recovery;
(ii) Numbers of pinnipeds estimated to have been harassed as a result of Falcon 9 First Stage recovery activities at the monitoring location;
(iii) For pinnipeds estimated to have been harassed as a result of Falcon 9 First Stage recovery noise, the length of time pinnipeds remained off the haulout or rookery;
(iv) Any other observed behavioral modifications by pinnipeds that were likely the result of Falcon 9 First Stage recovery activities, including sonic boom;
(v) Any cumulative impacts on marine mammals as a result of the activities, such as long term reductions in the number of pinnipeds at haulouts as a result of the activities; and
(vi) Results of acoustic monitoring including comparisons of modeled sonic booms with actual acoustic recordings of sonic booms.
(c) Reporting injured or dead marine mammals:
(1) In the unanticipated event that the specified activity clearly causes the take of a marine mammal in a manner prohibited by this IHA (as determined by the lead marine mammal observer), such as an injury (Level A harassment), serious injury, or mortality, SpaceX must immediately cease the specified activities and report the incident to the NMFS Office of Protected Resources and the NMFS West Coast Region Stranding Coordinator. The report must include the following information:
A. Time and date of the incident;
B. Description of the incident;
C. Status of all Falcon 9 First Stage recovery activities in the 48 hours preceding the incident;
D. Description of all marine mammal observations in the 48 hours preceding the incident;
E. Environmental conditions (
F. Species identification or description of the animal(s) involved;
G. Fate of the animal(s); and
H. Photographs or video footage of the animal(s).
Activities may not resume until NMFS is able to review the circumstances of the prohibited take. NMFS will work with SpaceX to determine what measures are necessary to minimize the likelihood of further prohibited take and ensure MMPA compliance. SpaceX may not resume their activities until notified by NMFS via letter, email, or telephone.
(2) In the event that SpaceX discovers an injured or dead marine mammal, and the lead observer determines that the cause of the injury or death is unknown and the death is relatively recent (
(3) In the event that SpaceX discovers an injured or dead marine mammal, and the lead observer determines that the injury or death is not associated with or related to the activities authorized in the IHA (
6. Modification and suspension
(a) This IHA may be modified, suspended or withdrawn if the holder fails to abide by the conditions prescribed herein, or if NMFS determines that the authorized taking is having more than a negligible impact on the species or stock of affected marine mammals.
We request comment on our analyses, the proposed authorization, and any other aspect of this Notice of Proposed IHA for the proposed boost-back and landings of Falcon 9 First Stage rockets. We also request comment on the potential for renewal of this proposed IHA as described in the paragraph below. Please include with your comments any supporting data or literature citations to help inform our final decision on the request for MMPA authorization.
On a case-by-case basis, NMFS may issue a second one-year IHA without additional notice when (1) another year of identical or nearly identical activities as described in the Specified Activities section is planned or (2) the activities would not be completed by the time the IHA expires and a second IHA would allow for completion of the activities beyond that described in the Dates and Duration section, provided all of the following conditions are met:
• A request for renewal is received no later than 60 days prior to expiration of the current IHA.
• The request for renewal must include the following:
(1) An explanation that the activities to be conducted beyond the initial dates either are identical to the previously analyzed activities or include changes so minor (
(2) A preliminary monitoring report showing the results of the required monitoring to date and an explanation showing that the monitoring results do not indicate impacts of a scale or nature not previously analyzed or authorized.
• Upon review of the request for renewal, the status of the affected species or stocks, and any other pertinent information, NMFS determines that there are no more than minor changes in the activities, the mitigation and monitoring measures remain the same and appropriate, and the original findings remain valid.
National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice.
The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general
Written comments must be submitted on or before January 14, 2019.
Direct all written comments to Jennifer Jessup, Departmental Paperwork Clearance Officer, Department of Commerce, Room 6616, 14th and Constitution Avenue NW, Washington, DC 20230 (or via the internet at
Requests for additional information or copies of the information collection instrument and instructions should be directed to Liana Heberer, at telephone number: 858-546-5626 or
The International Billfish Angler Survey began in 1969 and is an integral part of the Billfish Research Program at the National Oceanic and Atmospheric Administration's (NOAA) Southwest Fisheries Science Center (SWFSC). The survey tracks recreational angler fishing catch and effort for billfish in the Pacific and Indian Oceans in support of the Pacific and Western Pacific Fishery Management Councils, authorized under the Magnuson-Stevens Fishery Conservation and Management Act (MSA). The data are used by scientists and fishery managers to assist with assessing the status of billfish stocks. The survey is intended for anglers cooperating in the Billfish Program and is entirely voluntary. This survey is specific to recreational anglers fishing for Istiophorid and Xiphiid billfish in the Pacific and Indian Oceans; as such it provides the only estimates of catch per unit of effort for recreational billfish fishing in those areas.
The paper form is sent to anglers with recent participation in the SWFSC Billfish Research Program and is also available for downloading on the SWFSC Billfish Program website. Completed forms are submitted by mail.
Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden (including hours and cost) of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.
Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record.
National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice.
The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.
Written comments must be submitted on or before January 14, 2019.
Direct all written comments to Jennifer Jessup, Departmental Paperwork Clearance Officer, Department of Commerce, Room 6616, 14th and Constitution Avenue NW, Washington, DC 20230 (or via the internet at
Requests for additional information or copies of the information collection instrument and instructions should be directed to Brian Fredieu, (301) 427-8505 or
This request is for an extension of a currently approved information collection.
The Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), as amended in 1996, provides for the nomination for members of Fishery Management Councils by state governors and Indian treaty tribes, for the designation of a principal state fishery official who will perform duties under the Magnuson-Stevens Act, and for a request by a state for reinstatement of state authority over a managed fishery. Nominees for council membership must provide the governor or tribe with background documentation, which is then submitted to NOAA with the nomination. The information submitted with these actions will be used to ensure that the requirements of the Magnuson-Stevens Act are being met.
State governors and Indian treaty tribes submit written nominations to the Secretary of Commerce, together with recommendations and statements of candidates' qualifications. Designations of state officials and requests for reinstatement of state authority are also made in writing in response to regulations. NMFS provides guidance on what information to include in order to comply with current regulations.
Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden (including hours and cost) of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.
Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record.
Department of the Navy, DoD.
Notice.
The Department of the Navy hereby gives notice of its intent to grant to Sirchie Acquisition Company, LLC. (Youngsville, NC) a revocable, nonassignable, co-exclusive license to practice worldwide, the Government-owned inventions described and claimed in U.S. Patent No. 8,5574,658 issued November 5, 2013: FUMELESS LATENT FINGERPRINT DETECTION. The Navy intends to grant no more than two co-exclusive licenses to the above invention.
Anyone wishing to object to the grant of this co-exclusive license must file written objections along with supporting evidence, if any, not later than November 30, 2018.
Written objections are to be filed with the Office of Research and Technology Applications, Naval Air Warfare Center Weapons Division, Code 400000D, 1900 N Knox Road, Stop 6306, China Lake, CA 93555-6106.
Dylan Riley, Director, Technology Transfer Office, Naval Air Warfare Center Weapons Division, Code 498400D, 1900 N Knox Road, Stop 6312, China Lake, CA 93555-6106, telephone 760-939-2105, Email:
35 U.S.C. 207, 37 CFR part 404.
Department of the Navy, DoD.
Notice.
Pursuant to section 102(2)(c) of the National Environmental Policy Act of 1969, as implemented by the Council on Environmental Quality, the Department of the Navy (DoN) has prepared and filed with the United States Environmental Protection Agency a Draft Environmental Impact Statement (EIS) to evaluate the potential environmental impacts of modernization of the Fallon Range Training Complex (FRTC), Naval Air Station Fallon, Nevada, to include renewing the current public land withdrawal, expanding land ranges, expanding and modifying airspace, and upgrading range infrastructure. The DoN is not proposing to change the level or type of training, rather activities would be redistributed across the expanded ranges. The DoN will hold seven public meetings to inform the public and receive oral and written comments on the Draft EIS. This notice announces the dates and locations of the public meetings and provides information about the environmental planning effort.
The 60-day public comment period begins November 16, 2018, and ends January 15, 2019. Public meetings will be held on December 10, 11, 12 and 13, 2018. All public comments are due by January 15, 2019.
The public meetings will be held in the following locations:
1. December 10, 2018, 10:00 a.m. to 1:00 p.m., Hawthorne Convention Center, 932 E Street, Hawthorne, NV 89415-2281.
2. December 10, 2018, 5:00 p.m. to 8:00 p.m., Gabbs School Gymnasium, 511 E Avenue, Gabbs, NV 89409-0147.
3. December 11, 2018, 10:00 a.m. to 1:00 p.m., Austin Town Hall, 135 Court Street, Austin, NV 89310-9302.
4. December 11, 2018, 5:00 p.m. to 8:00 p.m., Eureka Opera House, Grand Hall, 31 South Main Street, Eureka, NV 89316-1500.
5. December 12, 2018, 5:00 p.m. to 8:00 p.m., Fallon Convention Center, 100 Campus Way, Fallon, NV 89406-2661.
6. December 13, 2018, 10:00 a.m. to 1:00 p.m., C Punch Inn and Casino, Kumiva Room, 1420 Cornell Avenue, Lovelock, NV 89419-0056.
7. December 13, 2018, 5:00 p.m. to 8:00 p.m., West 2nd Events Center, 600 West 2nd Street, Reno, NV 89503-5312.
The DoN will hold seven public meetings to inform the public about the proposed action, alternatives under consideration, the environmental analysis, and to provide an opportunity for the public to submit oral and written comments on the Draft EIS. Public meetings will include an open house session with informational poster stations staffed by DoN representatives, followed by a brief presentation by the DoN, and a public oral comment session. A stenographer will be available throughout the meeting to record oral comments from the public. In the interest of available time, and to ensure all who wish to provide an oral statement to the stenographer have the opportunity to do so, each speaker's comments will be limited to three minutes. Equal weight will be given to oral and written statements. Federal, state, and local agencies and officials, Native American tribes, and interested organizations and individuals are encouraged to provide comments in person at the public meetings or in writing during the public review period.
Comments may be provided at the public meetings, by mail, and through the project website at:
All comments submitted during the public review period, oral or written, will become part of the public record and will be reviewed and considered in the preparation of the Final EIS. For consideration in the Final EIS, comments must be postmarked or received online by January 15, 2019.
Naval Facilities Engineering Command Southwest, Code EV21.SG, 1220 Pacific Highway; Building 1, 5th floor, San Diego, CA 92132-5190, Attn: Ms. Sara Goodwin, EIS Project Manager, 619-532-4463, or project website:
The Bureau of Land Management, Federal Aviation Administration, and United States Fish and Wildlife Service are federal cooperating agencies for this EIS. Additional state and county cooperating agencies include: Nevada Department of Wildlife, Nevada Division of Minerals, Nevada Department of Agriculture, Nevada Department of Transportation, Nevada Governor's Office of Energy, Churchill County, Eureka County, Lander County, Mineral County, Nye County, and Pershing County. The DoN is also working with thirteen federally recognized Native American tribes and one Tribal Council.
The FRTC is a training complex in the high desert of northern Nevada encompassing airspace, land ranges, and electronic systems used primarily for air and ground training activities. The DoN's proposed action is to modernize the FRTC by expanding land ranges and modifying associated airspace configurations. The proposed action has the following elements:
• Congressional renewal of the 1999 public land withdrawal of 202,864 acres which is scheduled to expire in November 2021.
• Withdrawal and reservation by Congress for military use of up to approximately 618,727 acres of additional federal land.
• Acquisition of approximately 65,153 acres of private or state-owned (non-federal) land.
• Expansion of associated special use airspace and reconfiguration of existing airspace.
• Modification of range infrastructure to support modernization, including construction of new targets.
The purpose of the proposed action is to provide sustainable and modernized airspace, range, maneuver areas, training facilities, and range infrastructure and resources that would support acceptably realistic air warfare training activities as well as special operations ground training activities in order to meet emergent and future threats. The proposed action would enable the DoN's execution of its congressionally mandated roles and responsibilities under 10 United States Code (U.S.C), section 5062 and 10 U.S.C. 167. Current range configurations do not support realistic training. Increasing the size of the range would allow the DoN to realistically train with precision-guided munitions, which require greater safety buffer zones because they are launched from aircraft at higher altitudes and longer distances from targets. It would also allow ground forces to realistically conduct tactical ground mobility training.
The Draft EIS is available at the project website at
1. Austin Branch Library, 88 Main Street, Austin, NV 89310-0121.
2. Carson City Library, 900 North Roop Street, Carson City, NV 89701-3101.
3. Churchill County Library, 553 S. Maine Street, Fallon, NV 89406-3306.
4. Crescent Valley Branch Library, Crescent Valley Town Center, 5045 Tenabo Avenue, Suite 103, Crescent Valley, NV 89821-8051.
5. Downtown Reno Library, 301 S. Center Street, Reno, NV 89501-2102.
6. Eureka Branch Library, 80 South Monroe Street, Eureka, NV 89316-0293.
7. Fernley Branch Library, 575 Silver Lace Blvd., Fernley, NV 89408-1591.
8. Gabbs Community Library, 602 3rd Street, Gabbs, NV 89409-0206.
9. Mineral County Library 110 First Street, Hawthorne, NV 89415-1390.
10. Pershing County Library, 1125 Central Avenue, Lovelock, NV 89419-0781.
11. Yerington Branch Library, 20 Nevin Way, Yerington, NV 89447-2399.
A compact disc of the Draft EIS will be made available upon written request by contacting: Naval Facilities Engineering Command Southwest, Code EV21.SG, 1220 Pacific Highway; Building 1, 5th floor, San Diego, CA 92132-5190, Attn: Ms. Sara Goodwin, EIS Project Manager.
Department of the Navy; DoD.
Notice.
The Department of the Navy (DoN) announces the availability of the inventions listed below, assigned to the United States Government, as represented by the Secretary of the Navy, for domestic and foreign licensing by the Department of the Navy.
Requests for copies of the patents cited should be directed to Office of Counsel, Naval Surface Warfare Center Carderock Division, 9500 MacArthur Blvd., West Bethesda, MD 20817-5700.
Dr. Joseph Teter, Director, Technology Transfer Office, Naval Surface Warfare Center Carderock Division, Code 00T, 9500 MacArthur Blvd., West Bethesda, MD 20817-5700, telephone 301-227-4299.
The following patents are available for licensing: //U.S. Patent No. 9,783,321: RETRACTABLE VERTICAL FLOW-CONTROL DEVICE FOR TOPSIDE MITIGATION OF AIRWAKES OVER SHIP FLIGHT DECKS//U.S. Patent No. 9,822,040: PRESSURELESS SINTERING-BASED METHOD FOR MAKING A TWO-PHASE CERAMIC COMPOSITE BODY//U.S. Patent No. 9,858,527: ALGORITHMIC METHOD FOR MODELING HUMAN DECISION-MAKING//U.S. Patent No. 9,975,135: LIGHTWEIGHT APPARATUS FOR CAPTURING OVERSPRAY AND AIRBORNE PARTICULATES//U.S. Patent No. 10,024,579: SOLAR PANEL DEPLOYMENT SYSTEM//U.S. Patent No. 10,053,195: SHIPBOARD SIDE-MOUNTED EXTENDING ARTICULATED BOOM FOR FUELING AND MAINTENANCE OPERATIONS//
35 U.S.C. 207, 37 CFR part 404
Federal Student Aid, Department of Education.
Notice.
Federal Student Aid (FSA), as required by the Public Health Service Act (the Act) is publishing this list of Health Education Assistance Loan (HEAL) borrowers who have defaulted on their loans as of June 30, 2018. This information is also made available for
If you use a telecommunications device for the deaf (TDD) or a text telephone (TTY), call the Federal Relay Service, toll free, at 1-800-877-8339.
From fiscal year 1978 through fiscal year 1998, the HEAL program insured loans made by participating lenders to eligible graduate students in schools of medicine, osteopathy, dentistry, veterinary medicine, optometry, podiatry, public health, pharmacy, and chiropractic, and in programs in health administration and clinical psychology. Authorization for new HEAL program loans was discontinued on September 30, 1998.
Under division H, title V, section 525 of the Consolidated Appropriations Act, 2014 (Pub. L. 113-76), and title VII, part A, subpart I of the Public Health Service Act, the authority to administer the HEAL program, including servicing, collecting, and enforcing any loans made under the HEAL program that remain outstanding, was transferred from the Secretary of Health and Human Services to the Secretary of Education effective July 1, 2014. The Act and a system of records notice published in the
Information on the HEAL program is available on the Department of Education's Information for Financial Aid Professionals (IFAP) website at:
In accordance with section 709(c)(2) of the Act (42 U.S.C. 292h(c)(2)), FSA will provide the information included in this
You may also access documents of the Department published in the
20 U.S.C. 1070b
Take notice that on October 29, 2018, Sabine Pass LNG, L.P. (SPLNG), 700 Milam Street, Suite 1900, Houston, Texas 77002, filed an application under section 3(a) of the Natural Gas Act (NGA) and Part 153 and 380 of the Commission's regulations, seeking authorization to site, construct and operate an expansion of the existing Sabine Pass liquefied natural gas (LNG) facility (SPLNG Terminal), located in Cameron Parish, Louisiana on the Sabine Pass Channel. The proposed expansion of the SPLNG Terminal consists of the addition of a third marine berth (Third Berth) and supporting facilities (SPLNG Third Berth Expansion Project), all as more fully set forth in the application which is on file with the Commission and open to public inspection. The filing may also be viewed on the web at
Any questions regarding the application should be directed to Karri Mahmoud, Cheniere Energy, Inc., 700 Milam Street, Suite 1900, Houston, TX 77002, or by telephone at (713) 375-5000, or email at
On March 8, 2018 the Commission granted SPLNG's request to utilize the Pre-Filing Process and assigned Docket No. PF18-3-000 to staff activities involved in the Project. Now, as of the filing of the October 29, 2018 application, the Pre-Filing Process for this Project has ended. From this time forward, this proceeding will be conducted in Docket No. CP19-11-000 as noted in the caption of this Notice.
Pursuant to section 157.9 of the Commission's rules (18 CFR 157.9), within 90 days of this Notice, the Commission staff will either: Complete its environmental assessment (EA) and place it into the Commission's public record (eLibrary) for this proceeding; or issue a Notice of Schedule for Environmental Review. If a Notice of Schedule for Environmental Review is issued, it will indicate, among other milestones, the anticipated date for the Commission staff's issuance of the final environmental impact statement (FEIS) or EA for this proposal. The filing of the EA in the Commission's public record for this proceeding or the issuance of a Notice of Schedule for Environmental Review will serve to notify federal and state agencies of the timing for the completion of all necessary reviews, and the subsequent need to complete all federal authorizations within 90 days of the date of issuance of the Commission staff's FEIS or EA.
There are two ways to become involved in the Commission's review of this project. First, any person wishing to obtain legal status by becoming a party to the proceedings for this project should, on or before the comment date stated below file with the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426, a motion to intervene in accordance with the requirements of the Commission's Rules of Practice and Procedure (18 CFR 385.214 or 385.211) and the Regulations under the NGA (18 CFR 157.10). A person obtaining party status will be placed on the service list
However, a person does not have to intervene in order to have comments considered. The second way to participate is by filing with the Secretary of the Commission, as soon as possible, an original and two copies of comments in support of or in opposition to this project. The Commission will consider these comments in determining the appropriate action to be taken, but the filing of a comment alone will not serve to make the filer a party to the proceeding. The Commission's rules require that persons filing comments in opposition to the project provide copies of their protests only to the party or parties directly involved in the protest.
Persons who wish to comment only on the environmental review of this project should submit an original and two copies of their comments to the Secretary of the Commission. Environmental commentors will be placed on the Commission's environmental mailing list and will be notified of any meetings associated with the Commission's environmental review process. Environmental commentors will not be required to serve copies of filed documents on all other parties. However, the non-party commentors will not receive copies of all documents filed by other parties or issued by the Commission and will not have the right to seek court review of the Commission's final order.
As of the February 27, 2018 date of the Commission's order in Docket No. CP16-4-001, the Commission will apply its revised practice concerning out-of-time motions to intervene in any new Natural Gas Act section 3 or section 7 proceeding.
The Commission strongly encourages electronic filings of comments, protests and interventions in lieu of paper using the “eFiling” link at
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:
In accordance with the National Environmental Policy Act of 1969 and the Federal Energy Regulatory Commission's (Commission or FERC's) regulations, 18 Code of Federal Regulations (CFR) Part 380, the Office of Energy Projects has reviewed an application filed by the California Department of Water Resources (California DWR), licensee for the Feather River Hydroelectric Project, to repair the Oroville Dam main spillway, modify the existing emergency spillway, and relocate a buried transmission line. The specifications for the proposal were filed with the Commission on January 29, 2018, and supplemented with additional supporting information on February 13, July 16, and August 1, 2018. The project is located on the Feather River in Butte County, California.
California DWR proposes to repair and reconstruct the Lake Oroville main spillway as a result of the failure of the main spillway beginning on February 7, 2017. California DWR also proposes to fortify the existing emergency spillway located adjacent to the main spillway and to relocate a buried transmission line near the Hyatt Power Plant. The proposed work would take place over two years, with major portions of the work at the main spillway completed on an expedited basis prior to the commencement of the normal wet season on November 1, 2017. The remainder of the work would be completed by January 2019. Staff prepared a draft environmental assessment (EA), which analyzes the potential environmental effects associated with the reconstruction and modification of project structures. The draft EA also discusses the environmental effects of California DWR's response to the spillway failure and concludes that California DWR's proposed activities, with specified environmental protection measures, would not constitute a major federal action that would significantly affect the quality of the human environment.
A copy of the draft EA is available for review at the Commission's Public Reference Room or it may be viewed on the Commission's website at
The Commission strongly encourages electronic filing. Please file comments using the Commission's eFiling system at
For further information, contact Mr. John Aedo at (415) 369-3335 or by email at
Take notice that on November 1, 2018, Florida Gas Transmission Company, LLC (FGT), 1300 Main St., Houston, Texas 77002, filed in Docket No. CP19-12-000 a prior notice request pursuant to sections 157.205, 157.208, and 157.210 of the Commission's regulations under the Natural Gas Act and FGT's blanket certificate issued in Docket No. CP82-553-000 for authorization of the East Louisiana Project. FGT proposes to construct/modify, own, and operate, certain natural gas mainline facilities and appurtenances at an existing compressor station site in Perry County, Mississippi. In addition, FGT proposes to install a new regulator, valves, Electronic Flow Meter and Supervisory Control and Data Acquisition, and appurtenances, in FGT's permanent right of-way easement at an existing mainline valve site in Washington Parish, Louisiana. This project will allow FGT to provide additional capacity of up to 75 million cubic feet per day of available firm transportation service to Entergy Louisiana, LLC in Washington Parish, Louisiana, all as more fully set forth in the request which is on file with the Commission and open to public inspection.
The filing is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's website web at
Any questions regarding this application should be directed to Blair Lichtenwalter, Senior Director of Certificates, Florida Gas Transmission Company, LLC, 1300 Main St., Houston, Texas 77002, or via eMail to
Any person or the Commission's staff may, within 60 days after issuance of the instant notice by the Commission, file pursuant to Rule 214 of the Commission's Procedural Rules (18 CFR 385.214) a motion to intervene or notice of intervention and pursuant to section 157.205 of the regulations under the NGA (18 CFR 157.205), a protest to the request. If no protest is filed within the time allowed therefore, the proposed activity shall be deemed to be authorized effective the day after the time allowed for filing a protest. If a protest is filed and not withdrawn within 30 days after the allowed time for filing a protest, the instant request shall be treated as an application for authorization pursuant to section 7 of the NGA.
Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9, within 90 days of this Notice the Commission staff will either: Complete its environmental assessment (EA) and place it into the Commission's public record (eLibrary) for this proceeding; or issue a Notice of Schedule for Environmental Review. If a Notice of Schedule for Environmental Review is issued, it will indicate, among other milestones, the anticipated date for the Commission staff's issuance of the EA for this proposal. The filing of the EA in the Commission's public record for this proceeding or the issuance of a Notice of Schedule for Environmental Review will serve to notify federal and state agencies of the timing for the completion of all necessary reviews, and the subsequent need to complete all federal authorizations within 90 days of the date of issuance of the Commission staff's EA.
Persons who wish to comment only on the environmental review of this project should submit an original and two copies of their comments to the Secretary of the Commission. Environmental commenters will be placed on the Commission's environmental mailing list and will be notified of any meetings associated with the Commission's environmental review process. Environmental commenters will not be required to serve copies of filed documents on all other parties. However, the non-party commenters will not receive copies of all documents filed by other parties or issued by the Commission and will not have the right to seek court review of the Commission's final order.
The Commission strongly encourages electronic filings of comments, protests and interventions in lieu of paper using the eFiling link at
Take notice that the Commission received the following electric corporate filings:
Take notice that the Commission received the following electric rate filings:
Take notice that the Commission received the following foreign utility company status 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 on November 7, 2018, pursuant to Rule 207 of the Commission's Rules of Practice and Procedure,
Any person desiring to intervene or to protest in this proceeding must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the comment date. Anyone filing a motion to intervene or protest must serve a copy of that document on the Petitioners.
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 proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the website that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email
This is a supplemental notice in the above-referenced NTE Southeast Electric Company, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is November 28, 2018.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the website that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email
Take notice that the following hydroelectric applications have been filed with the Commission and are available for public inspection.
a.
b.
c.
d.
e.
f.
g.
h.
i.
j.
The Commission strongly encourages electronic filing. Please file comments, recommendations, terms and conditions, and prescriptions using the Commission's eFiling system at
The Commission's Rules of Practice require all intervenors filing documents with the Commission to serve a copy of that document on each person on the official service list for the project. Further, if an intervenor files comments or documents with the Commission relating to the merits of an issue that may affect the responsibilities of a particular resource agency, they must also serve a copy of the document on that resource agency.
k. This application has been accepted and is now ready for environmental analysis.
l. The project consists of the following existing facilities:
(1) A 14-foot-high, 250-foot-long rock masonry gravity dam impounding Swan Lake with a surface area of approximately 1,364 acres at an elevation of 201 feet above sea level; (2) a concrete inlet structure; (3) three 3.5-foot-high, 4-foot-wide manually operated butterfly gates that regulate flow through the inlet structure; (4) two culverts that convey flow under Route 141; and (5) appurtenant facilities.
(1) A 15-foot-high, 86-foot-long rock masonry dam impounding a reservoir with a storage capacity of approximately 1,621 acre-feet at an elevation of 188 feet above sea level; (2) a concrete inlet structure; (3) a manually operated butterfly gate regulating flow from the inlet structure to the penstock; (4) a 3-foot-diameter, 350-foot-long steel penstock; (5) a 266-square-foot concrete powerhouse containing two Kaplan turbines and generating units with a licensed capacity of 100 kW; (6) a 300-foot-long, 12-kilovolt (kV) transmission line; and (7) appurtenant facilities. Mason's Development generates when flows in excess of 5 cfs are available and when an operator is present.
(1) A 15-foot-high, 135-foot-long masonry gravity dam impounding a reservoir with a storage capacity of approximately 200 acre-feet at an elevation of approximately 159 feet above sea level; and (2) three 3-foot-high, 2.5-foot-wide manually operated butterfly gates.
(1) A 6-foot-tall, 70-foot-wide masonry dam impounding a reservoir with a storage capacity of approximately 7 acre-feet at an elevation of approximately 128 feet above sea level; (2) a concrete inlet structure; (3) a trash sluice with wooden stop logs; (4) a powerhouse containing a Francis-type turbine and generator unit with a licensed capacity of 75 kW; (5) a 60-foot-wide concrete spillway; and (6) an approximately 100-foot-long, 12-kV transmission line. The penstock used to deliver water to the powerhouse has been removed due to deterioration and subsequent leakage; thus, the powerhouse is not operating.
(1) A 21-foot-high, 231-foot-long buttress dam impounding a reservoir with a storage capacity of approximately 72 acre-feet at an elevation of approximately 109 feet above sea level; (2) a manually operated low-level water release lift gate; (3) a manually operated lift gate regulating flow to the penstock; (4) a 5-foot-diameter, 1,200-foot-long steel penstock; (5) a 300-square-foot concrete and timber powerhouse with a Kaplan-type turbine and generator unit with a licensed capacity of 200 kW; (6) a 42-foot-long spillway; and (7) an approximately 500-foot-long, 12-kV transmission line. The penstock used to deliver water to the powerhouse is currently out of service due to damage, deterioration, and subsequent leakage; thus, the powerhouse is not operating.
m. Copies of the applications are available for review at the Commission in the Public Reference Room or may be viewed on the Commission's website at
All filings must (1) bear in all capital letters the title COMMENTS, REPLY COMMENTS, RECOMMENDATIONS, TERMS AND CONDITIONS, or PRESCRIPTIONS; (2) set forth in the heading the name of the applicant and the project number of the application to which the filing responds; (3) furnish the name, address, and telephone number of the person submitting the filing; and (4) otherwise comply with the requirements of 18 CFR 385.2001 through 385.2005. All comments, recommendations, terms and conditions or prescriptions must set forth their evidentiary basis and otherwise comply with the requirements of 18 CFR 4.34(b). Agencies may obtain copies of the applications directly from the applicant. Each filing must be accompanied by proof of service on all persons listed on the service list prepared by the Commission in this proceeding, in accordance with 18 CFR 4.34(b), and 385.2010.
You may also register online at
n.
o.
Environmental Protection Agency (EPA).
Notice.
EPA is announcing the availability of and seeking public comment on the draft Risk Evaluation for Colour Index (C. I.) Pigment Violet 29 (PV29) and associated documents developed under EPA's existing chemical substance process under the Toxic Substances Control Act (TSCA). The purpose of the risk evaluation is to determine whether a chemical substance presents an unreasonable risk to health or the environment under the conditions of use, including an unreasonable risk to a relevant potentially exposed or susceptible subpopulation. EPA is also submitting these same documents to the TSCA Science Advisory Committee on Chemicals (SACC) which will peer review the draft risk evaluation, and EPA will provide the peer review meeting details in a separate
Comments must be received on or before January 14, 2019.
Submit your written comments, identified by docket identification (ID) number EPA-HQ-OPPT-2018-0604, 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
Jeffrey Dawson, Office of Pollution Prevention and Toxics (7403M), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (202) 564-0331; email address:
This action is directed to the public in general. This action may be of interest to persons who are interested in risk evaluations of existing chemical substances under the Toxic Substances Control Act (TSCA). Since other entities may also be interested in this draft risk evaluation, the Agency has not attempted to describe all the entities that may be interested in this action.
EPA is announcing the availability of and seeking public comment on the draft Risk Evaluation for Colour Index (C. I.) Pigment Violet 29 (PV29) and associated documents, which is available at the docket identified by ID No. EPA-HQ-OPPT-2018-0604 at
In addition to any new comments on the draft risk evaluation, the public should resubmit or clearly identify at this time any previously filed comments, modified as appropriate, that are relevant to this risk evaluation and that the submitter feels have not been addressed. EPA does not intend to further respond to comments submitted prior to the release of this draft risk evaluation.
All comments on the draft risk evaluation in response to this Notice of Availability, and all information and views submitted to the peer review panel as directed in the subsequent
TSCA section 6, 15 U.S.C. 2605, requires EPA to conduct risk evaluations to “determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant to the risk evaluation by the Administrator under the conditions of use.” 15 U.S.C. 2605(b)(4)(A). TSCA sections 6(b)(4)(A) through (H) enumerate the deadlines and minimum requirements applicable to this process, including provisions that direct which chemical substances must undergo evaluation, the development of criteria for manufacturer-requested evaluations, the minimum components of an Agency risk evaluation, and the timelines for public comment and completion of the risk evaluation. The law also requires that EPA operate in a manner that is consistent with the best available science and make decisions based on the weight of the scientific evidence. 15 U.S.C. 2625(h) and (i).
The statute identifies the minimum components EPA must include in all chemical substance risk evaluations. For each risk evaluation, EPA must publish a document that outlines the scope of the risk evaluation to be conducted, which includes the hazards, exposures, conditions of use, and the potentially exposed or susceptible subpopulations that EPA expects to consider. 15 U.S.C 2605(b)(4)(D). The statute further provides that each risk evaluation must also: (1) Integrate and assess available information on hazards and exposure for the conditions of use of the chemical substance, including information on specific risks of injury to health or the environment and information on potentially exposed or susceptible subpopulations; (2) describe whether aggregate or sentinel exposures were considered and the basis for that consideration; (3) take into account, where relevant, the likely duration, intensity, frequency, and number of exposures under the conditions of use; and (4) describe the weight of the scientific evidence for the identified hazards and exposure. 15 U.S.C. 2605(b)(4)(F)(i), and (iii)-(v). The risk evaluation must not consider costs or other non-risk factors. 15 U.S.C. 2605(b)(4)(F)(ii).
The statute requires that the risk evaluation process last no longer than three years, with a possible additional six-month extension. 15 U.S.C. 2605(b)(4)(G). The statute also requires that the Agency allow for no less than a 30-day public comment period on the draft risk evaluation, prior to publishing a final risk evaluation. 15 U.S.C. 2605(b)(4)(H).
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The risk evaluation process is the second step in EPA's existing chemical process under TSCA, following prioritization and before risk management. The purpose of risk evaluation is to determine whether a chemical substance presents an unreasonable risk to health or the environment, under the conditions of use, including an unreasonable risk to a relevant potentially exposed or susceptible subpopulation. As part of this process, EPA must evaluate both hazard and exposure, not consider costs or other non-risk factors, use scientific information and approaches in a manner that is consistent with the requirements in TSCA for the best available science, and ensure decisions are based on the weight-of-scientific-evidence.
The specific risk evaluation process that EPA has established by rule to implement the statutory process is set out in 40 CFR part 702 and summarized on our website at
Pigment Violet 29 (Anthra[2,1,9-def:6,5,10-d′e′f′] diisoquinoline-1,3,8,10(2H,9H)-tetrone) (pigment violet 29) is a perylene derivative used to color materials and as an intermediate for other perylene pigments. The pigment is utilized as an intermediate to create or adjust the color of other pigments, as well as in commercial paints, coatings, plastics, and rubber products. C.I. Pigment Violet 29 is an organic pigment that has a low solubility, low volatility, is expected to be highly persistent and has low bioaccumulation potential in fish and other animals.
Information about the problem formulation and scope phases of the risk evaluation for this chemical is available at
The TSCA SACC was established by EPA to support activities under TSCA, 15 U.S.C. 2601
15 U.S.C. 2601
Environmental Protection Agency (EPA).
Notice.
EPA has received applications to register new uses for pesticide products containing currently registered active ingredients. 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 December 17, 2018.
Submit your comments, identified by the Docket Identification (ID) Number and the File Symbol or EPA Registration Number of interest as shown in the body of this document, by one of the following methods:
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Michael Goodis, Registration Division (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).
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EPA has received applications to register new uses for pesticide products containing currently registered active ingredients. 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 of public meeting.
The Environmental Protection Agency (EPA) will host a meeting of the Interagency Steering Committee on Radiation Standards (ISCORS) on Thursday, December 6, 2018 in Washington, DC. The purpose of ISCORS is to foster early resolution and coordination of regulatory issues associated with radiation standards. Member agencies include: EPA; the Nuclear Regulatory Commission; and Departments of Energy; Defense; Transportation; Homeland Security; Health and Human Services; and Labor's Occupational Safety and Health Administration. Observer agencies include: The Office of Science and Technology Policy, Office of Management and Budget, Defense Nuclear Facilities Safety Board, as well as state representatives from Pennsylvania and Washington. ISCORS maintains several objectives: Facilitate a consensus on allowable levels of radiation risk to the public and workers; promote consistent and scientifically sound risk assessment and risk management approaches in setting and implementing standards for occupational and public protection from ionizing radiation; promote completeness and coherence of Federal standards for radiation protection; and identify interagency radiation protection issues and coordinate their resolution. ISCORS meetings include presentations by Subcommittee Chairs and discussions of current radiation protection issues. Committee meetings normally involve pre-decisional intra-governmental discussions and, as such, are normally not open for observation by members of the public or media. This particular ISCORS meeting is open to all interested members of the public. Time will be reserved on the agenda for members of the public to ask questions and provide comments.
The meeting will be held on Thursday, December 6, 2018, from 1:00 p.m. to 4:30 p.m.
The ISCORS meeting will be held in Room 1153 at the USEPA William Jefferson Clinton East Building (WJC East), 1201 Constitution Avenue NW, Washington, DC. Attendees are required to present a photo ID such as a government agency photo identification badge or valid driver's license. The Department of Homeland Security has begun implementing REAL ID Act requirements for visitors who present state-issued driver's licenses as IDs at restricted federal facilities. Driver's licenses from states and territories that do not comply with the REAL ID Act will not be accepted as identification. More details on these ID requirements can be found at
Marisa D. Thornton, Radiation Protection Division, Office of Radiation and Indoor Air, Mailcode 6608T, U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue NW, Washington, DC 20460; email
Pay parking is available for visitors at multiple garages around the Ronald Reagan building and Federal Triangle complex. Visitors can also ride metro to the Federal Triangle station (Blue Orange and Silver Line). After exiting the turnstiles, go up both escalators to street level. Turn around and walk towards 12th Street NW. Turn right on 12th street and continue walking until you get to Constitution Avenue. Then turn right onto Constitution Avenue and 1201 William Jefferson Clinton EAST is the first building on your right.
Visit the ISCORS website,
Environmental Protection Agency (EPA).
Notice.
This notice announces EPA's order for the cancellations and amendments to terminate uses, voluntarily requested by the registrants and accepted by the Agency, of the products listed in Table 1, Table 1A, Table 1B and Table 2 of Unit II, pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). This cancellation order follows an August 10, 2018
The cancellations and amendments are effective November 15, 2018.
Christopher Green, Information Technology and Resources Management Division (7502P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (703) 347-0367; email address:
This action is directed to the public in general, and may be of interest to a wide range of stakeholders including environmental, human health, and agricultural advocates; the chemical industry; pesticide users; and members of the public interested in the sale, distribution, or use of pesticides. Since others also may 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-OPP-2018-0014, is available at
This notice announces the cancellations and amendments to delete uses, as requested by registrants, of products registered under FIFRA section 3 (7 U.S.C. 136a). These registrations are listed in sequence by registration number in Table 1, Table 1A, Table 1B, and Table 2 of this unit. The cancellations of the two triforine products, EPA Reg. Nos. 239-2435 and 82534-1, are the last registered products containing this active ingredient. The cancellation of the ten siduron products listed in Table 1A, are the last registered products containing this active ingredient.
The registrants for the pesticide product registrations listed in Table 1A have requested to the Agency via letter, that the cancellations become effective December 31, 2020.
The registrant for the pesticide product registration listed in Table 1B has requested to the Agency via letter, that the cancellation becomes effective at the federal level on December 31, 2018.
Table 3 of this unit includes the names and addresses of record for all registrants of the products in Table 1, Table 1A, Table1B and Table 2 of this unit, in sequence by EPA company number. This number corresponds to the first part of the EPA registration numbers of the products listed in Table 1, Table 1A, Table1B and Table 2 of this unit.
During the public comment period provided, EPA received no comments in response to the August 10, 2018
Pursuant to FIFRA section 6(f) (7 U.S.C. 136d(f)(1)), EPA hereby approves the requested cancellations and amendments to terminate uses of the registrations identified in Table 1, Table 1A, Table1B, and Table 2 of Unit II. Accordingly, the Agency hereby orders that the product registrations identified in Table 1 and Table 2 of Unit II are canceled and amended to terminate the affected uses effective November 15, 2018. The product registrations identified in Table 1A of Unit II will be canceled effective December 31, 2020. The product registration identified in Table 1B of Unit II will be canceled effective December 31, 2018. Any distribution, sale, or use of existing stocks of the products identified in Table 1, Table 1A, Table1B, and Table 2 of Unit II in a manner inconsistent with any of the provisions for disposition of existing stocks set forth in Unit VI will be a violation of FIFRA.
Section 6(f)(1) of FIFRA (7 U.S.C. 136d(f)(1)) provides that a registrant of a pesticide product may at any time request that any of its pesticide registrations be canceled or amended to terminate one or more uses. FIFRA further provides that, before acting on the request, EPA must publish a notice of receipt of any such request in the
Existing stocks are those stocks of registered pesticide products which are currently in the United States and which were packaged, labeled, and released for shipment prior to the effective date of the action. The existing stocks provision for the products subject to this order is as follows.
The registrant has requested to the Agency via letter, an 18-month sell thru period so the registrant may continue to sell and distribute existing stocks of this product for 18 months after the effective date of the cancellation, which is the date of publication of this cancellation order in the
Registrants may continue to sell and distribute existing stocks of these products for 1 year after the effective date of the cancellation, which is the date of publication of this cancellation order in the
Registrants may continue to sell and distribute existing stocks of these products until December 31, 2021, which is 1 year after the effective date of the cancellation.
The registrant may continue to sell and distribute existing stocks of this product until December 31, 2019, which is 1 year after the effective date of the cancellation.
Thereafter, the registrants are prohibited from selling or distributing products listed in Table 1, Table 1A, and Table 1B of Unit II, except for export in accordance with FIFRA section 17 (7 U.S.C. 136o) or for proper disposal.
Now that EPA has approved product labels reflecting the requested amendments to terminate uses, registrants are permitted to sell or distribute products listed in Table 2 of Unit II under the previously approved labeling for 18 months after the effective date of the cancellation, which is the date of publication of this order in the
7 U.S.C. 136
Federal Communications Commission.
Notice.
The agency must receive comments on or before January 14, 2019.
Federal Communications Commission, 445 Twelfth Street SW, Washington, DC 20554.
Rolanda F. Smith, 202-418-2054.
The following applicants filed AM or FM proposals to change the community of license: ETERNITY MEDIA GROUP WERM, LLC, WERM(AM), Fac. ID No. 32848, Channel 1220 kHz, To AFRICA TOWN, AL, From FAIRHOPE, AL, BP-20180723AAR; HI-LINE RADIO FELLOWSHIP INC., KNPC(FM), Fac. ID No. 177237, Channel 203C3, To HARDIN, MT, From COLSTRIP, MT, BPED-20180723AAK; FLORIDA KEYS MEDIA, LLC, WAVK(FM), Fac. ID No. 23294, Channel 249C1, To CUDJOE KEY, FL, From MARATHON, FL, BPH-20181012AAN; UNIVISION RADIO STATIONS GROUP, INC., KRGT(FM),
The full text of these applications is available for inspection and copying during normal business hours in the Commission's Reference Center, 445 12th Street SW, Washington, DC 20554 or electronically via the Media Bureau's Consolidated Data Base System,
The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841
The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The applications will also be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States.
Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than December 10, 2018.
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Department of Defense (DOD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA).
Notice.
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 regarding small business subcontracting plans.
Submit comments on or before December 17, 2018.
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 Officer for GSA, Room 10236, NEOB, Washington, DC 20503. Additionally submit a copy to GSA by any of the following methods:
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Ms. Zenaida Delgado, Procurement Analyst, at telephone 202-969-7207, or email
This information collection requirement, OMB Control No. 9000-0007, currently titled “Summary Subcontract Report,” is proposed to be retitled “Subcontracting Plans,” due to consolidation with currently approved information collection requirement OMB Control No. 9000-0006, Subcontracting Plans/Individual Subcontract Report (SF 294) and ISRS, and 9000-0192, Utilization of Small Business Subcontractors.
This clearance covers the information that offerors and contractors must submit to comply with the requirements in Federal Acquisition Regulation (FAR) 52.219-9, Small Business Subcontracting Plans, regarding subcontracting plans as follows:
1. Subcontracting plan. In accordance with Section 8(d) of the Small Business Act (15 U.S.C. 637(d)), any contractor receiving a contract for more than the simplified acquisition threshold must agree in the contract that small business, veteran-owned small business, service-disabled veteran-owned small business, HUBZone small business, small disadvantaged business, and women-owned small business concerns will have the maximum practicable opportunity to participate in contract performance. Further, 15 U.S.C. 637(d) imposes the requirement that contractors receiving a contract that is expected to exceed, or a contract modification that causes a contract to exceed, $700,000 ($1.5 million for
2. Summary Subcontract Report (SSR). In conjunction with the subcontracting plan requirements, contractors with subcontracting plans must submit an annual summary of subcontracts awarded as prime and subcontractors for each specific Federal Government agency. Contractors submit the information in a SSR through the Electronic Subcontracting Reporting System (eSRS). This is required for all contractors with subcontracting plans regardless of the type of plan (
3. Individual Subcontract Report (ISR). In conjunction with the subcontracting plan requirements, contractors with individual subcontracting plans must submit semi-annual reports of their small business subcontracting progress. Contractors submit the information through eSRS in an ISR, the electronic equivalent of the Standard Form (SF) 294, Subcontracting Report for Individual Contracts. Contracts that are not reported in the Federal Procurement Data System (FPDS) in accordance with FAR 4.606(c)(5) do not submit ISRs in eSRS; they will continue to use the SF 294 to submit the information to the agency.
4. Written explanation for not using a small business subcontractor as specified in the proposal or subcontracting plan. Section 1322 of the Small Business Jobs Act of 2010 (Jobs Act), Public Law 111-240, amends the Small Business Act (15 U.S.C. 637(d)(6)) to require as part of a subcontracting plan that a prime contractor make good faith effort to utilize a small business subcontractor during performance of a contract to the same degree the prime contractor relied on the small business in preparing and submitting its bid or proposal. If a prime contractor does not utilize a small business subcontractor as described above, the prime contractor is required to explain, in writing, to the contracting officer the reasons why it is unable to do so.
A 60 day notice was published in the
1. Subcontracting plan. Subcontracting plans are provided on a contract-by-contract basis for individual subcontracting plans. Individual subcontracting plans cover the entire contract period, including options. Commercial plans are provided on an entity basis and cover the fiscal year of the contractor. The time required for development of the plan (including commercial and individual plans) is estimated as follows:
2. Summary Subcontract Report (SSR). SSRs are submitted annually for all types of subcontracting plans. One SSR is submitted for each commercial subcontracting plan. For individual subcontracting plans, an SSR is required for every agency that funds work under the contract that the plan covers. Time required for reading, preparing information, and data entry into eSRS is estimated as follows:
3. Individual Subcontract Report (ISR). ISRs are submitted semi-annually for each contract with an individual subcontracting plan. The ISR consists of data for subcontracting under a given contract. ISRs are not required for commercial plans. Time required for reading, preparing information, and data entry into eSRS is estimated as follows:
4. Written explanation for not using a small business subcontractor as specified in the proposal or subcontracting plan. This explanation is submitted on a contract-by-contract basis. FPDS for FY 2017 identified 3,808 contracts with individual subcontracting plans and 542 entities awarded contracts with commercial plans, for a total of 4,350 plans for FY 2017. We estimate that at most 50%, or 2,175, of these contracts with subcontracting plans may have instances of the prime contractor not using a small business subcontractor to the same extent used in preparing the bid or proposal. We estimate two hours as the average time required to read and prepare information for this collection.
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In accordance with the Paperwork Reduction Act of 1995, the Agency for Toxic Substances and Disease Registry (ATSDR) has submitted the information collection request titled “Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery” to the Office of Management and Budget (OMB) for review and approval. ATSDR previously published a “Proposed Data Collection Submitted for Public Comment and Recommendations” notice on March 1, 2018 to obtain comments from the public and affected agencies. ATSDR received four non-substantive comments related to the previous notice. This notice serves to allow an additional 30 days for public and affected agency comments.
ATSDR will accept all comments for this proposed information collection project. The Office of Management and Budget is particularly interested in comments that:
(a) 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;
(b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(c) Enhance the quality, utility, and clarity of the information to be collected;
(d) 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,
(e) Assess information collection costs.
To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570 or send an email to
Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery (OMB Control Number 0923-0047, Expiration Date 12/31/2018)—Extension—National Center for Environmental Health and Agency for Toxic Substances and Disease Registry (NCEH/ATSDR), Centers for Disease Control and Prevention (CDC).
The information collection activity will garner qualitative customer and stakeholder feedback in an efficient, timely manner, in accordance with the Administration's commitment to improving service delivery. By qualitative feedback we mean information that provides useful insights on perceptions and opinions, but are not statistical surveys that yield quantitative results that can be generalized to the population of study. This feedback will provide insights into customer or stakeholder perceptions, experiences and expectations, provide an early warning of issues with service, or focus attention on areas where communication, training or changes in operations might improve delivery of products or services. These collections will allow for ongoing, collaborative and actionable communications between the Agency and its customers and stakeholders. It will also allow feedback to contribute directly to the improvement of program management.
Feedback collected under this generic clearance will provide useful information, but it will not yield data that can be generalized to the overall population. This type of generic clearance for qualitative information will not be used for quantitative information collections that are designed to yield reliably actionable results, such as monitoring trends over time or documenting program performance. Such data uses require more rigorous designs that address: The target population to which generalizations will be made, the sampling frame, the sample design (including stratification and clustering), the precision requirements or power calculations that justify the proposed sample size, the expected response rate, methods for assessing potential non-response bias, the protocols for data collection, and any testing procedures that were or will be undertaken prior fielding the study. Depending on the degree of influence the results are likely to have, such collections may still be eligible for submission for other generic mechanisms that are designed to yield quantitative results.
The Agency received four non-substantive comments in response to the 60-day notice published in the
Respondents will be screened and selected from Individuals and Households, Businesses, Organizations, and/or State, Local or Tribal Government. There is no cost to respondents other than their time. The estimated annualized burden hours for this data collection activity are 7,075.
In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled National Notifiable Diseases Surveillance System to the Office of Management and Budget (OMB) for review and approval. CDC previously published a “Proposed Data Collection Submitted for Public Comment and Recommendations” notice on June 13, 2018 to obtain comments from the public and affected agencies. CDC received 2 comments related to the previous notice. This notice serves to allow an additional 30 days for public and affected agency comments.
CDC will accept all comments for this proposed information collection project. The Office of Management and Budget is particularly interested in comments that:
(a) 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;
(b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(c) Enhance the quality, utility, and clarity of the information to be collected;
(d) 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,
(e) Assess information collection costs.
To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570 or send an email to
National Notifiable Diseases Surveillance System (OMB Control Number: 0920-0728, Exp. Date: February 28, 2021)—Revision—Center for Surveillance, Epidemiology and Laboratory Services (CSELS), Centers for Disease Control and Prevention (CDC).
The Public Health Services Act (42 U.S.C. 241) authorizes CDC to disseminate nationally notifiable condition information. The National Notifiable Diseases Surveillance System (NNDSS) is based on data collected at the state, territorial and local levels as a result of legislation and regulations in those jurisdictions that require health care providers, medical laboratories, and other entities to submit health-related data on reportable conditions to public health departments. These reportable conditions, which include infectious and non-infectious diseases, vary by jurisdiction depending upon each jurisdiction's health priorities and needs. Infectious disease agents and environmental hazards often cross geographical boundaries. Each year, the Council of State and Territorial Disease Epidemiologists (CSTE), supported by CDC, determines which reportable conditions should be designated nationally notifiable or under standardized surveillance and voluntarily submitted to CDC so that information can be shared across jurisdictional boundaries and surveillance and prevention and control activities can be coordinated at regional and national levels.
CDC requests a three-year approval for this Revision which includes (1) receipt of case notification data for
The burden estimates include the number of hours that the public health department uses to process and send case notification data from their jurisdiction to CDC. Specifically, the burden estimates include separate burden hours incurred for automated and non-automated transmissions, separate weekly burden hours incurred
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Notice with comment period.
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled “Assessments to Inform Program Refinement for HIV, other STD, and Pregnancy Prevention among Middle and High-School Aged Youth,” a generic information collection package that supports qualitative and quantitative data collection from adolescents (ages 11-19) and their parents/caregivers for the purpose of needs assessment and program refinement for programs and services designed to prevent HIV, other sexually transmitted diseases (STDs), and pregnancy among middle and high school aged adolescents.
CDC must receive written comments on or before January 14, 2019.
You may submit comments, identified by Docket No. CDC-2018-0100 by any of the following methods:
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To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Leroy A. Richardson, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email:
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the
The OMB is particularly interested in comments that will help:
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,
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,
5. Assess information collection costs.
Assessments to Inform Program Refinement for HIV, other STD, and Pregnancy Prevention among Middle and High-School Aged Youth—Revision—Division of Adolescent and School Health, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention (CDC).
The Centers for Disease Control and Prevention (CDC) requests three-year OMB approval for the revision of a generic information collection package (OMB #0920-1235) that supports collection of quantitative and qualitative information from adolescents (ages 11-19) and their parents/caregivers for the purpose of needs assessment and program refinement for programs and services to prevent HIV, other sexually transmitted diseases (STDs), and pregnancy among middle and high school aged adolescents.
NCHHSTP conducts behavioral and health service assessments and research projects as part of its response to the domestic HIV/AIDS epidemic, STD prevention, TB elimination and viral hepatitis control with national, state, and local partners. Adolescents are a population with specific developmental, health and social, and resource needs, and their health risk factors and access to health care are addressed as a primary mission by the Division of Adolescent and School Health (DASH), and adolescents are a population of interest for several other NCHHSTP divisions. The assessment and research conducted by NCHHSTP is one pillar upon which recommendations and guidelines are revised and updated. Recommendations and guidelines for adolescent sexual risk reduction require that foundation of scientific evidence. Assessment of programmatic practices for adolescents helps to assure effective and evidence-based sexual risk reduction practices and efficient use of resources. Such assessments also help to improve programs through better identification of strategies relevant to adolescents as a population as well as specific sub-groups of adolescents at highest risk for HIV and other STDs so that programs can be better tailored for them.
The information collection requests under this generic package are intended to allow for data collection with two types of respondents:
• Adolescents (11-19 years old) of middle and high school age; and
• Parents and/or caregivers of adolescents of middle and high school age. For the purposes of this generic package, parents/caregivers include the adult primary caregiver(s) for a child's basic needs (
The types of information collection activities included in this generic package are:
(1) Quantitative data collection through electronic, telephone, or paper questionnaires to gather information about programmatic and service activities related to the prevention of HIV and other STDs among adolescents of middle- and high-school age.
(2) Qualitative data collection through electronic, telephone, or paper means to gather information about programmatic and service activities related to the prevention of HIV and other STDs among adolescents of middle- and high-school age. Qualitative data collection may involve focus groups and in-depth interviewing through group interviews, and cognitive interviewing.
For adolescents, data collection instruments will include questions on demographic characteristics; experiences with programs and services to reduce the risk of HIV and other STD transmission; and knowledge, attitudes, behaviors, and skills related to sexual risk and protective factors on the individual, interpersonal, and community levels.
For parents and caregivers, data collection instruments will include questions on demographic characteristics as well as parents'/caregivers' (1) perceptions about programs and services provided to adolescents; (2) knowledge, attitudes, and perceptions about their adolescents' health risk and protective behaviors; and (3) parenting knowledge, attitudes, behaviors, and skills.
Any data collection request put forward under this generic clearance will identify the programs and/or services to be informed or refined with the information from the collection and will include a cross-walk of data elements to the aspects of the program the project team seeks to inform or refine. Because this request includes a wide range of possible data collection instruments, specific requests will include items of information to be collected and copies of data collection instruments. It is expected that all data collection instruments will be pilot-tested, and will be culturally, developmentally, and age appropriate for the adolescent populations included. Similarly, parent data collection instruments will be pilot-tested, and the data collection instruments will reflect the culture, developmental stage, and age of the parents' adolescent children. All data collection procedures will receive review and approval by an Institutional Review Board for the Protection of Human Subjects and follow appropriate consent and assent procedures as outlined in the IRB-approved protocols and these will be described in the individual information collection requests put forward under this generic package.
The table below provides the estimated annualized response burden for up to 15 individual data collections per year. Average burden per response is based on pilot testing and timing of quantitative and qualitative instrument administration during previous studies. Response times include the time to read and respond to consent forms and to read or listen to instructions. The proposed information collections combine for a total estimated annualized burden of up to 57,584 hours for respondents. Participation of respondents is voluntary. There is no cost to the respondents other than their time.
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Notice with comment period.
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Emerging Infections Program (EIP). The EIP is a population-based surveillance activity performed via active, laboratory case finding that is used for detecting, identifying, and monitoring emerging pathogens.
CDC must receive written comments on or before January 14, 2019.
You may submit comments, identified by Docket No. CDC-2018-0098 by any of the following methods:
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To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Jeffrey M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email:
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the
The OMB is particularly interested in comments that will help:
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,
5. Assess information collection costs.
Emerging Infections Program OMB# 0920-0978 Exp. Date: 05/31/2021—Revision—National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC).
The Emerging Infections Programs (EIPs) are population-based centers of excellence established through a network of state health departments collaborating with academic institutions; local health departments; public health and clinical laboratories; infection control professionals; and healthcare providers. EIPs assist in local, state, and national efforts to prevent, control, and monitor the public health impact of infectious diseases.
Activities of the EIPs fall into the following general categories: (1) Active surveillance; (2) applied public health epidemiologic and laboratory activities; (3) implementation and evaluation of
A revision is being submitted to make existing collection instruments clearer and to add several new forms specifically surveying laboratory practices. These forms will allow the EIP to better detect, identify, track changes in laboratory testing methodology, gather information about laboratory utilization in the EIP catchment area to ensure that all cases are being captured, and survey EIP staff to evaluate program quality.
The total estimated burden is 40,601 hours. There is no cost to respondents other than their time.
Centers for Medicare & Medicaid Services, HHS.
Notice.
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the
Comments must be received by January 14, 2019.
When commenting, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in any one of the following ways:
1.
2.
To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following:
1. Access CMS' website address at website address at
2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to
3. Call the Reports Clearance Office at (410) 786-1326.
William Parham at (410) 786-4669.
This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection's supporting statement and associated materials (see
Under the PRA (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA requires federal agencies to publish a 60-day notice in the
CMS plans to use the findings from surveys and qualitative interviews for multiple purposes. The qualitative interviews and standardized survey will inform CMS about the impact of measures used to assess care in HHAs. The surveys will help CMS understand whether the use of performance measures has been associated with changes in HHA behavior—namely, what quality improvements (QI) investments HHAs are making and whether adoption of QI changes is associated with higher performance on the measures. The survey will help CMS identify characteristics associated with high performance, which, if understood, could be used to leverage improvements in care among lower-performing HHAs. The survey and interviews, assuming approval by August 2019, would be fielded from fall 2019 through spring 2020.
Food and Drug Administration, HHS.
Notice of public workshop.
The Food and Drug Administration (FDA, the Agency, or we) is announcing a public workshop entitled “Evaluating the Pressor Effects of Drugs.” This public workshop is convened by the Duke-Robert J. Margolis, MD, Center for Health Policy at Duke University and supported by a cooperative agreement with FDA. The purpose of this public workshop is to bring the stakeholder community together to discuss the premarketing assessment of a drug's effect on blood pressure. Elevated blood pressure is known to increase the risk of stroke, heart attack, and death. The effect of a drug on blood pressure may therefore be an important consideration in benefit-risk assessment. Agency staff will present findings related to the use of ambulatory blood pressure monitoring to assess treatment effects.
The public workshop will be held on Monday, February 4, 2019 from 8:30 a.m. to 5 p.m. See the
The public workshop will be held at 1777 F Street NW, Washington, DC 20006. For additional travel and hotel information, please refer to the following website:
Norman Stockbridge, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4166, Silver Spring, MD 20903, 301-796-2240, email:
FDA is announcing a public workshop regarding FDA's assessment of the pressor effects of drugs. Elevated blood pressure is known to increase the risk of stroke, heart attack, and death. The effect of a drug on blood pressure may therefore be an important consideration in benefit-risk assessment. Following FDA's announcement in the
Topics for discussion during this meeting include:
• Risk associated with blood pressure change
• Aspects and FDA analyses related to ambulatory blood pressure monitoring
• Evaluating a drug's effect on blood pressure and understanding the optimal regulatory approach to assigning risk
Registration is free and based on space availability, with priority given to early registrants. Persons interested in attending this public workshop must register by Thursday, January 31, 2019, midnight Eastern Time. There will be no onsite registration. Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization. Registrants will receive confirmation when they have been accepted. If you are unable to attend the meeting in person, you can register to view a live webcast of the meeting. Duke-Margolis will post on its website if registration closes before the day of the public meeting.
If you need special accommodations due to a disability, please contact Sarah Supsiri at the Duke-Margolis Center for Health Policy (202-791-9561, email:
All event materials will be provided to registered attendees via email prior to the workshop and will be publicly available at the Duke-Margolis Center for Health Policy website
Science and Technology Directorate, Department of Homeland Security.
30-Day Notice of Information Collection; request for comment. (Re-instatement of a Currently Approved Collection, 1640-0016).
The Department of Homeland Security (DHS), Science and Technology (S&T) is proposing to reinstate OMB 1640-0016, an information collection, by inviting the public to comment on the collection: First Responders Community of Practice (FRCoP) User Registration Page (DHS Form 10059 (9/09)). The FRCoP web based tool collects profile information from first responders and select authorized non-first responder users to facilitate networking and formation of online communities. All users are required to authenticate prior to entering the site. In addition, the tool provides members the capability to create wikis, discussion threads, blogs, documents, etc., allowing them to enter and upload content in accordance with the site's Rules of Behavior. Members are able to participate in threaded discussions and comment on other members' content. The FRCoP program is responsible for providing a collaborative environment for the first responder community to share information, best practices, and lessons learned. The Homeland Security Act of 2002 established this requirement. Interested persons may receive a copy of the collection by contacting the DHS S&T Paperwork Reduction Act (PRA) Coordinator.
Comments are encouraged and accepted until December 17, 2018.
You may submit comments, identified by docket number DHS-2018-0063, at:
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DHS/S&T/FRG System Owner: Marc Caplan,
DHS, in accordance with the PRA (6 U.S.C. 193), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collection 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 provides the requested data in the desired format. DHS is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Homeland Security is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.
Science and Technology Directorate (S&T), Department of Homeland Security (DHS).
60-Day notice of information collection; new request for comment.
S&T will submit the following Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995. The information collection activity will garner qualitative customer and stakeholder feedback in an efficient, timely manner, in accordance with the Administration's commitment to improving service delivery.
Comments are encouraged and accepted until January 14, 2019.
You may submit comments, identified by docket number DHS-2018-0038, at:
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DHS/S&T/OCIO Program Manager: Mary Cantey,
The information collection activity will garner qualitative customer and stakeholder feedback in an efficient, timely manner, in accordance with the S&T's commitment to improving service delivery. By qualitative feedback we mean information that provides useful insights on perceptions and opinions, but are not statistical surveys that yield quantitative results that can be generalized to the population of study. This feedback will provide insights into customer or stakeholder perceptions, experiences and expectations, provide an early warning of issues with service, or focus attention on areas where communication, training or changes in operations might improve delivery of products or services. These collections will allow for ongoing, collaborative and actionable communications between S&T and its customers and stakeholders. It will also allow feedback to contribute directly to the improvement of S&T's program management. Feedback collected under this generic clearance will provide useful information, but it will not yield data that can be generalized to the overall population. This type of generic clearance for qualitative information will not be used for quantitative information collections that are designed to yield reliably actionable results, such as monitoring trends over time or documenting program performance. Such data uses require more rigorous designs that address: The target population to which generalizations will be made, the sampling frame, the sample design (including stratification and clustering), the precision requirements or power calculations that justify the proposed sample size, the expected response rate, methods for assessing potential nonresponse bias, the protocols for data collection, and any testing procedures that were or will be undertaken prior fielding the study. Depending on the degree of influence the results are likely to have, such collections may still be eligible for submission for other generic mechanisms that are designed to yield quantitative results. DHS, in accordance with the Paperwork Reduction Act (PRA), 44 U.S.C. 3501
Office of Public and Indian Housing, HUD.
Notice of new performance measurement system (“Composite Score”) for the Family Self-Sufficiency Program.
This notice describes and responds to comments on a performance measurement system that HUD plans to implement for Public Housing Agencies (PHAs) that receive HUD Family Self-Sufficiency (FSS) program coordinator grants. The desired effect of this notice is to notify the public regarding the criteria for evaluating FSS programs.
Questions on this notice may be addressed to
On December 12, 2017, HUD published a notice in the
Under section 23(i) of the Housing Act of 1937 (42 U.S.C. 1437u(i)), HUD is required to establish criteria to evaluate eligible entities' implementation of local FSS programs. HUD has developed this new FSS performance measurement system to provide HUD, Congress, public housing agencies (PHAs), and other eligible entities with information on the performance of individual FSS programs. The information will help grantees determine how their programs compare to others across the country in efforts to help participants to successfully graduate from the program and make progress toward economic security. The information will also help HUD understand the extent to which FSS program performance—individually and collectively—improves or declines over time.
Initially, HUD plans to use the performance measures to identify high performing and low performing FSS programs, which could inform its understanding of best practices and its delivery of technical assistance. Toward these goals, at least once per year, HUD will analyze data collected through the Public Housing Information Center (PIC) to calculate FSS performance scores for each FSS program that received an FSS coordinator grant in one or more of the past three fiscal year NOFA competitions. Beginning in Fiscal Year 2019, HUD plans to consider the FSS performance score of an FSS program in determining FSS funding awards.
HUD developed the approach described in this Notice based in part on feedback received on an earlier performance measurement approach proposed in the FY 2014 FSS Notice of Funding Availability (NOFA). In the FY 2014 NOFA, HUD proposed, and asked for feedback on, evaluating FSS programs based on the share of FSS participants that experience an increase in earned income (also known as “earnings growth”) over a specified time period. Some commenters raised concerns that this approach did not adequately account for differences in local economic conditions and differences in the approaches of local FSS programs. While some FSS programs encourage participants to increase their earnings immediately, others encourage FSS participants to build skills and credentials first and then seek higher paying jobs. The FSS performance measurement system proposed in the December 2017 Notice was developed to address these issues, as well as many others, and to allow for a more nuanced evaluation of the performance of local FSS programs.
A PHA's FSS performance score will be calculated based on three measures, weighted as follows:
A. Earnings Performance Measure (50 percent);
B. FSS Graduation Rate (30 percent);
C. Participation Rate (20 percent).
HUD has selected these measures because they are important indicators of program performance and are verifiable using the data HUD collects through the PIC data system. No outside or additional reporting will be required, which ensures that the system will not increase the reporting burden of PHAs. No new Paperwork Reduction Act (PRA) Information Collection will be required for the scoring, as proposed.
The Earnings Performance Measure represents the difference between the
HUD has assigned the next highest weight to the Graduation Rate indicator—which represents the rate of FSS participants who successfully “graduate” from the program—to encourage PHAs to work closely with individual FSS participants to increase graduation rates. To graduate from FSS, a participant must be employed, be independent of cash welfare assistance for at least one year, and achieve the other goals set forth in the participant's contract of participation.
Finally, the FSS performance score looks at the local program's Participation Rate, which reflects the extent to which a PHA exceeds the minimum number of households that HUD requires the PHA to serve as a condition of receiving an FSS grant. PHAs with higher Participation Rates are serving more households than required, which is a desired output, provided the PHAs are serving those households effectively. Because the Earnings Performance Measure is weighted more heavily than the Participation Rate, however, PHAs should be careful not to execute more Contracts of Participation than they can serve effectively, because doing so would likely reduce their scores on the Earnings Performance Measure. Together, the Earnings Performance Measure, Graduation Rate, and Participation Rate are expected to provide a balanced measurement of the performance of an individual FSS program.
As indicated in the 2017 Notice soliciting public comment, HUD does not intend to use this performance measurement system for Tribes/Tribally Designated Housing Entities (TDHEs), who do not report into Public and Indian Housing Information Center (PIC), or for PHAs with a Moving to Work (MTW) designation, as they report differently into PIC, using Form HUD-50058-MTW. However, HUD is presently exploring a change to the reporting processes for MTW agencies, in order to include them in the FSS performance scoring process. Nor does HUD intend, after considering public comment, to use this performance measurement system for unfunded PHAs, and PHAs and private owners that serve Project-based Rental Assistance (PBRA) residents at this time.
HUD received 68 unique public comments on the planned measures, which are summarized below along with HUD's responses. HUD's responses to comments are organized into five categories: (A) Overall Comments; (B) Comments on Earnings Performance Measure; (C) Comments on FSS Graduation Rate Measure; (D) Comments on Participation Rate Measure; and (E) Comments on Weighting of the Measures. At the conclusion of this Notice, in Section III., Final Thresholds, HUD provides the final FSS performance measurement system thresholds that it intends to adopt to calculate FSS performance scores.
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It is important to note that each time the FSS performance scores are calculated, HUD will retrieve a new data report from the PIC system. This ensures that if a PHA has made changes to improve the accuracy of its reporting on any metric, for current or past participants, all of these changes will be reflected in its performance score.
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Several commenters also stated that inputs and outputs should be included in the measures, such as the work associated with serving participants, meeting with participants, connecting participants to services, making referrals, etc. Some indicated that, without these measures, they are not given adequate “credit” for serving high-needs participants or that they may be penalized for participant performance issues that are beyond their control (through the earnings and FSS graduation measures).
HUD recognizes the importance and value of setting a range of goals for participants, including goals other than employment. Over time, however, HUD believes the achievement of these goals will support the ultimate goal of the program, which is increased earnings, which will then be captured in the performance measurement system. This is one of the benefits of having five (or more) years to work with participants. The long duration of the FSS program provides PHAs an opportunity to work with participants on a range of issues—including education, training, work readiness, etc.—that will, over time, contribute to earnings gains that can be measured and reflected in the FSS performance measurement system. The earnings and FSS graduation rate measures accommodate this long time-frame, examining data for FSS participants that entered the program as far back as 7.5 to 8 years ago, respectively.
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The goals of improving earnings and helping FSS participants graduate successfully from the program should not come as a surprise to PHAs administering FSS programs. These goals have been clear since the program's inception and NOFAs have been announcing HUD's intent to use increased earnings as an evaluation metric since FY 2014. The participation rate also should not come as a surprise to PHAs, as HUD has historically based funding decisions on the number of FSS families served by PHAs. HUD's interest in PHAs serving more families (so long as they can do so without undermining earnings growth and FSS graduation rates), as reflected in the participation rate, is a factor that PHAs can influence going forward by adjusting their caseloads.
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HUD has also examined the FSS performance composite scores of PHAs to determine if small programs systematically receive lower composite scores and determined that, there is not a strong relationship between program size and composite FSS performance score. In fact, the decile of PHAs with the second smallest FSS programs (10th through 19th percentile) had the second highest median composite scores of any decile (the highest was the group of PHAs in the 70th through the 79th percentile in size). PHAs with the very smallest FSS programs (0 to 9th percentile) did have the lowest median composite score, but the next lowest score was recorded by PHAs in the 80th to 89th percentile in size. This is an indication that there is not a strong relationship between program size and composite FSS performance score. However, HUD may continue to monitor scores to determine if there are any patterns that might help with the targeting of technical assistance efforts or the interpretation of performance data.
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In response to this comment, HUD has considered whether the increased precision of adding additional comparison factors would outweigh the dilution of the weight of the existing factors and lead to an insufficient number of comparison households. Further analysis has determined that number of children under 18 is better than presence of children under age 5 in predicting whether a household would join FSS and therefore is a better factor in choosing comparison households. HUD will therefore remove presence of children under age 5 from the factors used to match comparison households and instead include number of children under 18.
After further analysis, it has been determined that the presence of a child with a disability and presence of a non-head of household adult with a disability are not substantial factors predicting a household's choice to participate in FSS, but each of these factors is associated with a large and significant difference in a household's future earnings change. As a result, HUD will include both factors in selecting comparison households.
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In PHAs that serve a very large geographical area, such as statewide PHAs, however, this point may not hold true since the economic conditions may be very different in different parts of the state. Accordingly, HUD plans to modify the protocol to require, under certain circumstances, that comparison households be in the same county and PHA as the FSS participants to which they are being compared. HUD will apply this protocol to all state PHAs and to non-State PHAs serving three or more counties where at least 10 percent of the PHA's housing choice voucher (HCV) or public housing households are leased in each of those counties. To ensure this approach does not unduly dilute the ability to find comparable households, HUD will require that FSS participants be matched to comparison households in the same county only in counties where there are at least four times as many non-FSS households as FSS households being served by the PHA.
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Based on these comments, however, HUD has conducted additional analysis to determine if there are some residual effects of strong economic conditions that are not accounted for in this methodology and therefore a need to account for it in assigning earnings performance scores. This analysis found that there is in fact still a relationship between the earnings performance measures and county median income. Accordingly, HUD has decided to apply an adjustment factor to the earnings performance measure to account for the residual effect of local economic conditions.
To compute this adjustment factor, HUD first used a linear regression model to examine the relationship between the earnings growth of comparison households within a PHA and the average county median income of those households. On average, earnings growth of comparison households was higher in counties with high median incomes, and lower in counties with low median incomes. HUD developed an adjustment factor that eliminated this relationship and then applied this
Using these adjusted earnings performance measures, HUD has recalculated the thresholds for awarding a 10, 7.5, or 0 earnings performance score by focusing on the 80th, 60th, and 20th percentile, respectively, of the distribution of adjusted measures. In selecting the revised thresholds, HUD has analyzed the distribution of scores across all funded PHAs, rather than the narrower universe described in the December 12, 2017
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Together, the Earnings Performance Measure, Graduation Rate, and Participation Rate provide a balanced measurement of the performance of an individual FSS program. Because the Earnings Performance Measure is weighted more heavily than the Graduation Rate, PHAs should balance the need to graduate participants with setting ambitious employment goals so participants can maximize their earnings growth while in the program. In addition, while PHAs have the discretion to terminate the FSS participation of non-compliant participants, HUD would encourage PHAs to first work with participants to determine if their challenges can be addressed so participants can successfully complete the FSS program. Additional guidance can be found in the FSS Promising Practices Guidebook.
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HUD examined FSS performance data to determine if there is a correlation between a PHA's participation rate and its earnings and FSS graduation rate, paying particular attention to the participation rate threshold for obtaining a score of 10 points (80th percentile). This analysis did not find a strong relationship between participation rate and earnings performance measure. In fact, PHAs with participation rates between the 80th and 90th percentile had the highest average earnings performance measure of any decile and a median earnings performance measure that was typical for the sample as a whole, confirming that the threshold for obtaining a score of 10 points is not one that leads to lower earnings performance scores.
In terms of FSS graduation rates, the median FSS graduation rate was fairly similar for most deciles of participation rate, except for the very highest and lowest deciles, which both had lower FSS graduation rates than the other deciles. However, the threshold for qualifying for 10 points on the participation rate is set at the 80th percentile and not the 90th percentile (the starting point for the highest decile) and PHAs with participation rates between the 80th and 90th percentile had median and average FSS graduation rates that were typical for the sample as a whole, confirming that this threshold does not inherently lead to sub-par performance.
Based on this analysis, HUD has determined that it is appropriate to encourage PHAs to adopt higher participation rates, so long as they can do so without compromising their earnings performance and FSS graduation rates. However, HUD has decided to change the final scoring so as to reward incremental improvements in participation rates, rather than only participation rates that exceed one of two specific thresholds. Accordingly, HUD will assign PHAs with participation rates above .95 a score of 5, 6, 7, 8, 9 or 10, depending on their participation rate, as specified in Section III of this notice. A score of 10 will be awarded for a participation rate at or above 2.0, which is close to the 80th percentile level HUD previously identified.
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While there is a case for weighting FSS graduation rate and participation rate equally, HUD believes weights of 30 percent for the FSS graduation rate and 20 percent of the participation rate are appropriate. As noted above, FSS graduation is an important milestone for the FSS program and HUD would like to see PHAs raise FSS graduation rates. HUD would also like to see PHAs serve more families if and to the extent they can do so without jeopardizing their achievement of strong earnings and FSS graduation rates. Weighting FSS graduation rate more heavily than participation rate is consistent with HUD's goal of not creating incentives for PHAs to raise caseloads beyond the point where families can be served effectively.
After considering all of the public comments, HUD is adopting the proposed FSS performance measurement system, with the adjustments noted above, which will henceforth be used by HUD to evaluate the performance of PHAs receiving HUD program coordinator funding. These adjustments are summarized in the table below:
After making these adjustments to the methodology, HUD has recalculated the thresholds for translating the FSS performance measures into individual component scores and the final composite score and notes the final thresholds below.
The following are the updated thresholds HUD will use to compute an FSS Performance Score for each PHA. See the December 12, 2017
In Step One, HUD will assign a score of 0 to 10 to each PHA's FSS program for each of the three measures. Scores will be assigned using the thresholds and procedures described below. The ranges for awarding points between two values include those values as well as all intermediary values.
a. Earnings Performance Measure (50 percent of final score):
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b. FSS Graduation Rate (30 percent of final score):
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c. Participation Rate (20 percent of final score):
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In Step Two, after computing individual scores for each of the three measures, HUD will aggregate each PHA's scores using the weights noted above to develop a final FSS Performance Score from 0 to 10. Based on this score, HUD will assign the following ranking to the PHA's performance:
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This notice does not direct, provide for assistance or loan and mortgage insurance for, or otherwise govern or regulate, real property acquisition, disposition, leasing, rehabilitation, alteration, demolition, or new construction, or establish, revise or provide for standards for construction or construction materials, manufactured housing, or occupancy. Accordingly, under 24 CFR 50.19(c)(1), this notice is categorically excluded from environmental review under the National Environmental Policy Act of 1969 (42 U.S.C. 4321).
Fish and Wildlife Service, Interior.
Notice of receipt of permit applications; request for comments.
We, the U.S. Fish and Wildlife Service, have received applications for permits to conduct activities intended to enhance the propagation or survival of endangered or threatened species under the Endangered Species Act. We invite the public and local, State, Tribal, and Federal agencies to comment on these applications. Before issuing any of the requested permits, we will take into consideration any information that we receive during the public comment period.
We must receive your written comments on or before December 17, 2018.
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Carlita Payne, 612-713-5343;
We, the U.S. Fish and Wildlife Service, invite the public to comment on applications for permits under section 10(a)(1)(A) of the Endangered Species Act of 1973, as amended (ESA; 16 U.S.C. 1531
With some exceptions, the ESA prohibits activities that constitute take of listed species unless a Federal permit is issued that allows such activity. The ESA's definition of “take” includes such activities as pursuing, harassing, trapping, capturing, or collecting in addition to hunting, shooting, harming, wounding, or killing.
A recovery permit issued by us under section 10(a)(1)(A) of the ESA authorizes the permittee to conduct activities with endangered or threatened species for scientific purposes that promote recovery or for enhancement of propagation or survival of the species. These activities often include such prohibited actions as capture and collection. Our regulations implementing section 10(a)(1)(A) for these permits are found in the Code of Federal Regulations at 50 CFR 17.22 for endangered wildlife species, 50 CFR 17.32 for threatened wildlife species, 50 CFR 17.62 for endangered plant species, and 50 CFR 17.72 for threatened plant species.
Proposed activities in the following permit requests are for the recovery and enhancement of propagation or survival of the species in the wild. The ESA requires that we invite public comment before issuing such permits. Accordingly, we invite local, State, Tribal, and Federal agencies and the public to submit written data, views, or arguments with respect to these applications. The comments and recommendations that will be most useful and likely to influence agency decisions are those supported by quantitative information or studies.
Written comments we receive become part of the administrative record associated with this action. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can request in your comment that we withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so. Moreover, all submissions from organizations or businesses, and from individuals identifying themselves as representatives or officials of organizations or businesses, will be made available for public disclosure in their entirety.
If we decide to issue permits to any of the applicants listed in this notice, we will publish a notice in the
Section 10(c) of the Endangered Species Act of 1973, as amended (16 U.S.C. 1531
United States Geological Survey, Department of the Interior.
Notice of request for nominees.
The U.S. Department of the Interior (Interior) is seeking nominations for individuals to be considered as Committee members and/or alternates to serve on the Advisory Committee on Water Information (ACWI).
Ms. Adrienne Bartlewitz, Acting ACWI Executive Secretary, U.S. Geological Survey, 12201 Sunrise Valley Drive, Reston, VA 20192. Telephone: 703-648-4304; Fax: 703-648-5002.
The ACWI was established under the authority of the Office of Management and Budget and Budget Memorandum No. M-92-01 and the Federal Advisory Committee Act, as amended, (5 U.S.C. App. 2), and with the concurrence of the General Services Administration.
Membership represents a wide range of water resources interests and functions. The ACWI has a maximum of 35 members. Members will represent the interests of water oriented organizations and will be selected from among, but not limited to the following groups: Federal agencies, professional water-related associations, State and county water-related associations, academia, private industry, water utility associations, civil engineering societies, watershed and land conservation associations, ecological societies, lake, coastal, and ocean associations, environmental and educational groups.
Member organizations designate their representatives and alternates. Membership rests not with the individual person but rather with the member organization, who names their representative, and sometimes an alternate.
Nominations should include a résumé providing an adequate description of the nominee's qualifications, including information that would enable the Department of the Interior to make an informed decision regarding meeting the membership requirements of the ACWI and permit the Department of the Interior to contact a potential member. No individual who is currently registered as a Federal lobbyist is eligible to serve as a member of the ACWI.
The Committee functions solely as an advisory body, and in compliance with the provisions of the Federal Advisory Committee Act. Nominations for member organizations should be submitted to the Executive Secretary, at the address listed in
The purpose of the ACWI is to represent the interests of water-information users and professionals in advising the Federal Government on Federal water-information programs and their effectiveness in meeting the Nation's water-information needs. Member organizations help to foster communications between the Federal and non-Federal sectors on sharing water information.
Bureau of Indian Affairs, Interior.
Notice of information collection; request for comment.
In accordance with the Paperwork Reduction Act of 1995, we, the Bureau of Indian Affairs (BIA) are proposing to renew an information collection.
Interested persons are invited to submit comments on or before January 14, 2019.
Send your comments on this information collection request (ICR) by mail to the Calvert L. Curley, Office of Trust Services, Branch of Natural Resources, P.O. Box 1060, Gallup, New Mexico 87105; telephone: (505) 863-8221; email:
To request additional information about this ICR, contact Calvert L. Curley at telephone: (505) 863-8204, or email:
In accordance with the Paperwork Reduction Act of 1995, we provide the general public and other Federal agencies with an opportunity to comment on new, proposed, revised, and continuing collections of information. This helps us assess the impact of our information collection requirements and minimize the public's reporting burden. It also helps the public understand our information collection requirements and provide the requested data in the desired format.
We are soliciting comments on the proposed ICR that is described below. We are especially interested in public comment addressing the following issues: (1) Is the collection necessary to the proper functions of the BIA; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the BIA enhance the quality, utility, and clarity of the information to be collected; and (5) how might the BIA minimize the burden of this collection on the respondents, including through the use of information technology.
Comments that you submit in response to this notice are a matter of public record. We will include or summarize each comment in our request to OMB to approve this ICR. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
This information collection allows BIA to receive the information necessary to determine whether an applicant to obtain, modify, or assign a grazing permit on Navajo Partitioned Lands is eligible and complies with all applicable grazing permit requirements. BIA, in coordination with the Navajo Nation, will continue to collect grazing permit information up to and beyond the initial reissuing of the grazing permits, likely within a 1-3 year time period from the date of publication of this notice. The data is collected by electronic global positioning systems and field office interviews by BIA & Navajo Nation staff. The data is maintained by BIA's Navajo Partitioned Lands office. The burden hours for this continued collection of information are reflected in the Estimated Total Annual Hour Burden in this notice.
An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
The authority for this action is the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Office of the Secretary, Interior.
Notice to solicit nominations.
The Exxon Valdez Oil Spill Trustee Council is soliciting nominations for the Public Advisory Committee. The Public Advisory Committee advises the Trustee Council on decisions related to the planning, evaluation, funds allocation, and conduct of injury assessment and restoration activities related to the T/V
All nominations must be received by December 17, 2018.
A complete nomination package should be submitted by hard copy or via email to Elise Hsieh, Executive Director,
Questions should be directed to Cherri Womac,
The
The Trustee Council consists of representatives of the U.S. Department of the Interior, U.S. Department of Agriculture, National Oceanic and Atmospheric Administration, Alaska Department of Fish and Game, Alaska Department of Environmental Conservation, and Alaska Department of Law.
The Public Advisory Committee consists of 10 members to reflect balanced representation from each of the following principal interests: aquaculture/mariculture, commercial tourism, conservation/environmental, recreation, subsistence use, commercial fishing, native landownership, sport hunting/fishing, science/technology, and public-at-large.
Nominations for membership may be submitted by any source.
Nominations should include a resume providing an adequate description of the nominee's qualifications, including information that would enable the Department of the Interior to make an informed decision regarding meeting the membership requirements of the Public Advisory Committee and permit the Department of the Interior to contact a potential member.
Individuals who are federally registered lobbyists are ineligible to serve on all FACA and non-FACA boards, committees, or councils in an individual capacity. The term “individual capacity” refers to individuals who are appointed to exercise their own individual best judgment on behalf of the government, such as when they are designated Special Government Employees, rather than being appointed to represent a particular interest.
5 U.S.C. Appendix 2.
National Park Service, Interior.
Notice.
In accordance with the Federal Advisory Committee Act of 1972, the National Park Service is hereby giving notice that the Made in
The teleconference meeting will be held on Friday, November 30, 2018, from 11:00 a.m. to 1:00 p.m., EST.
The teleconference meeting will be conducted in the South Penthouse of the Stewart Lee Udall Department of the Interior Building, 1849 C Street NW, Washington, DC 20240, telephone 202-354-3950.
Shirley Sears, Office of Policy, National Park Service, 1849 C Street NW, Mail Stop 2659, Washington, DC 20240, telephone number 202-354-3955, or email
The Committee will meet to receive and deliberate the report of its Subcommittee on Recreation Enhancement Through Reorganization, and to receive status updates from its subcommittees on Partnership and Collaboration, Public Access and Infrastructure, and Technology and the Digital Experience. The Committee meeting will be open to the public in the same way as all committee meetings are open to the public. Space and facilities to accommodate the public are limited and attendees will be accommodated on a first-come basis. Opportunity for oral comment will be limited to no more than 3 minutes per speaker and no more than 15 minutes total. The Committee Chair will determine how time for oral comments will be allocated.
Anyone may file with the Committee a written statement concerning matters to be discussed.
5 U.S.C. Appendix 2.
National Park Service, Interior.
Request for nominations.
The National Park Service (NPS), U.S. Department of the Interior, is requesting nominations for qualified persons to serve as members of the Acadia National Park Advisory Commission (Commission).
Written nominations must be postmarked by December 17, 2018.
Nominations should be sent to Michael Madell, Deputy Superintendent, Acadia National Park, P.O. Box 177, Bar Harbor, Maine 04609, telephone (207) 288-8701, or email
Michael Madell, Deputy Superintendent, Acadia National Park, P.O. Box 177, Bar Harbor, Maine 04609, telephone (207) 288-8701, or email
The Commission was established by section 103 of Public Law 99-420, as amended, (16 U.S.C. 341 note), and in accordance with the Federal Advisory Committee Act (5 U.S.C. Appendix 1-16). The Commission advises the Secretary and the NPS on matters relating to the management and development of Acadia National Park, including but not limited to, the acquisition of lands and interests in lands (including conservation easements on islands) and the termination of rights of use and occupancy.
The Commission is composed of 16 members appointed by the Secretary, as follows:
(a) Three members at large; (b) three members appointed from among individuals recommended by the Governor of Maine; (c) four members appointed from among individuals recommended by each of the four towns on the island of Mount Desert; (d) three members appointed from among individuals recommended by each of the three Hancock County mainland communities of Gouldsboro, Winter Harbor, and Trenton, and; (e) three members appointed from among individuals recommended by each of the three island towns of Cranberry Isles, Swans Island, and Frenchboro.
The NPS is seeking nominees for the three members at large. Fifteen member terms will end on February 19, 2019. This notice also informs the public about other opportunities for nominations to represent the Governor of Maine or local municipalities that will have vacancies in February. Nominations received by the park will be sent directly to either the Governor's office or local municipalities for their consideration.
Nominations should be typed and should include a resume providing an adequate description of the nominee's qualifications, including information that would enable the Department of the Interior to make an informed decision regarding meeting the membership requirements of the Commission and permit the Department to contact a potential member. All documentation, including letters of recommendation, must be compiled and submitted in one complete package. All those interested in membership, including current members whose terms are expiring, must follow the same nomination process. Members may not appoint deputies or alternates.
Members of the Commission serve without compensation. However, while away from their homes or regular places of business in the performance of services for the Committee as approved by the NPS, members may be allowed travel expenses, including per diem in lieu of subsistence, in the same manner as persons employed intermittently in Government service are allowed such expenses under section 5703 of title 5 of the United States Code.
5 U.S.C. Appendix 2.
Office of the Secretary, Office of Natural Resources Revenue, Interior.
Notice of information collection; request for comment.
In accordance with the Paperwork Reduction Act (PRA) of 1995, the Office of Natural Resources Revenue (ONRR), is proposing to renew the Accounts Receivable Confirmations Reporting information collection. Every year, under the Chief Financial Officers Act of 1990, mineral lessees are asked to confirm the accuracy of randomly-selected ONRR accounts receivable. Accounts receivable confirmations are a common financial audit practice that require approval under the PRA.
Interested persons are invited to submit comments on or before December 17, 2018.
Send written comments on this information collection request (ICR) to the Office of Management and Budget's Desk Officer for the Department of the Interior by email at
For questions on technical issues, contact Mr. Hans Meingast, Financial Services, ONRR, at (303) 231-3382, or email to
In accordance with the Paperwork Reduction Act of 1995, we provide the general public and other Federal agencies with an opportunity to comment on new, proposed, revised, and continuing collections of information. This helps us assess the impact of our information collection requirements and minimize the public's reporting burden. It also helps the public understand our information collection requirements and provide the requested data in the desired format. A
We are again soliciting comments on the proposed ICR that is described below. We are especially interested in public comment addressing the following issues: (1) Is the collection necessary to the proper functions of the ONRR; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the ONRR enhance the quality, utility, and clarity of the information to be collected; and (5) how might the ONRR minimize the burden of this collection on the respondents, including through the use of information technology.
Comments that you submit in response to this notice are a matter of public record. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
When a company or an individual enters into a lease to explore, develop, produce, sell, or otherwise dispose of minerals, from Federal and Indian lands and the OCS, that company or individual agrees to pay the lessor a share in an amount or value of production from the leased lands. For oil, gas, and solid minerals, the lessee is required to report various types of information to ONRR relative to the disposition of the leased minerals. Specifically, companies submit financial information to ONRR on a monthly basis by submitting form ONRR-2014 [Report of Sales and Royalty Remittance for oil and gas reported in OMB Control Number 1012-0004], and form ONRR-4430 [Solid Minerals Production and Royalty Report reported in OMB Control Number 1012-0010]. These royalty reports result in accounts receivables and capture the vast majority of the mineral revenue collected by ONRR.
The basis for the data that companies submit on forms ONRR-2014 and ONRR-4430 is generally available within the records of the lessee or others involved in developing, transporting, processing, purchasing, or selling such minerals. The information that we collect under the ICR includes data necessary to ensure that ONRR's accounts receivables are accurately based on the value of the mineral production, as reported to ONRR on forms ONRR-2014 and ONRR-4430.
Every year, the Chief Financial Officer (CFO) under Chief Financial Officers Act of 1990, the Office of Inspector General, or its agent (agent), audits the accounts receivable portions of the Department's financial statements, which are based on ONRR forms ONRR-2014 and ONRR-4430. Accounts receivable confirmations are a common financial audit practice. A third-party audit provides confirmation of the validity of ONRR's financial records.
As part of the CFO audit, the agent selects a sample of accounts receivable items based on forms ONRR-2014 and ONRR-4430, and provides the sample items to ONRR. ONRR then identifies the company names and addresses for the sample items selected and creates accounts receivable confirmation letters. In order to meet the CFO requirements, the letters must be on ONRR letterhead and the Deputy Director for ONRR, or his or her designee, must sign the letters. The letter requests third-party confirmation responses by a specified date on whether or not ONRR's accounts
We will request OMB approval to continue to collect this information. Not collecting this information would limit the Secretary's ability to discharge the duties of the office, could result in a violation of the Chief Financial Officers Act of 1990, and may also result in the inability to confirm the accuracy of ONRR's accounts receivables which are based on the accurate reporting of forms ONRR-2014 and ONRR-4430. ONRR protects the proprietary information received and does not collect items of a sensitive nature.
An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
The authority for this action is the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has received a complaint entitled
Lisa R. Barton, Secretary to the Commission, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436, telephone (202) 205-2000. The public version of the complaint can be accessed on the Commission's Electronic Document Information System (EDIS) at
General information concerning the Commission may also be obtained by accessing its internet server at United States International Trade Commission (USITC) at
The Commission has received a complaint and a submission pursuant to § 210.8(b) of the Commission's Rules of Practice and Procedure filed on behalf of Ingevity Corp and Ingevity South Carolina, LLC, on November 8, 2018. The complaint alleges violations of section 337 of the Tariff Act of 1930 (19 U.S.C. 1337) in the importation into the United States, the sale for importation, and the sale within the United States after importation of certain multi-stage fuel vapor canister systems and activated carbon components thereof. The complaint names as respondents: MAHLE Filter Systems North America, Inc. of Murfreesboro, TN; MAHLE Filter Systems Japan Corp. of Japan; MAHLE Sistemas de Filtración de México S.A. de C.V. of Mexico; MAHLE Filter Systems Canada, ULC of Canada; Kuraray Co., Ltd. of Japan; Kuraray America, Inc. of Houston, TX and Nagamine Manufacturing Co., Ltd. of Japan. The complainant requests that the Commission issue a limited exclusion order, cease and desist orders and impose a bond during the 60-day review period pursuant to 19 U.S.C. 1337(j).
Proposed respondents, other interested parties, and members of the public are invited to file comments, not to exceed five (5) pages in length, inclusive of attachments, on any public interest issues raised by the complaint or § 210.8(b) filing. Comments should address whether issuance of the relief specifically requested by the complainant in this investigation would affect the public health and welfare in the United States, competitive conditions in the United States economy, the production of like or directly competitive articles in the United States, or United States consumers.
In particular, the Commission is interested in comments that:
(i) Explain how the articles potentially subject to the requested remedial orders are used in the United States;
(ii) identify any public health, safety, or welfare concerns in the United States relating to the requested remedial orders;
(iii) identify like or directly competitive articles that complainant, its licensees, or third parties make in the United States which could replace the subject articles if they were to be excluded;
(iv) indicate whether complainant, complainant's licensees, and/or third party suppliers have the capacity to replace the volume of articles potentially subject to the requested exclusion order and/or a cease and desist order within a commercially reasonable time; and
(v) explain how the requested remedial orders would impact United States consumers.
Written submissions on the public interest must be filed no later than by close of business, eight calendar days after the date of publication of this notice in the
Persons filing written submissions must file the original document electronically on or before the deadlines stated above and submit 8 true paper copies to the Office of the Secretary by noon the next day pursuant to § 210.4(f) of the Commission's Rules of Practice and Procedure (19 CFR 210.4(f)). Submissions should refer to the docket number (“Docket No. 3351”) in a prominent place on the cover page and/or the first page. (
Any person desiring to submit a document to the Commission in confidence must request confidential treatment. All such requests should be directed to the Secretary to the Commission and must include a full statement of the reasons why the Commission should grant such treatment.
This action is taken under the authority of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and of §§ 201.10 and 210.8(c) of the Commission's Rules of Practice and Procedure (19 CFR 201.10, 210.8(c)).
By order of the Commission.
The Foreign Claims Settlement Commission, pursuant to its regulations (45 CFR part 503.25) and the Government in the Sunshine Act (5 U.S.C. 552b), hereby gives notice in regard to the scheduling of open meetings as follows:
Open.
All meetings are held at the Foreign Claims Settlement Commission, 601 D Street NW, Suite 10300, Washington, DC. Requests for information, or advance notices of intention to observe an open meeting, may be directed to: Patricia M. Hall, Foreign Claims Settlement Commission, 601 D Street NW, Suite 10300, Washington, DC 20579. Telephone: (202) 616-6975.
30-Day notice of information collection under review: Federal Coal Lease Request.
The Department of Justice (DOJ), Antitrust Division (ATR), will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The proposed information collection is published to obtain comments from the public and affected agencies. This proposed information collection was previously published in the
The purpose of this notice is to allow for an additional 30 days for public comment until December 17, 2018. This process is conducted in accordance with 5 CFR 1320.10.
If you have comments (especially regarding the estimated public burden or associated response time), suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Jill Ptacek, Antitrust Division, United States Department of Justice, 450 5th Street NW, Suite 8000, Washington, DC 20530. Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
(1)
(2)
(3)
(4)
(5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond. It is estimated that 10 respondents will complete each form, with each response taking approximately two hours.
(6) An estimate of the total public burden (in hours) associated with the collection: There are an estimated 20 annual burden hours associated with this collection, in total.
Mine Safety and Health Administration, Labor.
Notice.
This notice is a summary of a petition for modification submitted to the Mine Safety and Health Administration (MSHA) by the parties listed below.
All comments on the petition must be received by MSHA's Office of Standards, Regulations, and Variances on or before December 17, 2018.
You may submit your comments, identified by “docket number” on the subject line, by any of the following methods:
1.
2.
3.
MSHA will consider only comments postmarked by the U.S. Postal Service or proof of delivery from another delivery service such as UPS or Federal Express on or before the deadline for comments.
Barbara Barron, Office of Standards, Regulations, and Variances at 202-693-9447 (voice),
Section 101(c) of the Federal Mine Safety and Health Act of 1977 and Title 30 of the Code of Federal Regulations Part 44 govern the application, processing, and disposition of petitions for modification.
Section 101(c) of the Federal Mine Safety and Health Act of 1977 (Mine Act) allows the mine operator or representative of miners to file a petition to modify the application of any mandatory safety standard to a coal or other mine if the Secretary of Labor (Secretary) determines that:
1. An alternative method of achieving the result of such standard exists which will at all times guarantee no less than the same measure of protection afforded the miners of such mine by such standard; or
2. That the application of such standard to such mine will result in a diminution of safety to the miners in such mine.
In addition, the regulations at 30 CFR 44.10 and 44.11 establish the requirements and procedures for filing petitions for modification.
The petitioner states that:
(1) The nonpermissible electronic testing and diagnostic equipment would be limited to laptop computers, oscilloscopes, vibration analysis machines, cable fault detectors, point temperature probes, infrared temperature devices, signal analyzer devices, ultrasonic measuring devices, electronic component testers, and electronic tachometers.
(2) Permissible, approved voltage measuring instruments will be used when possible.
(3) All other testing and diagnostic equipment used in or inby the last open crosscut will be permissible
(4) Other testing and diagnostic equipment may be used if approved in advance by MSHA's District office.
(5) All nonpermissible, low-voltage or battery-powered electronic testing and diagnostic equipment to be used in or inby the last open crosscut will be examined prior to use by a certified person to ensure equipment is being maintained in a safe operating condition.
(6) The results of such inspection will be recorded and retained for one year and made available to MSHA on request.
(7) A qualified person, as defined in 30 CFR 75.151, will continuously monitor for methane immediately before
(8) Nonpermissible electronic testing and diagnostic equipment will not be used if methane is detected in concentrations at or above one percent. When methane is detected at such levels while the nonpermissible electronic testing and diagnostic equipment is being used, the equipment will be deenergized immediately and withdrawn outby the last open crosscut.
(9) All hand-held methane detectors will be MSHA-approved and maintained in permissible and proper operating condition as defined in 30 CFR 75.320.
(10) Coal production will cease, except for the time necessary to troubleshoot under actual mining conditions. Coal may remain in or on the equipment in order to test and diagnose the equipment under load. Accumulations of coal and combustible materials referenced in 30 CFR 75.400 will be removed before testing begins to provide additional safety to miners.
(11) Nonpermissible electronic test and diagnostic equipment will not be used to test equipment when float coal dust is in suspension.
(12) All electronic and diagnostic equipment will be used in accordance with the manufacturer's recommended safe use procedures.
(13) Qualified personnel engaged in the use of nonpermissible electronic testing and diagnostic equipment will be properly trained to recognize the hazards and limitations associated with the use of such equipment in areas where methane could be present.
(14) The nonpermissible electronic testing and diagnostic equipment will not be put into service until MSHA has inspected the equipment and determined that it is in compliance with all the above terms and conditions.
(15) Cables supplying power to low-voltage testing and diagnostic equipment will only be used when permissible testing and diagnostic equipment is unavailable.
(16) Within 60 days after the Proposed Decision and Order (PDO) becomes final, the petitioner will submit proposed revisions for its approved 30 CFR part 48 training plan to the District Manager. The revisions will specify initial and refresher training regarding the terms and conditions in the PDO.
The petitioner asserts that the proposed alternative method will at all times guarantee no less than the same measure of protection afforded by the existing standard.
Mine Safety and Health Administration, Labor.
Notice; correction.
This notice amends a notice published in the
Roslyn B. Fontaine, 202-693-9440.
A petition for modification for Docket Number M-2017-019-C, for Marfork Coal Company, LLC, 500 Lee Street East, Suite 701 (25301), Post Office Box 2548, Charleston, West Virginia 25329, referenced in the October 30, 2018
National Science Foundation.
Notice and request for comments.
The National Science Foundation (NSF) is announcing plans to request a new, one time data collection. The primary purpose of this data collection is to provide critical evidence for the Evaluation of the Centers for Chemical Innovation (CCI) Program. The National Science Foundation (NSF) has submitted this information collection requirement to OMB for review and clearance under the Paperwork Reduction Act of 1995. This is the second notice for public comment; the first was published in the
Comments regarding these information collections are best assured of having their full effect if received within 30 days of this notification.
Office of Information and Regulatory Affairs of OMB, Attention: Desk Officer for National Science Foundation, 725—17th Street, NW Room 10235, Washington, DC 20503, and Suzanne H. Plimpton, Reports Clearance Officer, National Science Foundation, 2415 Eisenhower Avenue, Alexandria, VA 22314, or send email to
Copies of the submission(s) may be obtained by calling 703-292-7556.
NSF may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.
Comments regarding (a) whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) the accuracy of the agency's estimate of burden 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 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 should be addressed to the points of contact in the
The National Science Foundation Act of 1950, as subsequently amended, includes a statutory charge to “. . . provide a central clearinghouse for the collection, interpretation, and analysis of data on scientific and engineering resources, and to provide a source of information for policy formulation by other agencies of the Federal Government.” The NSCG is designed to comply with these mandates by providing information on the supply and utilization of the nation's scientists and engineers.
The U.S. Census Bureau, as in the past, will conduct the NSCG for NCSES. The survey data collection will begin in February 2019 using web and mail questionnaires. Non-respondents to the web or mail questionnaire will be followed up by computer-assisted telephone interviewing. The individual's response to the survey is voluntary. The survey will be conducted in conformance with Census Bureau statistical quality standards and, as such, the NSCG data will be afforded protection under the applicable Census Bureau confidentiality statutes.
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing for the Commission's consideration concerning a negotiated service agreement. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202-789-6820.
The Commission gives notice that the Postal Service filed request(s) for the Commission to consider matters related to negotiated service agreement(s). The request(s) may propose the addition or removal of a negotiated service agreement from the market dominant or the competitive product list, or the modification of an existing product currently appearing on the market dominant or the competitive product list.
Section II identifies the docket number(s) associated with each Postal Service request, the title of each Postal Service request, the request's acceptance date, and the authority cited by the Postal Service for each request. For each request, the Commission appoints an officer of the Commission to represent the interests of the general public in the proceeding, pursuant to 39 U.S.C. 505 (Public Representative). Section II also establishes comment deadline(s) pertaining to each request.
The public portions of the Postal Service's request(s) can be accessed via the Commission's website (
The Commission invites comments on whether the Postal Service's request(s) in the captioned docket(s) are consistent with the policies of title 39. For request(s) that the Postal Service states concern market dominant product(s), applicable statutory and regulatory requirements include 39 U.S.C. 3622, 39 U.S.C. 3642, 39 CFR part 3010, and 39 CFR part 3020, subpart B. For request(s) that the Postal Service states concern
1.
This Notice will be published in the
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Elizabeth Reed, 202-268-3179.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on November 6, 2018, it filed with the Postal Regulatory Commission a
2:00 p.m. on Thursday, November 15, 2018.
The meeting will be held at the Commission's headquarters, 100 F Street NE, Washington, DC 20549.
This meeting will be closed to the public.
Commissioners, Counsel to the Commissioners, the Secretary to the Commission, and recording secretaries will attend the closed meeting. Certain staff members who have an interest in the matters also may be present.
The General Counsel of the Commission, or his designee, has certified that, in his opinion, one or more of the exemptions set forth in 5 U.S.C. 552b(c)(3), (5), (6), (7), (8), 9(B) and (10) and 17 CFR 200.402(a)(3), (a)(5), (a)(6), (a)(7), (a)(8), (a)(9)(ii) and (a)(10), permit consideration of the scheduled matters at the closed meeting.
Commissioner Stein, as duty officer, voted to consider the items listed for the closed meeting in closed session.
The subject matters of the closed meeting will be:
Institution and settlement of injunctive actions;
Institution and settlement of administrative proceedings;
Resolution of litigation claims; and
Other matters relating to enforcement proceedings.
At times, changes in Commission priorities require alterations in the scheduling of meeting items.
For further information and to ascertain what, if any, matters have been added, deleted or postponed; please contact Brent J. Fields from the Office of the Secretary at (202) 551-5400.
Pursuant to Section 19(b)(1)
The Exchange proposes to amend the NYSE Arca Equities Fees and Charges (“Fee Schedule”) to remove certain obsolete text that reference [sic] Pillar phase I protocols now that Pillar phase I protocols are no longer available for ETP Holders to communicate with the NYSE Arca Marketplace. The Exchange proposes to implement the fee changes effective November 1, 2018. The proposed rule change is available on the Exchange's website at
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of those statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant parts of such statements.
The Exchange proposes to amend the Fee Schedule to remove certain obsolete text that reference Pillar phase I protocols now that Pillar phase I protocols are no longer available for ETP Holders to communicate with the NYSE Arca Marketplace. The Exchange proposes to implement the fee changes effective November 1, 2018.
As a general matter, ETP Holders enter orders and order instructions by using communication protocols that map to the order types and modifiers described in Exchange rules. Prior to the implementation of Pillar, ETP Holders communicated with the NYSE Arca Marketplace using Pillar phase I protocols. When the Exchange introduced trading on its Pillar trading platform, the Exchange also introduced new technology to support how ETP Holders communicate with the NYSE Arca Marketplace, referred to in the Exchange's rules as Pillar phase II protocols. During the Pillar implementation, there was a period of time when both Pillar phase I protocols and Pillar phase II protocols were available to ETP Holders. Effective October 1, 2018, Pillar phase I protocols are no longer available to ETP Holders. All ETP Holders now use Pillar phase II protocols to communicate with the NYSE Arca Marketplace. As a result, there is no longer a need to distinguish between Pillar phase I protocols and Pillar phase II protocols in the Exchange's Fee Schedule.
In April 2018, the Exchange filed a proposed rule change to adopt a new pricing tier—BBO Setter Tier.
Additionally, in August 2017, in connection with the introduction of Pillar phase II protocols, the Exchange amended the Fee Schedule to adopt a cap, for August and September 2017, on monthly fees for the use of ports connecting to the NYSE Arca Marketplace.
Finally, in October 2017, the Exchange amended the Fee Schedule to adopt a Decommission Extension Fee applicable to ETP Holders for the use of Pillar phase I protocols to connect with the NYSE Arca Marketplace for a three-month period from March 2018 through May 2018 as an incentive for ETP Holders to fully transition to the use of Pillar phase II protocols to connect with the NYSE Arca Marketplace.
The Exchange believes that the proposed rule change is consistent with Section 6(b) of the Act,
The Exchange believes that it is reasonable, equitable and not unfairly discriminatory to delete reference to obsolete rule text and dates from the Fee Schedule. The Exchange believes that the proposed changes are reasonable because they would result in greater specificity and precision within the Fee Schedule, which would contribute to reasonably ensuring that the fees and credits described there are clear and accurate. Specifically, the proposed changes are reasonable because they would remove obsolete rule text and dates from the Fee Schedule related to the use of ports that are no longer available to connect to the NYSE Arca Marketplace and a Decommission Extension Fee that is no longer charged by the Exchange. The Exchange also believes that the proposed changes are equitable and not unfairly discriminatory because all readers of the Fee Schedule, including all ETP Holders, would benefit from the increased specificity and clarity that this proposed rule change would provide.
For the foregoing reasons, the Exchange believes that the proposal is consistent with the Act.
In accordance with Section 6(b)(8) of the Act,
No written comments were solicited or received with respect to the proposed rule change.
The foregoing rule change is effective upon filing pursuant to Section 19(b)(3)(A)
At any time within 60 days of the filing of such proposed rule change, the Commission summarily may
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”),
ICE Clear Europe proposes to make certain amendments to the Policy, Rules and Finance Procedures relating to the calculation methodology for F&O Clearing Member contributions, the minimum size of the F&O Guaranty Fund and the review cycle and to make various drafting clarifications and improvements.
In its filing with the Commission, ICE Clear Europe 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. ICE Clear Europe has prepared summaries, set forth in sections (A), (B), and (C) below, of the most significant aspects of such statements.
ICE Clear Europe is generally amending the Policy to address the following aspects of the F&O Guaranty Fund: Changing the calculation methodology for F&O Clearing Member contributions to incorporate an uncollateralized stress loss factor (in addition to a factor based on the intraday original margin requirement), in line with the Clearing House principle of `polluter pays'; specifying the minimum size of the F&O Guaranty Fund at 2% of the amount of F&O original margin; and changing the review cycle for the F&O Guaranty Fund level from quarterly to every two months, in line with the F&O Risk Committee meeting schedule. Various drafting clarifications and improvements have also been made, and certain descriptions in the Policy that duplicate or describe provisions in other Rules, ICE Clear Europe Procedures and policies have been removed as unnecessary. ICE Clear Europe is also making corresponding amendments to the Rules and Finance Procedures to accommodate the changes being made to the Policy. Set out below are further details regarding the specific proposed amendments.
ICE Clear Europe is proposing to amend its description of the purposes and objectives of the Policy to include a broader statement that the Policy defines how and how often the F&O Guaranty Fund is sized, how Clearing Member contributions are apportioned and the sizing frequency, as well as that the Policy also defines stress margin and its uses, eligible assets covering F&O Guaranty Fund requirement liabilities, the default sequence and powers of assessment. Certain descriptions of the
The provisions of the Policy relating to the sizing of the F&O Guaranty Fund would be amended to remove details found in other Clearing House policies and documentation, including the methodology used to calculate and allocate the additional guaranty fund apportionment (“AGA”) between the energy and financials & softs segments of the F&O Guaranty Fund. Detail regarding the review of the validity of the stress testing scenario(s) is being removed, as it is covered by other existing stress-testing policies. These changes do not represent a modification to ICE Clear Europe's current practices.
The amendments to the Policy also reflect that the frequency of certain reviews will be changed from a quarterly basis to each time the F&O Risk Committee meets (which is typically every two months). Corresponding amendments to the Rules specify that the Guaranty Fund Period will be set pursuant to the Finance Procedures, instead of being a fixed three month period. The amendments to the Finance Procedures state that the start and end dates of Guaranty Fund Periods will be communicated to F&O Clearing Members.
The amendments change the deadline for Clearing Members to deposit additional funds to comply with an increased F&O Guaranty Fund requirement. Specifically, as amended in section 6.1(i)(iii) of the Finance Procedures and as set out in the amended Policy, the deadline has been reduced from ten business days to five business days.
The proposed amendments define the minimum overall F&O Guaranty Fund size as 2% of the total F&O original margin requirement (averaged over the review period), as compared to the current minimum which is based on the fixed ICE Clear Europe initial contribution to the F&O Guaranty Fund.
The discussion of extraordinary reviews of the F&O Guaranty Fund is being amended to remove certain details relating to actions that will be taken by the clearing risk department when the stress testing results are observed to exceed the level of the relevant F&O Guaranty Fund segment, as this is documented in other Clearing House policies and documentation. The description instead notes that the amber and red limits defined as part of the Board Risk Appetite will potentially trigger an extraordinary review of the F&O Guaranty Fund which would be communicated via the standard process for review.
The requirements of the Policy regarding information presented to the F&O Risk Committee are being simplified such that the following information will be presented to the F&O Risk Committee at each review of the level of the Fund: Historical daily stress-testing results from the Members showing at least the first and second largest uncollateralized losses; details of the stress scenario driving the largest exposures; and any other information supporting a resizing decision. Certain more prescriptive information requirements have been removed, as ICE Clear Europe believes they are unnecessary.
The provisions of the Policy relating to recommendations as to changes in the overall level of the F&O Guaranty Fund have been condensed and simplified. The revised Policy identifies several factors on which the Clearing House will base its recommendations on the level of the Fund (including the level of uncollateralized losses as compared to the F&O Guaranty Fund or relevant segments and the level of stress margin called for relevant F&O product categories), rather than describing specific circumstances under which a `no change' recommendation or a recommendation to increase a Fund segment will be made. The Clearing House believes the more flexible approach better takes into account the range of factors that may warrant a change in the F&O Guaranty Fund level. In any case, as under the current Policy, a full explanation of the conclusions and related data is to be presented to the F&O Risk Committee and Board Risk Committee.
As noted above, the amendments alter the calculation of F&O Clearing Member contributions to take into account potential uncollateralized, or stress, loss as well as the maximum intraday original margin requirement. The governing principle with respect to this determination is that each Clearing Member's contribution to each of the Fund segments should reflect their relative share of clearing activity as well as their relative share of uncollateralized loss. Under the revised approach, subject to minimum contribution requirements set out in the Policy, an F&O Clearing Member's relative share of the F&O Guaranty Fund requirement will be based 40% on its maximum intraday original margin requirement and 60% on its uncollateralized loss. This will be recalculated at each review (instead of on a quarterly cycle). This two factor contribution model is intended to offer a balanced contribution taking into account clearing activity and stress results. Various conforming and clarifying changes have been made throughout the Policy. As discussed above, F&O Clearing Members will have five (instead of ten) UK business days from notification to cover any increase in their F&O Guaranty Fund requirement. The description of the data validation process is being deleted (as the process is documented in other Clearing House procedures). The proposed amendments to the Policy also specify the minimum fund contribution for an F&O Clearing Member to be the larger of USD 1 million or the calculated member's contribution under the revised methodology. The corresponding proposed amendments to section 14.1(b) of the Finance Procedures accommodate this change, by specifying that the Clearing House will establish from time to time a minimum fund contribution for an F&O Clearing Member based on a methodology adopted by the Clearing House, of not less than USD 1 million.
The proposed amendments also remove a description of the manner in which a drawdown of the F&O Guaranty Fund is made across the different fund segments, as that is covered in greater detail in the existing Rules.
Finally, references to quarterly reviews of stress test results are being replaced with references to general review cycles throughout the Policy and an appendix with an example of a stress margin request is being deleted as unnecessary.
ICE Clear Europe believes that the proposed amendments are consistent with the requirements of Section 17A of the Act
The amendments are also consistent with relevant requirements of Rule 17Ad-22.
(4) Effectively identify, measure, monitor, and manage its credit exposures to participants and those arising from its payment, clearing, and settlement processes, including by:
(i) Maintaining sufficient financial resources to cover its credit exposure to each participant fully with a high degree of confidence;
(ii) To the extent not already maintained pursuant to paragraph (e)(4)(i) of this section, for a covered clearing agency providing central counterparty services that is either systemically important in multiple jurisdictions or a clearing agency involved in activities with a more complex risk profile, maintaining additional financial resources at the minimum to enable it to cover a wide range of foreseeable stress scenarios that include, but are not limited to, the default of the two participant families that would potentially cause the largest aggregate credit exposure for the covered clearing agency in extreme but plausible market conditions;
(iii) To the extent not already maintained pursuant to paragraph (e)(4)(i) of this section, for a covered clearing agency not subject to paragraph (e)(4)(ii) of this section, maintaining additional financial resources at the minimum to enable it to cover a wide range of foreseeable stress scenarios that include, but are not limited to, the default of the participant family that would potentially cause the largest aggregate credit exposure for the covered clearing agency in extreme but plausible market conditions;
(iv) Including prefunded financial resources, exclusive of assessments for additional guaranty fund contributions or other resources that are not prefunded, when calculating the financial resources available to meet the standards under paragraphs (e)(4)(i) through (iii) of this section, as applicable;
(v) Maintaining the financial resources required under paragraphs (e)(4)(ii) and (iii) of this section, as applicable, in combined or separately maintained clearing or guaranty funds;”
Rule 17Ad-22(e)(2)
(2) Provide for governance arrangements that:
(i) Are clear and transparent
(ii) Clearly prioritize the safety and efficiency of the covered clearing agency;
(iii) Support the public interest requirements in Section 17A of the Act (15 U.S.C. 78q-1) applicable to clearing agencies, and the objectives of owners and participants;
(iv) Establish that the board of directors and senior management have appropriate experience and skills to discharge their duties and responsibilities;
(v) Specify clear and direct lines of responsibility; and
(vi) Consider the interests of participants' customers, securities issuers and holders, and other relevant stakeholders of the covered clearing agency.”
ICE Clear Europe does not believe the proposed rule changes would have any impact, or impose any burden, on competition not necessary or appropriate in furtherance of the purposes of the Act. The changes are being proposed in order to clarify and enhance the Policy and reduce overlap with other Clearing House Rules and policies. The amendments will apply to all F&O Clearing Members. ICE Clear Europe does not believe the amendments will generally affect the overall cost of clearing for F&O Clearing Members or other market participants or otherwise affect access to clearing generally. The amendments may alter the allocation of F&O Guaranty Fund requirements across F&O Clearing Members, which could increase requirements for some members, but such changes are designed to more appropriately take into account potential stress losses as well as clearing activity of such members. In ICE Clear Europe's view, such amendments will enhance the risk management of the Clearing House and tailor the F&O Guaranty Fund requirements to the risks presented by F&O Clearing Members. As a result, any additional burdens placed on F&O Clearing Members will be appropriate in furtherance of that goal. The amendments will provide a transparent and objective methodology for the calculation of F&O Guaranty Fund requirements, and are not intended to disadvantage any particular Clearing Member. As a result, ICE Clear Europe believes that any impact on competition is appropriate in furtherance of the purposes of the Act.
Written comments relating to the proposed amendments have not been solicited or received by ICE Clear Europe. ICE Clear Europe will notify the Commission of any comments received
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A) of the Act and paragraph (f) of Rule 19b-4 thereunder. At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
All comments received will be posted without change. Persons submitting comments are cautioned that we do not redact or edit personal identifying information from comment submissions. You should submit only information that you wish to make available publicly. All submissions should refer to File Number SR-ICEEU-2018-011 and should be submitted on or before December 6, 2018.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
U.S. Small Business Administration.
Amendment 2.
This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the State of Georgia (FEMA-4400-DR), dated 11/01/2018.
Issued on 11/07/2018.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW, Suite 6050, Washington, DC 20416, (202) 205-6734.
The notice of the President's major disaster declaration for Private Non-Profit organizations in the State of Georgia, dated 11/01/2018, is hereby amended to include the following areas as adversely affected by the disaster.
All other information in the original declaration remains unchanged.
U.S. Small Business Administration (SBA).
Notice of open Federal Advisory Committee Meeting.
The SBA is issuing this notice to announce the location, date, time, and agenda for the next meeting of the Advisory Committee on Veterans Business Affairs (ACVBA). The meeting is open to the public.
Thursday, December 6, 2018, from 9:00 a.m. to 4:00 p.m. EST.
The meeting will be held at SBA, 409 3rd Street SW, Eisenhower Conference Room B, Washington, DC 20416, and via webinar.
The meeting is open to the public; however advance notice of attendance is requested. To RSVP and confirm attendance, the general public should email
Anyone wishing to make comments to the ACVBA must contact SBA's Office of Veterans Business Development (OVBD) no later than December 1, 2018 via email
Additionally, special accommodation requests should also be directed to OVBD at (202) 205-6773 or
1. Present a valid photo ID to receive a visitor badge.
2. Know the name of the event being attended: The meeting event is the Advisory Committee on Veterans Business Affairs (ACVBA).
3. Visitor badges are issued by the security officer at the main entrance. Visitors are required to display their visitor badge at all times while inside the building.
4. Laptops and other electronic devices may be inspected and logged for identification purposes.
5. Due to limited parking options, Metro's Federal Center SW station is the easiest way to access SBA headquarters.
Pursuant to section 10(a)(2) of the Federal Advisory Committee Act (5 U.S.C., Appendix 2), SBA announces the meeting of the Advisory Committee on Veterans Business Affairs. The ACVBA is established pursuant to 15 U.S.C. 657(b) note, and serves as an independent source of advice and policy. The purpose of this meeting is to discuss efforts that support veteran-owned small businesses, updates on past and current events, and the ACVBA's objectives for fiscal year 2019.
U.S. Small Business Administration (SBA).
Notice of open Federal Advisory Committee meeting.
The SBA is issuing this notice to announce the location, date, time and agenda for the next meeting of the Interagency Task Force on Veterans Small Business Development (Task Force). The meeting is open to the public.
Wednesday, December 5, 2018, from 1:00 p.m. to 4:00 p.m. EST.
The meeting will be held at SBA, 409 3rd Street SW, Eisenhower Conference Room B, Washington, DC 20416, and via webinar.
The meeting is open to the public; however advance notice of attendance is requested. To RSVP and confirm attendance, the general public should email
Anyone wishing to make comments to the Task Force must contact SBA's Office of Veterans Business Development (OVBD) no later than December 1, 2018 via email
Additionally, special accommodation requests should also be directed to OVBD at (202) 205-6773 or
1. Present a valid photo ID to receive a visitor badge.
2. Know the name of the event being attended: The meeting event is the Advisory Committee on Veterans Business Affairs (ACVBA).
3. Visitor badges are issued by the security officer at the main entrance. Visitors are required to display their visitor badge at all times while inside the building.
4. Laptops and other electronic devices may be inspected and logged for identification purposes.
5. Due to limited parking options, Metro's Federal Center SW station is the easiest way to access SBA headquarters.
Pursuant to section 10(a)(2) of the Federal Advisory Committee Act (5 U.S.C., Appendix 2), SBA announces the meeting of the Interagency Task Force on Veterans Small Business Development (Task Force). The Task Force is established pursuant to Executive Order 13540 to coordinate the efforts of Federal agencies to improve capital, business development opportunities, and pre-established federal contracting goals for small business concerns owned and controlled by veterans and service-disabled veterans. The purpose of this meeting is to discuss efforts that support service-disabled veteran-owned small businesses, updates on past and current events, and the Task Force's objectives for fiscal year 2019.
U.S. Small Business Administration.
Amendment 5.
This is an amendment of the Presidential declaration of a major disaster for the State of South Carolina (FEMA-4394-DR), dated 09/21/2018.
Issued on 11/05/2018.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW, Suite 6050, Washington, DC 20416, (202) 205-6734.
The notice of the President's major disaster declaration for the State of South Carolina, dated 09/21/2018, is hereby amended to extend the deadline for filing applications for physical damages as a result of this disaster to 12/05/2018.
All other information in the original declaration remains unchanged.
Catalog of Federal Domestic Assistance Number 59008.
Office of the General Counsel, Social Security Administration (SSA).
Notice of a new system of records.
In accordance with the Privacy Act, we are issuing public notice of our intent to establish a new system of records entitled,
The system of records notice (SORN) is applicable upon its publication in today's
The public, Office of Management and Budget (OMB), and Congress may comment on this publication by writing to the Executive Director, Office of Privacy and Disclosure, Office of the General Counsel, SSA, Room G-401 West High Rise, 6401 Security Boulevard, Baltimore, Maryland 21235-6401, or through the Federal e-Rulemaking Portal at
Corey Smith, Government Information Specialist, Privacy Implementation Division, Office of Privacy and Disclosure, Office of the General Counsel, SSA, G-401 West High Rise, 6401 Security Boulevard, Baltimore, Maryland 21235-6401, telephone: (410) 966-1768, email:
We are establishing a new system of records to record agency decisions for requests for waivers of employee overpayments and requests for employee hearings contesting the validity of the debt. Title 31 Section 3711 of the United States Code provides that the head of an executive agency shall try to collect a claim of the United States Government for money or property arising out of the activities of, or referred to, the agency after providing proper notice and explanation of the right to dispute the agency's information regarding the claim or for administrative review of the claim. Title 5 Section 5584 of the United States Code provides that a claim of the United States against a person arising out of an erroneous payment of pay or allowances made on or after July 1, 1960, or arising out of an erroneous payment of travel, transportation or relocation expenses and allowances, to an employee of the agency, the collection of which would be against equity and good conscience and not in the best interests of the United States, may be waived in whole or in part by the authorized official, the head of the agency and the Director of the Administrative Office of the United States Courts. The authority to waive employee salary overpayments has been delegated to the heads of Federal agencies, thus we are establishing this system of records.
In accordance with 5 U.S.C. 552a(r), we have provided a report to OMB and Congress on this new system of records.
Requests for Waiver of Employee Salary Overpayments, 60-0271.
Unclassified.
Social Security Administration, Office of the General Counsel, Office of General Law, West High Rise Building, 6401 Security Boulevard, Baltimore, MD 21235.
Associate General Counsel, Social Security Administration, Office of the General Counsel, Office of General Law, West High Rise Building, 6401 Security Boulevard, Baltimore, MD 21235,
Title 5 Sections 5514 and 5584 and Title 31 Section 3711 of the United States Code and 20 CFR part 422.
We will use the information we collect to make administrative decisions on employee salary overpayment waiver, requests and appeals.
Individuals who are current or former SSA employees who file administrative requests and appeals with SSA, for waiver of their salary and travel reimbursement overpayments.
This system maintains information that we collect for the administrative request and appeals process. This may include contact information; information pertaining to the requestor/employee debtor and appeals, initial request or appeal, personnel records, reports of investigation, recommendations and waiver decision letters.
We obtain information in this system from employees and former employees, personnel, program and component offices, and other Federal agencies as necessary, including our payroll provider.
We will disclose records pursuant to the following routine uses, however, we will not disclose any information defined as “return or return information” under 26 U.S.C. 6103 of the Internal Revenue Service Code, unless authorized by statute, the Internal Revenue Service (IRS), or IRS regulations.
1. To a congressional office in response to an inquiry from that office made on behalf of, and at the request of, the subject of the record or a third party acting on the subject's behalf.
2. To the Office of the President in response to an inquiry from that office made on behalf of, and at the request of, the subject of the record or a third party acting on the subject's behalf.
3. To Federal, State and local government agencies, private individuals, private attorneys, or other representatives or individuals working on behalf of the employee or former employee in seeking waiver of the overpayment, and other persons or entities with relevant information for the purpose of investigating, settling, or adjudicating claims.
4. To student volunteers, individuals working under a personal services contract, and other workers who technically do not have the status of Federal employees, when they are performing work for SSA, as authorized by law, and they need access to personally identifiable information (PII) in SSA records in order to perform their assigned agency duties.
5. To the National Archives and Records Administration (NARA) under 44 U.S.C. 2904 and 2906.
6. To appropriate agencies, entities, and persons when:
(a) SSA suspects or has confirmed that there has been a breach of the system of records;
(b) SSA has determined that as a result of the suspected or confirmed breach, there is a risk of harm to individuals, SSA (including its information systems, programs, and operations), the Federal Government, or national security; and
(c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with SSA's efforts to respond to the suspected or confirmed breach or to prevent, minimize, or remedy such harm.
7. To the Department of Justice (DOJ), a court or other tribunal, or another party before such court or tribunal, when:
(a) SSA, or any component thereof; or
(b) any SSA employee in his/her official capacity; or
(c) any SSA employee in his/her individual capacity where DOJ (or SSA when it is authorized to do so) has agreed to represent the employee; or
(d) the United States, or any agency thereof, when SSA determines the litigation is likely to affect the operations of SSA or any of its components,
is a party to the litigation or has an interest in such litigation, and SSA determines that the use of such records by DOJ, a court or other tribunal, or another party before the court or tribunal is relevant and necessary to the litigation, provided, however, that in each case, the agency determines that disclosure of the records to DOJ, court or other tribunal, or another party is a use of the information contained in the records that is compatible with the purpose for which the records were collected.
8. To contractors and other Federal agencies, as necessary, for the purpose of assisting SSA in the efficient administration of its programs. We will disclose information under this routine use only in situations in which SSA may enter into a contractual or similar agreement with a third party to assist in accomplishing an agency function relating to this system of records.
9. To Federal, State, and local law enforcement agencies and private security contractors, as appropriate, information necessary:
(a) to enable them to protect the safety of SSA employees and customers, the security of the SSA workplace, and the operation of SSA facilities, or
(b) to assist in investigations or prosecutions with respect to activities that affect such safety and security or activities that disrupt the operation of SSA facilities.
10. To third parties when an individual involved with the claim needs assistance to communicate because a hearing impairment or a language barrier exists (
11. To the Equal Employment Opportunity Commission when requested in connection with investigation into alleged or possible discriminatory practices in the Federal sector, examination of Federal affirmative employment programs, compliance by Federal agencies with the Uniform Guidelines on Employee Procedures, or other functions vested in the Commission.
12. To the Office of Personnel Management, Merit Systems Protection Board, or the Office of Special Counsel in connection with appeals, special studies of the civil service and other merit systems, review of rules and regulations, investigations of alleged or possible prohibited personnel practices, and other such functions promulgated in 5 U.S.C. Chapter 12, or as may be required by law.
13. To the Federal Labor Relations Authority, the Office of the Special Counsel, the Federal Mediation and Conciliation Service, the Federal Service Impasses Panel, or an arbitrator requesting information in connection with the investigations of allegations of unfair practices, matters before an arbitrator or the Federal Service Impasses Panel.
14. To another Federal agency or Federal entity, when SSA determines that information from this system of records is reasonably necessary to assist the recipient agency or entity in:
(a) responding to a suspected or confirmed breach; or
(b) preventing, minimizing, or remedying the risk of harm to individuals, the recipient agency or entity (including its information systems, programs, and operations), the Federal Government, or national security, resulting from a suspected or confirmed breach.
We maintain records in this system in paper and electronic form.
We retrieve records by the name of the employee, former employee, or individual requesting the waiver of overpayment.
We retain the records for a period of six years in accordance with the approved National Archives and Records Schedule N1-47-10-4. The Office of the General Counsel reserves the right to retain for an indefinite period certain records that, in the judgment of that office are of precedential value.
We retain electronic and paper files containing personal identifiers in secure storage areas accessible only by our authorized employees and contractors who have a need for the information when performing their official duties. Security measures include, but are not limited to, the use of codes and profiles, personal identification number and password, and personal identification verification cards. We restrict access to specific correspondence within the system based on assigned roles and authorized users. We use audit mechanisms to record sensitive transactions as an additional measure to protect information from unauthorized disclosure or modification. We keep paper records in locked cabinets within secure areas, with access limited to only those employees who have an official need for access in order to perform their duties.
We annually provide our employees and contractors with appropriate security awareness training that includes reminders about the need to protect PII and the criminal penalties that apply to unauthorized access to, or disclosure of, PII (5 U.S.C. 552a(i)(1)). Furthermore, employees and contractors with access to databases maintaining PII must sign a sanctions document annually, acknowledging their accountability for inappropriately accessing or disclosing such information.
Individuals may submit requests for information about whether this system contains a record about them by submitting a written request to the system manager at the above address, which includes their name, SSN, or other information that may be in this system of records that will identify them. Individuals requesting notification of, or access to, a record by mail must include: (1) A notarized statement to us to verify their identity; or (2) must certify in the request that they are the individual they claim to be and that they understand that the knowing and willful request for, or acquisition of, a record pertaining to another individual under false pretenses is a criminal offense.
Individuals requesting notification of or access to, records in person must
These procedures are in accordance with our regulations at 20 CFR 401.40 and 401.45.
Same as record access procedures. Individuals should also reasonably identify the record, specify the information they are contesting, and state the corrective action sought and the reasons for the correction with supporting justification showing how the record is incomplete, untimely, inaccurate, or irrelevant. These procedures are in accordance with our regulations at 20 CFR 401.65(a).
Same as record access procedures. These procedures are in accordance with our regulations at 20 CFR 401.40 and 401.45.
None.
None.
Deputy Commissioner for Human Resources, Social Security Administration (SSA).
Notice of a new system of records.
In accordance with the Privacy Act, we are issuing public notice of our intent to establish a new system of records entitled, Security and Suitability Files (60-0377). This notice publishes details of the new system as set forth under the caption,
The system of records notice (SORN) is applicable upon its publication in today's
The public, Office of Management and Budget (OMB), and Congress may comment on this publication by writing to the Executive Director, Office of Privacy and Disclosure, Office of the General Counsel, SSA, Room G-401 West High Rise, 6401 Security Boulevard, Baltimore, Maryland 21235-6401, or through the Federal e-Rulemaking Portal at
Jasson Seiden, Government Information Specialist, Privacy Implementation Division, Office of Privacy and Disclosure, Office of the General Counsel, SSA, Room G-401 West High Rise, 6401 Security Boulevard, Baltimore, Maryland 21235-6401, telephone: (410) 597-4307, email:
Persons appointed to, and under consideration for, Federal service or contract employment are required, with limited exceptions, to submit to a suitability background investigation. In addition, other individuals granted access to agency facilities and records may be required to complete such an investigation. The Deputy Commissioner for Human Resources, Office of Personnel, Center for Suitability and Personnel Security (CSPS) oversees and is responsible for adjudicating these investigations. Suitability and security related information that we collect during the investigations process and send to the Office of Personnel Management (OPM) is covered by OPM/Central-9, Personnel Investigations Records. The new Security and Suitability Files system of records covers suitability and security related information that we generate during the investigation process but that we do not send to OPM. We will use the information we collect to conduct background investigations for the purpose of establishing that individuals employed by us, working under contract for us, or otherwise granted access to our facilities and records are suitable for such employment or access.
In accordance with 5 U.S.C. 552a(r), we have provided a report to OMB and Congress on this new system of records.
This document was received for publication by the Office of the Federal Register on November 8, 2018.
Unclassified.
Social Security Administration, Deputy Commissioner for Human Resources, Office of Personnel, Center for Suitability and Personnel Security (CSPS), 6401 Security Boulevard, Baltimore, MD 21235; or the initiating regional office (See Appendix C for address information).
Office of Personnel Management, National Background Investigations Bureau (NBIB), 1137 Branchton Road, PO Box 618, Boyers, PA 16018.
Defense Information Systems Agency (DISA), DISA Defense Enterprise Computing Center (DECC), 3990 E Broad Street, Columbus, OH 43213-1152.
Social Security Administration, Deputy Commissioner for Human Resources, Office of Personnel, Center for Suitability and Personnel Security (CSPS), 6401 Security Boulevard, Baltimore, MD 21235; or the initiating regional office (See Appendix C for address information).
Section 205(a) of the Social Security Act, as amended, HSPD-12 (Policy for a Common Identification Standard for Federal Employees and Contractors), Executive Orders 13764 (Amending the Civil Service Rules, Executive Order 13488, and Executive Order 13467 To Modernize the Executive Branch-Wide Governance Structure and Processes for Security Clearances, Suitability and Fitness for Employment, and Credentialing, and Related Matters) and 12968 (Access to Classified Information), Sections 3301 and 3302 of Title 5, U.S.C., and Parts 5, 731, 732, and 736 of Title 5 of the Code of Federal Regulations; and Fair Credit Reporting Act.
We will use the information in the Security and Suitability Files to determine the suitability of individuals for appointment or retention as an SSA employee, for access to SSA facilities and information systems, to hold sensitive positions, and to perform work or services for or on behalf of SSA as a contractor or volunteer. This will ensure that all of our prospective, current, and former employees, students, contractors, grantees, appointees, cooperative agreement awardees, volunteers, and others granted access to our facilities and records are investigated appropriately for security and suitability, and that the results of the investigations when necessary, are adjudicated based on federal law and regulations and are recorded in the official records.
Individuals seeking, or who have sought, to fill an available vacancy with SSA, or to otherwise be granted access to SSA facilities and records. This category of individuals include, but are not limited to, prospective, current, and former employees, students, contractors, grantees, appointees, cooperative agreement awardees, volunteers, and others who perform services for SSA.
This system maintains information collected as part of our security and suitability investigative process. This information may include the individual's name, address, date of birth (DOB), Social Security number (SSN), phone number, driver's license information, fingerprints, residential and employment addresses, employment history (
We obtain information in this system primarily from the individuals to whom the record pertains. Information may also be obtained from, but not limited to references, credit reporting agencies, other federal agencies, and educational institutions.
We will disclose records pursuant to the following routine uses; however, we will not disclose any information defined as “return or return information” under 26 U.S.C. 6103 of the Internal Revenue Service Code, unless authorized by statute, the Internal Revenue Service (IRS), or IRS regulations.
1. To the Office of the President in response to an inquiry from that office made on behalf of, and at the request of, the subject of the record or third party acting on the subject's behalf.
2. To a congressional office in response to an inquiry from that office made on behalf of, and at the request of, the subject of the record or a third party acting on the subject's behalf.
3. To the Department of Justice (DOJ), a court or other tribunal, or another party before such court or tribunal, when:
(a) SSA, or any component thereof; or
(b) any SSA employee in his/her official capacity; or:
(c) any SSA employee in his/her individual capacity where DOJ (or SSA where it is authorized to do so) has agreed to represent the employee; or
(d) the United States or any agency thereof where SSA determines the litigation is likely to affect SSA or any of its components,
is a party to the litigation or has an interest in such litigation, and SSA determines that the use of such records by DOJ, a court or other tribunal, or another party before the tribunal is relevant and necessary to the litigation, provided, however, that in each case, the agency determines that disclosure of the records to DOJ, a court or other tribunal, or another party is a use of the information contained in the records that is compatible with the purpose for which the records were collected.
4. To contractors and other Federal agencies, as necessary, for assisting SSA in the efficient administration of its programs. We disclose information under this routine use only in situations in which SSA may enter into a contractual or similar agreement with a third party to assist the accomplishing an agency function relating to this system of records.
5. To student volunteers, individuals working under a personal services contract, and other workers who technically do not have the status of Federal employees, when they are performing work for SSA, as authorized by law, and they need access to personally identifiable information (PII) in SSA records in order to perform their assigned agency functions.
6. To the Equal Employment Opportunity Commission (EEOC or Commission) when requested in connection with investigations into alleged or possible discriminatory practices in the Federal sector, examination of Federal affirmative employment programs, compliance by Federal agencies with the Uniform Guidelines on Employee Selection Procedures, or other functions vested in the Commission.
7. To the Federal Labor Relations Authority, its General Counsel, the Federal Mediation and Conciliation Service, the Federal Service Impasses Panel, or an arbitrator when information is requested in connection with investigations of allegations of unfair practices, matters before an arbitrator or the Federal Service Impasses Panel.
8. To the Office of Personnel Management (OPM), the Merit Systems Protection Board, or the Office of Special Counsel in connection with appeals, special studies of the civil service and other merit systems, review of rules and regulations, investigations of alleged or possible prohibited practices, and other such functions promulgated in 5 U.S.C. Chapter 12, or as may be required by law.
9. To Federal, State, and local law enforcement agencies and private security contractors, as appropriate, information necessary:
(a) To enable them to protect the safety of SSA employees and customers, the security of the SSA workplace, and the operation of SSA facilities, or
(b) to assist in investigations or prosecutions with respect to activities that affect such safety and security or activities that disrupt the operation of SSA facilities.
10. To the National Archives and Records Administration (NARA) under 44 U.S.C. 2904 and 2906.
11. To a Federal agency in response to its request, or at SSA's initiative, in connection with decisions to hire or retain an employee, issue a security clearance, conduct a security or suitability investigation, classify a job, award a contract, or regarding the requesting agency's decision to issue a license, grant, or other benefit, to the extent that the information is relevant and necessary to the requesting agency's decision.
12. To officials of labor organizations recognized under 5 U.S.C. Chapter 71 when relevant and necessary to their
13. To appropriate agencies, entities, and persons when:
(a) SSA suspects or has confirmed that there has been a breach of the system of records;
(b) SSA has determined that as the result of the suspected or confirmed breach there is a risk of harm to individuals, SSA (including its information systems, programs, and operations), the Federal Government, or national security; and
(c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with SSA's efforts to respond to the suspected or confirmed breach or to prevent, minimize, or remedy such harm.
14. To any source from which information is requested in the course of an investigation, to the extent necessary to identify the individual, inform the source of the nature and purpose of the investigation, and to identify the type of information requested.
15. To another Federal agency or Federal entity, when SSA determines that information from this system of records is reasonably necessary to assist the recipient agency or entity in:
(a) Responding to a suspected or confirmed breach; or
(b) preventing, minimizing, or remedying the risk of harm to individuals, the recipient agency or entity (including its information systems, programs, and operations), the Federal Government, or national security, resulting from a suspected or confirmed breach.
16. To the Department of Defense or other Federal agencies in connection with providing approved shared services to subscribing agencies for hiring or retaining an employee; classifying a position; conducting a security, suitability, fitness, or credentialing background investigation (including continuous evaluation/continuous vetting); issuing a security clearance or sensitive position eligibility; making a suitability, fitness, or credentialing decision; or recording the results of any agency decision with respect to these functions.
We will maintain records in this system in paper and electronic form.
None.
We will retrieve records in this system by name, SSN, and DOB.
These records are temporary. We retain and destroy this information in accordance with the NARA approved General Records Schedules (GRS) 2.0, Human Resources, and GRS 5.6, Security Records. We retain investigative records on employees or applicants for employment, whether or not a security clearance is granted, and other persons, such as those performing work under contract or as volunteers in accordance with the approved records schedules. We retain investigative reports in accordance with OPM Central-9 (81 FR 70191) or successor Records Disposition Authority. Our shared service provider for tracking post-investigation data, the Department of Defense (DoD), retains post-investigative files and the computerized data bases in accordance with the Defense Manpower Data Center (DMDC) retention policies as published in DMDC 24 DoD (81 FR 39032) or successor Records Disposition Authority.
We retain electronic and paper files with personal identifiers in secure storage areas accessible only by our authorized employees and contractors who have a need for the information when performing their official duties. Security measures include, but are not limited to, the use of codes and profiles, personal identification number and password, and personal identification verification cards. We keep paper records in locked cabinets within secure areas, with access limited to only those employees who have an official need for access in order to perform their duties.
We annually provide our employees and contractors with appropriate security awareness training that includes reminders about the need to protect personally identifiable information (PII) and the criminal penalties that apply to unauthorized access to, or disclosure of, PII (5 U.S.C. 552a(i)(1)). Furthermore, employees and contractors with access to databases maintaining PII must sign a sanctions document annually, acknowledging their accountability for inappropriately accessing or disclosing such information.
The system is protected against compromise of PII and cyberattack by the full suite of defenses and sensors of the DoD cybersecurity perimeter. Data is encrypted where it is stored, and network traffic is encrypted based on the type of user traffic and risk to PII data. User access to data is protected using Identity and Access Management with multifactor authentication that will only allow an authenticated user to access and manipulate the specific records based on user role and permissions. The system audits access to information. Physical entry is restricted by the use of locks, guards, and administrative procedures. All individuals granted access to the system must complete Information Assurance and Privacy Act training before initially accessing the system and annually thereafter, and these users must have also been through the information technology and/or security clearance eligibility process.
This system of records has been exempted from the Privacy Act's access, contesting, and notification provisions as stated below. However, individuals may submit requests for information about whether this system contains a record about them by submitting a written request to the system manager at the above address, which includes their name, SSN, or other information that may be in this system of records that will identify them. Individuals requesting notification of, or access to, a record by mail must include (1) a notarized statement to us to verify their identity or (2) must certify in the request that they are the individual they claim to be and that they understand that the knowing and willful request for, or acquisition of, a record pertaining to another individual under false pretenses is a criminal offense.
Individuals requesting notification of, or access to, records in person must provide their name, SSN, or other information that may be in this system of records that will identify them, as well as provide an identity document, preferably with a photograph, such as a driver's license. Individuals lacking identification documents sufficient to establish their identity must certify in writing that they are the individual they claim to be and that they understand that the knowing and willful request for, or acquisition of, a record pertaining to another individual under false pretenses is a criminal offense.
These procedures are in accordance with our regulations at 20 CFR 401.40 and 401.45.
Same as record access procedures. Individuals should also reasonably
Same as record access procedures. These procedures are in accordance with our regulations at 20 CFR 401.40 and 401.45.
This system of records has been exempted from certain provisions of the Privacy Act pursuant to 5 U.S.C. 552a(k)(5). Rules have been promulgated in accordance with the requirements of 5 U.S.C. 553(b), (c), and (e) and have been published in today's
None.
Notice is hereby given of the following determinations: I hereby determine that certain objects to be included in the exhibition “Vija Celmins: To Fix the Image in Memory,” imported from abroad for temporary exhibition within the United States, are of cultural significance. The objects are imported pursuant to loan agreements with the foreign owners or custodians. I also determine that the exhibition or display of the exhibit objects at the San Francisco Museum of Modern Art, San Francisco, California, from on or about December 15, 2018, until on or about March 31, 2019; and at possible additional exhibitions or venues yet to be determined, is in the national interest. I have ordered that Public Notice of these determinations be published in the
Julie Simpson, Attorney-Adviser, Office of the Legal Adviser, U.S. Department of State (telephone: 202-632-6471; email:
The foregoing determinations were made pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), E.O. 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681,
Updated publication of list of entities and subentities.
The Department of State is publishing an update to its List of Restricted Entities and Subentities Associated with Cuba (Cuba Restricted List) with which direct financial transactions are generally prohibited under the Cuban Assets Control Regulations (CACR). This Cuba Restricted List is also considered during review of license applications submitted to the Department of Commerce's Bureau of Industry and Security (BIS) pursuant to the Export Administration Regulations (EAR).
The updates to the Cuba Restricted List are effective on November 15, 2018.
Benjamin Barron, Office of Economic Sanctions Policy and Implementation, tel.: 202-647-7489; Office of the Coordinator for Cuban Affairs, tel.: 202-453-8456, Department of State, Washington, DC 20520.
On June 16, 2017, the President signed the National Security Presidential Memorandum on Strengthening the Policy of the United States Toward Cuba (NSPM). As directed by the NSPM, on November 9, 2017, the Department of the Treasury's Office of Foreign Assets Control (OFAC) published a final rule in the
The publication of the updated Cuba Restricted List further implements the directive in paragraph 3(a)(i) of the NSPM for the Secretary of State to identify the entities or subentities, as appropriate, that are under the control of, or act for or on behalf of, the Cuban military, intelligence, or security services or personnel, and publish a list of those identified entities and subentities with which direct financial transactions would disproportionately benefit such services or personnel at the expense of the Cuban people or private enterprise in Cuba.
This document and additional information concerning the Cuba Restricted List are available from the Department of State's website (
Below is the U.S. Department of State's list of entities and subentities under the control of, or acting for or on behalf of, the Cuban military, intelligence, or security services or personnel with which direct financial transactions would disproportionately benefit such services or personnel at the expense of the Cuban people or private
The U.S. Advisory Commission on Public Diplomacy will hold a public meeting from 10:00 a.m. until 12:00 p.m., Tuesday, December 4, 2018, at the U.S. Capital Visitor Center in Room SVC 201-00 (First St. NE, Washington, DC 20515). The public meeting will focus on the release of the Commission's 2018 Comprehensive Annual Report.
This meeting is open to the public, including the media and members and staff of governmental and non-governmental organizations. Any requests for reasonable accommodation should be sent by email to Michelle Bowen at
The U.S. Advisory Commission on Public Diplomacy appraises U.S. government activities intended to understand, inform, and influence foreign publics. The Advisory Commission may conduct studies, inquiries, and meetings, as it deems necessary. It may assemble and disseminate information and issue reports and other publications, subject to the approval of the Chairperson, in
For more information on the U.S. Advisory Commission on Public Diplomacy, please visit
Office of the United States Trade Representative.
Request for comments and notice of public hearing.
On October 16, 2018, the United States Trade Representative notified Congress of the Administration's intention to enter into negotiations on a trade agreement with the European Union (EU). The Office of the United States Trade Representative (USTR) is seeking public comments on a proposed U.S.-EU trade agreement, including U.S. interests and priorities, in order to develop U.S. negotiating positions. You can provide comments in writing and orally at a public hearing. The Administration's aim in negotiations with the EU is to address both tariff and non-tariff barriers and to achieve fairer, more balanced trade.
You should submit notifications of intent to testify and written comments through the Federal eRulemaking Portal:
For procedural questions concerning written comments, please contact Yvonne Jamison at (202) 395-3475. Direct all other questions to David Weiner, Deputy Assistant U.S. Trade Representative for Europe, at (202) 395-9679.
The decision to launch negotiations for a U.S.-EU trade agreement is an important step toward achieving fairer, more balanced trade with the EU and follows the July 25, 2018 meeting between President Trump and European Commission President Jean-Claude Juncker. In the joint statement issued following their July 25th meeting, President Trump and President Juncker affirmed the intention of the United States and the EU to address both tariff and non-tariff barriers in their trading relationship.
On October 16, 2018, following consultations with relevant Congressional committees, the United States Trade Representative informed Congress that the President intends to commence negotiations with the EU for a U.S.-EU Trade Agreement.
The TPSC invites interested parties to submit comments and/or oral testimony to assist USTR as it develops negotiating objectives and positions for the agreement, including with regard to objectives identified in section 102 of the Bipartisan Congressional Trade Priorities and Accountability Act of 2015 (19 U.S.C. 4201). In particular, the TPSC invites interested parties to comment on issues including, but not limited to, the following:
a. General and product-specific negotiating objectives for the proposed agreement.
b. Relevant barriers to trade in goods and services between the U.S. and the EU that should be addressed in the negotiations.
c. Economic costs and benefits to U.S. producers and consumers of removal or reduction of tariffs and removal or reduction of non-tariff barriers on articles traded with the EU.
d. Treatment of specific goods (described by HTSUS numbers) under the proposed agreement, including comments on:
i. Product-specific import or export interests or barriers.
ii. Experience with particular measures that should be addressed in the negotiations.
iii. Ways to address export priorities and import sensitivities in the context of the proposed agreement.
e. Customs and trade facilitation issues that should be addressed in the negotiations.
f. Sanitary and phytosanitary measures and technical barriers to trade that should be addressed in the negotiations.
g. Other measures or practices that undermine fair market opportunities for U.S. businesses, workers, farmers, and ranchers that should be addressed in the negotiations.
USTR must receive written comments no later than Monday, December 10, 2018.
USTR requests that small businesses, generally defined by the Small Business Administration as firms with fewer than 500 employees, or organizations representing small business members, which submit comments to self-identify as such, so that we may be aware of issues of particular interest to small businesses.
The TPSC will hold a hearing on December 14, 2018, in the Auditorium of the Herbert C. Hoover Building, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230. If necessary, the hearing will continue on the next business day. Persons wishing to testify at the hearing must provide written notification of their intention by December 10, 2018. The notification of intent to testify must be made in the `type comment' field under docket number USTR-2018-0035 on the
In order to ensure the timely receipt and consideration of comments, USTR strongly encourages commenters to make on-line submissions, using the
To submit comments via
The
For any comments submitted electronically containing business confidential information, the file name of the business confidential version should begin with the characters `BC.' Any page containing business confidential information must be clearly marked BUSINESS CONFIDENTIAL on the top of that page. Filers of submissions containing business confidential information also must submit a public version of their comments. The file name of the public version should begin with the character `P.' The `BC' and `P' should be followed by the name of the person or entity submitting the comments or reply comments. Filers submitting comments containing no business confidential information should name their file using the name of the person or entity submitting the comments.
Please do not attach separate cover letters to electronic submissions; rather, include any information that might appear in a cover letter in the comments themselves. Similarly, to the extent possible, please include any exhibits, annexes, or other attachments in the same file as the submission itself, not as separate files.
As noted, USTR strongly urges submitters to file comments through
USTR will place comments in the docket for public inspection, except business confidential information. General information concerning USTR is available at
Office of the United States Trade Representative.
Notice.
The Office of the United States Trade Representative (USTR) is announcing the results of the 2016/2017 Annual Generalized System of Preferences (GSP) Review with respect to: Products considered for addition to the list of eligible products for GSP; products considered for removal from the list of eligible products for certain beneficiary countries; decisions related to competitive need limitations (CNLs), including petitions for waivers of CNLs; and requests to reinstate/redesignate products previously excluded from GSP eligibility for certain countries.
Lauren Gamache, Director for GSP at (202) 395-2974 or
The GSP program provides for the duty-free treatment of designated articles when imported from beneficiary developing countries (BDCs). The GSP program is authorized by title V of the Trade Act of 1974 (19 U.S.C. 2461-2467), as amended, and is implemented in accordance with Executive Order 11888 of November 24, 1975, as modified by subsequent Executive Orders and Presidential Proclamations.
Each year, USTR leads the interagency Trade Policy Staff Committee (TPSC) in reviewing the list of products eligible for GSP benefits. After completion of a process that includes public hearings, USTR provides recommendations to the President on appropriate actions based on statutory criteria, including exclusions from duty-free treatment of products from certain countries when they have reached the statutory CNL thresholds.
The GSP statute (19 U.S.C. 2463(c)(2)) establishes CNLs as a basis for withdrawing duty-free treatment. The statute provides that when the President determines that a GSP beneficiary has exported to the United States during any calendar year a quantity of an eligible article that either is greater than a specified amount ($180 million for 2017), or exceeds 50 percent of the appraised value of the total U.S. imports of that article, the President “shall, not later than November 1 of the next calendar year, terminate the duty-free treatment for that article” from that beneficiary, unless a waiver is granted.
The statute provides that the President may waive either CNL if, before November 1 of the calendar year following the year in which imports exceeded CNLs, the President (1) receives advice from the U.S. International Trade Commission (USITC) on whether any industry in the United States is “likely to be adversely affected by such waiver”; (2) determines, based on certain statutory considerations,
As part of the 2017/2018 GSP Annual Review, the TPSC reviewed three types of actions related to the CNLs: (1) Whether to grant CNL waivers for products from certain countries, (2) whether to redesignate products from certain countries previously excluded from GSP eligibility based on CNLs; and (3) whether to grant
In the 2017/2018 Annual GSP Review, the TPSC reviewed (1) petitions to add nine products to the list of those eligible for duty-free treatment under GSP; (2) petitions to remove the GSP eligibility of two products; (3) petitions to waive CNLs for five products from beneficiary countries; (4) 92 products eligible for one-year
Presidential Proclamation 9813 of October 30, 2018, implements the President's decisions regarding the 2017/2018 Annual GSP Review, including CNL waivers and product redesignations. The modifications to the GSP program that were implemented by Presidential Proclamation 9813 became effective on November 1, 2018. This notice provides a summary of the results of the 2017/2018 Annual GSP Review. You can also view the results, comprising six lists, at
As described in List I, the President denied all petitions to add products to the list of GSP-eligible products for all BDCs. The products in List I, however, remain eligible for duty-free preferences for least-developed beneficiary countries only. For ease of reference, a brief description and the U.S. Harmonized Tariff Schedule (HTS) categories of the nine products included in List I follows:
A complete description of the nine products is included in List I. By statute (19 U.S.C. 2463(a)(1)(C)), these products may not be reconsidered for addition to GSP for the next three years.
As described in List II, the President granted the petition to remove tart cherry juice concentrate and other cherry juice (HTS 2009.89.6011 and HTS 2009.89.6019) from GSP eligibility for Turkey. To reflect this change, cherry juice imported into the United States now falls under a new HTS category, 2009.89.65. Cherry juice from Turkey now enters the United States at the Normal Trade Relations (NTR) duty rate in column 1 of the HTS. In addition, the President denied the petition to remove nonadhesive plates and sheets (HTS 3920.51.50) from GSP for Indonesia and Thailand. These products will continue to enter the United States duty-free.
As described in List III, the President granted a petition to redesignate ammonium perrhentate (HTS 2841.90.20) from Kazakhstan to GSP. This product now enters the United States duty-free. The remaining redesignation petitions were denied: Apple, quince and pear pastes and purees (HTS 2007.9948) from Argentina; sunflower seed oilcake (HTS 2306.30.00) from Argentina; certain odoriferous or flavoring compounds (HTS 2909.50.40) from Indonesia; fancy bovine leather (full grain, whole, unsplit) (HTS 4107.11.80) from Argentina; certain tropical plywood (HTS 4412.31.41) from Indonesia; granite monumental or building stone (HTS 6802.93.00) from India; and certain ferroniobium (HTS 7202.93.80) from Brazil. These products will continue to enter the United States at NTR duty rates and, by statute (19 U.S.C. 2463(a)(1)(C)), may not be reconsidered for addition to GSP for the next three years.
As described in List IV, three articles exceeded the CNLs in 2017 for which no petition was received and now enter the United States at the NTR duty rates. These products are ethers of acyc monohydric alcohols (HTS 2909.19.18) and refined copper (HTS 7403.19.00) from Brazil, and washing machines (HTS 8450.20.00) from Thailand.
As described in List V, the President granted three petitions for CNL waivers: (1) Edible birds' nests (HTS 0410.00.00) from Thailand; (2) lithium carbonates (HTS 2836.91.00) from Argentina; and (3) ferrosilicon chromium (HTS 7202.50.00) from Kazakhstan. These three products will continue to enter the United States duty-free. The following products did not receive a CNL waiver and are therefore subject to the NTR duty rates: Essential oils of lemon (HTS 3301.03.00) from Argentina, and monumental or building stone (HTS 6802.99.00) from Brazil.
As described in List VI, the President did not grant
Federal Aviation Administration (FAA), DOT.
Notice of intent to rule on request to release airport property at the St. Louis Lambert International Airport (STL), St. Louis, Missouri.
The FAA proposes to rule and invites public comment on the release of land at the St. Louis Lambert International Airport, St. Louis, Missouri, under the provisions of 49 U.S.C. 47107(h)(2).
Comments must be received on or before December 17, 2018.
Lynn D. Martin, Airports Compliance Specialist, Federal Aviation Administration, Airports Division, ACE-610C, 901 Locust, Room 364, Kansas City, MO 64106, (816) 329-2644,
The request to release property may be reviewed, by appointment, in person at this same location.
The FAA invites public comment on the request to release approximately 1.389 acres of airport property, at the St. Louis Lambert International Airport (STL) under the provisions of 49 U.S.C. 47107(h)(2). On June 13, 2018, the Director of Airports for the City of St. Louis, MO requested from the FAA that approximately 1.389 acres of property, be released for sale to Union Electric
The following is a brief overview of the request:
St. Louis Lambert International Airport (STL) is proposing the release of two parcels, one parcel on Monroe Avenue contains 0.826 acres and Parcel 2 on Jefferson Avenue containing 0.563 acres for a total containing 1.389 acres. The release of land is necessary to comply with Federal Aviation Administration Grant Assurances that do not allow federally acquired airport property to be used for non-aviation purposes. The sale of the subject property will result in the land at the St. Louis Lambert International Airport (STL) being changed from aeronautical to non-aeronautical use and release the lands from the conditions of the Airport Improvement Program Grant Agreement Grant Assurances. In accordance with 49 U.S.C. 47107(c)(2)(B)(i) and (iii), the airport will receive fair market value for the property, which will be subsequently reinvested in another eligible airport improvement project for aviation at the St. Louis Lambert International Airport.
In addition, any person may, upon appointment and request, inspect the application, notice and other documents determined by the FAA to be related to the application in person at the St. Louis Lambert International Airport.
Office of Foreign Assets Control, Treasury.
Notice.
The U.S. Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the names of one or more persons that have been placed on OFAC's Specially Designated Nationals and Blocked Persons List (the “SDN List”) based on OFAC's determination that one or more applicable legal criteria were satisfied. All property and interests in property subject to U.S. jurisdiction of these persons are blocked, and U.S. persons are generally prohibited from engaging in transactions with them.
See
The Specially Designated Nationals and Blocked Persons List and additional information concerning OFAC sanctions programs are available on OFAC's website (
On October 16, 2018, OFAC determined that the property and interests in property subject to U.S. jurisdiction of the following persons are blocked under the relevant sanctions authorities listed below.
1. TADBIRGARAN ATIYEH IRANIAN INVESTMENT COMPANY, No. 48, 14th Street, Ahmad Ghasir Avenue, Tehran, Iran; Additional Sanctions Information—Subject to Secondary Sanctions; National ID No. 10102867151 (Iran); Registration Number 246077 (Iran) [SDGT] [IFSR] (Linked To: MEHR-E EQTESAD-E IRANIAN INVESTMENT COMPANY).
Designated pursuant to section 1(c) of E.O. 13224 for being owned or controlled by MEHR EQTESAD IRANIAN INVESTMENT COMPANY, a person determined to be subject to E.O. 13224.
2. TAKTAR INVESTMENT COMPANY, Number 10, Seventh Fath Highway, 65 Metri Fath Highway, Tehran, Iran; Additional Sanctions Information—Subject to Secondary Sanctions; National ID No. 10103804463 (Iran); Registration Number 263015 (Iran) [SDGT] [IFSR] (Linked To: TECHNOTAR ENGINEERING COMPANY).
Designated pursuant to section 1(c) of E.O. 13224 for being owned or controlled by TECHNOTAR ENGINEERING COMPANY, a person determined to be subject to E.O. 13224.
3. CALCIMIN (a.k.a. KALSIMIN), No. 12, St. Bilal Habashi, Khorramshahr Ave., Zanjan 4516773541, Iran; Second Floor, No. 13, Street 8th, Ghaem Magham Farahari Ave., Tehran 1586868513, Iran; website
Designated pursuant to section 1(c) of E.O. 13224 for being owned or controlled by IRAN ZINC MINES DEVELOPMENT COMPANY, a person determined to be subject to E.O. 13224.
4. QESHM ZINC SMELTING AND REDUCTION COMPANY (a.k.a. QESHM ZINC SMELTING AND REDUCTION COMPLEX), 20 Km Dargahan-to-Loft Road, Qeshm Island, Hormozgan, Iran; website
Designated pursuant to section 1(c) of E.O. 13224 for being owned or controlled by CALCIMIN, a person determined to be subject to E.O. 13224.
5. BANDAR ABBAS ZINC PRODUCTION COMPANY, No. 15, Zarir Alley, Turkmenistan Street, Motahhari Avenue, Tehran 1565613115, Iran; website
Designated pursuant to section 1(c) of E.O. 13224 for being owned or controlled by CALCIMIN, a person determined to be subject to E.O. 13224.
6. ZANJAN ACID PRODUCTION COMPANY (a.k.a. ZANJAN ACID MAKERS; a.k.a. ZANJAN ACID MAKERS AND ALVAND ROUINKARAN; a.k.a. ZANJAN ACID SAZAN), The end of the Tenth Bahrevari Street, Zinc Industrial Town, 5 km off Bijar Road, Zanjan, Iran; website
Designated pursuant to section 1(c) of E.O. 13224 for being owned or controlled by CALCIMIN, a person determined to be subject to E.O. 13224.
7. NEGIN SAHEL ROYAL INVESTMENT COMPANY (a.k.a. NEGIN SAHEL ROYAL CO.), No. 48, 14th Street, Ahmad Ghasir Avenue, Argentina Square, Tehran, Iran; Additional Sanctions Information—Subject to Secondary Sanctions; National ID No. 10103589144 (Iran); Registration Number 322430 (Iran) [SDGT] [IFSR] (Linked To: MEHR-E EQTESAD-E IRANIAN INVESTMENT COMPANY).
Designated pursuant to section 1(c) of E.O. 13224 for being owned or controlled by MEHR EQTESAD IRANIAN INVESTMENT COMPANY, a person determined to be subject to E.O. 13224.
8. IRAN ZINC MINES DEVELOPMENT COMPANY, No. 13, 8th Street, Ghaem Maghame Farahani Ave., Tehran, Iran; No. 45, 4th Street, Amir Alame Ghazanfarian Avenue, Etemadiyeh, Zanjan, Iran; website
Designated pursuant to section 1(c) of E.O. 13224 for being owned or controlled by
9. TECHNOTAR ENGINEERING COMPANY, Number 10, Seventh Fath Street, 65 Metri Fath Highway, Tehran, Iran; website
Designated pursuant to section 1(c) of E.O. 13224 for being owned or controlled by MEHR EQTESAD IRANIAN INVESTMENT COMPANY, a person determined to be subject to E.O. 13224.
10. IRAN TRACTOR MANUFACTURING COMPANY (a.k.a. IRAN TRACTOR MANUFACTURING), Sephabod Gharani Avenue, Km 9/5 Karaj Special Road, Corner of Yazar Zarin Street, Opposite Shahab Khodro, Office of The Tractor Engineering, Tehran, Iran; website
Designated pursuant to section 1(c) of E.O. 13224 for being owned or controlled by MEHR EQTESAD IRANIAN INVESTMENT COMPANY, a person determined to be subject to E.O. 13224.
Designated pursuant to section 1(c) of E.O. 13224 for being owned or controlled by NEGIN SAHEL ROYAL COMPANY, a person determined to be subject to E.O. 13224.
11. PARSIAN CATALYST CHEMICAL COMPANY, Sixth Bahrevari Street, Zinc Special Town, 5 km of Bijar Road, Zanjan 453515357, Iran; website
Designated pursuant to section 1(c) of E.O. 13224 for being owned or controlled by CALCIMIN, a person determined to be subject to E.O. 13224.
12. ANDISHEH MEHVARAN INVESTMENT COMPANY, No. 13, 8th Street, Ghaem Magham Farahani Ave, Tehran, Iran; Additional Sanctions Information—Subject to Secondary Sanctions [SDGT] [IFSR] (Linked To: IRAN ZINC MINES DEVELOPMENT COMPANY).
Designated pursuant to section 1(c) of E.O. 13224 for being owned or controlled by IRAN ZINC MINES DEVELOPMENT COMPANY, a person determined to be subject to E.O. 13224.
Designated pursuant to section 1(d)(i) of E.O. 13224 for assisting in, sponsoring, or providing financial, material, techological support for, or financial or other services to or in support of, IRAN ZINC MINES DEVELOPMENT COMPANY, a person determined to be subject to E.O. 13224.
13. BAHMAN GROUP, No. 37, Saba Boulevard, Africa Street, P.O. Box 14335-835, Tehran 1917773844, Iran; website
Designated pursuant to section 1(d)(i) of E.O. 13224 for assisting in, sponsoring, or providing financial, material, techological support for, or financial or other services to or in support of, ANDISHEH MEHVARAN INVESTMENT COMPANY, a person determined to be subject to E.O. 13224.
14. ESFAHAN'S MOBARAKEH STEEL COMPANY (a.k.a. MOBARAKEH STEEL COMPANY), P.O. Box 161-84815, Mobarakeh, Esfahan 11131-84881, Iran; Mobarakeh Steel Company, Sa'adat Abad St., Azadi SQ., Esfahan, Esfahan, Iran; Mobarakeh Steel Company, No. 2, Gol Azin Alley, Kouhestan St., Ketah SQ., Sa'adat Abad, Tehran, Iran; website
Designated pursuant to section 1(d)(i) of E.O. 13224 for assisting in, sponsoring, or providing financial, material, techological support for, or financial or other services to or in support of, MEHR EQTESAD IRANIAN INVESTMENT COMPANY, a person determined to be subject to E.O. 13224.
15. MEHR-E EQTESAD-E IRANIAN INVESTMENT COMPANY (a.k.a. MEHR EGHTESAD IRANIAN INVESTMENT COMPANY; a.k.a. MEHR IRANIAN ECONOMY COMPANY; a.k.a. MEHR IRANIAN ECONOMY INVESTMENTS; a.k.a. MEHR EQTESAD IRANIAN INVESTMENT COMPANY; f.k.a. TEJARAT TOSE'E EQTESADI IRANIAN), No. 18, Iranian Building, 14th Alley, Ahmad Qassir Street, Argentina Square, Tehran, Iran; No. 48, 14th Alley, Ahmad Qassir Street, Argentina Square, Tehran, Iran; website
Designated pursuant to section 1(c) of E.O. 13224 for being owned or controlled by MEHR EQTESAD BANK, a person determined to be subject to E.O. 13224.
Designated pursuant to section 1(d)(i) of E.O. 13224 for assisting in, sponsoring, or providing financial, material, techological support for, or financial or other services to or in support of, MEHR EQTESAD BANK, a person determined to be subject to E.O. 13224.
16. BASIJ RESISTANCE FORCE (a.k.a. BASEEJ; a.k.a. BASIJ; a.k.a. BASIJ-E MELLI; a.k.a. MOBILIZATION OF THE OPPRESSED ORGANIZATION; f.k.a. SAZMAN BASIJ MELLI; a.k.a. SAZMAN-E MOGHAVEMAT-E BASIJ; f.k.a. VAHED-E BASIJ-E MOSTAZAFEEN; f.k.a. “NATIONAL MOBILIZATION ORGANIZATION”; a.k.a. “NATIONAL RESISTANCE MOBILIZATION”; a.k.a. “RESISTANCE MOBILIZATION FORCE”), Iran; Additional Sanctions Information—Subject to Secondary Sanctions [SDGT] [IRGC] [IFSR] [IRAN-HR] (Linked To: ISLAMIC REVOLUTIONARY GUARD CORPS (IRGC)-QODS FORCE; Linked To: ISLAMIC REVOLUTIONARY GUARD CORPS).
Designated pursuant to section 1(c) of E.O. 13224 for being owned or controlled by Iran's ISLAMIC REVOLUTIONARY GUARD CORPS, a person determined to be subject to E.O. 13224.
Designated pursuant to section 1(d)(i) of E.O. 13224 for assisting in, sponsoring, or providing financial, material, techological support for, or financial or other services to or in support of, Iran's ISLAMIC REVOLUTIONARY GUARD CORPS-QODS FORCE, a person determined to be subject to E.O. 13224.
17. BONYAD TAAVON BASIJ (a.k.a. BASIJ COOPERATIVE FOUNDATION), Tehran, Iran; Additional Sanctions Information—Subject to Secondary Sanctions [SDGT] [IFSR] (Linked To: BASIJ RESISTANCE FORCE).
Designated pursuant to section 1(c) of E.O. 13224 for being owned or controlled by Iran's BASIJ RESISTANCE FORCE, a person determined to be subject to E.O. 13224.
Designated pursuant to section 1(d)(i) of E.O. 13224 for assisting in, sponsoring, or providing financial, material, techological support for, or financial or other services to or in support of, Iran's BASIJ RESISTANCE FORCE, a person determined to be subject to E.O. 13224.
18. BANK MELLAT, Head Office Bldg, 276 Taleghani Ave, Tehran, Iran; SWIFT/BIC BKMTIRTH; website
Designated pursuant to section 1(d)(i) of E.O. 13224 for assisting in, sponsoring, or providing financial, material, techological support for, or financial or other services to or in support of, MEHR EQTESAD BANK, a person determined to be subject to E.O. 13224.
19. MEHR EQTESAD BANK (a.k.a. MEHR INTEREST-FREE BANK), No. 182, Shahid Tohidi St, 4th Golsetan, Pasdaran Ave, Tehran 1666943, Iran; website
Designated pursuant to section 1(c) of E.O. 13224 for being owned or controlled by BONYAD TAAVON BASIJ, a person determined to be subject to E.O. 13224.
Designated pursuant to section 1(d)(i) of E.O. 13224 for assisting in, sponsoring, or providing financial, material, techological support for, or financial or other services to or in support of, BONYAD TAAVON BASIJ, a person determined to be subject to E.O. 13224.
Designated pursuant to section 1(d)(i) of E.O. 13224 for assisting in, sponsoring, or providing financial, material, techological
20. MEHR EQTESAD FINANCIAL GROUP, Tehran, Iran; Additional Sanctions Information—Subject to Secondary Sanctions; National ID No. 10101471388 (Iran) [SDGT] [IFSR] (Linked To: MEHR-E EQTESAD-E IRANIAN INVESTMENT COMPANY).
Designated pursuant to section 1(c) of E.O. 13224 for being owned or controlled by MEHR EQTESAD IRANIAN INVESTMENT COMPANY, a person determined to be subject to E.O. 13224.
21. SINA BANK (a.k.a. SINA FINANCE AND CREDIT INSTITUTE), Between Miremad Street and Mofateh Street, Motahari Avenue, Tehran 15888-6457, Iran; SWIFT/BIC SINAIRTH; website
Designated pursuant to section 1(d)(i) of E.O. 13224 for assisting in, sponsoring, or providing financial, material, techological support for, or financial or other services to or in support of, ANDISHEH MEHVARAN INVESTMENT COMPANY, a person determined to be subject to E.O. 13224.
22. PARSIAN BANK, No. 4, Zarafshan Street, Shahid Farahzadi Boulevard, Sharak Ghods, Tehran, Iran; SWIFT/BIC BKPAIRTH; website
Designated pursuant to section 1(d)(i) of E.O. 13224 for assisting in, sponsoring, or providing financial, material, techological support for, or financial or other services to or in support of, ANDISHEH MEHVARAN INVESTMENT COMPANY, a person determined to be subject to E.O. 13224.
In light of their designations, the following entities no longer are blocked solely pursuant to Executive Order 13599 of February 5, 2012 and Section 560.211 of the Iranian Transactions and Sanctions Regulations (ITSR), 31 CFR part 560, and, thus, they have been removed from the List of Persons Identified as Blocked Solely Pursuant to Executive Order 13599 (the E.O. 13599 List) and placed on the SDN List:
1. BANK MELLAT, Head Office Bldg, 276 Taleghani Ave, Tehran, Iran; SWIFT/BIC BKMTIRTH; website
2. SINA BANK (a.k.a. SINA FINANCE AND CREDIT INSTITUTE), Between Miremad Street and Mofateh Street, Motahari Avenue, Tehran 15888-6457, Iran; SWIFT/BIC SINAIRTH; website
3. PARSIAN BANK, No. 4, Zarafshan Street, Shahid Farahzadi Boulevard, Sharak Ghods, Tehran, Iran; SWIFT/BIC BKPAIRTH; website
Office of Foreign Assets Control, Treasury.
Notice.
The Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the names of one individual and seven entities that have been placed on OFAC's Specially Designated Nationals and Blocked Persons List based on OFAC's determination that one or more applicable legal criteria were satisfied. All property and interests in property subject to U.S. jurisdiction of this person and these entities are blocked, and U.S. persons are generally prohibited from engaging in transactions with them.
See
OFAC: Associate Director for Global Targeting, tel.: 202-622-2420; Assistant Director for Sanctions Compliance & Evaluation, tel.: 202-622-2490; Assistant Director for Licensing, tel.: 202-622-2480; Assistant Director for Regulatory Affairs, tel. 202-622-4855; or the Department of the Treasury's Office of the General Counsel: Office of the Chief Counsel (Foreign Assets Control), tel.: 202-622-2410.
The Specially Designated Nationals and Blocked Persons List and additional information concerning OFAC sanctions programs are available on OFAC's website (
On October 4, 2018, OFAC determined that the property and interests in property subject to U.S. jurisdiction of the following individual and entities are blocked under the relevant sanctions authority listed below.
1. AL-AMIN, Muhammad `Abdallah (a.k.a. AL AMEEN, Mohamed Abdullah; a.k.a. AL AMIN, Mohammad; a.k.a. AL AMIN, Muhammad Abdallah; a.k.a. AL AMIN, Muhammed; a.k.a. AL-AMIN, Mohamad; a.k.a. ALAMIN, Mohamed; a.k.a. AMINE, Mohamed Abdalla; a.k.a. EL AMINE, Muhammed), Yusif Mishkhas T: 3 Ibn Sina, Bayrut Marjayoun, Lebanon; Beirut, Lebanon; DOB 11 Jan 1975; POB El Mezraah, Beirut, Lebanon; nationality Lebanon; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations; Gender Male (individual) [SDGT] (Linked To: TABAJA, Adham Husayn).
Designated pursuant to section 1(d)(i) of Executive Order 13224 of September 23, 2001, “Blocking Property and Prohibiting Transactions With Persons Who Commit, Threaten to Commit, or Support Terrorism” (E.O. 13224) for assisting in, sponsoring, or providing financial, material, or technological support for, or financial or other services to or in support of TABAJA, Adham Husayn, an individual determined to be subject to E.O. 13224.
1. IMPULSE INTERNATIONAL S.A.L. OFFSHORE (a.k.a. STATURA S.A.L. OFFSHORE), Unesco Center, 4th Floor, Office No. 19, Verdun, Beirut, Lebanon; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations; Commercial Registry Number 1801124 (Lebanon) [SDGT] (Linked To: AL-AMIN, Muhammad `Abdallah).
Designated pursuant to section 1(c) of Executive Order 13224 of September 23, 2001, “Blocking Property and Prohibiting Transactions With Persons Who Commit, Threaten to Commit, or Support Terrorism” (E.O. 13224) for being owned or controlled by AL-AMIN, Muhammad `Abdallah, an individual determined to be subject to E.O. 13224.
2. IMPULSE S.A.R.L., Floor 4, Unesco Center, Verdun, Beirut, Lebanon; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations; Commercial Registry Number 1003871 (Lebanon) [SDGT] (Linked To: AL-AMIN, Muhammad `Abdallah).
Designated pursuant to section 1(c) of Executive Order 13224 of September 23, 2001, “Blocking Property and Prohibiting Transactions With Persons Who Commit, Threaten to Commit, or Support Terrorism” (E.O. 13224) for being owned or controlled by AL-AMIN, Muhammad `Abdallah, an individual determined to be subject to E.O. 13224.
3. LAMA FOODS INTERNATIONAL OFFSHORE S.A.L. (a.k.a. LAMA FOOD INTERNATIONAL OFF SHORE S.A.L.; a.k.a. LAMA FOODS INTERNATIONAL S.A.R.L.), Unesco Center, 4th Floor, Office No. 19, Verdun, Beirut, Lebanon; Additional
Designated pursuant to section 1(c) of Executive Order 13224 of September 23, 2001, “Blocking Property and Prohibiting Transactions With Persons Who Commit, Threaten to Commit, or Support Terrorism” (E.O. 13224) for being owned or controlled by AL-AMIN, Muhammad `Abdallah, an individual determined to be subject to E.O. 13224.
4. LAMA FOODS S.A.R.L., Airport Road, Dahieh Area, Cocodi sector, Beirut, Lebanon; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations; Commercial Registry Number 1005341 (Lebanon) [SDGT] (Linked To: AL-AMIN, Muhammad `Abdallah).
Designated pursuant to section 1(c) of Executive Order 13224 of September 23, 2001, “Blocking Property and Prohibiting Transactions With Persons Who Commit, Threaten to Commit, or Support Terrorism” (E.O. 13224) for being owned or controlled by AL-AMIN, Muhammad `Abdallah, an individual determined to be subject to E.O. 13224.
5. M. MARINE S.A.L. OFFSHORE, Unesco Center, 4th Floor, Office No. 19, Verdun, Beirut, Lebanon; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations; Commercial Registry Number 1804696 (Lebanon) [SDGT] (Linked To: AL-AMIN, Muhammad `Abdallah).
Designated pursuant to section 1(c) of Executive Order 13224 of September 23, 2001, “Blocking Property and Prohibiting Transactions With Persons Who Commit, Threaten to Commit, or Support Terrorism” (E.O. 13224) for being owned or controlled by AL-AMIN, Muhammad `Abdallah, an individual determined to be subject to E.O. 13224.
6. SIERRA GAS S.A.L. OFFSHORE (a.k.a. SIRRA GAS S.A.L. OFF SHORE), Unesco Center, 4th Floor, Office No. 19, Verdun, Beirut, Lebanon; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations; Commercial Registry Number 1804895 (Lebanon) [SDGT] (Linked To: AL-AMIN, Muhammad `Abdallah).
Designated pursuant to section 1(c) of Executive Order 13224 of September 23, 2001, “Blocking Property and Prohibiting Transactions With Persons Who Commit, Threaten to Commit, or Support Terrorism” (E.O. 13224) for being owned or controlled by AL-AMIN, Muhammad `Abdallah, an individual determined to be subject to E.O. 13224.
7. THAINGUI S.A.L. OFFSHORE (a.k.a. “SHANGHAI S.A.L. OFFSHORE COMPANY”), Unesco Center, 4th Floor, Beirut, Lebanon; Additional Sanctions Information—Subject to Secondary Sanctions Pursuant to the Hizballah Financial Sanctions Regulations; Commercial Registry Number 1804869 (Lebanon) [SDGT] (Linked To: AL-AMIN, Muhammad `Abdallah).
Designated pursuant to section 1(c) of Executive Order 13224 of September 23, 2001, “Blocking Property and Prohibiting Transactions With Persons Who Commit, Threaten to Commit, or Support Terrorism” (E.O. 13224) for being owned or controlled by AL-AMIN, Muhammad `Abdallah, an individual determined to be subject to E.O. 13224.
Office of Foreign Assets Control, Treasury.
Notice.
The Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the names of one or more persons that have been placed on OFAC's Specially Designated Nationals and Blocked Persons List based on OFAC's determination that one or more applicable legal criteria were satisfied. All property and interests in property subject to U.S. jurisdiction of these persons are blocked, and U.S. persons are generally prohibited from engaging in transactions with them.
See
OFAC: Associate Director for Global Targeting, tel.: 202-622-2420; Assistant Director for Sanctions Compliance & Evaluation, tel.: 202-622-2490; Assistant Director for Licensing, tel.: 202-622-2480; Assistant Director for Regulatory Affairs, tel.: 202-622-4855; or the Department of the Treasury's Office of the General Counsel: Office of the Chief Counsel (Foreign Assets Control), tel.: 202-622-2410.
The Specially Designated Nationals and Blocked Persons List and additional information concerning OFAC sanctions programs are available on OFAC's website (
On November 8, 2018, OFAC determined that the property and interests in property subject to U.S. jurisdiction of the following persons are blocked under the relevant sanctions authorities listed below.
1. BASOV, Aleksandr Vasilevich (a.k.a. BASOV, Alexander; a.k.a. BASOV, Oleksandr), Ukraine; DOB 16 Oct 1971; Gender Male (individual) [CAATSA—RUSSIA] (Linked To: MINISTRY OF STATE SECURITY).
Designated pursuant to section 11(a)(3) of Support for the Sovereignty, Integrity, Democracy, and Economic Stability of Ukraine Act, as amended by the section 228(a) of the Countering America's Adversaries Through Sanctions Act, Public Law 115-44, (SSIDES), 22 U.S.C. 8910(a)(3) for acting or purporting to act for or on behalf of, directly, or indirectly, the MINISTRY OF STATE SECURITY, a person whose property and interests in property are blocked pursuant to Section 11(a)(1) of SSIDES.
2. SUSHKO, Andriy Volodymyrovych (a.k.a. SUSHKO, Andrey; a.k.a. SUSHKO, Andrey Vladimirovich; a.k.a. SUSHKO, Andrii), Bldg. 78, Apt. 74, ulitsa Generala Petrova, city of Kerch, Crimea; DOB 23 Jan 1976; POB Village of Leninskoe, Leninskiy Region, Autonomous Region of Crimea; Gender Male (individual) [CAATSA—RUSSIA].
Designated pursuant to section 11(a)(1) of SSIDES, 22 U.S.C. 8910(a)(1), for being responsible for, complicit in, or responsible for ordering, controlling, or otherwise directing, the commission of serious human rights abuses in any territory forcibly occupied or otherwise controlled by the Government of the Russian Federation.
3. ZARITSKY, Vladimir Nikolaevich (a.k.a. ZARITSKY, Vladimir Nikolayevich), Russia; DOB 15 Jun 1948; POB Ostany Village, Korosten District, Zhitomir region, Ukraine; Gender Male (individual) [UKRAINE—E.O. 13685].
Designated pursuant to section 2(a)(i) of Executive Order 13685 of December 19, 2014, “Blocking Property of Certain Persons and Prohibiting Certain Transactions With Respect to the Crimea Region of Ukraine” (E.O. 13685) for operating in the Crimea region of Ukraine.
1. JOINT STOCK COMPANY SANATORIUM AY-PETRI (a.k.a. JOINT STOCK COMPANY AI-PETRI SANATORIUM; a.k.a. JSC SANATORIUM AY-PETRI), House 15, Alupkinskoye shosse, Urban Village Koreiz, City of Yalta, Crimea 298671, Ukraine; Tax ID No. 9103082749 (Russia); Registration Number 1169102093797 (Russia) [UKRAINE—E.O. 13685].
Designated pursuant to section 2(a)(i) of E.O. 13685 for operating in the Crimea region of Ukraine.
2. JOINT STOCK COMPANY SANATORIUM DYULBER (a.k.a. JOINT STOCK COMPANY DIULBER SANATORIUM; a.k.a. JSC SANATORIUM DYULBER), House 19, Alupkinskoye shosse, Koreiz, Yalta, Crimea 298671, Ukraine; Tax ID No. 9103084143 (Russia); Registration Number 1179102009525 (Russia) [UKRAINE—E.O. 13685].
Designated pursuant to section 2(a)(i) of E.O. 13685 for operating in the Crimea region of Ukraine.
3. JOINT STOCK COMPANY SANATORIUM MISKHOR (a.k.a. JSC SANATORIUM MISKHOR), House 9, Alupkinskoye shosse, Koreiz, Yalta, Crimea 298671, Ukraine; Tax ID No. 9103082756 (Russia); Registration Number 1169102093930 (Russia) [UKRAINE—E.O. 13685].
Designated pursuant to section 2(a)(i) of E.O. 13685 for operating in the Crimea region of Ukraine.
4. KRYMTETS, AO (a.k.a. AKTSIONERNOE OBSHCHESTVO KRYMTEPLOELEKTROTSENTRAL; a.k.a. AO, KRIMTETS; f.k.a. KRYMTEPLOELEKTROTSENTRAL, AO), 1, ul. Montazhnaya Pgt. Gresovski, Simferopol, Crimea 295493, Ukraine; website
Designated pursuant to section 2(a)(i) of E.O. 13685 for operating in the Crimea region of Ukraine.
5. LIMITED LIABILITY COMPANY GARANT-SV (a.k.a. GARANT-SV; a.k.a. GARANT-SV LIMITED LIABILITY COMPANY; a.k.a. GARANT-SV LLC; a.k.a. GARANT-SV, OOO; a.k.a. LLC GARANT-SV; a.k.a. OOO GARANT-SV), House 9, Generala Ostryakova Street, Opolznevoye Village, Yalta, Crimea 298685, Ukraine; 9, Generala Ostryakova St., Opolznevoye, Yalta, Crimea 298685, Ukraine; website
Designated pursuant to section 2(a)(i) of E.O. 13685 for operating in the Crimea region of Ukraine.
6. LIMITED LIABILITY COMPANY INFRASTRUCTURE PROJECTS MANAGEMENT COMPANY (a.k.a. MANAGEMENT COMPANY FOR INFRASTRUCTURE PROJECTS; a.k.a. UPRAVLYAYUSHCHAYA KOMPANIYA INFRASTRUKTURNYKH PROEKTOV; a.k.a. “LLC UKIP”; a.k.a. “UKIP”; a.k.a. “UKIP, OOO”), Sevastopolskaya Street, House 4
Designated pursuant to section 2(a)(i) of E.O. 13685 for operating in the Crimea region of Ukraine.
7. LIMITED LIABILITY COMPANY SOUTHERN PROJECT (a.k.a. LLC SOUTHERN PROJECT; a.k.a. OBSHCHESTVO S OGRANICHENNOI OTVETSTVENNOSTYU YUZHNY PROEKT; a.k.a. YUZHNY PROEKT, OOO), Room 15-H, Litera A, House 2, Rastrelli Place, City of St. Petersburg 191124, Russia; Tax ID No. 7842144503 (Russia); Registration Number 1177847378279 (Russia) [UKRAINE—E.O. 13661] [UKRAINE—E.O. 13685] (Linked To: BANK ROSSIYA; Linked To: KOVALCHUK, Yuri Valentinovich).
Designated pursuant to section 2(a)(i) of E.O. 13685 for operating in the Crimea region of Ukraine.
Designated pursuant to section 1(a)(ii)(C)(2) of Executive Order 13661 of March 16, 2014, “Blocking Property of Additional Persons Contributing to the Situation in Ukraine” (E.O. 13661) for being owned or controlled by BANK ROSSIYA, a person whose property and interests in property are blocked pursuant to E.O. 13661.
Designated pursuant to section 1(a)(ii)(C)(2) of E.O. 13661 for being owned or controlled by Yuri Valentinovich KOVALCHUK, a person whose property and interests in property are blocked pursuant to E.O. 13661.
8. MINISTRY OF STATE SECURITY (a.k.a. “MGB”), Luhansk People's Republic, Luhansk City, Ukraine [CAATSA—RUSSIA].
Designated pursuant to section 11(a)(1) of SSIDES, 22 U.S.C. 8910(a)(1), for being responsible for, complicit in, or responsible for ordering, controlling, or otherwise directing, the commission of serious human rights abuses in any territory forcibly occupied or otherwise controlled by the Government of the Russian Federation.
9. MRIYA RESORT & SPA (a.k.a. MRIYA RESORT; a.k.a. MRIYA RESORT AND SPA; a.k.a. MRIYA SANATORIUM COMPLEX; a.k.a. MRIYA SANATORIUM RESORT COMPLEX; a.k.a. SANATORIUM-RESORT COMPLEX MRIYA), 9, Generala Ostryakova Street, Opolznevoye Village, Yalta, Crimea 298685, Ukraine; website
Designated pursuant to section 2(a)(i) of E.O. 13685 for operating in the Crimea region of Ukraine.
Designated pursuant to section 2(a)(iii) of E.O. 13685 for being owned or controlled by, directly or indirectly, LIMITED LIABILITY COMPANY GARANT-SV, a person whose property and interests in property are blocked pursuant to E.O. 13685.
Additionally, OFAC is updating the listing on the Specially Designated Nationals and Blocked Persons List of seven entities that are identified pursuant to Executive Order 13599. The entities' listings will be updated from:
1. HEKMAT IRANIAN BANK (a.k.a. BANK-E HEKMAT IRANIAN), Argentine Circle, beginning of Africa St., Corner of 37th St., (Dara Cul-de-sac), No.26, Tehran, Iran; Additional Sanctions Information—Subject to Secondary Sanctions [IRAN].
-to-
1. HEKMAT IRANIAN BANK (a.k.a. BANK-E HEKMAT IRANIAN), Argentine Circle, beginning of Africa St., Corner of 37th St., (Dara Cul-de-sac), No.26, Tehran, Iran [IRAN].
2. KHAVARMIANEH BANK (a.k.a. MIDDLE EAST BANK), No. 22, Second Floor Sabounchi St., Shahid Beheshti Ave., Tehran, Iran; SWIFT/BIC KHMIIRTH; Additional Sanctions Information—Subject to Secondary Sanctions; All offices worldwide [IRAN].
-to-
2. KHAVARMIANEH BANK (a.k.a. MIDDLE EAST BANK), No. 22, Second Floor Sabounchi St., Shahid Beheshti Ave., Tehran, Iran; SWIFT/BIC KHMIIRTH; All offices worldwide [IRAN].
3. KISH INTERNATIONAL BANK (a.k.a. KISH INTERNATIONAL BANK OFFSHORE COMPANY PJS), NBO-9, Andisheh Blvd., Sanayi Street, Kish Island, Iran; Additional Sanctions Information—Subject to Secondary Sanctions; All offices worldwide [IRAN].
-to-
3. KISH INTERNATIONAL BANK (a.k.a. KISH INTERNATIONAL BANK OFFSHORE COMPANY PJS), NBO-9, Andisheh Blvd., Sanayi Street, Kish Island, Iran; All offices worldwide [IRAN].
4. MEHR IRAN CREDIT UNION BANK (a.k.a. BANK-E GHARZOLHASANEH MEHR IRAN; a.k.a. GHARZOLHASANEH MEHR IRAN BANK), Taleghani St., No.204, Before the intersection of Mofateh, across from the former U.S. embassy, Tehran, Iran; Additional Sanctions Information—Subject to Secondary Sanctions [IRAN].
-to-
4. MEHR IRAN CREDIT UNION BANK (a.k.a. BANK-E GHARZOLHASANEH MEHR IRAN; a.k.a. GHARZOLHASANEH MEHR IRAN BANK), Taleghani St., No.204, Before the intersection of Mofateh, across from the former U.S. embassy, Tehran, Iran [IRAN].
5. CREDIT INSTITUTION FOR DEVELOPMENT, 53 Saanee, Jahan-e Koodak, Crossroads Africa St., Tehran, Iran; Additional Sanctions Information—Subject to Secondary Sanctions [IRAN].
-to-
5. CREDIT INSTITUTION FOR DEVELOPMENT, 53 Saanee, Jahan-e Koodak, Crossroads Africa St., Tehran, Iran [IRAN].
6. NATIONAL IRANIAN TANKER COMPANY (a.k.a. NITC), NITC Building, 67-88, Shahid Atefi Street, Africa Avenue, Tehran, Iran; website
-to-
6. NATIONAL IRANIAN TANKER COMPANY (a.k.a. NITC), NITC Building, 67-88, Shahid Atefi Street, Africa Avenue, Tehran, Iran; website
7. NATIONAL IRANIAN OIL COMPANY (a.k.a. NIOC), Hafez Crossing, Taleghani Avenue, P.O. Box 1863 and 2501, Tehran, Iran; National Iranian Oil Company Building, Taleghani Avenue, Hafez Street, Tehran, Iran; website
-to-
7. NATIONAL IRANIAN OIL COMPANY (a.k.a. NIOC), Hafez Crossing, Taleghani Avenue, P.O. Box 1863 and 2501, Tehran, Iran; National Iranian Oil Company Building, Taleghani Avenue, Hafez Street, Tehran, Iran; website
Internal Revenue Service (IRS), Treasury.
Notice of meeting.
An open meeting of the Taxpayer Advocacy Panel Notices and Correspondence Project Committee will be conducted. The Taxpayer Advocacy Panel is soliciting public comments, ideas, and suggestions on improving customer service at the Internal Revenue Service.
The meeting will be held Thursday, November 29, 2018.
Otis Simpson at 1-888-912-1227 or 202-317-3332.
Notice is hereby given pursuant to Section 10(a)(2) of the Federal Advisory Committee Act, 5 U.S.C. App. (1988) that a meeting of the Taxpayer Advocacy Panel Notices and Correspondence Project Committee will be held Thursday, November 29, 2018, at 10:00 a.m. Eastern Time via teleconference. The public is invited to make oral comments or submit written statements for consideration. Due to limited conference lines, notification of intent to participate must be made with Otis Simpson. For more information please contact Otis Simpson at 1-888-912-1227 or 202-317-3332, or write TAP Office, 1111 Constitution Ave. NW, Room 1509, Washington, DC 20224 or contact us at the website:
The agenda will include a discussion on various letters, and other issues related to written communications from the IRS.
Internal Revenue Service, Department of the Treasury; Employee Benefits Security Administration, Department of Labor; and Centers for Medicare & Medicaid Services, Department of Health and Human Services.
Final rules.
These rules finalize, with changes based on public comments, interim final rules concerning religious exemptions and accommodations regarding coverage of certain preventive services issued in the
Jeff Wu, at (301) 492-4305 or
The primary purpose of this rule is to finalize, with changes in response to public comments, the interim final regulations with requests for comments (IFCs) published in the
These rules finalize exemptions provided in the Religious IFC for the group health plans and health insurance coverage of various entities and individuals with sincerely held religious beliefs opposed to coverage of some or all contraceptive or sterilization methods encompassed by HRSA's Guidelines. The rules finalize exemptions to the same types of organizatons and individuals for which exemptions were provided in the Religious IFC: Non-governmental plan sponsors including a church, an integrated auxiliary of a church, a convention or association of churches, or a religious order; a nonprofit organization; for-profit entities; an institution of higher education in arranging student health insurance coverage; and, in certain circumstances, issuers and individuals. The rules also finalize the regulatory restatement in the Religious IFC of language from section 2713(a) and (a)(4) of the Public Health Service Act.
In response to public comments, various changes are made to clarify the intended scope of the language in the Religious IFC. The prefatory language to the exemptions is clarified to ensure exemptions apply to a group health plan established or maintained by an objecting organization, or health insurance coverage offered or arranged by an objecting organization, to the extent of the objections. The Departments add language to clarify that, where an exemption encompasses a plan or coverage established or maintained by a church, an integrated auxiliary of a church, a convention or association of churches, a religious order, a nonprofit organization, or other non-governmental organization or association, the exemption applies to each employer, organization, or plan sponsor that adopts the plan. Language is also added to clarify that the exemptions apply to non-governmental entities, including as the exemptions apply to institutions of higher education. The Departments revise the exemption applicable to health insurance issuers to make clear that the group health plan established or maintained by the plan sponsor with which the health insurance issuer contracts remains subject to any requirement to provide coverage for contraceptive services under Guidelines issued under § 147.130(a)(1)(iv) unless it is also exempt from that requirement. The Departments also restructure the provision describing the religious objection for entities. That provision specifies that the entity objects, based on its sincerely held religious beliefs, to its establishing, maintaining, providing, offering, or arranging for either: coverage or payments for some or all contraceptive services; or, a plan, issuer, or third party administrator that provides or arranges such coverage or payments.
The Departments also clarify language in the exemption applicable to plans of objecting individuals. The final rule specifies that the individual exemption ensures that the HRSA Guidelines do not prevent a willing health insurance issuer offering group or individual health insurance coverage, and as applicable, a willing plan sponsor of a group health plan, from offering a separate policy, certificate or contract of insurance or a separate group health plan or benefit package option, to any group health plan sponsor (with respect to an individual) or individual, as applicable, who objects to coverage or payments for some or all contraceptive services based on sincerely held religious beliefs. The exemption adds that, if an individual objects to some but not all contraceptive services, but the issuer, and as applicable, plan sponsor, are willing to provide the plan sponsor or individual, as applicable, with a separate policy, certificate or contract of insurance or a separate group health plan or benefit package option that omits all contraceptives, and the individual agrees, then the exemption applies as if the individual objects to all contraceptive services.
These rules also finalize provisions from the Religious IFC that maintain the accommodation process as an optional process for entities that qualify for the exemption. Under that process, entities can choose to use the accommodation process so that contraceptive coverage to which they object is omitted from their plan, but their issuer or third party administrator, as applicable, will arrange for the persons covered by their plan to receive contraceptive coverage or payments.
In response to public comments, these final rules make technical changes to the accommodation regulations maintained in parallel by HHS, the Department of Labor, and the Department of the Treasury. The Departments modify the regulations governing when an entity, that was using or will use the accommodation, can revoke the accommodation and operate under the exemption. The modifications set forth a transitional
The Departments also modify the Religious IFC by adding a provision that existed in rules prior to the Religious IFC, namely, that if an issuer relies reasonably and in good faith on a representation by the eligible organization as to its eligibility for the accommodation, and the representation is later determined to be incorrect, the issuer is considered to comply with any applicable contraceptive coverage requirement from HRSA's Guidelines if the issuer complies with the obligations under this section applicable to such issuer. Likewise, the rule adds pre-existing “reliance” language deeming an issuer serving an accommodated organization compliant with the contraceptive coverage requirement if the issuer relies reasonably and in good faith on a representation by an organization as to its eligibility for the accommodation and the issuer otherwise complies with the accommodation regulation, and likewise deeming a group health plan compliant with the contraceptive coverage requirement if it complies with the accommodation regulation.
Over many decades, Congress has protected conscientious objections, including those based on religious beliefs, in the context of health care and human services including health coverage, even as it has sought to promote and expand access to health services.
The ACA reorganizes, amends, and adds to the provisions of part A of title XXVII of the Public Health Service Act (PHS Act) relating to group health plans and health insurance issuers in the group and individual markets. The ACA adds section 715(a)(1) to the Employee Retirement Income Security Act of 1974 (ERISA) and section 9815(a)(1) to the Internal Revenue Code (Code), in order to incorporate the provisions of part A of title XXVII of the PHS Act into ERISA and the Code, and to make them applicable to group health plans and health insurance issuers providing health insurance coverage in connection with group health plans. The sections of the PHS Act incorporated into ERISA and the Code are sections 2701 through 2728.
In section 2713(a)(4) of the PHS Act (hereinafter “section 2713(a)(4)”), Congress provided administrative discretion to require that certain group health plans and health insurance issuers cover certain women's preventive services, in addition to other preventive services required to be covered in section 2713. Congress granted that discretion to the Health Resources and Services Administration (HRSA), a component of the U.S. Department of Health and Human Services (HHS). Specifically, section 2713(a)(4) allows HRSA discretion to specify coverage requirements, “with respect to women, such additional preventive care and screenings . . . as provided for in comprehensive guidelines supported by” HRSA's Guidelines.
Since 2011, HRSA has exercised that discretion to require coverage for, among other things, certain contraceptive services.
The Departments most recently solicited public comments on these issues again in two interim final regulations with requests for comments (IFCs) published in the
In the preamble to the Religious IFC, the Departments explained several reasons why it was appropriate to reevaluate the religious exemptions and accommodations for the contraceptive Mandate and to take into account the religious beliefs of certain employers concerning that Mandate. The Departments also sought public comment on those modifications. The Departments considered, among other things, Congress's history of providing protections for religious beliefs regarding certain health services (including contraception, sterilization, and items or services believed to involve abortion); the text, context, and intent of section 2713(a)(4) and the ACA; protection of the free exercise of religion in the First Amendment and, by Congress, in RFRA; Executive Order 13798, “Promoting Free Speech and Religious Liberty” (May 4, 2017); previously submitted public comments;
After consideration of the comments and feedback received from stakeholders, the Departments are finalizing the Religious IFC, with changes based on comments as indicated herein.
We provided a 60-day public comment period for the Religious IFC, which closed on December 5, 2017. The Departments received over 56,000 public comment submissions, which are posted at
These rules expand exemptions to protect religious beliefs for certain entities and individuals with religious objections to contraception whose health plans are subject to a mandate of contraceptive coverage through guidance issued pursuant to the ACA. These rules do not alter the discretion of HRSA, a component of HHS, to maintain the Guidelines requiring contraceptive coverage where no regulatorily recognized objection exists. These rules finalize the accommodation process, which was previously established in response to objections of religious organizations that were not protected by the original exemption, as an optional process for any exempt entities. These rules do not alter multiple other federal programs that provide free or subsidized contraceptives or related education and counseling for women at risk of unintended pregnancy.
The Departments received conflicting comments on their legal authority to provide the expanded exemptions and accommodation for religious beliefs. Some commenters agreed that the Departments are legally authorized to provide the expanded exemptions and accommodation, noting that there was no requirement of contraceptive coverage in the ACA and no prohibition on providing religious exemptions in Guidelines issued under section 2713(a)(4). Other commenters, however, asserted that the Departments have no legal authority to provide any exemptions to the contraceptive Mandate, contending, based on statements in the ACA's legislative history, that the ACA requires contraceptive coverage. Still other commenters contended that the Departments are legally authorized to provide the exemptions that existed prior to the Religious IFC, but not to expand them.
Some commenters who argued that section 2713(a)(4) does not allow for exemptions said that the previous exemptions for houses of worship and integrated auxiliaries, and the previous accommodation process, were set forth in the ACA itself, and therefore were acceptable while the expanded exemptions in the Religious IFC were not. This is incorrect. The ACA does not prescribe (or prohibit) the previous exemptions for house of worship and the accommodation processes that the Departments issued through regulations.
The Departments conclude that legal authority exists to provide the expanded exemptions and accommodation for religious beliefs set forth in these final rules. These rules concern section 2713 of the PHS Act, as also incorporated into ERISA and the Code. Congress has granted the Departments legal authority, collectively, to administer these statutes.
Where it applies, section 2713(a)(4) requires coverage without cost sharing for “such additional” women's preventive care and screenings “as provided for” and “supported by” Guidelines developed by HHS through HRSA. When Congress enacted this provision, those Guidelines did not exist. And nothing in the statute mandated that the Guidelines had to include contraception, let alone for all types of employers with covered plans. Instead, section 2713(a)(4) provided a positive grant of authority for HSRA to develop those Guidelines, thus delegating authority to HHS, as the administering agency of HRSA, and to all three agencies, as the administering agencies of the statutes by which the Guidelines are enforced, to shape that development.
Congress did not specify the extent to which HRSA must “provide for” and “support” the application of Guidelines that it chooses to adopt. HRSA's authority to support “comprehensive guidelines” involves determining both the types of coverage and scope of that coverage. Section 2714(a)(4) requires coverage for preventive services only “as provided for in comprehensive guidelines supported by [HRSA].” That is, services are required to be included in coverage only to the extent that the Guidelines supported by HRSA provide for them. Through use of the word “as” in the phrase “as provided for,” it requires that HRSA support how those services apply—that is, the manner in which the support will happen, such as in the phrase “as you like it.”
Nor is it simply a textual aberration that the word “as” is missing from the other three provisions in PHS Act section 2713(a). Rather, this difference mirrors other distinctions within that section that demonstrate that Congress intended HRSA to have the discretion the Agencies invoke. For example, sections (a)(1) and (a)(3) require “evidence-based” or “evidence-informed” coverage, while section (a)(4) does not. This difference suggests that the Agencies have the leeway to incorporate policy-based concerns into their decision-making. This reading of section 2713(a)(4) also prevents the statute from being interpreted in a cramped way that allows no flexibility or tailoring, and that would force the Departments to choose between ignoring religious objections in violation of RFRA or else eliminating the contraceptive coverage requirement from the Guidelines altogether. The Departments instead interpret section 2713(a)(4) as authorizing HRSA's Guidelines to set forth both the kinds of items and services that will be covered, and the scope of entities to which the contraceptive coverage requirement in those Guidelines will apply.
The religious objections at issue here, and in regulations providing exemptions from the inception of the Mandate in 2011, are considerations that, consistent with the statutory provision, permissibly inform what HHS, through HRSA, decides to provide for and support in the Guidelines. Since the first rulemaking on this subject in 2011, the Departments have consistently interpreted the broad discretion granted to HRSA in section 2713(a)(4) as including the power to reconcile the ACA's preventive-services requirement with sincerely held views of conscience on the sensitive subject of contraceptive coverage—namely, by exempting churches and their integrated auxiliaries from the contraceptive Mandate. (
The conclusions on which these final rules are based are consistent with the Departments' interpretation of section 2713 of the PHS Act since 2010, when the ACA was enacted, and since the Departments started to issue interim final regulations implementing that section. The Departments have consistently interpreted section 2713(a)(4)'s grant of authority to include broad discretion regarding the extent to which HRSA will provide for, and support, the coverage of additional women's preventive care and screenings, including the decision to exempt certain entities and plans, and not to provide for or support the application of the Guidelines with respect to those entities or plans. The Departments defined the scope of the exemption to the contraceptive Mandate when HRSA issued its Guidelines for contraceptive coverage in 2011, and then amended and expanded the exemption and added an accommodation process in multiple rulemakings thereafter. The accommodation process requires the provision of coverage or payments for contraceptives to participants in an eligible organization's health plan by the organization's insurer or third party administrator. However, the accommodation process itself, in some cases, failed to require contraceptive coverage for many women, because—as the Departments acknowledged at the time—the enforcement mechanism for that process, section 3(16) of ERISA, does not provide a means to impose an obligation to provide contraceptive coverage on the third party administrators of self-insured church plans.
The Departments' interpretation of section 2713(a)(4) is confirmed by the ACA's statutory structure. Congress did not intend to require coverage of preventive services for every type of plan that is subject to the ACA.
Some commenters argue that Executive Order 13535's reference to
The extent to which RFRA provides authority for these final rules is discussed below in section II.C., The First Amendment and the Religious Freedom Restoration Act.
Some commenters supported the expanded exemptions and accommodation in the Religious IFC, and the entities and individuals to which they applied. They asserted the expanded exemptions and accommodation are appropriate exercises of discretion and are consistent with religious exemptions Congress has provided in many similar contexts. Some further commented that the expanded exemptions are necessary under the First Amendment or RFRA. Similarly, commenters stated that the accommodation was an inadequate means to resolve religious objections, and that the expanded exemptions are needed. They objected to the accommodation process because it was another method to require compliance with the Mandate. They contended its self-certification or notice involved triggering the very contraceptive coverage that organizations objected to, and that such coverage flowed in connection with the objecting organizations' health plans. The commenters contended that the seamlessness cited by the Departments between contraceptive coverage and an accommodated plan gives rise to the religious objections that organizations would not have with an expanded exemption.
Several other commenters asserted that the exemptions in the Religious IFC are too narrow and called for there to be no mandate of contraceptive coverage. Some of them contended that HRSA should not include contraceptives in their women's preventive services Guidelines because fertility and pregnancy are generally healthy conditions, not diseases that are appropriately the target of preventive health services. They also contended that contraceptives can pose medical risks for women and that studies do not show that contraceptive programs reduce abortion rates or rates of unintended pregnancies. Some commenters contended that, to the extent the Guidelines require coverage of certain drugs and devices that may prevent implantation of an embryo after fertilization, they require coverage of items that are abortifacients and, therefore, violate federal conscience protections such as the Weldon Amendment,
Other commenters contended that the expanded exemptions are too broad. In general, these commenters supported the inclusion of contraceptives in the Guidelines, contending they are a necessary preventive service for women. Some said that the Departments should not exempt various kinds of entities such as businesses, health insurance issuers, or other plan sponsors that are not nonprofit entities. Other commenters contended the exemptions and accommodation should not be expanded, but should remain the same as they were in the July 2015 final regulations (80 FR 41318). Some commenters said the Departments should not expand the exemptions, but simply expand or adjust the accommodation process to resolve religious objections to the Mandate and accommodation. Some commenters contended that even the previous regulations allowing an exemption and accommodation were too broad, and said that no exemptions to the Mandate should exist, in order that contraceptive coverage would be provided to as many women as possible.
After consideration of the comments, the Departments are finalizing the provisions of the Religious IFC without contracting the scope of the exemptions and accommodation set forth in the Religious IFC. Since HRSA issued its Guidelines in 2011, the Departments have recognized that religious exemptions from the contraceptive Mandate are appropriate. The details of the scope of such exemptions are discussed in further detail below. In general, the Departments conclude it is appropriate to maintain the exemptions created by the Religious IFC to avoid instances where the Mandate is applied in a way that violates the religious beliefs of certain plan sponsors, issuers, or individuals. The Departments do not believe the previous exemptions are adequate, because some religious objections by plan sponsors and individuals were favored with exemptions, some were not subjected to contraceptive coverage if they fell under the indirect exemption for certain self-insured church plans, and others had to choose between the Mandate and the accommodation even though they objected to both. The Departments wish to avoid inconsistency in respecting religious objections in connection with the provision of contraceptive coverage. The lack of a congressional mandate that contraceptives be covered, much less that they be covered without religious exemptions, has also informed the Departments' decision to expand the exemptions. And Congress's decision not to apply PHS Act section 2713 to grandfathered plans has likewise informed the Departments' decision whether exemptions to the contraceptive Mandate are appropriate.
Congress has also established a background rule against substantially burdening sincere religious beliefs except where consistent with the stringent requirements of the Religious Freedom Restoration Act. And Congress has consistently provided additional, specific exemptions for religious beliefs in statutes addressing federal requirements in the context of health care and specifically concerning issues such as abortion, sterilization, and contraception. Therefore, the Departments consider it appropriate, to the extent we impose a contraceptive coverage Mandate by the exercise of agency discretion, that we also include exemptions for the protection of religious beliefs in certain cases. The expanded exemptions finalized in these rules are generally consistent with the scope of exemptions that Congress has established in similar contexts. They are also consistent with the intent of Executive Order 13535 (March 24, 2010), which was issued upon the signing of the ACA and declared that, “[u]nder the Act, longstanding federal laws to protect conscience (such as the Church Amendment, 42 U.S.C. 300a-7, and the Weldon Amendment, section 508(d)(1) of Public Law 111-8) remain intact” and that “[n]umerous executive agencies have a role in ensuring that these restrictions are enforced, including the HHS.”
Some commenters argued that Congress's failure to explicitly include
If there is to be a federal contraceptive mandate that fails to include some—or, in the views of some commenters, any—religious exemptions, the Departments do not believe it is appropriate for us to impose such a regime through discretionary administrative measures. Instead, such a serious imposition on religious liberty should be created, if at all, by Congress, in response to citizens exercising their rights of political participation. Congress did not prohibit religious exemptions under this Mandate. It did not even require contraceptive coverage under the ACA. It left the ACA subject to RFRA, and it specified that additional women's preventive services will only be required coverage as provided for in Guidelines supported by HRSA. Moreover, Congress legislated in the context of the political consensus on conscientious exemptions for health care that has long been in place. Since
Some commenters contended that, even though Executive Order 13535 refers to the Church Amendments, the intention of those statutes is narrow, should not be construed to extend to entities, and should not be construed to prohibit procedures. But those comments mistake the Departments' position. The Departments are not construing the Church Amendments to require these exemptions, nor do the exemptions prohibit any procedures. Instead, through longstanding federal conscience statutes, Congress has established consistent principles concerning respect for religious beliefs in the context of certain Federal health care requirements. Under those principles, and absent any contrary requirement of law, the Departments are offering exemptions for sincerely held religious beliefs to the extent the Guidelines otherwise include contraceptive coverage.
The Departments note that their decision is also consistent with state practice. A significant majority of states either impose no contraceptive coverage requirement or offer broader exemptions than the exemption contained in the July 2015 final regulations.
The Departments decline to adopt the suggestion of some commenters to use these final rules to revoke the contraceptive Mandate altogether, such as by declaring that HHS through HRSA shall not include contraceptives in the list of women's preventive services in Guidelines issued under section 2713(a)(4). Although previous regulations were used to authorize religious exemptions and accommodations to the imposition of the Guidelines' coverage of contraception, the issuance of the Guidelines themselves in 2011 describing what items constitute recommended women's preventive services, and the update to those recommendations in December 2016, did not occur through the regulations that preceded the 2017 Religious IFC and these final rules. The Guidelines' specification of which women's preventive services were recommended were issued, not by regulation, but directly by HRSA, after consultation with external organizations that operated under cooperative agreements with HRSA to consider the issue, solicit public comment, and provide recommendations. The Departments decline to accept the invitation of some commenters to use these rules to specify whether HRSA includes contraceptives in the Guidelines at all. Instead the Departments conclude it is appropriate for these rules to continue to focus on restating the statutory language of PHS Act section 2713 in regulatory form, and delineating what exemptions and accommodations apply if HRSA lists contraceptives in its Guidelines. Some commenters said that if contraceptives are not removed from the Guidelines entirely, some entities or individuals with religious objections might not qualify for the exemptions or accommodation. As discussed below, however, the exemptions in the Religious IFC and these final rules cover a broad range of entities and individuals. The Departments are not aware of specific groups or individuals whose religious beliefs would still be substantially burdened by the Mandate after the issuance of these final rules.
Some commenters asserted that HRSA should remove contraceptives from the Guidelines because the Guidelines have not been subject to the notice and comment process under the Administrative Procedure Act. Some commenters also contended that the Guidelines should be amended to omit items that may prevent (or possibly dislodge) the implantation of a human embryo after fertilization, in order to ensure consistency with conscience provisions that prohibit requiring plans to pay for or cover abortions.
Whether and to what extent the Guidelines continue to list contraceptives, or items considered to prevent implantation of an embryo, for entities not subject to exemptions and an accommodation, and what process is used to include those items in the Guidelines, is outside the scope of these final rules. These rules focus on what religious exemptions and accommodations shall apply if Guidelines issued under section 2713(a)(4) include contraceptives or items considered to be abortifacients.
Members of the public that support or oppose the inclusion of some or all contraceptives in the Guidelines, or wish to comment concerning the content of, and the process for developing and updating, the Guidelines, are welcome to communicate their views to HRSA, at
The Departments conclude that it would be inadequate to merely attempt to amend or expand the accommodation process instead of expanding the exemption. In the past, the Departments had stated in our regulations and court briefs that the previous accommodation process required contraceptive coverage or payments in a way that is “seamless” with the coverage provided by the objecting employer. As a result, in significant respects, that previous accommodation process did not actually accommodate the objections of many entities, as many entities with religious objections have argued. The Departments have attempted to identify an accommodation process that would eliminate the religious objections of all plaintiffs, including seeking public comment through a Request For Information, 81 FR 47741 (July 26, 2016), but we stated in January 2017 that we were unable to develop such an approach at that time.
Comments considering the appropriateness of exempting certain specific kinds of entities or individuals are discussed in more detail below.
Some commenters said that the Supreme Court ruled that the exemptions to the contraceptive Mandate, which the Departments previously provided to houses of worship and integrated auxiliaries, were required by the First Amendment. From this, commenters concluded that the exemptions for houses of worship and integrated auxiliaries are legally authorized, but exemptions beyond those are not. But in
Commenters disagreed about the scope of RFRA's protection in this context. Some commenters said that the expanded exemptions and accommodation are consistent with RFRA. Some also said that they are required by RFRA, as the Mandate imposes substantial burdens on religious exercise and fails to satisfy the compelling-interest and least-restrictive- means tests imposed by RFRA. Other commenters, however, contended that the expanded exemptions and accommodation are neither required by, nor consistent with, RFRA. In this vein, some argued that the Departments have a compelling interest to deny religious exemptions, that there is no less restrictive means to achieve its goals, or that the Mandate or its accommodation process do not impose a substantial burden on religious exercise.
For the reasons discussed below, the Departments believe that agencies charged with administering a statute that imposes a substantial burden on the exercise of religion under RFRA have discretion in determining whether the appropriate response is to provide an exemption from the burdensome requirement, or to merely attempt to create an accommodation that would mitigate the burden. Here, after further consideration of these issues and review of the public comments, the Departments have determined that a broader exemption, rather than a mere accommodation, is the appropriate response.
In addition, with respect to religious employers, the Departments conclude that, without finalizing the expanded exemptions, and therefore requiring certain religiously objecting entities to choose between the Mandate, the accommodation, or penalties for noncompliance—or requiring objecting individuals to choose between purchasing insurance with coverage to which they object or going without insurance—the Departments would violate their rights under RFRA.
In the Religious IFC, we explained that even if RFRA does not compel the Departments to provide the religious exemptions set forth in the IFC, the Departments believe the exemptions are the most appropriate administrative response to the religious objections that have been raised.
The Departments received conflicting comments on this issue. Some commenters agreed that the Departments have administrative discretion to address the religious objections even if the Mandate and accommodation did not violate RFRA. Other commenters expressed the view that RFRA does not provide such discretion, but only allows exemptions when RFRA requires exemptions. They contended that RFRA does not require exemptions for entities covered by the expanded exemptions of the Religious IFC, but that subjecting those entities to the accommodation satisfies RFRA, and therefore RFRA provides the Departments with no additional authority to exempt those entities. Those commenters further contended that because, in their view, section 2713(a)(4) does not authorize the
As discussed above, the Departments disagree with the suggestions of commenters that section 2713(a)(4) does not authorize the Departments to adopt the expanded exemptions. Nevertheless, the Departments note that the expanded exemptions for religious objectors also rest on an additional, independent ground: The Departments have determined that, in light of RFRA, an expanded exemption rather than the existing accommodation is the most appropriate administrative response to the substantial burden identified by the Supreme Court in
The Departments' determination about their authority under RFRA rests in part on the Departments' reassessment of the interests served by the application of the Mandate in this specific context. Although the Departments previously took the position that the application of the Mandate to objecting employers was narrowly tailored to serve a compelling governmental interest, as discussed below the Departments have now concluded, after reassessing the relevant interests and for the reasons stated below, that it does not. Particularly under those circumstances, the Departments believe that agencies charged with administering a statute that imposes a substantial burden on the exercise of religion under RFRA have discretion in determining whether the appropriate response is to provide an exemption from the burdensome requirement or instead to attempt to create an accommodation that would mitigate the burden. And here, the Departments have determined that a broader exemption rather than the existing accommodation is the appropriate response. That determination is informed by the Departments' reassessment of the relevant interests, as well as by their desire to bring to a close the more than five years of litigation over RFRA challenges to the Mandate.
Although RFRA prohibits the government from substantially burdening a person's religious exercise where doing so is not the least restrictive means of furthering a compelling interest—as is the case with the contraceptive Mandate, pursuant to
Although the foregoing analysis is independently sufficient, additional support for this view is provided by the Departments' conclusion, as explained more fully below, that an expanded exemption is required by RFRA for at least some objectors. In the Religious IFC, the Departments reaffirmed their conclusion that there is not a way to satisfy all religious objections by amending the accommodation, (82 FR at 47800), a conclusion that was confirmed by some commenters (and the continued litigation over the accommodation).
In the Departments' view, after considering all the comments and the preceding years of contention over this issue, it is appropriate to finalize the expanded exemptions rather than merely attempt to change the accommodation to satisfy religious objections. This is because if the accommodation still delivers contraceptive coverage through use of the objecting employer's plan, issuer, or third party administrator, it does not address the religious objections. If the accommodation could deliver contraceptive coverage independent and separate from the objecting employer's plan, issuer, and third party administrator, it could possibly address the religious objections, but there are two problems with such an approach. First, it would effectively be an exemption, not the accommodation as it has existed, so it would not be a reason not to offer the expanded exemptions finalized in these rules. Second, although (as explained above) the Departments have authority to provide exemptions to the Mandate, the Departments are not aware of the authority, or of a practical mechanism, for using section 2713(a)(4) to require contraceptive coverage be provided
Before the Religious IFC, the Departments had previously contended that the Mandate did not impose a substantial burden on entities and individuals under RFRA; that it was supported by a compelling government interest; and that it was, in combination with the accommodation, the least restrictive means of advancing that interest. With respect to the coverage Mandate itself, apart from the accommodation, and as applied to entities with sincerely held religious objections, that argument was rejected in
In general, commenters disagreed about this issue. Some commenters agreed with the Departments, and with some courts, that requiring entities to choose between the contraceptive Mandate and its accommodation violated their rights under RFRA, because it imposed a substantial burden on their religious exercise, did not advance a compelling government interest, and was not the least restrictive means of achieving such an interest. Other commenters contended that requiring compliance either with the Mandate or the accommodation did not violate RFRA, agreeing with some courts that have concluded the accommodation does not substantially burden the religious exercise of organizations since, in their view, it does not require organizations to facilitate contraceptive coverage except by submitting a self-certification form or notice, and requiring compliance was the least restrictive means of advancing the compelling interest of providing contraceptive access to women covered by objecting entities' plans.
The Departments have examined further, including in light of public comments, the issue of whether requiring compliance with the combination of the contraceptive Mandate and the accommodation process imposes a substantial burden on entities that object to both, and is the least restrictive means of advancing a compelling government interest. The Departments now reaffirm the conclusion set forth in the Religious IFC, that requiring certain religiously objecting entities or individuals to choose between the Mandate, the accommodation, or incurring penalties for noncompliance imposes a substantial burden on religious exercise under RFRA.
The Departments concur with the description of substantial burdens expressed recently by the Department of Justice:
A governmental action substantially burdens an exercise of religion under RFRA if it bans an aspect of an adherent's religious observance or practice, compels an act inconsistent with that observance or practice, or substantially pressures the adherent to modify such observance or practice.
Because the government cannot second-guess the reasonableness of a religious belief or the adherent's assessment of the connection between the government mandate and the underlying religious belief, the substantial burden test focuses on the extent of governmental compulsion involved. In general, a government action that bans an aspect of an adherent's religious observance or practice, compels an act inconsistent with that observance or practice, or substantially pressures the adherent to modify such observance or practice, will qualify as a substantial burden on the exercise of religion.
The Mandate and accommodation under the previous regulation forced certain non-exempt religious entities to choose between complying with the Mandate, complying with the accommodation, or facing significant penalties. Various entities sincerely contended, in litigation or in public comments, that complying with either the Mandate or the accommodation was inconsistent with their religious observance or practice. The Departments have concluded that withholding an exemption from those entities has imposed a substantial burden on their exercise of religion, either by compelling an act inconsistent with that observance or practice, or by substantially pressuring the adherents to modify such observance or practice. To this extent, the Departments believe that the Court's analysis in
Although the Departments previously took the position that the application of the Mandate to certain objecting employers was necessary to serve a compelling governmental interest, the Departments have concluded, after reassessing the relevant interests and, in light of the public comments received, that it does not. This is based on several independent reasons.
First, as discussed above, the structure of section 2713(a)(4) and the ACA evince a desire by Congress to
Second, since the day the contraceptive Mandate came into effect in 2011, the Mandate has not applied in many circumstances. To begin, the ACA does not apply the Mandate, or any part of the preventive services coverage requirements, to grandfathered plans. To continue, the Departments under the last Administration provided exemptions to the Mandate and expanded those exemptions through multiple rulemaking processes. Those rulemaking processes included an accommodation that effectively left employees of many non-exempt religious nonprofit entities without contraceptive coverage, in particular with respect to self-insured church plans exempt from ERISA. Under the previous accommodation, once a self-insured church plan filed a self-certification or notice, the accommodation relieved it of any further obligation with respect to contraceptive services coverage. Having done so, the accommodation process would generally have transferred the obligation to provide or arrange for contraceptive coverage to a self-insured plan's third party administrator (TPA). But the Departments recognized that they lack authority to compel church plan TPAs to provide contraceptive coverage or levy fines against those TPAs for failing to provide it. This is because church plans are exempt from ERISA pursuant to section 4(b)(2) of ERISA. Section 2761(a) of the PHS Act provides that States may enforce the provisions of title XXVII of the PHS Act as they pertain to health insurance issuers, but does not apply to church plans that do not provide coverage through a policy issued by a health insurance issuer. The combined result of PHS Act section 2713's authority to remove contraceptive coverage obligations from self-insured church plans, and HHS's and DOL's lack of authority under the PHS Act or ERISA to require TPAs of those plans to provide such coverage, led to significant disparity in the requirement to provide contraceptive coverage among nonprofit organizations with religious objections to the coverage.
Third party administrators for some, but not all, religious nonprofit organizations were subject to enforcement for failure to provide contraceptive coverage under the accommodation, depending on whether they administer a self-insured church plan. Notably, many of those nonprofit organizations were not houses of worship or integrated auxiliaries. Under section 3(33)(C) of ERISA, organizations whose employees participate in self-insured church plans need not be churches so long as they are controlled by or “share[ ] common religious bonds and convictions with” a church or convention or association of churches. The effect is that many similar religious organizations were being treated differently with respect to their employees receiving contraceptive coverage based solely on whether organization employees participate in a church plan.
This arrangement encompassed potentially hundreds of religious non-profit organizations that were not covered by the exemption for houses of worship and integrated auxiliaries. For example, the Departments were sued by two large self-insured church plans—Guidestone and Christian Brothers.
Third, the Departments now believe the administrative record on which the Mandate rested was—and remains—insufficient to meet the high threshold to establish a compelling governmental interest in ensuring that women covered by plans of objecting organizations receive cost-free contraceptive coverage through those plans. The Mandate is not narrowly tailored to advance the government's interests and appears both overinclusive and underinclusive. It includes some entities where a contraceptive coverage requirement seems unlikely to be effective, such as religious organizations of certain faiths, which, according to commenters, primarily hire persons who agree with their religious views or make their dedication to their religious views known to potential employees who are expected to respect those views. The Mandate also does not apply to a significant number of entities encompassing many employees and for-profit businesses, such as grandfathered plans. And it does not appear to target the population defined, at the time the Guidelines were developed, as being the most at-risk of unintended pregnancy, that is, “women who are aged 18 to 24 years and unmarried, who have a low income, who are not high school graduates, and who are members of a racial or ethnic minority.”
The Department received conflicting comments on this issue. Some commenters agreed that the government does not have a compelling interest in applying the Mandate to objecting religious employers. They noted that the expanded exemptions will impact only a small fraction of women otherwise affected by the Mandate and argued that refusing to provide those exemptions would fail to satisfy the compelling interest test. Other commenters, however, argued that the government has a broader interest in the Mandate because all women should be considered at-risk of unintended pregnancy. But the Institute of Medicine (IOM), in discussing whether contraceptive coverage is needed, provided a very specific definition of the population of women most at-risk of unintended pregnancy.
Fourth, the availability of contraceptive coverage from other possible sources—including some objecting entities that are willing to provide some (but not all) contraceptives, or from other governmental programs for low-income women—detracts from the government's interest to refuse to expand exemptions to the Mandate. The Guttmacher Institute recently published a study that concluded, “[b]etween 2008 and 2014, there were no significant changes in the overall proportion of women who used a contraceptive method both among all women and among women at risk of unintended pregnancy,” and “there was no significant increase in the use of methods that would have been covered under the ACA (most or moderately effective methods) during the most recent time period (2012-2014) excepting small increases in implant use.”
Fifth, the Departments previously created the accommodation, in part, as a way to provide for payments of contraceptives and sterilization in a way that is “seamless” with the coverage that eligible employers provide to their plan participants and their beneficiaries. (80 FR 41318). As noted above, some commenters contended that seamlessness between contraceptive coverage and employer sponsored insurance is important and is a compelling governmental interest, while other commenters disagreed. Neither Congress, nor the Departments in other contexts, have concluded that seamlessness, as such, is a compelling interest in the federal government's delivery of contraceptive coverage. For example, the preventive services Mandate itself does not require contraceptive coverage and does not apply to grandfathered plans, thereby failing to guarantee seamless contraceptive coverage. The exemption for houses of worship and integrated auxiliaries, and the application of the accommodation to certain self-insured church plans, also represents a failure to achieve seamless contraceptive coverage. HHS's Title X program provides contraceptive coverage in a way that is not necessarily seamless with beneficiaries' employer sponsored insurance plans. After reviewing the public comments and reconsidering this issue, the Departments no longer believe that if a woman working for an objecting religious employer receives contraceptive access in ways that are not seamless to her employer sponsored insurance, a compelling government interest has nevertheless been undermined. Therefore the Departments conclude that guaranteeing seamlessness between contraceptive access and employer sponsored insurance does not constitute a compelling interest that overrides employers' religious objections to the contraceptive Mandate.
Some commenters contended that obtaining contraceptive coverage from other sources could be more difficult or more expensive for women than obtaining it from their group health plan or health insurance plan. The Departments do not believe that such differences rise to the level of a compelling interest or make it inappropriate for us to issue the expanded exemptions set forth in these final rules. Instead, after considering this issue, the Departments conclude that the religious liberty interests that would be infringed if we do not offer the expanded exemptions are not overridden by the impact on those who will no longer obtain contraceptives through their employer sponsored coverage as a result. This is discussed in more detail in following section, II.D., Burdens on Third Parties.
The Departments received a number of comments on the question of burdens that these rules might impose on third parties. Some commenters asserted that the expanded exemptions and accommodation do not impose an impermissible or unjustified burden on third parties, including on women who might not otherwise receive contraceptive coverage with no cost-sharing. These included commenters agreeing with the Departments' explanations in the Religious IFC, stating that unintended pregnancies were decreasing before the Mandate was implemented, and asserting that any benefit that third parties might receive in getting contraceptive coverage does not justify forcing religious persons to provide such products in violation of their beliefs. Other commenters disagreed, asserting that the expanded exemptions unacceptably burden women who might lose contraceptive coverage as a result. They contended the exemptions may remove contraceptive coverage, causing women to have higher contraceptive costs, fewer contraceptive options, less ability to use contraceptives more consistently, more unintended pregnancies,
The Departments note that the exemptions in the Religious IFC and these final rules, like the exemptions created by the previous Administration, do not impermissibly burden third parties. Initially, the Departments observe that these final rules do not create a governmental burden; rather, they relieve a governmental burden. The ACA did not impose a contraceptive coverage requirement. HHS exercised discretion granted to HRSA by the Congress to include contraceptives in the Guidelines issued under section 2713(a)(4). That decision is what created and imposed a governmental burden. These rules simply relieve part of that governmental burden. If some third parties do not receive contraceptive coverage from private parties who the government chose not to coerce, that result exists in the absence of governmental action—it is not a result the government has imposed. Calling that result a governmental burden rests on an incorrect presumption: that the government has an obligation to force private parties to benefit those third parties and that the third parties have a right to those benefits. But Congress did not create a right to receive contraceptive coverage from other private citizens through PHS Act section 2713, other portions of the ACA, or any other statutes it has enacted. Although some commenters also contended such a right might exist under treaties the Senate has ratified or the Constitution, the Departments are not aware of any source demonstrating that the Constitution or a treaty ratified by the Senate creates a right to receive contraceptive coverage from other private citizens.
The fact that the government at one time exercised its administrative discretion to require private parties to provide coverage to benefit other private parties, does not prevent the government from relieving some or all of the burden of its Mandate. Otherwise, any governmental coverage requirement would be a one-way ratchet. In the Religious IFC and these rules, the government has simply restored a zone of freedom where it once existed. There is no statutory or constitutional obstacle to the government doing so, and the doctrine of third-party burdens should not be interpreted to impose such an obstacle. Such an interpretation would be especially problematic given the millions of women, in a variety of contexts, whom the Mandate does not ultimately benefit, notwithstanding any expanded exemptions—including through grandfathering of plans, the previous religious exemptions, and the failure of the accommodation to require delivery of contraceptive coverage in various self-insured church plan contexts.
In addition, the Government is under no constitutional obligation to fund contraception.
As the Department of Justice has observed, the fact that exemptions may relieve a religious adherent from conferring a benefit on a third party “does not categorically render an exemption unavailable,” and RFRA still applies.
When government relieves burdens on religious exercise, it does not violate the Establishment Clause; rather, “it follows the best of our traditions.”
Before 2012 (when HRSA's Guidelines went into effect), there was no federal women's preventive services coverage mandate imposed nationally on health insurance and group health plans. The ACA did not require contraceptives to be included in HRSA's Guidelines, and it did not require any preventive services required under PHS
Commenters offered various assessments of the impact these rules might have on state or local governments. Some commenters said that the expanded exemptions will not burden state or local governments, or that such burdens should not prevent the Departments from offering those exemptions. Others said that if the Departments provide expanded exemptions, states or local jurisdictions may face higher costs in providing birth control to women through government programs. The Departments consider it appropriate to offer expanded exemptions, notwithstanding the objection of some state or local governments. The ACA did not require a contraceptive Mandate, and its discretionary creation by means of HRSA's Guidelines does not translate to a benefit that the federal government owes to states or local governments. We are not aware of instances where the various situations recited in the previous paragraph, in which the federal government has not imposed contraceptive coverage (other than through the Religious and Moral IFCs), have been determined to cause a cognizable injury to state or local governments. Some states that were opposed to the IFCs submitted comments objecting to the potential impacts on their programs resulting from the expanded exemptions, but they did not adequately demonstrate that such impacts would occur, and they did not explain whether, or to what extent, they were impacted by the other kinds of instances mentioned above in which no federal mandate of contraceptive coverage has applied to certain plans. The Departments find no legal prohibition on finalizing these rules based on the speculative suggestion of an impact on state or local governments, and we disagree with the suggestion that once we have exercised our discretion to deny exemptions—no matter how recently or incompletely—we cannot change course if some state and local governments believe they are receiving indirect benefits from the previous decision.
In addition, these expanded exemptions apply only to a small fraction of entities to which the Mandate would otherwise apply—those with qualifying religious objections. Public comments did not provide reliable data on how many entities would use these expanded religious exemptions, in which states women in such plans would reside, how many of those women would qualify for or use state and local government subsidies of contraceptives as a result, or in which states such women, if they are low income, would go without contraceptives and potentially experience unintended pregnancies that state Medicaid programs would have to cover. As mentioned above, at least one study, published by the Guttmacher Institute, concluded the Mandate has caused no clear increase in contraceptive use; one explanation proposed by the authors of the study is that women eligible for family planning from safety net programs were already receiving free or subsidized contraceptive access through them, notwithstanding the Mandate's effects on the overall market. Some commenters who opposed the expanded exemptions admitted that this information is unclear at this stage; other commenters that estimated considerably more individuals and entities would seek an exemption also admitted the difficulty of quantifying estimates.
In the discussion below concerning estimated economic impacts of these rules, the Departments explain there is not reliable data available to accurately estimate the number of women who may lose contraceptive coverage under these rules, and the Departments set forth various reasons why it is difficult to know how many entities will use these exemptions or how many women will be impacted by those decisions. Solely for the purposes of determining whether the rules have a significant economic impact under Executive Order 12,866, and in order to estimate the broadest possible impact so as to determine the applicability of the procedures set forth in that Executive Order, the Departments propose that the rules will affect no more than 126,400 women of childbearing age who use contraceptives covered by the Guidelines, and conclude the economic impact falls well below $100 million. As explained below, that estimate assumes that a certain percentage of employers which did not cover contraceptives before the ACA will use these exemptions based on sincerely held religious beliefs. The Departments do not actually know that such entities will do so, however, or that they operate based on sincerely held religious beliefs against contraceptive coverage. The Departments also explain that other exemptions unaffected by these rules may encompass many or most women potentially affected by the expanded exemptions. In other words, the houses of worship and integrated auxiliaries exemption, the accommodation's failure to require contraceptive coverage in certain self-insured church plans, the non-applicability of PHS Act section 2713 to grandfathered plans, and the permanent injunctive relief many religious litigants have received against section 2713(a)(4), may encompass a large percentage of women potentially affected by religious objections, and therefore many women in those plans may not be impacted by these rules at all. In addition, even if 126,400 women might be affected by these rules, that number constitutes less than 0.1% of all women in the United States.
Some commenters contended that the expanded exemptions would constitute unlawful sex discrimination, such as under section 1557 of the Affordable Care Act, Title VII of the Civil Rights Act of 1964, Title IX of the Education Amendments of 1972, or the Fifth Amendment. Some commenters suggested the expanded exemptions
But these final rules do not discriminate or draw any distinctions on the basis of sex, pregnancy, race, disability, socio-economic class, LGBT status, or otherwise, nor do they discriminate on any unlawful grounds. The expanded exemptions in these rules do not authorize entities to comply with the Mandate for one person, but not for another person, based on that person's status as a member of a protected class. Instead they allow entities that have sincerely held religious objections to providing some or all contraceptives included in the Mandate to not be forced to provide coverage of those items to anyone.
These commenters' contentions about discrimination are unpersuasive for still additional reasons. First, Title VII is applicable to discrimination committed by employers, and these rules have been issued in the government's capacity as a regulator of group health plans and group and individual health insurance, not an employer.
It is simply not the case that the government's implementation of section 2713(a)(4) is discriminatory against women because exemptions are expanded to encompass religious objections. The previous regulations, as discussed elsewhere herein, do not require contraceptive coverage in a host of plans, including grandfathered plans, plans of houses of worship, and—through inability to enforce the accommodation on certain third party administrators—plans of many religious non-profits in self-insured church plans. Below, the Departments estimate that few women of childbearing age in the country will be affected by these expanded exemptions.
It is not clear that these expanded exemptions will significantly burden women most at risk of unintended pregnancies. Some commenters observed that contraceptives are often readily accessible at relatively low cost. Other commenters disagreed. Some objected to the suggestion in the Religious IFC that many forms of contraceptives are available for around $50 per month and other forms, though they bear a higher one-time cost, cost a similar amount over the duration of use. But some of those commenters cited sources maintaining that birth control pills can cost up to $600 per year (that is, $50 per month), and said that IUDs, which can last three to six years or more,
The Departments do not believe that these general considerations make it inappropriate to issue the expanded exemptions set forth in these rules. In addition, the Departments note that the HHS Office of Population Affairs, within the Office of the Assistant Secretary for Health, has recently issued a proposed regulation to amend the regulations governing its Title X family planning program. The proposed regulation would amend the definition of “low income family”—individuals eligible for free or low cost contraceptive services—to include women who are unable to obtain certain family planning services under their employer-sponsored health coverage due to their employers' religious beliefs or moral convictions (see 83 FR 25502). If that regulation is finalized as proposed, it could further reduce any potential effect of these final rules on women's access to contraceptives. That proposal also demonstrates that the government has other means available to it for increasing women's access to contraception. Some of those means are less restrictive of religious exercise than imposition of the contraceptive Mandate on employers with sincerely held religious objections to providing such coverage.
Some commenters stated that the expanded exemptions would violate section 1554 of the ACA. That section says the Secretary of HHS “shall not promulgate any regulation” that “creates any unreasonable barriers to the ability of individuals to obtain appropriate medical care,” “impedes timely access to health care services,” “interferes with communications regarding a full range of treatment options between the patient and the provider,” “restricts the ability of health care providers to provide full disclosure of all relevant information to patients making health care decisions,” “violates the principles of informed consent and the ethical standards of health care professionals,” or “limits the
The Departments disagree with these comments about section 1554. The Departments issued previous exemptions and accommodations that allowed various plans to not provide contraceptive coverage on the basis of religious objections. The Departments, which administer both ACA section 1554 and PHS Act section 2713, did not conclude that the exemptions or accommodations in those regulations violated section 1554. Moreover, the decision not to impose a governmental mandate is not the “creation” of a “barrier,” especially when that mandate requires private citizens to provide services to other private citizens. Nor, in any event, are the exemptions from the Mandate unreasonable. Section 1554 of the ACA does not require the Departments to require coverage of, or to keep in place a requirement to cover, certain services, including contraceptives, that was issued pursuant to HHS's exercise of discretion under section 2713(a)(4). Nor does section 1554 prohibit the Departments from providing exemptions for burdens on religious exercise, or, as is the case here, from refraining to impose the Mandate in cases where religious exercise would be burdened by it. In light of RFRA and the First Amendment, providing religious exemptions is a reasonable administrative response in the context of this federally mandated burden, especially since the burden itself is a subregulatory creation that does not apply in various contexts. Religious exemptions from federal mandates in sensitive health contexts have existed in federal laws for decades, and President Obama referenced them when he issued Executive Order 13535 (March 24, 2010), declaring that, under the ACA, “longstanding Federal laws to protect conscience (such as the Church Amendment, 42 U.S.C. 300a-7, and the Weldon Amendment, section 508(d)(1) of Pub. L. 111-8) remain intact,” and that “[n]umerous executive agencies have a role in ensuring that these restrictions are enforced, including the HHS.” While the text of Executive Order 13535 does not require the expanded exemptions issued in these rules, the expanded exemptions are, as explained below, consistent with longstanding federal laws to protect religious beliefs.
In short, the Departments do not believe sections 1554 or 1557 of the ACA, other nondiscrimination statutes, or any constitutional doctrines, create an affirmative obligation to create, maintain, or impose a Mandate that forces covered entities to provide coverage of preventive contraceptive services in health plans. The ACA's grant of authority to HRSA to provide for, and support, the Guidelines is not transformed by any of the laws cited by commenters into a requirement that, once those Guidelines exist, they can never be reconsidered or amended because doing so would only affect women's coverage or would allegedly impact particular populations disparately.
Members of the public have widely divergent views on whether expanding the exemptions is good public policy. Some commenters said the exemptions would burden workers, families, and the economic and social stability of the country, and interfere with the physician-patient relationship. Other commenters disagreed, favoring the public policy behind expanding the exemptions and arguing that the exemptions would not interfere with the physician-patient relationship. For all the reasons explained at length in this preamble, the Departments have determined that these rules are good policy. Because of the importance of the religious liberty values being accommodated, the limited impact of these rules, and uncertainty about the impact of the Mandate overall according to some studies, the Departments do not believe these rules will have any of the drastic negative consequences on third parties or society that some opponents of these rules have suggested.
The Departments received several comments about their decision to issue the Religious IFC as interim final rules with requests for comments, instead of as a notice of proposed rulemaking. Several commenters asserted that the Departments had the authority to issue the Religious IFC in that way, agreeing that the Departments had explicit statutory authority to do so, good cause under the Administrative Procedure Act (APA), or both. Other commenters held the opposite view, contending that there was neither statutory authority to issue the rules on an interim final basis, nor good cause under the APA to make the rules immediately effective.
The Departments continue to believe legal authority existed to issue the Religious IFC as interim final rules. Section 9833 of the Code, section 734 of ERISA, and section 2792 of the PHS Act authorize the Secretaries of the Treasury, Labor, and HHS (collectively, the Secretaries) to promulgate any interim final rules that they determine are appropriate to carry out the provisions of chapter 100 of the Code, part 7 of subtitle B of title I of ERISA, and part A of title XXVII of the PHS Act, which include sections 2701 through 2728 of the PHS Act and the incorporation of those sections into section 715 of ERISA and section 9815 of the Code. The Religious and Moral IFCs fall under those statutory authorizations for the use of interim final rulemaking. Prior to the Religious IFC, the Departments issued three interim final rules implementing this section of the PHS Act because of the needs of covered entities for immediate guidance and the weighty matters implicated by the HRSA Guidelines, including issuance of new or revised exemptions or accommodations. (75 FR 41726; 76 FR 46621; 79 FR 51092). The Departments also had good cause to issue the Religious IFC as interim final rules, for the reasons discussed therein.
In any event, the objections of some commenters to the issuance of the Religious IFC as interim final rules with request for comments does not prevent the issuance of these final rules. These final rules are being issued after receiving and thoroughly considering public comments as requested in the Religious IFC. These final rules therefore comply with the APA's notice and comment requirements.
The Departments received numerous comments on the health effects of contraception and pregnancy. As noted above, some commenters supported the expanded exemptions, and others urged that contraceptives be removed from the Guidelines entirely, based on the view that pregnancy and the unborn children resulting from conception are not diseases or unhealthy conditions that are properly the subject of preventive care coverage. Such commenters further contended that hormonal contraceptives may present health risks to women. For example, they contended that studies show certain contraceptives cause or are associated with an increased risk of depression,
Other commenters disagreed, citing a variety of studies they contend show health benefits caused by, or associated with, contraceptive use or the prevention of unintended pregnancy. Commenters cited, for example, the 2011 IOM Report's discussions of the negative effects associated with unintended pregnancies, as well as other studies. Such commenters contended that, by reducing unintended pregnancy, contraceptives reduce the risk of unaddressed health complications, low birth weight, preterm birth, infant mortality, and maternal mortality.
Some commenters said that, in the Religious IFC, the Departments made incorrect statements concerning scientific studies. For example, some commenters argued there is no proven increased risk of breast cancer or other risks among contraceptive users. They criticized the Religious IFC for citing studies, including one previewed in the 2011 IOM Report itself (Agency for Healthcare Research and Quality Report No.: 13-E002-EF (June 2013) (cited above)), discussing an association between contraceptive use and increased risks of breast and cervical cancer, and concluding there are no net cancer-reducing benefits of contraceptive use. As described in the Religious IFC, 82 FR at 47804, the 2013 Agency for Healthcare Research and Quality study, and others, reach conclusions with which these commenters appear to disagree. The Departments consider it appropriate to take into account both of those studies, as well as the studies cited by commenters who disagree with those conclusions.
Some commenters further criticized the Departments for saying two studies cited by the 2011 IOM Report, which asserted an associative relationship between contraceptive use and decreases in unintended pregnancy, did not on their face establish a causal relationship between a broad coverage mandate and decreases in unintended pregnancy. In this respect, as noted in the Religious IFC,
Commenters disagreed about the effects of some FDA-approved contraceptives on embryos. Some
The objection on this issue appears to be partially one of semantics. People disagree about whether to define “conception” or “pregnancy” to occur at fertilization, when the sperm and ovum unite, or days later at implantation, when that embryo has undergone further cellular development, travelled down the fallopian tube, and implanted in the uterine wall. This question is independent of the question of what mechanisms of action FDA-approved or cleared contraceptives may have. It is also a separate question from whether members of the public assert, or believe, that it is appropriate to consider the items “abortifacient”—that is, a kind of abortion, or a medical product that causes an abortion—because they believe abortion means to cause the demise of a post-fertilization embryo inside the mother's body. Commenters referenced scientific studies and sources on both sides of the issue of whether certain contraceptives prevent implantation. Commenters and litigants have positively stated that some of them view certain contraceptives as abortifacients, for this reason.
The Departments do not take a position on the scientific, religious, or moral debates on this issue by recognizing that some people have sincere religious objections to providing contraception coverage on this basis. The Supreme Court has already recognized that such a view can form the basis of a sincerely held religious belief under RFRA.
The Departments also received comments about their discussion of the uncertain effects of the expanded exemptions on teen sexual activity. In this respect, the Departments stated, “With respect to teens, the Santelli and Melnikas study cited by IOM 2011 observes that, between 1960 and 1990, as contraceptive use increased, teen sexual activity outside of marriage likewise increased (although the study does not assert a causal relationship). Another study, which proposed an economic model for the decision to engage in sexual activity, stated that `[p]rograms that increase access to contraception are found to decrease teen pregnancies in the short run but increase teen pregnancies in the long run.' ”
Many commenters opposing the Religious IFC misunderstood the Departments' discussion of this issue. Teens are a significant part, though not the entirety, of women the IOM identified as being most at risk of unintended pregnancy. The Departments do not take a position on the empirical question of whether contraception has caused certain reductions in teen pregnancy. Rather, we note that studies suggesting various causes of teen pregnancy and unintended pregnancy in general support the Departments' conclusion that it is difficult to establish causation between granting religious exemptions to the contraceptive Mandate and either an increase in teen pregnancies in particular, or unintended pregnancies in general. For example, a 2015 study investigating the decline in teen pregnancy since 1991 attributed it to multiple factors (including but not limited to reduced sexual activity, falling welfare benefit levels, and expansion of family planning services in Medicaid, with the latter accounting for less than 13 percent of the decline), and concluded “that none of the relatively easy, policy-based explanations for the recent decline in teen childbearing in the United States hold up very well to careful empirical scrutiny.”
As the Departments stated in the Religious IFC, we do not take a position on the variety of empirical questions discussed above. Likewise, these rules do not address the substantive question of whether HRSA should include contraceptives in the women's preventive services Guidelines issued under section 2713(a)(4). Rather, reexamination of the record and review of the public comments has reinforced the Departments' conclusion that significantly more uncertainty and ambiguity exists on these issues than the Departments previously acknowledged when we declined to extend the exemption to certain objecting organizations and individuals. The uncertainty surrounding these weighty and important issues makes it appropriate to maintain the expanded exemptions and accommodation if and for as long as HRSA continues to include contraceptives in the Guidelines. The federal government has a long history, particularly in certain sensitive and multi-faceted health issues, of providing religious exemptions from governmental mandates. These final rules are consistent with that history and with the discretion Congress vested in the Departments for implementing the ACA.
The Departments also received comments about the health and equality effects of the Mandate more broadly. Some commenters contended that the contraceptive Mandate promotes the health and equality of women, especially low income women and promotes female participation and equality in the workforce. Other commenters contended that there was insufficient evidence that the expanded exemptions would harm those interests. Some of those commenters further questioned whether there was evidence that broad health coverage mandates of contraception lead to increased contraceptive use, reductions in unintended pregnancies, or reductions in negative effects said to be associated with unintended pregnancies. In particular, some commenters discussed the study quoted above, published and revised by the Guttmacher Institute in October 2017, concluding that through 2014 there were no significant changes in the overall proportion of women who used a contraceptive method both among all women and among women at risk of unintended pregnancy, that there was no significant shift from less effective to more effective methods, and that it was “unclear” whether this Mandate impacted contraceptive use because there was no significant increase in the use of contraceptive methods the Mandate covered.
The Departments have considered these experiences as relevant to the effect the expanded exemptions in these rules might have on the Mandate more broadly. The state mandates apply to a very large number of plans and plan participants, notwithstanding ERISA preemption, and public commenters did not point to studies showing those state mandates reduced unintended pregnancies. The federal contraceptive Mandate, likewise, applies to a broad, but not entirely comprehensive, number of employers. For example, to the extent that houses of worship and integrated auxiliaries may have self-insured to avoid state health insurance contraceptive coverage mandates or for other reasons, those groups are, and have been, exempt from the federal Mandate prior to the Religious IFC. The exemptions as set forth in the Religious IFC and in these final rules leave the contraceptive Mandate in place for nearly all entities and plans to which the Mandate has applied. The Departments are not aware of data showing that these expanded exemptions would negate any reduction in unintended pregnancies that might
Some commenters expressed concern that providing exemptions to the Mandate that private parties provide contraception may lead to exemptions regarding other medications or services, like vaccines. The exemptions provided in these rules, however, do not apply beyond the contraceptive coverage requirement implemented through section 2713(a)(4). Specifically, PHS Act section 2713(a)(2) requires coverage of “immunizations,” and these exemptions do not encompass that requirement. The fact that the Departments have exempted houses of worship and integrated auxiliaries from the contraceptive Mandate since 2011 did not lead to those entities receiving exemptions under section 2713(a)(2) concerning vaccines. In addition, hundreds of entities have sued the Departments over the implementation of section 2713(a)(4), leading to two decisions of the U.S. Supreme Court, but no similar wave of lawsuits has challenged section 2713(a)(2). The expanded exemptions in these final rules are consistent with a long history of statutes protecting religious beliefs from certain health care mandates concerning issues such as sterilization, abortion and birth control.
Some commenters took issue with the conclusion set forth in the Religious IFC, which is similar to that asserted in the 2017 Guttmacher study, that “[t]he role that the contraceptive coverage guarantee played in impacting use of contraception at the national level remains unclear, as there was no significant increase in the use of methods that would have been covered under the ACA.” They observed that more women have coverage of contraceptives and contraception counseling under the Mandate and that more contraceptives are provided without co-pays than before. Still other commenters argued that the Mandate, or other expansions of contraceptive coverage, have led women to increase their use of contraception in general, or to change from less effective, less expensive contraceptive methods to more effective, more expensive contraceptive methods. Some commenters lamented that exemptions would include exemption from the requirement to cover contraception counseling. Some commenters pointed to studies cited in the 2011 IOM Report recommending contraception be included in the Guidelines and argued that certain women will go without certain health care, or contraception specifically, because of cost. They contended that a smaller percentage of women delay or forego health care overall under the ACA
The Departments have reviewed the comments, including studies submitted by commenters either supporting or opposing these expanded exemptions. Based on our review, it is not clear that merely expanding exemptions as done in these rules will have a significant effect on contraceptive use and health, or workplace equality, for the vast majority of women benefitting from the Mandate. There is conflicting evidence regarding whether the Mandate alone, as distinct from birth control access more generally, has caused increased contraceptive use, reduced unintended pregnancies, or eliminated workplace disparities, where all other women's preventive services were covered without cost sharing. Without taking a definitive position on those evidentiary issues, however, we conclude that the Religious IFC and these final rules—which merely withdraw the Mandate's requirement from what appears to be a small group of newly exempt entities and plans—are not likely to have negative effects on the health or equality of women nationwide. We also conclude that the expanded exemptions are an appropriate policy choice left to the agencies under the relevant statutes, and, thus, are an appropriate exercise of the Departments' discretion.
Moreover, we conclude that the best way to balance the various policy interests at stake in the Religious IFC and these final rules is to provide the expanded exemptions set forth herein, even if certain effects may occur among the populations actually affected by the employment of these exemptions. These rules will provide tangible protections for religious liberty, and impose fewer governmental burdens on various entities and individuals, some of whom have contended for several years that denying them an exemption from the contraceptive Mandate imposes a substantial burden on their religious exercise. The Departments view the provision of those protections to preserve religious exercise in this health care context as an appropriate policy option, notwithstanding the widely divergent effects that public commenters have predicted based on different studies they cited. Providing the protections for religious exercise set forth in the Religious IFC and these final rules is not inconsistent with the ACA, and brings this Mandate into better alignment with various other federal conscience protections in health care, some of which have been in place for decades.
Here, the Departments describe the regulatory text set forth prior to the Religious IFC, the regulations from that IFC, public comments in response to the specific regulatory text set forth in the IFC, the Departments' response to those comments, and, in consideration of those comments, the regulatory text as finalized in this final rule. As noted above, various members of the public provided comments that were supportive, or critical, of the Religious IFC overall, or of significant policies pertaining to those regulations. To the extent those comments apply to the following regulatory text, the Departments have responded to them above. This section of the preamble responds to comments that pertain more specifically to particular regulatory text.
The previous regulations restated the statutory requirements of section 2713(a) of the PHS Act, at 26 CFR 54.9815-2713(a)(1) and (a)(1)(iv), 29 CFR 2590.715-2713(a)(1) and (a)(1)(iv), and 45 CFR 147.130(a)(1) and (a)(1)(iv). The Religious IFC modified these restatements to more closely align them with the text of PHS Act section 2713(a) and (a)(4).
Previous versions of these rules had varied from the statutory language. PHS Act section 2713(a) and (a)(4) require group health plans and health insurance issuers offering coverage to provide coverage without cost sharing for “such additional preventive care and screenings not described in paragraph (1) as provided for in comprehensive guidelines” supported by HRSA. In comparison, the previous version of regulatory restatements of this language (as drawn from 45 CFR 147.130(a)(1)
These rules adopt as final, without change, the provisions in the Religious IFC amending 26 CFR 54.9815-2713(a)(1) and (a)(1)(iv), 29 CFR 2590.715-2713(a)(1) and (a)(1)(iv), and 45 CFR 147.130(a)(1) and (a)(1)(iv). In this way, the regulatory text better conforms to the statutory language. In paragraph (a)(1) of the final regulations, instead of saying “must provide coverage for all of the following items and services, and may not impose any cost-sharing requirements . . . with respect to those items and services:”, the regulation now tracks the statutory language by saying “must provide coverage for and must not impose any cost-sharing requirements . . . for—”. By eliminating the language “coverage for all of the following items and services,” and “with respect to those items and services,” the Departments do not intend that coverage for specified items and services will not be required, but we simply intend to simplify the text of the regulation to track the statute and avoid duplicative language.
By specifying that paragraph (a)(1)(iv) concerning the women's preventive services Guidelines encompasses “such additional preventive care and screenings not described in paragraph (a)(1)(i) of this section as provided for in comprehensive guidelines supported by the Health Resources and Services Administration for purposes of section 2713(a)(4) of the Public Health Service Act, subject to §§ 147.131 and 147.132,” the regulatory text also better tracks the statutory language that the Guidelines are for “such additional” preventive services as HRSA may “provide[ ] for” and “support[ ].” This text also eliminates language, not found in the statute, that the Guidelines are “evidence-informed” and “binding.” Congress did not include the word “binding” in PHS Act section 2713, and did include the words “evidence-based” or “evidence-informed” in section 2713(a)(1) and (a)(3), but omitted such terms from section 2713(a)(4). In this way, the regulatory text better comports with the scope of the statutory text. This text of paragraph (a)(1)(iv) also acknowledges that the Departments have decided Guidelines issued under section 2713(a)(4) will not be provided for or supported to the extent they exceed the exemptions and accommodation set forth in 45 CFR 147.131 and 147.132. Previous versions of the regulation placed that limit in 45 CFR 147.130(a)(1), but did not reiterate it in § 147.130(a)(1)(iv). To clearly set forth the applicability of the exemptions and accommodation, the Departments adopt as final the Religious IFC language, which included the language “subject to §§ 147.131 and 147.132” in both § 147.130(a)(1) and § 147.130(a)(1)(iv). Because these final rules adopt as final the Religious IFC language which includes the exemptions and accommodation in both §§ 147.131 and 147.132, and not just in § 147.131 as under the previous rules, the Departments correspondingly included references to both sections in this part.
Some commenters supported restoring the statutory language from PHS Act section 2713(a) and (a)(4) in the regulatory restatements of that language. Other commenters opposed doing so, asserting that Guidelines issued pursuant to section 2713(a)(4) must be “evidence-informed” and “binding.” The Departments disagree with the position that, even though Congress omitted those terms from section 2713(a)(4), their regulatory restatement of the statutory requirement should include those terms. Instead, the Departments conclude that it is more appropriate for the regulatory restatements of section 2713(a)(4) to track the statutory language in this regard, namely, “as provided for in comprehensive guidelines supported by [HRSA] for purposes of” that paragraph.
These final rules adopt as final, with changes based on comments as set forth below, the regulatory provision in the Religious IFC that moved the religious exemption from 45 CFR 147.131(a) to 45 CFR 147.132.
In the previous regulations, the exemption stated, at § 147.131(a), that HRSA's Guidelines “may establish an exemption” for the health plan or coverage of a “religious employer,” defined as “an organization that is organized and operates as a nonprofit entity and is referred to in section 6033(a)(3)(A)(i) or (iii) of the Internal Revenue Code.” The Religious IFC moved the exemption to a new § 147.132, in which paragraph (a) discussed objecting entities, paragraph (b) discussed objecting individuals, paragraph (c) set forth a definition, and paragraph (d) discussed severability. The prefatory language to § 147.132(a)(1) stated that HRSA's Guidelines “must not provide for or support the requirement of coverage or payments for contraceptive services” for the health plan or coverage of an “objecting organization,” and thus that HRSA “will exempt” such an organization from the contraceptive coverage requirments of the Guidelines. The remainder of paragraph (a)(1), which is discussed in greater detail below, describes what entities are included as objecting organizations.
This language not only specifies that certain entities are “exempt,” but also explains that the Guidelines shall not support or provide for an imposition of the contraceptive coverage requirement to such exempt entities. This is an acknowledgement that section 2713(a)(4) requires women's preventive services coverage only “as provided for in comprehensive guidelines supported by the Health Resources and Services Administration.” To the extent the HRSA Guidelines do not provide for, or support, the application of such coverage to certain entities or plans, the Affordable Care Act does not require the coverage. Those entities or plans are “exempt” by not being subject to the requirements in the first instance. Therefore, in describing the entities or plans as “exempt,” and in referring to the “exemption” encompassing those entities or plans, the Departments also affirm the non-applicability of the Guidelines to them.
The Departments wish to make clear that the expanded exemption set forth in § 147.132(a) applies to several distinct entities involved in the provision of coverage to the objecting employer's employees. This explanation is consistent with how prior regulations have worked by means of similar language. When sections § 147.132(a)(1) and (a)(1)(i) specify that “[a] group health plan,” “health insurance coverage provided in connection with a group health plan,” and “health insurance coverage offered or arranged by an objecting organization” are exempt “to the extent” of the objections “as specified in paragraph (a)(2),” that language exempts the group health plans of the sponsors that object, and their health insurance issuers in providing the coverage in those plans (whether or not the issuers have their own objections). Consequently, with respect to Guidelines issued under § 147.130(a)(1)(iv) (and as referenced by the parallel provisions in 26 CFR 54.9815-2713(a)(1)(iv) and 29 CFR 2590.715-2713(a)(1)(iv)), the plan
The exemptions in § 147.132(a)(1) apply “to the extent” of the objecting entities' sincerely held religious convictions. Thus, entities that hold a requisite objection to covering some, but not all, contraceptive items would be exempt with respect to the items to which they object, but not with respect to the items to which they do not object. Some commenters said it was unclear whether the plans of entities or individuals that religiously object to some but not all contraceptives would be exempt from being required to cover just the contraceptive methods as to which there is an objection, or whether the objection to some contraceptives leads to an exemption from that plan being required to cover all contraceptives. The Departments intend that a requisite religious objection against some but not all contraceptives would lead to an exemption only to the extent of that objection: That is, the exemption would encompass only the items to which the relevant entity or individual objects, and would not encompass contraceptive methods to which the objection does not apply. To make this clearer, in these final rules, the Departments finalize the prefatory language of § 147.132(a) with the following change, so that the final rules state that an exemption shall be included, and the Guidelines must not provide for contraceptive coverage, “to the extent of the objections specified below.”
The Departments have made corresponding changes to language throughout the regulatory text, to describe the exemptions as applying “to the extent” of the objection(s).
In 45 CFR 147.132(a)(1)(i) through (iii) and (b), the Religious IFC expands the exemption to plans of additional entities and individuals not encompassed by the exemption set forth in the regulations prior to the Religious IFC. Specific entities to which the expanded exemptions apply are discussed below.
The exemptions contained in previous regulations, at § 147.131(a), did not require exempt entities to submit any particular self-certification or notice, either to the government or to their issuer or third party administrator, in order to obtain or qualify for the exemption. Similarly, under the expanded exemptions in § 147.132, the Religious IFC did not require exempt entities to comply with a self-certification process. We finalize that approach in this respect without change. Although exempt entities do not need to file notices or certifications of their exemption, and these final rules do not impose any new notice requirements on them, existing ERISA rules governing group health plans require that, with respect to plans subject to ERISA, a plan document must include a comprehensive summary of the benefits covered by the plan and a statement of the conditions for eligibility to receive benefits. Under ERISA, the plan document identifies what benefits are provided to participants and beneficiaries under the plan; if an objecting employer would like to exclude all or a subset of contraceptive services, it must ensure that the exclusion is clear in the plan document. Moreover, if there is a reduction in a covered service or benefit, the plan has to disclose that change to plan participants.
Some commenters supported the expanded exemption's approach which maintained the policy of the previous exemption in not requiring exempt entities to comply with a self-certification process. They suggested that self-certification forms for an exemption are not necessary, could add burdens to exempt entities beyond those imposed by the previous exemption, and could give rise to religious objections to the self-certification process itself. Commenters also stated that requiring an exemption form for exempt entities could cause additional operational burdens for plans that have existing processes in place to handle exemptions. Other commenters, however, favored including a self-certification process for exempt entities. They suggested that entities might abuse the availability of an exemption or use exempt status insincerely if no self-certification process exists, and that the Mandate might be difficult to enforce without a self-certification process. Some commenters asked that the government publish a list of entities that claim the exemption.
The Departments believe it is appropriate to not require exempt entities to submit a self-certification or notice. The previous exemption did not require a self-certification or notice, and the Departments did not collect a list of all entities that used the exemption. The Departments believe the approach under the previous exemption is appropriate for the expanded exemption. Adding a self-certification or notice to the exemption process would impose an additional paperwork burden on exempt entities that the previous regulations did not impose, and would also involve additional public costs if those certifications or notices were to be reviewed or kept on file by the government.
The Departments are not aware of instances where the lack of a self-certification under the previous exemption led to abuses or to an inability to engage in enforcement. The Mandate is enforceable through various mechanisms in the PHS Act, the Code, and ERISA. Entities that insincerely or otherwise improperly operate as if they are exempt would do so at the risk of enforcement under such mechanisms. The Departments are not aware of sufficient reasons to believe those measures and mechanisms would fail to deter entities from improperly operating as if they are exempt. Moreover, as noted above, ERISA and other plan disclosure requirements governing group health plans require provision of a comprehensive summary of the benefits covered by the plan and disclosure of any reductions in covered services or benefits, so beneficiaries in plans that reduce or eliminate contraceptive benefits as a result of the exemption will know whether their health plan claims an exemption and will be able to raise appropriate challenges to such claims. As a consequence, the Departments believe it is an appropriate balance of various concerns expressed by commenters for these rules to continue to not require notices or self-certifications for using the exemption.
Some commenters asked the Departments to add language indicating that an exemption cannot be invoked in the middle of a plan year, nor should it be used to the extent inconsistent with laws that apply to, or state approval of, fully insured plans. None of the previous iterations of the exemption regulations included such provisions, and the Departments do not consider them necessary in these rules. The expanded exemptions in these rules only purport to exempt plans and entities from the application of the federal contraceptive coverage requirement of the Guidelines issued under section 2713(a)(4). They do not purport to exempt entities or plans from state laws concerning contraceptive coverage, or laws governing whether an entity can make a change (of whatever kind) during a plan year. The rules governing the accommodation likewise do not purport to obviate the need to follow otherwise applicable rules about making changes during a plan year. (Below, these rules discuss in more detail the accommodation and when an entity seeking to revoke it would be able to do so or to notify plan participants of the revocation.)
Commenters also asked that clauses be added to the regulatory text holding issuers harmless where exemptions are invoked by plan sponsors. As discussed above, the exemption rules already specify that, where an exemption applies to a group health plan, it encompasses both the group health plan and health insurance coverage provided in connection with the group health plan, and therefore encompasses any impact on the issuer of the contraceptive coverage requirement with respect to that plan. In addition, as discussed below, the Departments are including, in these final rules, language from the previous regulations protecting issuers that act in reliance on certain representations made in the accommodation process. To the extent that commenters seek language offering additional protections for other incidents that might occur in connection with the invocation of an exemption, the previous exemption regulations did not include such provisions, and the Departments do not consider them necessary in these final rules. As noted above, the expanded exemptions in these final rules simply remove or narrow the contraceptive Mandate contained in and derived from the Guidelines for certain plans. The previous regulations included a reliance clause in the accommodation provisions, but did not specify further details regarding the relationship between exempt entities and their issuers or third party administrators.
Regarding the Religious IFC's expansion of the exemption to other kinds of entities and individuals in general, commenters disagreed about the likely effects of the exemptions on the health coverage market. Some commenters said that expanding the exemptions would not cause complications in the market, while others said that it could, due to such causes as a lack of uniformity among plans or permitting multiple risk pools. The Departments note that the extent to which plans cover contraception under the prior regulations is already far from uniform. Congress did not require all entities to comply with section 2713 of the PHS Act (under which the Mandate was promulgated)—most notably by exempting grandfathered plans. Moreover, under the previous regulations, issuers were already able to offer plans that omit contraceptives—or offer only some contraceptives—to houses of worship and integrated auxiliaries; some commenters and litigants said that issuers were doing so. These cases where plans did not need to comply with the Mandate, and the Departments' previous accommodation process allowing coverage not to be provided in certain self-insured church plans, together show that the importance of a uniform health coverage system is not significantly harmed by allowing plans to omit contraception in some contexts.
Concerning the prospect raised by commenters of different risk pools between men and women, PHS Act section 2713(a) itself provides for some preventive services coverage that applies to both men and women, and some that would apply only to women. With respect to the latter, it does not specify what, if anything, HRSA's Guidelines for women's preventives services would cover, or if contraceptive coverage would be required. These rules do not require issuers to offer products that satisfy religiously objecting entities or individuals; they simply make it legal to do so. The Mandate has been imposed only relatively recently, and the contours of its application to religious entities has been in continual flux, due to various rulemakings and court orders. Overall, concerns raised by some public commenters have not led the Departments to consider it likely that offering these expanded exemptions will cause any injury to the uniformity or operability of the health coverage market.
With respect to employers and others that sponsor group health plans, in § 147.132(a)(1)(i), the Religious IFC provided exemptions for non-governmental plan sponsors that object to coverage of all, or a subset of, contraceptives or sterilization and related patient education and counseling based on sincerely held religious beliefs. The Departments finalize the prefatory text of § 147.132(a)(1)(i) without change.
The expanded exemptions covered any kind of non-governmental employer plan sponsor with the requisite objections, stating the exemption encompassed “[a] group health plan and health insurance coverage provided in connection with a group health plan to the extent the non-governmental plan sponsor objects as specified in paragraph (a)(2) of this section.” For the sake of clarity, the expanded exemptions also stated that “[s]uch non-governmental plan sponsors include, but are not limited to, the following entities,” followed by an illustrative, non-exhaustive list of non-governmental organizations whose objections qualify the plans they sponsor for an exemption. Each type of such entities, and comments specifically concerning them, are discussed below.
The plans of governmental employers are not covered by the plan sponsor exemption in § 147.132(a)(1)(i). Some commenters suggested that the expanded religious exemptions should include government entities. Others disagreed. The Departments are not aware of reasons why it would be appropriate or necessary to offer a religious exemption to governmental employer plan sponsors with respect to the contraceptive Mandate. We are unaware of government entities that would attempt to assert a religious exemption to the Mandate, and it is not clear to us that a governmental entity could do so. Accordingly, we conclude that it is appropriate for us to not further expand the religious exemption to include governmental entities in the religious plan-sponsor exemption.
Nevertheless, as discussed below, governmental employers are permitted to respect an individual's objection under § 147.132(b) and, thus, to provide
By the general extension of the exemption to the plans of plan sponsors in § 147.132(a)(1)(i), these final rules also exempt group health plans sponsored by an entity other than an employer (for example, a union, or a sponsor of a multiemployer plan) that objects based on sincerely held religious beliefs to coverage of contraceptives or sterilization. Some commenters objected to extending the exemption to such entities, arguing that they could not have the same kind of religious objection that a single employer might have. Other commenters supported the protection of any plan sponsor with the requisite religious objection. The Departments conclude that it is appropriate, where the plan sponsor of a union, multiemployer, or similar plan adopts a religious objection using the same procedures that such a plan sponsor might use to make other decisions, that the expanded exemptions should respect that decision by providing an exemption from the Mandate.
As noted above, the exemption in the previous regulations, found at § 147.131(a), included only “an organization that is organized and operates as a nonprofit entity and is referred to in section 6033(a)(3)(A)(i) or (iii) of the Internal Revenue Code of 1986, as amended.” Section 6033(a)(3)(A)(i) or (iii) of the Code encompasses “churches, their integrated auxiliaries, and conventions or associations of churches,” and “the exclusively religious activities of any religious order.”
The Religious IFC expanded the exemption to include, in § 147.132(a)(1)(i)(A), plans sponsored by “[a] church, an integrated auxiliary of a church, a convention or association of churches, or a religious order.” Most commenters did not oppose the exemptions continuing to include these entities, although some contended that the Departments have no authority to exempt any entity or plan from the Mandate, an objection to which the Departments respond above. Notably, this exemption exempts “a religious order,” and not merely “the exclusively religious activities of any religious order.” In addition, section 6033(a)(3)(A)(i) specifies that it covers churches, not merely “the exclusively religious activities” of a church. Some religious people might express their beliefs through a church, others might do so through a religious order, and still others might do so through religious bodies that take a different form, structure, or nomenclature based on a different cultural or historical tradition.
Moreover, the Departments also finalize the regulatory text to exempt plans “established or maintained by” a house of worship or integrated auxiliary on a plan, not employer, basis. Under previous regulations, the Departments stated that “the availability of the exemption or accommodation [was to] be determined on
The Departments do not believe there is a sufficient factual basis to exclude from this part of the exemption entities that are so closely associated with a house of worship or integrated auxiliary that they are permitted to participate in its health plan but are not themselves integrated auxiliaries. Additionally, this interpretation is not inconsistent with the operation of the accommodation under the prior regulation where with respect to self-insured church plans, hundreds of nonprofit religious entities participating in those plans were provided a mechanism by which their plan participants would not receive contraceptive coverage through the plan or third party administrator.
Therefore, the Departments believe it is most appropriate to use a plan basis, not an employer by employer basis, to determine the scope of an exemption for a group health plan established or maintained by a house of worship or integrated auxiliary.
The exemption under previous regulations did not encompass nonprofit religious organizations beyond one that is organized and operates as a nonprofit entity and is referred to in section 6033(a)(3)(A)(i) or (iii) of the Code. The Religious IFC expanded the exemption to include plans sponsored by any other
The Departments received comments in support of, and in opposition to, this expansion. Some commenters supported the expansion of the exemptions beyond houses of worship and integrated auxiliaries to other nonprofit organizations with religious objections (referred to herein as “religious nonprofit” organizations, groups or employers). They said that religious belief and exercise in American law has not been limited to worship, that religious people engage in service and social engagement as part of their religious exercise, and, therefore, that the Departments should respect the religiosity of nonprofit groups even when they are not houses of worship and integrated auxiliaries. Some public commenters and litigants have indicated that various religious nonprofit groups possess deep religious commitments even if they are not houses of worship or their integrated auxiliaries. Other commenters did not support the expansion of exemptions to nonprofit organizations. Some of them described churches as having a special status that should not be extended to religious nonprofit groups. Some others contended that women at nonprofit religious organizations may support or wish to use contraceptives and that if the exemptions are expanded, it would deprive all or most of the employees of various religious nonprofit organizations of contraceptive coverage.
After evaluating the comments, the Departments continue to believe that an expanded exemption is the appropriate administrative response to the substantial burdens on sincere religious beliefs imposed by the contraceptive Mandate, as well as to the litigation objecting to the same. We agree with the comments that religious exercise in this country has long been understood to encompass actions outside of houses of worship and their integrated auxiliaries. The Departments' previous assertion that the exemptions were intended to respect a certain sphere of church autonomy (80 FR 41325) is not, in itself, grounds to refuse to extend the exemptions to other nonprofit entities with religious objections. Respect for churches does not preclude respect for other religious entities. Among religious nonprofit organizations, the Departments no longer adhere to our previous assertion that “[h]ouses of worship and their integrated auxiliaries that object to contraceptive coverage on religious grounds are more likely than other employers to employ people of the same faith who share the same objection.” (78 FR 39874.) It is not clear to the Departments that the percentage of women who work at churches that oppose contraception, but who support contraception, is lower than the percentage of woman who work at nonprofit religious organizations that oppose contraception on religious grounds, but who support contraception. In addition, public comments and litigation reflect that many nonprofit religious organizations publicly describe their religiosity. Government records and those groups' websites also often reflect those groups' religious character. If a person who desires contraceptive coverage works at a nonprofit religious organization, the Departments believe it is sufficiently likely that the person would know, or would know to ask, whether the organization offers such coverage. The Departments are not aware of federal laws that would require a nonprofit religious organization that opposes contraceptive coverage to hire a person who the organization knows disagrees with the organization's view on contraceptive coverage. Instead, nonprofit organizations generally have access to a First Amendment right of expressive association and religious free exercise to choose to hire persons (or, in the case of students, to admit them) based on whether they share, or at least will be respectful of, their beliefs.
In addition, it is not at all clear to the Departments that expanding the exemptions would, as some commenters asserted, remove contraceptive coverage from employees of many large religious nonprofit organizations. Many large religious nonprofit employers, including but not limited to some Catholic hospitals, notified the Department under the last Administration that they had opted into the accommodation and expressed no objections to doing so. We also received public comments from organizations of similar nonprofit employers indicating that the accommodation satisfied their religious objections. These final rules leave the accommodation in place as an optional process. Thus, it is not clear to the Departments that all or most of such large nonprofit employers will choose to use the expanded exemption instead of the accommodation. If they continue to use the accommodation, their insurers or third party administrators would continue to be required to provide contraceptive coverage to the plan sponsors' employees through such accommodation.
Given the sincerely held religious beliefs of many nonprofit religious organizations, some commenters also contended that continuing to impose the contraceptive Mandate on certain nonprofit religious objectors might also undermine the Government's broader interests in ensuring health coverage by causing some entities to stop providing health coverage entirely.
The previous regulations did not exempt plans sponsored by closely held for-profit entities; however, the Religious IFC included in its list of exempt plan sponsors, at § 147.132(a)(1)(i)(C), “[a] closely held for-profit entity.” These rules finalize § 147.132(a)(1)(i)(C) without change.
Some commenters supported including these entities in the exemption, saying owners of such entities exercise their religious beliefs through their businesses and should not be burdened by a federal governmental contraceptive Mandate. Other commenters opposed extending the exemption to closely held for-profit entities, saying the entities cannot exercise religion or should not have their religious opposition to contraceptive coverage protected by the exemption. Some said the entities should not be able to impose their beliefs about contraceptive coverage on their employees, and that doing so constitutes discrimination.
As set forth in the Religious IFC, the Departments believe it is appropriate to expand the exemptions to include closely held for-profit employers in
Including closely held for-profit entities in the exemption is also consistent with the Supreme Court's ruling in
The previous regulations did not exempt for-profit entities that are not closely held. However, the Religious IFC included in its list of exempt plan sponsors, at § 147.132(a)(1)(i)(D), “[a] for-profit entity that is not closely held.” These rules finalize § 147.132(a)(1)(i)(D) without change.
Under § 147.132(a)(1)(i)(D), the rules extend the exemption to the plans of for-profit entities that are not closely held. Some commenters supported including such entities, including publicly traded businesses, in the scope of the exemption. Some of them said that publicly traded entities have historically taken various positions on important public concerns beyond merely (and exclusively) seeking the company's own profits, and that nothing in principle would preclude them from using the same mechanisms of corporate decision-making to exercise religious views against contraceptive coverage. They also said that other protections for religious beliefs in federal health care conscience statutes do not preclude the application of such protections to certain entities on the basis that they are not closely held, and federal law defines “persons,” protected under RFRA, to include corporations at 1 U.S.C. 1. Other commenters opposed including publicly traded companies in the expanded exemptions. Some of these commenters stated that such companies could not exercise religious beliefs, and opposed the effects on women if they could. These commenters also objected that including such employers, along with closely held businesses, would extend the exemptions to all or virtually all employers.
The Departments conclude it is appropriate to include entities that are not closely held within the expanded exemptions for entities with religious objection. RFRA prohibits the federal government from “substantially burden[ing] a person's exercise of religion . . . .” unless it demonstrates that the application of the burden to the person” is the least restrictive means to achieve a compelling governmental interest. 42 U.S.C. 2000bb-1(a) & (b). As commenters noted, the definition of “person” applicable in RFRA is found at 1 U.S.C. 1, which defines “person” as including “corporations, companies, associations, firms, partnerships, societies, and joint stock companies, as well as individuals.” Accordingly, the Departments' decision to extend the religious exemption to publicly traded for profit corporations is supported by the text of RFRA. The mechanisms for determining whether a company has adopted and holds certain principles or views, such as sincerely held religious beliefs, is a matter of well-established State law with respect to corporate decision-making,
As to the impact of so extending the religious exemption, the Departments are not aware of any publicly traded entities that have publicly objected to providing contraceptive coverage on the basis of religious belief. As noted above, before the ACA, a substantial majority of employers covered contraceptives. Some commenters opposed to including publicly traded entities in these exemptions noted that there did not appear to be any known religiously motivated objections to the Mandate from publicly traded for-profit corporations. These comments support our estimates that including publicly traded entities in the exemptions will have little, if any effect, on contraceptive coverage for women. We likewise agree with the Supreme Court's statement in
In the Departments' view, such estimate does not lead to the conclusion that the religious exemption should not be extended to publicly traded corporations. The Departments are generally aware that, in a country as large as the U.S., comprised of a supermajority of religious persons,
As noted above, the exemption in the previous regulations, found at § 147.131(a), included only churches, their integrated auxiliaries, conventions or associations of churches, and the exclusively religious activities of any religious order. The Religious IFC included, in its list of exempt plan sponsors at § 147.132(a)(1)(i)(E), “[a]ny other non-governmental employer.” These rules finalize § 147.132(a)(1)(i)(E) without change.
Some commenters objected to extending the exemption to other nongovernmental employers, asserting that it is not clear such employers should be protected, nor that they can assert religious objections. The Departments, however, agree with other commenters that supported that provision of the Religious IFC. The Departments believe it is appropriate that any nongovernmental employer asserting the requisite religious objections should be protected from the Mandate in the same way as other plan sponsors. Such other employers could include, for example, association health plans.
Based on the expressed intent in the Religious IFC, as discussed above, to expand the exemption to encompass plans established or maintained by nonprofit organizations with religious objections, and on public comments received concerning those exemptions, these rules finalize new language in § 147.132(a)(1)(ii) to better clarify the scope and application of the exemptions.
The preamble to the Religious IFC contained several discussions about the Departments' intent to exempt plans established or maintained by certain religious organizations that have the requisite objection to contraceptive coverage, including instances in which the plans encompass multiple employers. For example, as noted above, the Departments intended that the exemption for houses of worship and integrated auxiliaries be interpreted to apply on a plan basis, instead of on an employer-by-employer basis. In addition, the Departments discussed at length the fact that, under the prior regulations, where an entity was enrolled in a self-insured church plan exempt from ERISA under ERISA section 3(33) and the accommodation in the previous regulations was used, that accommodation process provided no mechanism to impose, or enforce, the accommodation requirement of contraceptive coverage against a third party administrator of such a plan. As a result, the prior accommodation served, in effect, as an exemption from requirements of contraceptive coverage for all organizations and employers covered under a self-insured church plan.
In response to these discussions in the Religious IFC, some commenters, including some church plans, supported the apparent intent to exempt such plans on a plan basis, but suggested that additional clarification is needed in the text of the rule to effect this intent. They observed that some plans are established or maintained by religious nonprofit entities that might not be houses of worship or integrated auxiliaries, and that some employers that adopt or participate in such plans may not be the “plan sponsors.” They recommended, therefore, that the final rules specify that the exemption applies on a plan basis when plans are established or maintained by houses of worship, integrated auxiliaries, or religious nonprofits, so as to shield employers that adopt such plans from penalties for noncompliance with the Mandate.
The text of the prefatory language of § 147.132(a)(1), as set forth in the Religious IFC, declared that the Guidelines would not apply “with respect to a group health plan established or maintained by an objecting organization, or health insurance coverage offered or arranged by an objecting organization.” We intended this language to exempt a plan and/or coverage where the entity that established or maintained a plan was an objecting organization, and not just to look at the views or status of individual employers (or other entities) participating in such plan. The Departments agree with commenters who stated that additional clarity is needed and appropriate in these final rules, in order to ensure that such plans are exempt on a plan basis, and that employers joining or adopting those plans are exempt by virtue of the plan itself being exempt. Doing so will make the application of the expanded exemption clearer, and protect employers (and other entities) participating in such plans from penalties for noncompliance with the Mandate. Clearer language will better realize the intent to exempt plans and coverage “established or maintained by an objecting organization,” and make the operation of that exemption simpler by specifying that the exemption applies based on the objection of the entity that established or maintains the plan. Such language would also resolve the anomaly that, under the previous rules, only self-insured church plans (not insured church plans) under ERISA section 3(33) were, in effect, exempt—but only indirectly through the Departments' inability to impose, or enforce, the accommodation process against the third party administrators of such plans, instead of being specifically exempt in the rules.
We believe entities participating in plans established or maintained by an objecting organization usually share the views of those organizations. Multiple lawsuits were filed against the Departments by churches that established or maintained plans, or the church plans themselves, and they generally declared that the entities or individuals participating in their plans
Therefore, the Departments finalize the text of § 147.132(a)(1) of the Religious IFC with the following change: adding a provision that makes explicit this understanding, in a new paragraph at § 147.132(a)(1)(ii). This language now specifies that the exemptions encompassed by § 147.132(a)(1) include: “[a] group health plan, and health insurance coverage provided in connection with a group health plan, where the plan or coverage is established or maintained by a church, an integrated auxiliary of a church, a convention or association of churches, a religious order, a nonprofit organization, or other organization or association, to the extent the plan sponsor responsible for establishing and/or maintaining the plan objects as specified in paragraph (a)(2) of this section. The exemption in this paragraph applies to each employer, organization, or plan sponsor that adopts the plan[.]”
The previous regulations did not exempt student health plans arranged by institutions of higher education, although it did, for purposes of the accommodation, treat plans arranged by institutions of higher education similar to the way in which the regulations treated plans of nonprofit religious employers.
These rules treat the plans of institutions of higher education that arrange student health insurance coverage similarly to the way in which the rules treat the plans of employers. These rules do so by making such student health plans eligible for the expanded exemptions, and by permitting them the option of electing to utilize the accommodation process. Thus, these rules specify, in § 147.132(a)(1)(iii), that the exemption is extended, in the case of institutions of higher education (as defined in 20 U.S.C. 1002) with objections to the Mandate based on sincerely held religious beliefs, to their arrangement of student health insurance coverage in a manner comparable to the applicability of the exemption for group health insurance coverage provided in connection with a group health plan established or maintained by a plan sponsor that is an employer.
Some commenters supported including, in the expanded exemptions, institutions of higher education that provide health coverage for students through student health plans but have religious objections to providing certain contraceptive coverage. They said that religious exemptions allow freedom for certain religious institutions of higher education to exist, and this in turn gives students the choice of institutions that hold different views on important issues such as contraceptives and abortifacients. Other commenters opposed including the exemption, asserting that expanding the exemptions would negatively impact female students because institutions of higher education might not cover contraceptives in student health plans, women enrolled in those plans would not receive access to birth control, and an increased number of unintended pregnancies would result among those women.
In the Departments' view, the reasons for extending the exemptions to institutions of higher education are similar to the reasons, discussed above, for extending the exemption to other nonprofit organizations. Only a minority of students in higher education receive health insurance coverage from plans arranged by their colleges or universities.
In addition, under the previous exemption and accommodation, it was possible for self-insured church plans exempt from ERISA that have religious objection to certain contraceptives to avoid any requirement that either they or their third party administrators provide contraceptive coverage. As seen
The Departments also note that the ACA does not require institutions of higher education to provide student health insurance coverage. As a result, some institutions of higher education that object to the Mandate appear to have chosen to stop arranging student health insurance plans, rather than comply with the Mandate or be subject to the accommodation.
As noted above, it is not clear that studies discussing various effects of birth control access clearly and specifically demonstrate a negative impact to students in higher education because of the expanded exemption in these final rules. The Departments consider these expanded exemptions to be an appropriate and permissible policy choice in light of various interests at stake and the lack of a statutory requirement for the Departments to impose the Mandate on entities and plans that qualify for these expanded exemptions.
Finally, the Religious IFC specified that the plan sponsor exemption applied to “non-governmental” plan sponsors (§ 147.132(a)(1)(i)), including “[a]ny other non-governmental employer” (§ 147.132(a)(1)(i)(E)). Then, in § 147.132(a)(1)(ii), the rule specified that the institution of higher education exemption applicable to the arrangement of student health insurance coverage applied “in a manner comparable to its applicability to group health insurance coverage provided in connection with a group health plan established or maintained by a plan sponsor that is an employer.” Consequently, the Religious IFC's expanded exemptions only applied to non-governmental institutions of higher education, including for student health insurance coverage, not to governmental institutions of higher education. Nevertheless, the term “non-governmental,” while appearing twice in § 147.132(a)(1)(i) concerning plan sponsors, was not repeated in in § 147.132(a)(1)(ii). To more clearly specify that this limitation was intended to apply to § 147.132(a)(1)(ii), we finalize this paragraph with a change by adding the phrase “which is non-governmental” after the phrase “An institution of higher education as defined in 20 U.S.C. 1002”.
The previous regulations did not exempt health insurance issuers. However, the Religious IFC included in its list of exemptions at § 147.132(a)(1)(iii), “[a] health insurance issuer offering group or individual insurance coverage to the extent the issuer objects as specified in paragraph (a)(2) of this section. Where a health insurance issuer providing group health insurance coverage is exempt under this paragraph (a)(1)(iii), the plan remains subject to any requirement to provide coverage for contraceptive services under Guidelines issued under § 147.130(a)(1)(iv) unless it is also exempt from that requirement[.]” These rules finalize this exemption with technical changes to clarify the language based on public comments, and redesignate the paragraph as § 147.132(a)(1)(iv).
The Religious IFC extends the exemption to health insurance issuers offering group or individual health insurance coverage that sincerely hold their own religious objections to providing coverage for contraceptive services. Under this exemption, the only plan sponsors—or in the case of individual insurance coverage, individuals—who are eligible to purchase or enroll in health insurance coverage offered by an exempt issuer that does not cover some or all contraceptive services, are plan sponsors or individuals who themselves object and whose plans are otherwise exempt based on their objection. An exempt issuer can then offer an exempt health insurance product to an entity or individual that is exempt based on either the moral exemptions for entities and individuals, or the religious exemptions for entities and individuals. Thus, the issuer exemption specifies that, where a health insurance issuer providing group health insurance coverage is exempt under paragraph (a)(1)(iii) of this section, the plan remains subject to any requirement to provide coverage for contraceptive services under Guidelines issued under § 147.130(a)(1)(iv), unless it is also exempt from that requirement.
Under these rules, issuers that hold their own objections, based on sincerely held religious beliefs, could issue policies that omit contraception to plan sponsors or individuals that are otherwise exempt based on their religious beliefs, or on their moral convictions under the companion final rules published elsewhere in today's
In the separate companion IFC to the Religious IFC—the Moral IFC—the Departments provided a similar exemption for issuers in the context of moral objections, but we used slightly different operative language. There, in the second sentence, instead of saying “the plan remains subject to any requirement to provide coverage for contraceptive services,” the exemption stated, “the group health plan established or maintained by the plan sponsor with which the health insurance issuer contracts remains subject to any requirement to provide coverage for contraceptive services.” Some commenters took note of this difference, and asked the Departments to clarify which language applies, and whether the Departments intended any difference in the operation of the two paragraphs. The Departments did not intend the language to operate differently. The language in the Moral IFC accurately, and more clearly, expresses the intent set forth in the Religious IFC about how the issuer exemption applies. Consequently, these rules finalize the issuer exemption paragraph from the Religious IFC with minor technical changes so that the final language will mirror language from the Moral IFC, stating that the exemption encompasses: “[a] health insurance issuer offering group or individual insurance coverage to the extent the issuer objects as specified in paragraph (a)(2) of this section. Where a health insurance issuer providing group health insurance coverage is exempt under paragraph (a)(1)(iv) of this section, the group health plan established or maintained by the plan sponsor with
Some commenters supported including this exemption for issuers in these rules, both to protect the religious exercise of issuers, and so that in the future religious issuers that may wish to specifically serve religious plan sponsors would be free to organize. Other commenters objected to including an exemption for issuers. Some objected that issuers cannot exercise religious beliefs, while others objected that exempting issuers would threaten contraceptive coverage for women. Some commenters said that it was arbitrary and capricious for the Departments to provide an exemption for issuers if we do not know that issuers with qualifying religious objections exist.
The Departments consider it appropriate to provide this exemption for issuers. Because the issuer exemption only applies where an independently exempt policyholder (entity or individual) is involved, the issuer exemption will not serve to remove contraceptive coverage obligations from any plan or plan sponsor that is not also exempt, nor will it prevent other issuers from being required to provide contraceptive coverage in individual or group insurance coverage. The issuer exemption therefore serves several interests, even though the Departments are not currently aware of existing issuers that would use it. As noted by some commenters, allowing issuers to be exempt, at least with respect to plan sponsors and plans that independently qualify for an exemption, will remove a possible obstacle to religious issuers being organized in the future to serve entities and individuals that want plans that respect their religious beliefs or moral convictions. Furthermore, permitting issuers to object to offering contraceptive coverage based on sincerely held religious beliefs will allow issuers to continue to offer coverage to plan sponsors and individuals, without subjecting them to liability under section 2713(a)(4), or related provisions, for their failure to provide contraceptive coverage. In this way, the issuer exemption serves to protect objecting issuers from being required to issue policies that cover contraception in violation of the issuers' sincerely held religious beliefs, and from being required to issue policies that omit contraceptive coverage to non-exempt entities or individuals, thus subjecting the issuers to potential liability if those plans are not exempt from the Guidelines.
The Departments reject the proposition that issuers cannot exercise religious beliefs. First, since RFRA protects the religious exercise of corporations as persons, the religious exercise of health insurance issuers—which are generally organized as corporations—is protected by RFRA. In addition, many federal health care conscience laws and regulations specifically protect issuers or plans. For example, 42 U.S.C. 1395w-22(j)(3)(B) and 1396u-2(b)(3) protect plans or managed care organizations in Medicaid or Medicare Advantage. The Weldon Amendment specifically protects, among other entities, provider-sponsored organizations, health maintenance organizations (HMOs), health insurance plans, and “any other kind of health care facilit[ies], organization[s], or plan[s]” as a “health care entity” from being required to pay for, or provide coverage of, abortions.
The issuer exemption does not specifically include third party administrators, although the optional accommodation process provided under these final rules specifies that third party administrators cannot be required to contract with an entity that invokes that process. Some religious third party administrators have brought suit in conjunction with suits brought by organizations enrolled in ERISA-exempt church plans. Such plans are now exempt under these final rules, and their third party administrators, as claims processors, are under no obligation under section 2713(a)(4) to provide benefits for contraceptive services, as that section applies only to plans and issuers. In the case of ERISA-covered plans, plan administrators are obligated under ERISA to follow the plan terms, but it is the Departments' understanding that third party administrators are not typically designated as plan administrators, and, therefore, would not normally act as plan administrators, under section 3(16) of ERISA. Therefore, to the Departments' knowledge, it is only under the existing accommodation process that third party administrators are required to undertake any obligations to provide or arrange for contraceptive coverage to which they might object. These rules make the accommodation process optional for employers and other plan sponsors, and specify that third party administrators that have their own objection to complying with the accommodation process may decline to enter into, or decline to continue, contracts as third party administrators of such plans.
The previous regulations did not specify what, if any, religious objection applied to its exemption; however, the Religious IFC set forth the scope of the religious objection of objecting entities in § 147.132(a)(2), as follows: “The exemption of this paragraph (a) will apply to the extent that an entity described in paragraph (a)(1) of this section objects to its establishing, maintaining, providing, offering, or arranging (as applicable) coverage, payments, or a plan that provides coverage or payments for some or all contraceptive services, based on its sincerely held religious beliefs.” These rules finalize this description with technical changes to clarify the scope of the objection as intended in the Religious IFC, and based on public comments.
Throughout the exemptions for objecting entities, the rules specify that they apply where the entities object as specified in § 147.132(a)(2) of the Religious IFC. That paragraph describes the religious objection by specifying that exemptions for objecting entities will apply to the extent that an entity described in paragraph (a)(1) objects to its establishing, maintaining, providing, offering, or arranging (as applicable) coverage, payments, or a plan that provides coverage or payments for some or all contraceptive services, based on its sincerely held religious beliefs.
In the separate companion IFC to the Religious IFC—the Moral IFC—the Departments, at § 147.133(a)(2), provided a similar description of the scope of the objection based on moral convictions rather than religious beliefs, but we used slightly different operative language. There, instead of saying the entity “objects to its establishing, maintaining, providing, offering, or arranging (as applicable) coverage, payments, or a plan that provides coverage or payments for some or all contraceptive services,” the paragraph stated the entity “objects to its establishing, maintaining, providing, offering, or arranging (as applicable) coverage or payments for some or all contraceptive services, or for a plan, issuer, or third party administrator that provides or arranges such coverage or payments.” Some commenters took note of this difference, and asked the Departments to clarify which language applies, and whether the Departments intended any difference in the operation of the two paragraphs. The Departments did not intend the language to operate differently. The language in the Moral IFC accurately, and more clearly, expresses the intent set forth in the Religious IFC about how the issuer exemption applies. The Religious IFC explained that the intent of the expanded exemptions was to encompass entities that objected to providing or arranging for contraceptive coverage in their plans, and to encompass entities that objected to the previous accommodation process, by which their issuers or third party administrators were required to provide contraceptive coverage or payments in connection with their plans. In other words, an entity would be exempt from the Mandate if it objected to complying with the Mandate, or if it objected to complying with the accommodation. The language in the Religious IFC encompassed both circumstances by encompassing an objection to providing “coverage [or] payments” for contraceptive services, and by encompassing an objection to “a plan that provides” coverage or payments for contraceptive services. But the language describing the objection set forth in the Moral IFC does so more clearly, and restructuring the sentence could make it clearer still. Questions by commenters about the scope of the description suggests that we should restructure the description, in a non-substantive way, to provide more clarity. The Departments do this by breaking some of the text out into subparagraphs, and rearranging clauses so that it is clearer which words they modify. The new structure specifies that it includes an objection to establishing, maintaining, providing, offering, or arranging for (as applicable) coverage or payments for contraceptive services, and it includes an objection to establishing, maintaining, providing, offering, or arranging for (as applicable) a plan, issuer, or third party administrator that provides contraceptive coverage. This more clearly encompasses objections to complying with either the Mandate or the accommodation. Consequently, these rules finalize the paragraph describing the religious objection in the Religious IFC with minor technical changes so that the final language will essentially mirror language from the Moral IFC. The introductory phrase of the religious objection set forth in paragraph (a)(2) is finalized to state the exemption “will apply to the extent that an entity described in paragraph (a)(1) of this section objects, based on its sincerely held religious beliefs, to its establishing, maintaining, providing, offering, or arranging for (as applicable)”. The remainder of the paragraph is broken into two sub-paragraphs, regarding either “coverage or payments for some or all contraceptive services,” or “a plan, issuer, or third party administrator that provides or arranges such coverage or payments.”
Some commenters observed that by allowing exempt groups to object to “some or all” contraceptives, this might yield a cafeteria-style approach where different plan sponsors choose various combinations of contraceptives that they wish to cover. Some commenters further observed that this might create a burden on issuers or third party administrators. The Departments have concluded, however, that, just as the exemption under the previous regulations allowed entities to object to some or all contraceptives, it is appropriate to maintain that flexibility for entities covered by the expanded exemption. Notably, even where an entity or individual qualifies for an exemption under these rules, these rules do not require the issuer or third party administrator to contract with that entity or individual if the issuer or third party administrator does not wish to do so, including because the issuer or third party administrator does not wish to offer an unusual variation of a plan. These rules simply remove the federal Mandate that, in some cases, could have led to penalties for an employer, issuer, or third party administrator if they wished to sponsor, provide, or administer a plan that omits contraceptive coverage in the presence of a qualifying religious objection. Similarly, under the previous exemption, the plans of houses of worship and integrated auxiliaries were exempt from offering some or all contraceptives, but the previous regulations did not require issuers and third party administrators to contract with those exempt entities if they chose not to do so.
The previous regulations did not provide an exemption for objecting individuals. However, the Religious IFC expanded the exemptions to encompass objecting individuals (referred to here as the “individual exemption”), at § 147.132(b). These rules finalize the individual exemption from the Religious IFC with changes, which reflect both non-substantial technical revisions, and changes based on public comments to more clearly express the intent of the Religious IFC.
In the separate companion IFC to the Religious IFC—the Moral IFC—the Departments, at § 147.133(b), provided a similar individual exemption, but we used slightly different operative language. Where the Religious IFC described what may be offered to objecting individuals as “a separate benefit package option, or a separate policy, certificate or contract of insurance,” the Moral IFC said a willing issuer and plan sponsor may offer “a separate policy, certificate or contract of insurance or a separate group health plan or benefit package option, to any individual who objects” under the individual exemption. Some commenters observed this difference and asked whether the language was intended to encompass the same options. The Departments intended these descriptions to include the same scope of options. Some commenters suggested that the individual exemption should not allow the offering of “a separate group health plan,” as set forth in the version found in § 147.133(b), because doing so could cause various administrative burdens. The Departments disagree, since group health plan sponsors and group and individual health insurance issuers would be free to decline to provide that option, including because of administrative burdens. In addition, the Departments wish to clarify that, where an employee claims the exemption, a willing issuer and a willing employer may, where otherwise permitted, offer the employee participation in a group health insurance policy or benefit option that complies with the employee's objection. Consequently, these rules finalize the individual
Some commenters supported the individual exemption as providing appropriate protections for the religious beliefs of individuals who obtain their insurance coverage in such places as the individual market or exchanges, or who obtain coverage from a group health plan sponsor that does not object to contraceptive coverage but is willing (and, as applicable, the issuer is also willing) to provide coverage that is consistent with an individual's religious objections. Some commenters also observed that, by specifying that the individual exemption only operates where the plan sponsor and issuer, as applicable, are willing to provide coverage that is consistent with the objection, the exemption would not impose burdens on the insurance market because the possibility of such burdens would be factored into the willingness of an employer or issuer to offer such coverage. Other commenters disagreed and contended that allowing the individual exemption would cause burden and confusion in the insurance market. Some commenters also suggested that the individual exemption should not allow the offering of a separate group health plan because doing so could cause various administrative burdens.
The Departments agree with the commenters who suggested the individual exemption will not burden the insurance market, and, therefore, conclude that it is appropriate to provide the individual exemption where a plan sponsor and, as applicable, issuer are willing to cooperate in doing so. As discussed in the Religious IFC, the individual exemption only operates in the case where the group health plan sponsor or group or individual market health insurance issuer is willing to provide the separate option; in the case of coverage provided by a group health plan sponsor, where the plan sponsor is willing; or in the case where both a plan sponsor and issuer are involved, both are willing. The Departments conclude that it is appropriate to provide the individual exemption so that the Mandate will not serve as an obstacle among these various options. Practical difficulties that may be implicated by one option or another will likely be factored into whether plan sponsors and issuers are willing to offer particular options in individual cases.
In addition, Congress has provided several protections for individuals who object to prescribing or providing contraceptives contrary to their religious beliefs.
The individual exemption extends to the coverage unit in which the plan participant, or subscriber in the individual market, is enrolled (for instance, to family coverage covering the participant and his or her beneficiaries enrolled under the plan), but does not relieve the plan's or issuer's obligation to comply with the Mandate with respect to the group health plan generally, or, as applicable, to any other individual policies the issuer offers.
This individual exemption allows plan sponsors and issuers that do not specifically object to contraceptive coverage to offer religiously acceptable coverage to their participants or subscribers who do object, while offering coverage that includes contraception to participants or subscribers who do not object. This individual exemption can apply with respect to individuals in plans sponsored by private employers or governmental employers.
By its terms, the individual exemption would also apply with respect to individuals in plans arranged by institutions of higher education, if the issuers offering those plans were willing to provide plans complying with the individuals' objections. Because federal law does not require institutions of higher education to arrange such plans, the institutions would not be required by these rules to arrange a plan compliant with an individual's objection if the institution did not wish to do so.
As an example, in one lawsuit brought against the Departments, the State of Missouri enacted a law under which the State is not permitted to discriminate against insurance issuers that offer group health insurance policies without coverage for contraception based on employees' religious beliefs, or against the individual employees who accept such offers.
This individual exemption cannot be used to force a plan (or its sponsor) or an issuer to provide coverage omitting contraception, or, with respect to health insurance coverage, to prevent the application of State law that requires coverage of such contraceptives or sterilization. Nor can the individual exemption be construed to require the guaranteed availability of coverage omitting contraception to a plan sponsor or individual who does not have a sincerely held religious objection. This individual exemption is limited to the requirement to provide contraceptive coverage under section 2713(a)(4), and does not affect any other federal or State law governing the plan or coverage. Thus, if there are other applicable laws or plan terms governing the benefits, these final rules do not affect such other laws or terms.
Some individuals commented that they welcomed the individual exemption so that their religious beliefs were not forced to be in tension with their desire for health coverage. The Departments believe the individual exemption may help to meet the ACA's goal of increasing health coverage because it will reduce the incidence of certain individuals choosing to forego health coverage because the only coverage available would violate their sincerely held religious beliefs.
Some commenters welcomed the ability of individuals covered by the individual exemption to be able to assert an objection to either some or all contraceptives. Other commenters expressed concern that there might be multiple variations in the kinds of contraceptive coverage to which individuals object, and this might make it difficult for willing plan sponsors and issuers to provide coverage that complies with the religious beliefs of an exempt individual. As discussed above, where the individual exemption applies, it only affects the coverage of an individual. If an individual only objects to some contraceptives, and the individual's issuer and, as applicable, plan sponsor are willing to provide the individual a package of benefits omitting such coverage, but for practical reasons they can only do so by providing the individual with coverage that omits all—not just some—contraceptives, the Departments believe that it favors individual freedom and market choice, and does not harm others, to allow the issuer and plan sponsor to provide, in that case, a plan omitting all contraceptives if the individual is willing to enroll in that plan. The language of the individual exemption set forth in the Religious IFC implied this conclusion, by specifying that the Guidelines requirement of contraceptive coverage did not apply where the individual objected to some or all contraceptives. Notably, this was different than the language applicable to the exemptions under § 147.132(a), which specifies that the exemptions apply “to the extent” of the religious objections, so that, as discussed above, the exemptions include only those contraceptive methods to which the objection applied. In response to comments suggesting the language of the individual exemption was not sufficiently clear on this distinction, however, the Departments in these rules finalize the individual exemption at § 147.133(b) with the following change, by adding the following sentence at the end of the paragraph: “Under this exemption, if an individual objects to some but not all contraceptive services, but the issuer, and as applicable, plan sponsor, are willing to provide the individual with a separate policy, certificate or contract of insurance or a separate group health plan or benefit package option that omits all contraceptives, and the individual agrees, then the exemption applies as if the individual objects to all contraceptive services.”
Some commenters asked for plain language guidance and examples about how the individual exemption might apply in the context of employer-sponsored insurance. Here is one such example. An employee is enrolled in group health coverage through her employer. The plan is fully insured. If the employee has sincerely held religious beliefs objecting to her plan including coverage for contraceptives, she could raise this with her employer. If the employer is willing to offer her a plan that omits contraceptives, the employer could discuss this with the insurance agent or issuer. If the issuer is also willing to offer the employer, with respect to this employee, a group health insurance policy that omits contraceptive coverage, the individual exemption would make it legal for the group health insurance issuer to omit contraceptives for her and her beneficiaries under a policy, for her employer to sponsor that plan for her, and for the issuer to issue such a plan to the employer, to cover that employee. This would not affect other employees' plans—those plans would still be subject to the Mandate and would continue to cover contraceptives. But if either the employer, or the issuer, is not willing (for whatever reason) to offer a plan or a policy for that employee that omits contraceptive coverage, these rules do not require them to. The employee would have the choice of staying enrolled in a plan with its coverage of contraceptives, not enrolling in that plan, seeking coverage elsewhere, or seeking employment elsewhere.
For all these reasons, these rules adopt the individual exemption language from the Religious IFC with clarifying changes to reflect the Departments' intent.
The previous regulations set forth an accommodation process at 45 CFR 147.131, 26 CFR 54.9815-2713A, and 29 CFR 2590.715-2713A, as an alternative method of compliance with the Mandate. Under the accommodation, if a religious nonprofit entity, or a religious closely held for-profit business, objected to coverage of some or all contraceptive services in its health plan, it could file a notice or fill out a form expressing this objection and describing its objection to its plan and issuer or third party administrator. Upon doing so, the plan would not cover some or all contraceptive services, and the issuer or third party administrator would be responsible for providing or arranging for persons covered by the plan to receive coverage or payments of those services (except in the case of self-insured church plans exempt from ERISA, in which case no such obligation was imposed on the third party administrator). The accommodation was set forth in regulations of each of the Departments. Based on each Department's regulatory authority, HHS regulations applied to insured group health plans, and DOL and Treasury regulations applied to both insured group health plans and self-insured group health plans.
The Religious IFC maintained the accommodation process. Nevertheless, by virtue of expanding the exemptions to encompass all entities that were eligible for the accommodation process under the previous regulations, in addition to other newly exempt entities, the Religious IFC rendered the accommodation process optional. Entities could choose not just between the Mandate and the accommodation, but between the Mandate, the exemption, and the accommodation. These rules finalize the optional accommodation process and its location in the Code of Federal Regulations at 45 CFR 147.131, 26 CFR 54.9815-2713A, and 29 CFR 2590.715-2713A, but the Departments do so with several changes based on public comments.
Many commenters supported keeping the accommodation as an optional process, including some commenters who otherwise supported creating the expanded exemptions. Some commenters opposed making the accommodation optional, but asked the Departments to return to the previous regulations in which entities that did not meet the narrower exemption could only choose between the accommodation process or direct compliance with the Mandate. Some commenters believed there should be no exemptions and no accommodation process.
The Departments continue to consider it appropriate to make the accommodation process optional for entities that are otherwise also eligible for the expanded exemptions—that is, to keep it in place as an option that exempt entities can choose. The accommodation provides contraceptive access, which is a result many opponents of the expanded exemptions said they desire. The accommodation involves some regulation of issuers and third party administrators, but the previous
Above, the Departments discussed public comments concerning whether we should have merely expanded the accommodation rather than expanding the exemptions. The Religious IFC and these final rules expand the kinds of entities that may use the optional accommodation, by expanding the exemptions and allowing any exempt entities to opt to make use of the accommodation. Consequently, under these rules, objecting employers may make use of the exemption or may choose to utilize the optional accommodation process. If an eligible organization uses the optional accommodation process through the EBSA Form 700 or other specified notice to HHS, it voluntarily shifts an obligation to provide separate but seamless contraceptive coverage to its issuer or third party administrator.
Some commenters asked that these final rules create an alternative payment mechanism to cover contraceptive services for third party administrators obligated to provide or arrange such coverage under the accommodation. These rules do not concern the payment mechanism, which is set forth in separate rules at 45 CFR 156.50. The Departments do not view an alternative payment mechanism as necessary. As discussed below, although the Departments do not know how many entities will use the accommodation, it is reasonably likely that some entities previously using it will continue to do so, while others will choose the expanded exemption, leading to an overall reduction in the use of the accommodation. The Departments have reason to believe that these final rules will not lead to a significant expansion of entities using the accommodation, since nearly all of the entities of which the Departments are aware that may be interested in doing so were already able to do so prior to the Religious IFC. Moreover, it is still the case under these rules that if an entity serving as a third party administrator does not wish to satisfy the obligations it would need to satisfy under an accommodation, it could choose not to contract with an entity that opts into the accommodation. This conflict is even less likely now that entities eligible for the accommodation are also eligible for the exemption. For these reasons, the Departments do not find it necessary to add an additional payment mechanism for the accommodation process.
If an eligible organization wishes to revoke its use of the accommodation, it can do so under these rules, and operate under its exempt status. As part of its revocation, the issuer or third party administrator of the eligible organization must provide participants and beneficiaries written notice of such revocation. Some commenters suggested HHS has not yet issued guidance on the revocation process, but CCIIO provided guidance concerning this process on November 30, 2017.
The guidance stated that an entity that was using the accommodation under the previous rules, or an entity that adopts the accommodation maintained by the IFCs, could revoke its use of the accommodation and use the exemption. This guideline applies under the final rules. This revocation process applies both prospectively to eligible organizations that decide at a later date to avail themselves of the optional accommodation and then decide to revoke that accommodation, as well as to organizations that invoked the accommodation prior to the effective date of the Religious IFC either by their submission of an EBSA Form 700 or notification, or by some other means under which their third party administrator or issuer was notified by DOL or HHS that the accommodation applies.
The guidance stated that, when the accommodation is revoked by an entity using the exemption, the issuer of the eligible organization must provide participants and beneficiaries written notice of such revocation. These rules adopt that guideline. Consistent with other applicable laws, the issuer or third party administrator of an eligible organization must promptly notify plan participants and beneficiaries of the change of status to the extent such participants and beneficiaries are currently being offered contraceptive coverage at the time the accommodated organization invokes its exemption. The guidance further stated that the notice may be provided by the organization itself, its group health plan, or its third party administrator, as applicable. The guidance stated that, under the regulation at 45 CFR 147.200(b), “[t]he notice of modification must be provided in a form that is consistent with the rules of paragraph (a)(4) of this section,” and (a)(4) has detailed rules on when electronic notice is permitted. These guidelines still apply under the final rules. These rules adopt those guidelines.
The guidance further specified that the revocation of the accommodation would be effective notice on the first day of the first plan year that begins on or after 30 days after the date of the revocation, or alternatively, whether or not the objecting entity's group health plan or issuer listed the contraceptive benefit in its Summary of Benefits of Coverage (SBC), the group health plan or issuer could revoke the accommodation by giving at least 60-days prior notice pursuant to section 2715(d)(4) of the PHS Act (incorporated into ERISA and the Code)
Some commenters asked that revocations only be permitted to occur on the first day of the next plan year, or no sooner than January 2019, to avoid burdens on plans and because some states do not allow for mid-year plan changes. The Departments believe that providing 60-days notice pursuant to section 2715(d)(4) of the PHS Act, where applicable, is a mechanism that already exists for making changes in health benefits covered by a group health plan during a plan year; that process already takes into consideration any applicable state laws. However, in response to public comments, these rules change the accommodation provisions from the Religious IFC to indicate that, as a transitional rule, providing 60-days notice for revoking an accommodation is only available, if applicable, to plans that are using the accommodation at the time of the
This change is implemented in the following manner. In the Religious IFC, the accommodation provisions addressing revocation were found at 45 CFR 147.131(c)(4), 26 CFR 54.9815-2713AT(a)(5),
The provisions in the Religious IFC (with technical variations among the HHS, Labor, and Treasury rules) state that a written notice of revocation must be provided “as specified in guidance issued by the Secretary of the Department of Health and Human Services.” On November 30, 2017, HHS issued the guidance regarding revocation. These final rules incorporate this guidance, with certain clarifications, and state that the revocation notice must be provided “as specified herein.” The final rule incorporates the two sets of directions for revoking the accommodation initially set forth in the interim guidance in the following manner. The first, designated as subparagprah (1) as a “[t]ransitional rule,” explains that if contraceptive coverage is being offered through the accommodation process on the date on which these final rules go into effect, 60-days notice may be provided to revoke the accommodation process, or they revocation may occur “on the first day of the first plan year that begins on or after 30 days after the date of the revocation” consistent with PHS Act section 2715(d)(4), 45 CFR 147.200(b), 26 CFR 54.9815-2715(b), or 29 CFR 2590.715-2715(b). The second direction, set forth in subparagraph (ii), explains the “[g]eneral rule” that, in plan years beginning after the date on which these final rules go into effect, revocation of the accommodation will be effective on “the first day of the first plan year that begins on or after 30 days after the date of the revocation.”
The Religious IFC states that if an accommodated entity objects to some, but not all, contraceptives, an issuer for an insured group health plan that covers contraceptives under the accommodation may, at the issuer's option, choose to provide coverage or payments for all contraceptive services, instead of just for the narrower set of contraceptive services to which the entities object. Some commenters supported this provision, saying that it allows flexibility for issuers that might otherwise face unintended burdens from providing coverage under the accommodation for entities that object to only some contraceptive items. The Departments have maintained this provision in these final rules. Note that this provision is consistent with the other assertions in the rules saying that an entity's objection applies “to the extent” of the entity's religious beliefs, because in this instance, under the accommodation, the plan participant or beneficiary still receives coverage or payments for all contraceptives, and this provision simply allows issuers more flexibility in choosing how to help provide that coverage.
Some commenters asked that the Departments retain the “reliance” provision, contained in the previous accommodation regulations, under which an issuer is deemed to have complied with the Mandate where the issuer relied reasonably and in good faith on a representation by an eligible organization as to its eligibility for the accommodation, even if that representation was later determined to be incorrect. The Departments omitted this provision from the Religious IFC, on the grounds that this provision was less necessary where any organization eligible for the optional accommodation is also exempt. Nevertheless, in order to respond to concerns in public comments, and to prevent any risk to issuers of a mistake or misrepresentation by an organization seeking the accommodation process, the Departments have finalized the Religious IFC with an additional change that restores this clause. The clause uses the same language that was in the regulations prior to the Religious IFC, and it is inserted at 45 CFR 147.131(f), 26 CFR 54.9815-2713A(e), and 29 CFR 2590.715-2713A(e). As a result, these rules renumber the subsequent paragraphs in each of those sections.
The previous regulations did not define contraceptive services. The Guidelines issued in 2011 included, under “Contraceptive methods and counseling,” “[a]ll Food and Drug Administration approved contraceptive methods, sterilization procedures, and patient education and counseling for all women with reproductive capacity.” The previous regulations concerning the exemption and the accommodation used the terms contraceptive services and contraceptive coverage as catch-all terms to encompass all of those Guidelines' requirements. The 2016 update to the Guidelines are similarly worded. Under “Contraception,” they include the “full range of contraceptive methods for women currently identified by the U.S. Food and Drug Administration,” “instruction in fertility awareness-based methods,” and “[c]ontraceptive care” to “include contraceptive counseling, initiation of contraceptive use, and follow-up care (for example, management, and evaluation as well as changes to and removal or discontinuation of the contraceptive method).”
To more explicitly state that the exemption encompasses any of the contraceptive or sterilization services, items, or information that have been required under the Guidelines, the Religious IFC included a definition at 45
The Departments finalize without change (except for certain paragraph redesignations), the severability clauses in the interim final rules, namely, at paragraph (g) of 26 CFR 54.9815-2713A, the redesignated paragraph (g) of 29 CFR 2590.715-2713A, and 45 CFR 147.132(d).
Some commenters noted that some drugs included in the preventive services contraceptive Mandate can also be useful for treating certain existing health conditions, and that women use them for non-contraceptive purposes. Certain commenters urged the Departments to clarify that the final rules do not permit employers to exclude from coverage medically necessary prescription drugs used for non-preventive services. Some commenters suggested that religious objections to the Mandate should not be permitted in cases where such methods are used to treat such conditions, even if those methods can also be used for contraceptive purposes.
Section 2713(a)(4) only applies to “preventive” care and screenings. The statute does not allow the Guidelines to mandate coverage of services provided solely for a non-preventive use, such as the treatment of an existing condition. The Guidelines implementing this section of the statute are consistent with that narrow authority. They state repeatedly that they apply to “preventive” services or care.
Some commenters observed that pharmacy claims do not include a medical diagnosis code, so plans may be unable to discern whether a drug approved by FDA for contraceptive uses is actually applied for a preventive or contraceptive use, or for another use. Section 2713(a)(4), however, draws a distinction between preventive care and screenings and other kinds of care and screenings. That subsection does not authorize the Departments to impose a coverage mandate of services that are not at least partly applied for a preventive use, and the Guidelines themselves do not require coverage of contraceptive methods or care unless such methods or care is contraceptive in purpose. These rules do not prohibit issuers from covering drugs and devices that are approved for contraceptive uses even when those drugs and devices are prescribed for non-preventive, non-contraceptive purposes. As discussed above, these final rules also do not purport to delineate the items HRSA will include in the Guidelines, but only concern expanded exemptions and accommodations that apply to the extent the Guidelines require contraceptive coverage. Therefore, the Departments do not consider it appropriate to specify in these final rules that under section 2713(a)(4), exempt organizations must provide coverage for drugs prescribed exclusively for a non-contraceptive and non-preventive use to treat an existing condition.
Some commenters agreed with the Departments' statement in the Religious IFC that the expanded exemptions are likely to affect only a small percentage of women otherwise receiving coverage under the Mandate. Other commenters disagreed, stating that the expanded exemptions could take contraceptive coverage away from many or most women. Still others opposed expanding the exemptions and contended that accurately determining the number of women affected by the expanded exemptions is not possible.
After reviewing the public comments, the Departments agree with commenters who said that estimating the impact of these final rules is difficult based on the limited data available to us, and with commenters who agreed with the Religious IFC that the expanded exemptions are likely to affect only a small percentage of women. The Departments do not find the estimates of large impacts submitted by some commenters more reliable than the estimates set forth in the Religious and Moral IFCs. Even certain commenters that “strongly oppos[ed]” the Religious IFC commented that merely “thousands” would be impacted, a number consistent with the Departments' estimate of the number of women who may be affected by the rule. The Departments' estimates of the impact of these final rules are discussed in more detail in the following section. Therefore, the Departments conclude that the estimates of regulatory impact made in the Religious IFC are still the best estimates available. Our estimates are discussed in more detail in the following section.
Some commenters asked the Departments to discuss the interaction between these final rules and state laws that either require contraceptive
Some commenters observed that, through ERISA, some entities may avoid state laws that require contraceptive coverage by self-insuring. This is a result of the application of the preemption and savings clauses contained in ERISA to state insurance regulation.
The Departments have examined the impacts of the Religious IFC and the final rules as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96 354), section 1102(b) of the Social Security Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 1999), the Congressional Review Act (5 U.S.C. 804(2)), and Executive Order 13771 on Reducing Regulation and Controlling Regulatory Costs (January 30, 2017).
Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, and 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.
Section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action that is likely to result in a regulation: (1) Having an annual effect on the economy of $100 million or more in any one year, or adversely and materially affecting a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities (also referred to as “economically significant”); (2) creating a serious inconsistency or otherwise interfering with an action taken or planned by another agency; (3) materially altering the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raising novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order.
A regulatory impact analysis must be prepared for major rules with economically significant effects ($100 million or more in any one year), and an “economically significant” regulatory action is subject to review by the Office of Management and Budget (OMB). As discussed below regarding their anticipated effects, the Religious IFC and these rules are not likely to have economic impacts of $100 million or more in any one year, and therefore do not meet the definition of “economically significant” under Executive Order 12866. However, OMB has determined that the actions are significant within the meaning of section 3(f)(4) of the Executive Order. Therefore, OMB has reviewed these final rules, and the Departments have provided the following assessment of their impact.
These final rules adopt as final and further change the amendments made by the Religious IFC, which amended the Departments' July 2015 final regulations. The Religious IFC and these final rules expand the exemption from the requirement to provide coverage for contraceptives and sterilization, established under the HRSA Guidelines, promulgated under section 2713(a)(4) of the PHS Act, section 715(a)(1) of ERISA, and section 9815(a)(1) of the Code, to include certain entities and individuals with objections to compliance with the Mandate based on sincerely held religious beliefs, and they revise the accommodation process to make it optional for eligible organizations. The expanded exemption applies to certain individuals and entities that have religious objections to some (or all) of the contraceptive and/or sterilization services that would be covered under the Guidelines. Such action has been taken, among other reasons discussed above, to provide for participation in the health insurance market by certain entities or individuals, by freeing them from penalties they could incur if they follow their sincerely held religious beliefs against contraceptive coverage.
Regarding entities and individuals that are extended an exemption by the Religious IFC and these final rules, without that exemption the Guidelines would require many of them to either pay for coverage of contraceptive services that they find religiously objectionable; submit self-certifications that would result in their issuer or third party administrator paying for such services for their employees, which
To the extent that entities choose to revoke their accommodated status to make use of the expanded exemption, a notice will need to be sent to enrollees (either by the objecting entity or by the issuer or third party administrator) that their contraceptive coverage is changing, and guidance will reflect that such a notice requirement is imposed no more than is already required by preexisting rules that require notices to be sent to enrollees of changes to coverage during a plan year. If the entities wait until the start of their next plan year to change to exempt status, instead of doing so during the current plan year, those entities generally will also be able to avoid sending any supplementary notices in addition to what they would otherwise normally send prior to the start of a new plan year. Additionally, these final rules provide such entities with an offsetting regulatory benefit by the exemption itself and its relief of burdens on their religious beliefs. As discussed below, assuming that more than half of the entities that have been using the previous accommodation will seek immediate revocation of their accommodated status and notices will be sent to all their enrollees, the total estimated cost of sending those notices will be $302,036.
The Departments estimate that these final rules will not result in any additional burdens or costs on issuers or third party administrators. As discussed below, the Departments believe that 109 of the 209 entities making use of the accommodation process will instead make use of their new exempt status. In contrast, the Departments expect that a much smaller number (which we assume to be 9) will make use of the accommodation to which they were not previously provided access. Reduced burdens for issuers and third party administrators due to reductions in use of the accommodation will more than offset increased obligations for serving the fewer number of entities that will now opt into the accommodation. This will lead to a net decrease in burdens and costs on issuers and third party administrators, who will no longer have continuing obligations imposed on them by the accommodation. While these rules make it legal for issuers to offer insurance coverage that omits contraceptives to exempt entities and individuals, these final rules do not require issuers to do so.
The Departments anticipate that the effect of these rules on adjustments made to the federally facilitated Exchange user fees under 45 CFR 156.50 will be that fewer overall adjustments will be made using the accommodation process, because there will be more entities who previously were reluctant users of the accommodation that will choose to operate under the newly expanded exemption than there will be entities not previously eligible to use the accommodation that will opt into it. The Departments' estimates of each number of those entities is set forth in more detail below.
These final rules will result in some persons covered in plans of newly exempt entities not receiving coverage or payments for contraceptive services. As discussed in the Religious IFC, the Departments did not have sufficient data on a variety of relevant factors to precisely estimate how many women would be impacted by the expanded exemptions or any related costs they may incur for contraceptive coverage or the results associated with any unintended pregnancies.
As referenced above and for reasons explained here, there are multiple levels of uncertainty involved in measuring the effect of the expanded exemption, including but not limited to—
• How many entities will make use of their newly exempt status.
• How many entities will opt into the accommodation maintained by these rules, under which their plan participants will continue receiving contraceptive coverage.
• Which contraceptive methods some newly exempt entities will continue to provide without cost-sharing despite the entity objecting to other methods (for example, as reflected in
• How many women will be covered by plans of entities using their newly exempt status.
• Which of the women covered by those plans want and would have used contraceptive coverage or payments for contraceptive methods that are no longer covered by such plans.
• Whether, given the broad availability of contraceptives and their relatively low cost, such women will obtain and use contraception even if it is not covered.
• The degree to which such women are in the category of women identified by IOM as most at risk of unintended pregnancy.
• The degree to which unintended pregnancies may result among those women, which would be attributable as an effect of these rules only if the women did not otherwise use contraception or a particular contraceptive method due to their plan making use of its newly exempt status.
• The degree to which such unintended pregnancies may be associated with negative health effects, or whether such effects may be offset by other factors, such as the fact that those women will be otherwise enrolled in insurance coverage.
• The extent to which such women will qualify for alternative sources of contraceptive access, such as through a parent's or spouse's plan, or through one of the many governmental programs that subsidize contraceptive coverage to supplement their access.
In the public comments, some commenters agreed with the Departments' estimate that, at most, the economic impact would lead to a potential transfer cost, from employers (or other plan sponsors) to affected women, of $63.8 million. Some commenters said the impact would be much smaller. Other commenters disagreed, suggesting that the expanded exemptions risked removing contraceptive coverage from more than 55 million women receiving the benefits of the preventive services Guidelines, or even risked removing contraceptive coverage from over 100 million women. Some commenters cited studies indicating that, nationally, unintended pregnancies have large public costs, and the Mandate overall led to large out-of-pocket savings for women.
These general comments do not, however, substantially assist us in
The Departments have access to the following general sources of information that are relevant to this issue, but these sources do not provide a full picture of the impact of these final rules. First, the regulations prior to the Religious IFC already exempted certain houses of worship and their integrated auxiliaries and, as explained elsewhere, effectively did not apply contraceptive coverage requirements to various entities in self-insured church plans. The effect of those previous exemptions or limitations are not included as effects of these rules, which leave those impacts in place. Second, in the Departments' previous regulations creating or expanding exemptions and the accommodation process we concluded that no significant burden or costs would result. 76 FR 46625; 78 FR 39889. Third, some entities, including some for-profit entities, object to only some but not all contraceptives, and in some cases will cover 14 of 18 FDA-approved women's contraceptive and sterilization methods.
Fourth, HHS previously estimated that 209 entities would make use of the accommodation process. To arrive at this number, the Departments used, as a placeholder, the approximately 122 nonprofit entities that brought litigation challenging the accommodation process, and the approximately 87 closely held for-profit entities that filed suit challenging the Mandate in general. The Departments' records indicate, as noted in the Religious IFC, that approximately 63 entities affirmatively submitted notices to HHS to use the accommodation,
These sources of information were outlined in the Religious IFC. Some commenters agreed with the Departments' estimates based on those sources, and while others disagreed, the Departments conclude that commenters did not provide information that allows us to make better estimates.
Based on these and other factors, the Departments considered two approaches in the Religious IFC to estimate the number of women affected among entities using the expanded exemptions. First, following the use in previous regulations of litigating entities to estimate the effect of the exemption and accommodation, the Departments attempted to estimate the number of women covered by plans of litigating entities that could be affected by expanded exemptions. Based on papers filed in litigation, and public sources, the Departments estimated in the Religious IFC that approximately 8,700 women of childbearing age could have their contraception costs affected by plans of litigating entities using these expanded exemptions. The Departments believe that number is lower based upon the receipt, by many of those litigating entities, of permanent injunctions against the enforcement of section 2713(a)(4) to the extent it supports a contraceptive Mandate, which have been entered by federal district courts since the issuance of the Religious IFC.
Together, this leads the Departments to estimate that approximately 6,400 women of childbearing age may have their contraception costs affected by plans of litigating entities using these expanded exemptions. As noted previously, the Departments do not have data indicating how many of those women agree with their employers' or educational institutions' opposition to contraception (so that fewer of them than the national average might actually use contraception). Nor do the Departments know how many would have alternative contraceptive access from a parent's or spouse's plan, or from federal, state, or local governmental programs, nor how many of those women would fall in the category of being most at risk of unintended pregnancy, nor how many of those entities would provide some contraception in their plans while only objecting to certain contraceptives.
In the Religious IFC, the Departments also examined data concerning user-fee reductions to estimate how many women might be affected by entities that are using the accommodation and would use the expanded exemptions under these final rules. Under the accommodation, HHS has received information from issuers that seek user fees adjustments under 45 CFR 156.50(d)(3)(ii), for providing contraceptive payments for self-insured plans that make use of the accommodation. HHS receives requests for fees adjustments both where Third Party Administrators (TPAs) for those self-insured accommodated plans are themselves issuers, and where the TPAs use separate issuers to provide the payments and those issuers seek fees adjustments. Where the issuers seeking adjustments are separate from the TPAs, the TPAs are asked to report the number of persons covered by those plans. Some users do not enter all the requested data, and not all the data for the 2017 plan year is complete. Nevertheless, HHS has reviewed the user fees adjustment data received for the 2017 plan year. HHS's best estimate from the data is that there were $38.4 million in contraception claims sought as the basis for user fees adjustments for plans, and that these claims were for plans covering approximately 1,823,000 plan participants and beneficiaries of all ages, male and female.
This number fluctuates from year to year. It is larger than the estimate used in the Religious IFC because, on closer examination of the data, this number better accounts for plans where TPAs were also issuers seeking user fees adjustments, in addition to plans where the TPA is separate from the issuer seeking user fees adjustments. The number of employers using the accommodation where user fees adjustments were sought cannot be determined from HHS data, because not all users are required to submit that information, and HHS does not necessarily receive information about fully insured plans using the accommodation. Therefore, the Departments still consider our previous estimate of 209 entities using the accommodation as the best estimate available.
As noted in the Religious IFC, HHS's information indicates that religious nonprofit hospitals or health systems sponsored a significant minority of the accommodated self-insured plans that were using contraceptive user fees adjustments, yet those plans covered more than 80 percent of the persons covered in all plans using contraceptive user fees adjustments. Some of those plans cover nearly tens of thousands of persons each and are proportionately much larger than the plans provided by other entities using the contraceptive user fees adjustments.
The Departments continue to believe that a significant fraction of the persons covered by previously accommodated plans provided by religious nonprofit hospitals or health systems may not be affected by the expanded exemption. A broad range of religious hospitals or health systems have publicly indicated that they do not conscientiously oppose participating in the accommodation.
Considering all these data points and limitations, the Departments offer the following estimate of the number of women who will be impacted by the expanded exemption in these final rules. In addition to the estimate of 6,400 women of childbearing age that use contraception covered by the Guidelines, who will be affected by use of the expanded exemption among litigating entities, the Departments calculate the following number of women who we estimate to be affected by accommodated entities using the expanded exemption. As noted above, approximately 1,823,000 plan participants and beneficiaries were covered by self-insured plans that received contraceptive user fee adjustments in 2017. Although additional self-insured entities may have participated in the accommodation without making use of contraceptive user fees adjustments, the Departments do not know what number of entities did so. We consider it likely that self-insured entities with relatively larger numbers of covered persons had sufficient financial incentive to make use of the contraceptive user fees adjustments. Therefore, without better data available, the Departments assume that the number of persons covered by self-insured plans using contraceptive user fees adjustments approximates the number of persons covered by all self-insured plans using the accommodation.
An additional but unknown number of persons were likely covered in fully insured plans using the accommodation. The Departments do not have data on how many fully insured plans have been using the accommodation, nor on how many persons were covered by those plans. DOL estimates that, among persons covered by employer-sponsored insurance in the private sector, 62.7 percent are covered by self-insured plans and 37.3 percent are covered by fully insured plans.
Although recognizing the limited data available for our estimates, the Departments estimate that 100 of the 209 entities that were using the accommodation under the previous regulations will continue to opt into it under these final rules and that those entities will cover the substantial majority of persons previously covered in accommodated plans. The data concerning accommodated self-insured plans indicates that plans sponsored by religious hospitals and health systems and other entities likely to continue using the accommodation constitute over 60 percent of plans using the accommodation, and encompass more than 90 percent of the persons covered in accommodated plans.
The Departments do not have specific data on which plans of which sizes will actually continue to opt into the accommodation, nor how many will make use of self-insured church plan status. The Departments assume that the proportions of covered persons in self-insured plans using contraceptive user fees adjustments also apply in fully insured plans, for which the Departments lack representative data. Based on these assumptions and without better data available, the Departments assume that the 100 accommodated entities that will remain in the accommodation will account for 75 percent of all the persons previously covered in accommodated plans. In comparison, the Departments assume the 109 accommodated entities that will make use of the expanded exemption will encompass 25 percent of persons
Applying these percentages to the estimated 2,907,000 persons covered in previously accommodated plans, the Departments estimate that approximately 727,000 persons will be covered in the 109 plans that use the expanded exemption, and 2,180,000 persons will be covered in the estimated 100 plans that continue to use the accommodation. According to the Census data cited above, women of childbearing age comprise 20.2 percent of the population, which means that approximately 147,000 women of childbearing age are covered in previously accommodated plans that the Departments estimate will use the expanded exemption. As noted above, approximately 43.6 percent of women of childbearing age use women's contraceptive methods covered by the Guidelines, so that the Departments expect approximately 64,000 women that use contraception covered by the Guidelines will be affected by accommodated entities using the expanded exemption.
It is not clear the extent to which this number overlaps with the number estimated above of 6,400 women in plans of litigating entities that may be affected by these rules. In order to more broadly estimate the possible effects of these rules, the Departments assume there is no overlap between the two numbers, and therefore that these final rules would affect the contraceptive costs of approximately 70,500 women.
Under the assumptions just discussed, the number of women whose contraceptive costs will be impacted by the expanded exemption in these final rules is approximately 0.1 percent of the 55.6 million women in private plans that HHS's Office of the Assistant Secretary for Planning and Evaluation (ASPE) estimated in 2015 received preventive services coverage under the Guidelines.
In order to estimate the cost of contraception to women affected by the expanded exemption, the Departments are aware that, under the previous accommodation process, the total amount of contraceptive claims sought for self-insured plans for the 2017 benefit year was $38.5 million.
Some commenters suggested that the Departments' estimate of women affected among litigating entities was too low, but they did not support their proposed higher numbers with citations or specific data that could be verified as more reliable than the estimates in the Religious IFC. Their estimates appeared to be overinclusive, for example, by counting all litigating entities and not just those that may be affected by these rules because they are not in church plans, or by counting all plan participants and not just women of childbearing age that use contraception. Moreover, since the Religious IFC was issued, additional entities have received permanent injunctions against enforcement of any regulations implementing the contraceptive Mandate and so will not be affected by these final rules. Taking all of these factors into account, the Departments are not aware of a better method of estimating the number of women affected by these expanded exemptions.
To account for uncertainty in the estimates above, the Departments conducted a second analysis using an alternative framework, in order to thoroughly consider the possible upper bound economic impact of these final rules.
In 2015, ASPE estimated that 55.6 million women aged 15 to 64 were covered by private insurance had preventive services coverage under the Affordable Care Act.
The methodology of both reports do not fully correspond to the number the Departments seek to estimate here for the purposes of
In response to public comments citing the more recent report, the Departments offer the following estimates based on more recent data than used in the Religious IFC. Data from the U.S. Census Bureau indicates that 167.6 million individuals, male and female, under 65 years of age, were covered by
The Kaiser Family Foundation's Employer Health Benefits Annual Survey 2018 states that 16% of covered workers at all firms are enrolled in a plan grandfathered under the ACA (and thus not subject to the preventive services coverage requirements), but that only 14% of workers receiving coverage from state and local government employer plans are in grandfathered plans.
Prior to the implementation of the Affordable Care Act, approximately 6 percent of employer survey respondents did not offer contraceptive coverage, with 31 percent of respondents not knowing whether they offered such coverage.
It is unknown what motivated those employers to omit contraceptive coverage—whether they did so for religious or other reasons. Despite the lack of information about their motives, the Departments attempt to make a reasonable estimate of the upper bound of the number of those employers that omitted contraception before the Affordable Care Act and that would make use of these expanded exemptions based on sincerely held religious beliefs.
To begin, the Departments estimate that publicly traded companies would not likely make use of these expanded exemptions. Even though the rule does not preclude publicly traded companies from dropping coverage based on a sincerely held religious belief, it is likely that attempts to object on religious grounds by publicly traded companies would be rare. The Departments take note of the Supreme Court's decision in
This assumption is significant because 31.3 percent of employees in the private sector work for publicly traded companies.
Moreover, because these final rules build on previous regulations that already exempted houses of worship and integrated auxiliaries and, as explained above, effectively eliminated obligations to provide contraceptive coverage within objecting self-insured church plans, the Departments attempt to estimate the number of such employers whose employees would not be affected by these rules. In attempting to estimate the number of such employers, the Departments consider the following information. Many Catholic dioceses have litigated or filed public comments opposing the Mandate, representing to the Departments and to courts around the country that official Catholic Church teaching opposes contraception. There are 17,651 Catholic parishes in the United States,
Taking all of these factors into account, the Departments estimate that the private, non-publicly traded employers that did not cover contraception pre-Affordable Care Act, and that were not exempt by the previous regulations nor were participants in self-insured church plans that oppose contraceptive coverage, covered approximately 379,000 women aged 15 to 44 that use contraceptives covered by the Guidelines. But to estimate the likely actual transfer impact of these final rules, the Departments must estimate not just the number of such women covered by those entities, but how many of those entities would actually qualify for, and use, the expanded exemptions.
The Departments do not have data indicating how many of the entities that omitted coverage of contraception pre- Affordable Care Act did so on the basis of sincerely held religious beliefs that might qualify them for exempt status under these final rules, as opposed to having done so for other reasons. Besides the entities that filed lawsuits or submitted public comments concerning previous regulations on this matter, the Departments are not aware of entities that omitted contraception pre-Affordable Care Act and then opposed the contraceptive coverage requirement after it was imposed by the Guidelines. For the following reasons, however, the Departments believe that a reasonable estimate is that no more than approximately one third of the persons covered by relevant entities—that is, no more than approximately 126,400 affected women—would likely be subject to potential transfer impacts under the expanded religious exemptions offered in these final rules. Consequently, as explained below, the Departments believe that the potential impact of these final rules falls substantially below the $100 million threshold for an economically significant major rule.
First, as mentioned, the Departments are not aware of information, or of data from public comments, that would lead us to estimate that all or most entities that omitted coverage of contraception pre-Affordable Care Act did so on the basis of sincerely held conscientious objections in general or, specifically, religious beliefs, as opposed to having done so for other reasons. It would seem reasonable to assume that many of those entities did not do so based on sincerely held religious beliefs. According to a 2016 poll, only 4% of Americans believe that using contraceptives is morally wrong (including from a religious perspective).
It may not be the case that all entities that objected on religious grounds to contraceptive coverage before the ACA brought suit against the Mandate. However, it is worth noting that, while less than 100 for-profit entities challenged the Mandate in court (and an unknown number joined two newly formed associational organizations bringing suit on their behalf), there are more than 3 million for-profit private sector establishments in the United States that offer health insurance.
Finally, among entities that omitted contraceptive coverage based on sincerely held conscientious objections as opposed to other reasons, it is likely that some, albeit a minority, did so based on moral objections that are non-religious, and therefore would not be compassed by the expanded exemptions in these final rules.
For the reasons stated above, the Departments believe it would be incorrect to assume that all or even most of the plans that did not cover contraceptives before the ACA did so on the basis of religious objections. Instead, without data available on the reasons those plans omitted contraceptive coverage before the ACA, we assume that no more than one third of those plans omitted contraceptive coverage based on sincerely held religious beliefs. Thus, of the estimated 379,000 women aged 15 to 44 that use contraceptives covered by the Guidelines, who received primary coverage from plans of private, non-publicly traded, third party employers that did not cover contraception pre-Affordable Care Act, and whose plans were neither exempt nor omitted from mandatory contraceptive coverage under the previous regulations, we estimate that no more than 126,400 women would be in plans that will use these expanded exemptions.
Based on the estimate of an average annual expenditure on contraceptive products and services of $584 per user, the effect of the expanded exemptions on 126,400 women would give rise to approximately $73.8 million in potential transfer impact. It is possible, however, that premiums would adjust to reflect changes in coverage, thus partially offsetting the transfer experienced by women who use the affected contraceptives. As referenced elsewhere in this analysis, such women may make up approximately 8.8 percent of the covered population,
Thus, in their most expansive estimate, the Departments conclude that no more than approximately 126,400 women would likely be subject to potential transfer impacts under the expanded religious exemptions offered in these final rules. The Departments estimate this financial transfer to be approximately $67.3 million. This falls substantially below the $100 million threshold for an economically significant and major rule.
As noted above, the Departments view this alternative estimate as being the highest possible bound of the transfer effects of these rules, but believe the number of establishments that will actually exempt their plans as the result of these rules will be far fewer than contemplated by this estimate. The Departments make these estimates only for the purposes of determining whether the rules are economically significant under Executive Orders 12866 and 13563.
After reviewing public comments, both those supporting and those disagreeing with these estimates and similar estimates from the Religious IFC, and because the Departments do not have sufficient data to precisely
These regulations are not subject to review under section 6(b) of Executive Order 12866 pursuant to the Memorandum of Agreement (April 11, 2018) between the Department of the Treasury and the Office of Management and Budget regarding review of tax regulations.
The Regulatory Flexibility Act (5 U.S.C. 601
The Departments also carefully considered the likely impact of the rule on small entities in connection with their assessment under Executive Order 12866 and do not expect that these final rules will have a significant economic effect on a substantial number of small entities. These final rules will not result in any additional costs to affected entities, and, in many cases, may relieve burdens and costs from such entities. By exempting from the Mandate small businesses and nonprofit organizations with religious objections to some (or all) contraceptives and/or sterilization—businesses and organizations that would otherwise be faced with the dilemma of complying with the Mandate (and violating their religious beliefs) or following their beliefs (and incurring potentially significant financial penalties for noncompliance)—the Departments have reduced regulatory burden on such small entities. Pursuant to section 7805(f) of the Code, the notice of proposed rulemaking preceding these regulations was submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on their impact on small business.
Under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
• The need for the information collection and its usefulness in carrying out the proper functions of our agency.
• The accuracy of our estimate of the information collection burden.
• The quality, utility, and clarity of the information to be collected.
Recommendations to minimize the information collection burden on the affected public, including automated collection techniques. In the October 13, 2017 (82 FR 47792) interim final rules, we solicited public comment on each of these issues for the following sections of the rule containing information collection requirements (ICRs). A description of the information collection provisions implicated in these final rules is given in the following section with an estimate of the annual burden. The burden related to these ICRs received emergency review and approval under OMB control number 0938-1344. They have been resubmitted to OMB in conjunction with these final rules and are pending re-approval. The Departments sought public comments on PRA estimates set forth in the Religious IFC, and are not aware of significant comments submitted that suggest there is a better way to estimate these burdens.
Average labor costs (including 100 percent fringe benefits and overhead) used to estimate the costs are calculated using data available derived from the Bureau of Labor Statistics.
Each organization seeking to be treated as an eligible organization that wishes to use the optional accommodation process offered under these final rules must either use the EBSA Form 700 method of self-certification or provide notice to HHS of its religious objection to coverage of all or a subset of contraceptive services. Specifically, these final rules continue to allow eligible organizations to notify an issuer or third party administrator using EBSA Form 700, or to notify HHS, of their religious objection to coverage of all or a subset of contraceptive services, as set forth in the July 2015 final regulations (80 FR 41318).
Notably, however, entities that are participating in the previous accommodation process, where a self-certification or notice has already been submitted, and where the entities choose to continue their accommodated status under these final rules, generally do not need to file a new self-certification or notice (unless they change their issuer or third party
In order to estimate the cost for an entity that chooses to opt into the accommodation process, HHS assumes that clerical staff for each eligible organization will gather and enter the necessary information and send the self-certification to the issuer or third party administrator as appropriate, or send the notice to HHS.
HHS estimates that each self-certification or notice to HHS will require $0.50 in postage and $0.05 in materials cost (paper and ink) and the total postage and materials cost for each self-certification or notice sent via mail will be $0.55. For purposes of this analysis, HHS assumes that 50 percent of self-certifications or notices to HHS will be mailed. The total cost for sending the self-certifications or notices to HHS by mail is approximately $2.75 for 5 entities. As DOL and HHS share jurisdiction they are splitting the cost burden so that each will account for $1.38 of the cost burden.
As required by the July 2015 final regulations (80 FR 41318), a health insurance issuer or third party administrator providing or arranging separate payments for contraceptive services for participants and beneficiaries in insured or self-insured group health plans (or student enrollees and covered dependents in student health insurance coverage) of eligible organizations is required to provide a written notice to plan participants and beneficiaries (or student enrollees and covered dependents) informing them of the availability of such payments. The notice must be separate from, but contemporaneous with (to the extent possible), any application materials distributed in connection with enrollment (or re-enrollment) in group or student coverage of the eligible organization in any plan year to which the accommodation is to apply and will be provided annually. To satisfy the notice requirement, issuers and third party administrators may, but are not required to, use the model language previously provided by HHS or substantially similar language.
As mentioned, HHS is anticipating that approximately 109 entities will use the optional accommodation (100 that used it previously, and 9 that will newly opt into it). It is unknown how many issuers or third party administrators provide health insurance coverage or services in connection with health plans of eligible organizations, but HHS will assume at least 109. It is estimated that each issuer or third party administrator will need approximately 1 hour of clerical labor (at $55.68 per hour) and 15 minutes of management review (at $117.40 per hour) to prepare the notices. The total burden for each issuer or third party administrator to prepare notices will be 1.25 hours with an associated cost of approximately $85.03. The total burden for all 109 issuers or third party administrators will be 136 hours, with an associated cost of approximately $9,268. As DOL and HHS share jurisdiction, they are splitting the burden each will account for 68 burden hours with an associated cost of $4,634, with approximately 55 respondents.
The Departments estimate that approximately 2,180,000 plan participants and beneficiaries will be covered in the plans of the 100 entities that previously used the accommodation and will continue doing so, and that an additional 9 entities will newly opt into the accommodation. We reach this estimate using calculations set forth above, in which we used 2017 data available to HHS for contraceptive user fees adjustments to estimate that approximately 2,907,000 plan participants and beneficiaries were covered by plans using the accommodation. We further estimated that the 100 entities that previously used the accommodation and will continue doing so will cover approximately 75 percent of the persons in all accommodated plans, based on HHS data concerning accommodated self-insured plans that indicates plans sponsored by religious hospitals and health systems encompass more than 80 percent of the persons covered in such plans. In other words, plans sponsored by such entities have a proportionately larger number of covered persons than do plans sponsored by other accommodated entities, which have smaller numbers of covered persons. As noted above, many religious hospitals and health systems have indicated that they do not object to the accommodation, and some of those entities might also qualify as self-insured church plans. The Departments do not have specific data on which plans of which employer sizes will actually continue to opt into the accommodation, nor how many will make use of self-insured church plan status. The Departments assume that the proportions of covered persons in self-insured plans using contraceptive user fees adjustments also apply in fully insured plans, for which we lack representative data.
Based on these assumptions and without better data available, the Departments estimate that previously accommodated entities encompassed approximately 2,907,000 persons; the estimated 100 entities that previously used the accommodation and continue to use it will account for 75 percent of those persons (that is, approximately 2,180,000 persons); and the estimated 109 entities that previously used the accommodation and will now use their exempt status will account for 25 percent of those persons (that is, approximately 727,000 persons). It is not known how many persons will be covered in the plans of the 9 entities we estimate will newly use the accommodation. Assuming that those 9 entities will have a similar number of covered persons per entity as the 100 entities encompassing 2,180,000
The Departments assume that sending one notice to each policyholder will satisfy the need to send the notices to all participants and dependents. Among persons covered by insurance plans sponsored by large employers in the private sector, approximately 50.1 percent are participants and 49.9 percent are dependents.
An eligible organization that now wishes to take advantage of the expanded exemption may revoke its use of the accommodation process; its issuer or third party administrator must provide written notice of such revocation to participants and beneficiaries as soon as practicable. As discussed above, HHS estimates that 109 entities that are using the accommodation process will revoke their use of the accommodation, and will therefore be required to send the notification; the issuer or third party administrator can send the notice on behalf of the entity. For the purpose of calculating the ICRs associated with revocations of the accommodation, and for various reasons discussed above, HHS assumes that litigating entities that were previously using the accommodation and that will revoke their use of the accommodation fall within the estimated 109 entities that will revoke the accommodation overall.
As before, HHS assumes that, for each issuer or third party administrator, a manager and inside legal counsel and clerical staff will need approximately 2 hours to prepare and send the notification to participants and beneficiaries and maintain records (30 minutes for a manager at a cost of $117.40 per hour, 30 minutes for legal counsel at a cost of $134.50 per hour, 1 hour for clerical staff at a cost of $55.68 per hour). The burden per respondent will be 2 hours with an associated cost of approximately $182; for 109 entities, the total hour burden will be 218 hours with an associated cost of approximately $19,798. As DOL and HHS share jurisdiction, they are splitting the hour burden so each will account for 109 burden hours with an associated cost of approximately $9,899.
As discussed above, HHS estimates that there are approximately 727,000 covered persons in accommodated plans that will revoke their accommodated status and use the expanded exemption.
We have submitted a copy of this rule to OMB for its review of the rule's information collection and recordkeeping requirements. These requirements are not effective until they have been approved by OMB.
Under the Paperwork Reduction Act, an agency may not conduct or sponsor, and an individual is not required to respond to, a collection of information unless it displays a valid OMB control number. In accordance with the requirements of the PRA, the ICR for the EBSA Form 700 and alternative notice have previously been approved by OMB under control numbers 1210-0150 and 1210-0152. A copy of the ICR may be obtained by contacting the PRA addressee shown below or at
The Religious final rules amended the ICR by changing the accommodation process to an optional process for exempt organizations and requiring a notice of revocation to be sent by the issuer or third party administrator to participants and beneficiaries in plans whose employer revokes their accommodation; these final rules confirm as final the Religious IFC provisions on the accommodation process. DOL submitted the ICRs to OMB in order to obtain OMB approval under the PRA for the regulatory revision. In an effort to consolidate the number of information collection requests, DOL is combining the ICR related to the OMB control number 1210-0152 with the ICR related to the OMB control number 1210-0150 and discontinuing OMB control number 1210-0152. Consistent with the analysis in the HHS PRA section above, the Departments expect that each of the estimated 9 eligible organizations newly opting into the accommodation will spend approximately 50 minutes in preparation time and incur $0.54 mailing cost to self-certify or notify HHS. Each of the 109 issuers or third party administrators for the 109 eligible organizations that make use of the accommodation overall will distribute Notices of Availability of Separate Payments for Contraceptive Services. These issuers and third party administrators will spend approximately 1.25 hours in preparation time and incur $0.54 cost per mailed notice. Notices of Availability of Separate Payments for Contraceptive Services will need to be sent to 1,190,613 policyholders, and 53.7 percent of the notices will be sent electronically, while 46.3 percent will be mailed. Finally, 109 entities using the previous accommodation process will revoke their use of the accommodation (in favor of the expanded exemption) and will therefore be required to cause the Notice of Revocation of Accommodation to be sent, with the issuer or third party administrator able to send the notice on behalf of the entity. These entities will spend approximately two hours in preparation time and incur $0.54 cost per mailed notice. Notice of Revocation of Accommodation will need to be sent to an average of 364,102 policyholders and 53.7 percent of the notices will be sent electronically. The DOL information collections in this rule are found in 29 CFR 2510.3-16 and 2590.715-2713A and are summarized as follows:
Executive Order 13765 (January 20, 2017) directs that, “[t]o the maximum extent permitted by law, the Secretary of the Department of Health and Human Services and the heads of all other executive departments and agencies (agencies) with authorities and responsibilities under the Act shall exercise all authority and discretion available to them to waive, defer, grant exemptions from, or delay the implementation of any provision or requirement of the Act that would impose a fiscal burden on any state or a cost, fee, tax, penalty, or regulatory burden on individuals, families, healthcare providers, health insurers, patients, recipients of healthcare services, purchasers of health insurance, or makers of medical devices, products, or medications.” In addition, agencies are directed to “take all actions consistent with law to minimize the unwarranted economic and regulatory burdens of the [Affordable Care Act], and prepare to afford the states more flexibility and control to create a freer and open healthcare market.” These final rules exercise the discretion provided to the Departments under the Affordable Care Act, RFRA, and other laws to grant exemptions and thereby minimize regulatory burdens of the Affordable Care Act on the affected entities and recipients of health care services.
Consistent with Executive Order 13771 (82 FR 9339, February 3, 2017), the Departments have estimated the costs and cost savings attributable to these final rules. As discussed in more detail in the preceding analysis, these final rules lessen incremental reporting costs.
The Unfunded Mandates Reform Act of 1995 (section 202(a) of Pub. L. 104-4), requires the Departments to prepare a written statement, which includes an assessment of anticipated costs and benefits, before issuing “any rule that includes any federal mandate that may result in the expenditure by state, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any one year.” In 2018, that threshold after adjustment for inflation is $150 million. For purposes of the Unfunded Mandates Reform Act, the Religious IFC and these final rules do not include any federal mandate that may result in expenditures by state, local, or tribal governments, nor do they include any federal mandates that may impose an annual burden of $150 million, adjusted for inflation, or more on the private sector.
Executive Order 13132 outlines fundamental principles of federalism, and requires the adherence to specific criteria by federal agencies in the process of their formulation and implementation of policies that have “substantial direct effects” on states, the relationship between the federal government and states, or the distribution of power and responsibilities among the various levels of government. Federal agencies promulgating regulations that have these federalism implications must consult with state and local officials, and describe the extent of their consultation and the nature of the concerns of state and local officials in the preamble to the regulation.
These final rules do not have any federalism implications, since they only provide exemptions from the contraceptive and sterilization coverage requirement in HRSA Guidelines supplied under section 2713 of the PHS Act.
The Department of the Treasury regulations are adopted pursuant to the authority contained in sections 7805 and 9833 of the Code, and Public Law 103-141, 107 Stat. 1488 (42 U.S.C. 2000bb-2000bb-4).
The Department of Labor regulations are adopted pursuant to the authority contained in 29 U.S.C. 1002(16), 1027, 1059, 1135, 1161-1168, 1169, 1181-1183, 1181 note, 1185, 1185a, 1185b, 1185d, 1191, 1191a, 1191b, and 1191c; sec. 101(g), Public Law 104-191, 110 Stat. 1936; sec. 401(b), Public Law 105-200, 112 Stat. 645 (42 U.S.C. 651 note); sec. 512(d), Public Law 110-343, 122 Stat. 3881; sec. 1001, 1201, and 1562(e), Public Law 111-148, 124 Stat. 119, as amended by Public Law 111-152, 124 Stat. 1029; Pub. L. 103-141, 107 Stat. 1488 (42 U.S.C. 2000bb-2000bb-4); Secretary of Labor's Order 1-2011, 77 FR 1088 (Jan. 9, 2012).
The Department of Health and Human Services regulations are adopted pursuant to the authority contained in sections 2701 through 2763, 2791, and 2792 of the PHS Act (42 U.S.C. 300gg through 300gg-63, 300gg-91, and 300gg-92), as amended; and Title I of the Affordable Care Act, sections 1301-1304, 1311-1312, 1321-1322, 1324, 1334, 1342-1343, 1401-1402, 1412, Public Law 111-148, 124 Stat. 119 (42 U.S.C. 18021-18024, 18031-18032, 18041-18042, 18044, 18054, 18061, 18063, 18071, 18082, 26 U.S.C. 36B, and 31 U.S.C. 9701); and Public Law 103-141, 107 Stat. 1488 (42 U.S.C. 2000bb-2000bb-4).
Excise taxes, Health care, Health insurance, Pensions, Reporting and recordkeeping requirements.
Continuation coverage, Disclosure, Employee benefit plans, Group health plans, Health care, Health insurance, Medical child support, Reporting and recordkeeping requirements.
Health care, Health insurance, Reporting and recordkeeping requirements, State regulation of health insurance.
Accordingly, 26 CFR part 54 is amended as follows:
26 U.S.C. 7805. * * *
(a) * * *
(1)
(iv) With respect to women, such additional preventive care and screenings not described in paragraph (a)(1)(i) of this section as provided for in comprehensive guidelines supported by the Health Resources and Services Administration for purposes of section 2713(a)(4) of the Public Health Service Act, subject to 45 CFR 147.131 and 147.132.
(a)
(1) The organization is an objecting entity described in 45 CFR 147.132(a)(1)(i) or (ii);
(2) Notwithstanding its status under paragraph (a)(1) of this section and under 45 CFR 147.132(a), the organization voluntarily seeks to be considered an eligible organization to invoke the optional accommodation under paragraph (b) or (c) of this section as applicable; and
(3) [Reserved]
(4) The organization self-certifies in the form and manner specified by the
(5) An eligible organization may revoke its use of the accommodation process, and its issuer or third party administrator must provide participants and beneficiaries written notice of such revocation, as specified herein.
(i)
(ii)
(b)
(i) The eligible organization or its plan must contract with one or more third party administrators.
(ii) The eligible organization must provide either a copy of the self-certification to each third party administrator or a notice to the Secretary of the Department of Health and Human Services that it is an eligible organization and of its objection as described in 45 CFR 147.132 to coverage of all or a subset of contraceptive services.
(A) When a copy of the self-certification is provided directly to a third party administrator, such self-certification must include notice that obligations of the third party administrator are set forth in 29 CFR 2510.3-16 and this section.
(B) When a notice is provided to the Secretary of Health and Human Services, the notice must include the name of the eligible organization; a statement that it objects as described in 45 CFR 147.132 to coverage of some or all contraceptive services (including an identification of the subset of contraceptive services to which coverage the eligible organization objects, if applicable), but that it would like to elect the optional accommodation process; the plan name and type (that is, whether it is a student health insurance plan within the meaning of 45 CFR 147.145(a) or a church plan within the meaning of section 3(33) of ERISA); and the name and contact information for any of the plan's third party administrators. If there is a change in any of the information required to be included in the notice, the eligible organization must provide updated information to the Secretary of the Department of Health and Human Services for the optional accommodation process to remain in effect. The Department of Labor (working with the Department of Health and Human Services) will send a separate notification to each of the plan's third party administrators informing the third party administrator that the Secretary of the Department of Health and Human Services has received a notice under paragraph (b)(1)(ii) of this section and describing the obligations of the third party administrator under 29 CFR 2510.3-16 and this section.
(2) If a third party administrator receives a copy of the self-certification from an eligible organization or a notification from the Department of Labor, as described in paragraph (b)(1)(ii) of this section, and is willing to enter into or remain in a contractual relationship with the eligible organization or its plan to provide administrative services for the plan, then the third party administrator will provide or arrange payments for contraceptive services, using one of the following methods—
(i) Provide payments for the contraceptive services for plan participants and beneficiaries without imposing any cost-sharing requirements (such as a copayment, coinsurance, or a deductible), premium, fee, or other charge, or any portion thereof, directly or indirectly, on the eligible organization, the group health plan, or plan participants or beneficiaries; or
(ii) Arrange for an issuer or other entity to provide payments for the contraceptive services for plan participants and beneficiaries without imposing any cost-sharing requirements (such as a copayment, coinsurance, or a deductible), premium, fee, or other charge, or any portion thereof, directly or indirectly, on the eligible organization, the group health plan, or plan participants or beneficiaries.
(3) If a third party administrator provides or arranges payments for contraceptive services in accordance with either paragraph (b)(2)(i) or (ii) of this section, the costs of providing or arranging such payments may be reimbursed through an adjustment to the federally facilitated Exchange user fee for a participating issuer pursuant to 45 CFR 156.50(d).
(4) A third party administrator may not require any documentation other than a copy of the self-certification from the eligible organization or notification from the Department of Labor described in paragraph (b)(1)(ii) of this section.
(5) Where an otherwise eligible organization does not contract with a third party administrator and files a self-certification or notice under paragraph (b)(1)(ii) of this section, the obligations under paragraph (b)(2) of this section do not apply, and the otherwise eligible organization is under no requirement to provide coverage or payments for contraceptive services to which it objects. The plan administrator for that otherwise eligible organization may, if it and the otherwise eligible organization choose, arrange for payments for contraceptive services from an issuer or other entity in accordance with paragraph (b)(2)(ii) of this section, and such issuer or other entity may receive reimbursements in accordance with paragraph (b)(3) of this section.
(6) Where an otherwise eligible organization is an ERISA-exempt church plan within the meaning of section 3(33) of ERISA and it files a self-certification or notice under paragraph (b)(1)(ii) of this section, the obligations under paragraph (b)(2) of this section do not
(c)
(i) The eligible organization or its plan must contract with one or more health insurance issuers.
(ii) The eligible organization must provide either a copy of the self-certification to each issuer providing coverage in connection with the plan or a notice to the Secretary of the Department of Health and Human Services that it is an eligible organization and of its objection as described in 45 CFR 147.132 to coverage for all or a subset of contraceptive services.
(A) When a self-certification is provided directly to an issuer, the issuer has sole responsibility for providing such coverage in accordance with § 54.9815-2713.
(B) When a notice is provided to the Secretary of the Department Health and Human Services, the notice must include the name of the eligible organization; a statement that it objects as described in 45 CFR 147.132 to coverage of some or all contraceptive services (including an identification of the subset of contraceptive services to which coverage the eligible organization objects, if applicable) but that it would like to elect the optional accommodation process; the plan name and type (that is, whether it is a student health insurance plan within the meaning of 45 CFR 147.145(a) or a church plan within the meaning of section 3(33) of ERISA); and the name and contact information for any of the plan's health insurance issuers. If there is a change in any of the information required to be included in the notice, the eligible organization must provide updated information to the Secretary of Department of Health and Human Services for the optional accommodation process to remain in effect. The Department of Health and Human Services will send a separate notification to each of the plan's health insurance issuers informing the issuer that the Secretary of the Department Health and Human Services has received a notice under paragraph (c)(2)(ii) of this section and describing the obligations of the issuer under this section.
(2) If an issuer receives a copy of the self-certification from an eligible organization or the notification from the Department of Health and Human Services as described in paragraph (c)(2)(ii) of this section and does not have its own objection as described in 45 CFR 147.132 to providing the contraceptive services to which the eligible organization objects, then the issuer will provide payments for contraceptive services as follows—
(i) The issuer must expressly exclude contraceptive coverage from the group health insurance coverage provided in connection with the group health plan and provide separate payments for any contraceptive services required to be covered under § 54.9815-2713(a)(1)(iv) for plan participants and beneficiaries for so long as they remain enrolled in the plan.
(ii) With respect to payments for contraceptive services, the issuer may not impose any cost-sharing requirements (such as a copayment, coinsurance, or a deductible), or impose any premium, fee, or other charge, or any portion thereof, directly or indirectly, on the eligible organization, the group health plan, or plan participants or beneficiaries. The issuer must segregate premium revenue collected from the eligible organization from the monies used to provide payments for contraceptive services. The issuer must provide payments for contraceptive services in a manner that is consistent with the requirements under sections 2706, 2709, 2711, 2713, 2719, and 2719A of the PHS Act, as incorporated into section 9815 of the PHS Act. If the group health plan of the eligible organization provides coverage for some but not all of any contraceptive services required to be covered under § 54.9815-2713(a)(1)(iv), the issuer is required to provide payments only for those contraceptive services for which the group health plan does not provide coverage. However, the issuer may provide payments for all contraceptive services, at the issuer's option.
(3) A health insurance issuer may not require any documentation other than a copy of the self-certification from the eligible organization or the notification from the Department of Health and Human Services described in paragraph (c)(1)(ii) of this section.
(d)
(e)
(2) A group health plan is considered to comply with any applicable requirement under § 54.9815-2713(a)(1)(iv) to provide contraceptive coverage if the plan complies with its obligations under paragraph (c) of this section, without regard to whether the issuer complies with the obligations under this section applicable to such issuer.
(f)
(g)
For the reasons set forth in the preamble, the Department of Labor adopts as final the interim final rules amending 29 CFR part 2590 published on October 13, 2017 (82 FR 47792) with the following changes:
29 U.S.C. 1027, 1059, 1135, 1161-1168, 1169, 1181-1183, 1181 note, 1185, 1185a, 1185b, 1191, 1191a, 1191b, and 1191c; sec. 101(g), Pub. L. 104-191, 110 Stat. 1936; sec. 401(b), Pub. L. 105-200, 112 Stat. 645 (42 U.S.C. 651 note); sec. 512(d), Pub. L. 110-343, 122 Stat. 3881; sec. 1001, 1201, and 1562(e), Pub. L. 111-148, 124 Stat. 119, as amended by Pub. L. 111-152, 124 Stat. 1029; Division M, Pub. L. 113-235, 128 Stat. 2130; Secretary of Labor's Order 1-2011, 77 FR 1088 (Jan. 9, 2012).
The revision and addition read as follows:
(a) * * *
(5) An eligible organization may revoke its use of the accommodation process, and its issuer or third party administrator must provide participants and beneficiaries written notice of such revocation, as specified herein.
(i)
(ii)
(e)
(2) A group health plan is considered to comply with any applicable requirement under § 2590.715-2713(a)(1)(iv) to provide contraceptive coverage if the plan complies with its obligations under paragraph (c) of this section, without regard to whether the issuer complies with the obligations under this section applicable to such issuer.
For the reasons set forth in the preamble, the Department of Health and Human Services adopts as final the interim final rules amending 45 CFR part 147 published on October 13, 2017 (82 FR 47792) with the following changes:
42 U.S.C. 300gg through 300gg-63, 300gg-91, and 300gg-92, as amended.
The revision and addition read as follows:
(c) * * *
(4) An eligible organization may revoke its use of the accommodation process, and its issuer must provide participants and beneficiaries written notice of such revocation, as specified herein.
(i)
(ii)
(f)
(2) A group health plan is considered to comply with any applicable requirement under § 147.130(a)(1)(iv) to provide contraceptive coverage if the plan complies with its obligations under paragraph (d) of this section, without regard to whether the issuer complies with the obligations under this section applicable to such issuer.
The revisions and addition read as follows:
(a) * * *
(1) Guidelines issued under § 147.130(a)(1)(iv) by the Health Resources and Services Administration must not provide for or support the requirement of coverage or payments for contraceptive services with respect to a group health plan established or maintained by an objecting organization, or health insurance coverage offered or arranged by an objecting organization, to the extent of the objections specified below. Thus the Health Resources and Service Administration will exempt from any guidelines' requirements that relate to the provision of contraceptive services:
(ii) A group health plan, and health insurance coverage provided in connection with a group health plan, where the plan or coverage is established or maintained by a church, an integrated auxiliary of a church, a convention or association of churches, a religious order, a nonprofit organization, or other non-governmental organization or association, to the extent the plan sponsor responsible for establishing and/or maintaining the plan objects as specified in paragraph (a)(2) of this section. The exemption in this paragraph applies to each employer, organization, or plan sponsor that adopts the plan;
(iii) An institution of higher education as defined in 20 U.S.C. 1002, which is non-governmental, in its arrangement of student health insurance coverage, to the extent that institution objects as specified in paragraph (a)(2) of this section. In the case of student health insurance coverage, this section is applicable in a manner comparable to its applicability to group health insurance coverage provided in connection with a group health plan established or maintained by a plan sponsor that is an employer, and references to “plan participants and beneficiaries” will be interpreted as references to student enrollees and their covered dependents; and
(iv) A health insurance issuer offering group or individual insurance coverage to the extent the issuer objects as specified in paragraph (a)(2) of this section. Where a health insurance issuer providing group health insurance coverage is exempt under this subparagraph (iv), the group health plan established or maintained by the plan sponsor with which the health insurance issuer contracts remains subject to any requirement to provide coverage for contraceptive services under Guidelines issued under § 147.130(a)(1)(iv) unless it is also exempt from that requirement.
(2) The exemption of this paragraph (a) will apply to the extent that an entity described in paragraph (a)(1) of this section objects, based on its sincerely held religious beliefs, to its establishing, maintaining, providing, offering, or arranging for (as applicable):
(i) Coverage or payments for some or all contraceptive services; or
(ii) A plan, issuer, or third party administrator that provides or arranges such coverage or payments.
(b)
Internal Revenue Service, Department of the Treasury; Employee Benefits Security Administration, Department of Labor; and Centers for Medicare & Medicaid Services, Department of Health and Human Services.
Final rules.
These rules finalize, with changes based on public comments, the interim final rules issued in the
The primary purpose of these final rules is to finalize, with changes in response to public comments, the interim final regulations with requests for comments (IFCs) published in the
These rules finalize exemptions provided in the Moral IFC for the group health plans and health insurance coverage of various entities and individuals with sincerely held moral convictions opposed to coverage of some or all contraceptive or sterilization methods encompassed by HRSA's guidelines. As in the Moral IFC, the exemptions include plan sponsors that are nonprofit organization plan sponsors or for-profit entities that have no publicly traded ownership interests (defined as any class of common equity securities required to be registered under section 12 of the Securities Exchange Act of 1934). The exemptions also continue to include institutions of higher education in their arrangement of student health insurance coverage; health insurance issuers (but only with respect to plans that are otherwise also exempt under the rules); and objecting individuals with respect to their own coverage, where their health insurance issuer and plan sponsor, as applicable, are willing to provide coverage complying with the individual's moral objection. After considering public comments, the Departments have decided not to extend the moral exemptions to non-federal governmental entities at this time, although individuals receiving employer-sponsored insurance from a governmental entity may use the individual exemption if the other terms of the individual exemption apply, including that their employer is willing to offer them a plan consistent with their moral objection.
In response to public comments, various changes are made to clarify the intended scope of the language in the Moral IFC's exemptions. The prefatory exemption language is clarified to ensure exemptions apply to a group health plan established or maintained by an objecting organization, or health insurance coverage offered or arranged by an objecting organization, to the extent of the objections. The Departments add language to specify that the exemption for institutions of higher education applies to non-governmental entities. The Departments also modified language describing the moral objection applicable to the exemptions, to specify that the entity objects, based on its sincerely held moral convictions, to its establishing, maintaining, providing, offering, or arranging for (as applicable) either: Coverage or payments for some or all contraceptive services; or a plan, issuer, or third party administrator that provides or arranges such coverage or payments.
The Departments also clarify language in the exemption applicable to plans of objecting individuals. The clarification is made to ensure that the HRSA guidelines do not prevent a willing health insurance issuer offering group or individual health insurance coverage, and as applicable, a willing plan sponsor of a group health plan, from offering a separate policy, certificate or contract of insurance or a separate group health plan or benefit package option, to any group health plan sponsor (with respect to an individual) or individual, as applicable, who objects to coverage or payments for some or all contraceptive services based on sincerely held moral convictions. The exemption adds that, if an individual objects to some but not all contraceptive services, but the issuer, and as applicable, plan sponsor, are willing to provide the plan sponsor or individual, as applicable, with a separate policy, certificate or contract of insurance or a separate group health plan or benefit package option that omits all contraceptives, and the individual agrees, then the exemption applies as if the individual objects to all contraceptive services.
These rules finalize without change the references to the moral exemptions that were inserted by the Moral IFC into the rules that regulatorily restate the statutory language from section 2713(a) and (a)(4) of the Public Health Service Act. Similarly, these rules finalize without change from the Moral IFC references to the moral exemptions that were inserted into the regulations governing the optional accommodation process. These references operationalize the effect of the moral exemptions rule, and they allow contraceptive services to be made available to women if any employers with non-religious moral objections to contraceptive coverage choose to use the optional accommodation process.
Over many decades, Congress has protected conscientious objections including based on moral convictions in the context of health care and human services, and including health coverage, even as it has sought to promote access to health services.
The ACA reorganized, amended, and added to the provisions of part A of title XXVII of the Public Health Service Act (PHS Act) relating to group health plans and health insurance issuers in the group and individual markets. The ACA added section 715(a)(1) to the Employee Retirement Income Security Act of 1974 (ERISA) and section 9815(a)(1) to the Internal Revenue Code (Code), in order to incorporate the provisions of part A of title XXVII of the PHS Act into ERISA and the Code, and to make them applicable to group health plans and health insurance issuers providing health insurance coverage in connection with group health plans. The sections of the PHS Act incorporated into ERISA and the Code are sections 2701 through 2728.
In section 2713(a)(4) of the PHS Act (hereinafter “section 2713(a)(4)”), Congress provided administrative discretion to require that certain group health plans and health insurance issuers cover certain women's preventive services, in addition to other preventive services required to be covered in section 2713. Congress granted that discretion to the Health Resources and Services Administration (HRSA), a component of the U.S. Department of Health and Human Services (HHS). Specifically, section 2713(a)(4) allows HRSA discretion to specify coverage requirements, “with respect to women, such additional preventive care and screenings as provided for in comprehensive guidelines supported” by HRSA (the “Guidelines”).
Since 2011, HRSA has exercised that discretion to require coverage for, among other things, certain contraceptive services.
During the period when the Departments were publishing and modifying the regulations, organizations and individuals filed dozens of lawsuits challenging the contraceptive coverage requirement and regulations (hereinafter, the “contraceptive Mandate,” or the “Mandate”). Plaintiffs included religious nonprofit organizations, businesses run by religious families, individuals, and others, including several non-religious organizations that opposed coverage of certain contraceptives under the Mandate on the basis of non-religious moral convictions. For-profit entities with religious objections won various court decisions leading to the Supreme Court's ruling in
Beginning in 2015, lawsuits challenging the Mandate were also filed by various non-religious organizations with moral objections to contraceptive coverage. These organizations stated that they believe some methods classified by the Food and Drug Administration (FDA) as contraceptives may have an abortifacient effect and, therefore, in their view, are morally equivalent to abortion to which they have a moral objection. Under regulations preceding October 2017, these organizations neither received an exemption from the Mandate nor qualified for the accommodation. For example, March for Life filed a complaint claiming that the Mandate violated the equal protection component of the Due Process Clause of the Fifth Amendment, and was arbitrary and capricious under the Administrative Procedure Act (APA). Citing, for example, 77 FR 8727, March for Life argued that the Departments' stated interests behind the Mandate were only advanced among women who “want” the coverage so as to prevent “unintended” pregnancy. March for Life contended that, because it only hires employees who publicly advocate against abortion, including what they regard as abortifacient contraceptive items, the Departments' interests were not rationally advanced by imposing the Mandate upon it and its employees. Accordingly, March for Life contended that applying the Mandate to it (and other similarly situated organizations) lacked a rational basis and, therefore, was arbitrary and capricious in violation of the APA. March for Life further contended that, because the Departments concluded the government's interests were not undermined by exempting houses of worship and integrated auxiliaries (based on the assumption that such entities are relatively more likely than other nonprofits with religious objections to have employees that share their views against certain contraceptives), applying the Mandate to March for Life or similar organizations that definitively hire only employees who oppose certain contraceptives lacked a rational basis and, therefore, violated their right of equal protection under the Due Process Clause.
March for Life's employees, who stated they were personally religious (although personal religiosity was not a condition of their employment), also sued as co-plaintiffs. They contended that the Mandate violated their rights under RFRA by making it impossible for them to obtain health coverage consistent with their religious beliefs, either from the plan March for Life wanted to offer them, or in the individual market, because the Departments offered no exemptions in either circumstance. Another non-religious nonprofit organization that opposed the Mandate's requirement to provide certain contraceptive coverage on moral grounds also filed a lawsuit challenging the Mandate.
Challenges by non-religious nonprofit organizations led to conflicting opinions among the federal courts. A district court agreed with the March for Life plaintiffs on the organization's equal protection claim and the employees' RFRA claims, while not specifically ruling on the APA claim, and issued a permanent injunction against the Departments that is still in place.
The Departments most recently solicited public comments on these issues again in two interim final regulations with request for comments published in the
In the preamble to the Moral IFC, the Departments explained several reasons why, after exercising our discretion to reevaluate the exemptions and accommodations for the contraceptive Mandate, we sought public comment on whether to protect moral convictions in the Moral IFC and these final rules. The Departments noted that we considered, among other things, Congress's history of providing protections for moral convictions regarding certain health services (including contraception, sterilization, and items or services believed to involve abortion); the text, context, and intent of section 2713(a)(4) and the ACA; Executive Order 13798, “Promoting Free Speech and Religious Liberty” (May 4, 2017); previously submitted public comments; and the extensive litigation over the contraceptive Mandate. The Departments concluded that it was appropriate that HRSA take into account the moral convictions of certain employers, individuals and health insurance issuers where the coverage of contraceptive services is concerned. Comments were requested on the interim final regulations.
After consideration of the comments and feedback received from stakeholders, the Departments are finalizing the Moral IFC, with changes based on comments as indicated herein.
During the 60-day comment period for the Moral IFC, which closed on December 5, 2017, the Departments received over 54,000 public comment submissions, which are posted to
These rules expand exemptions to protect certain entities and individuals with moral convictions that oppose contraception whose health plans are subject to a mandate of contraceptive coverage through guidance issued pursuant to the ACA. These rules do not alter the discretion of HRSA, a component of HHS, to maintain the Guidelines requiring contraceptive coverage where no regulatorily recognized objection exists. These rules also make available to exempt organizations the accommodation process, which was previously established in response to some objections of religious organizations, as an optional process for exempt entities that wish to use it voluntarily. These rules do not alter multiple other federal programs that provide free or subsidized contraceptives or related education and counseling for women at risk of unintended pregnancy.
The Departments received conflicting comments on their legal authority to provide exemptions and accommodations to the Mandate. Some commenters agreed that the Departments are legally authorized to provide expanded exemptions and an accommodation for moral convictions, noting that there was no requirement of contraceptive coverage in the ACA and no prohibition on providing moral exemptions in Guidelines issued under section 2713(a)(4). Other commenters, however, asserted that the Departments have no legal authority to provide any exemptions to the contraceptive Mandate, contending, based on statements in the ACA's legislative history, that the ACA requires contraceptive coverage. Still other commenters contended that the Departments are legally authorized to provide the religious exemptions that existed prior to the 2017 IFCs, but not to protect moral convictions.
The Departments conclude that we are legally authorized to provide the exemption and accommodation for moral convictions set forth in the Moral IFC and these final rules. These rules concern section 2713 of the PHS Act, as incorporated into ERISA and the Code. Congress has granted the Departments legal authority, collectively, to administer these statutes. (26 U.S.C. 9833; 29 U.S.C. 1191c; 42 U.S.C. 300gg-92).
Where it applies, section 2713(a)(4) requires coverage without cost sharing for “such additional” women's preventive care and screenings “as provided for” and “supported by” guidelines developed by HHS acting through HRSA. When Congress enacted this provision, those Guidelines did not exist. And nothing in the statute mandated that the Guidelines had to include contraception, let alone for all types of employers with covered plans. Instead, section 2713(a)(4) provided a
Congress did not specify the extent to which HRSA must “provide for” and “support” the application of Guidelines that it chooses to adopt. HRSA's authority to support “comprehensive guidelines” involves determining both the types of coverage and scope of that coverage. Section 2714(a)(4) requires coverage for preventive services only “as provided for in comprehensive guidelines supported by [HRSA].” That is, services are required to be included in coverage only to the extent that the Guidelines supported by HRSA provide for them. Through use of the word “as” in the phrase “as provided for,” it requires that HRSA support how those services apply—that is, the manner in which the support will happen, such as in the phrase “as you like it.”
Nor is it simply a textual aberration that the word “as” is missing from the other three provisions in section 2713(a) of the PHS Act. Rather, this difference mirrors other distinctions within that section that demonstrate that Congress intended HRSA to have the discretion the Agencies invoke. For example, sections (a)(1) and (a)(3) require “evidence-based” or “evidence-informed” coverage, while section (a)(4) does not. This difference suggests that the Agencies have the leeway to incorporate policy-based concerns into their decision-making. This reading of section 2713(a)(4) also prevents the statute from being interpreted in a cramped way that allows no flexibility or tailoring, and that would force the Departments to choose between ignoring religious objections in violation of RFRA or else eliminating the contraceptive coverage requirement from the Guidelines altogether. The Departments instead interpret section 2713(a)(4) as authorizing HRSA's Guidelines to set forth both the kinds of items and services that will be covered, and the scope of entities to which the contraceptive coverage requirement in those Guidelines will apply.
The moral objections at issue here, like the religious objections prompting exemptions dating back to the inception of the Mandate in 2011, may, consistent with the statutory provision, permissibly inform what HHS, through HRSA, decides to provide for and support in the Guidelines. Since the first rulemaking on this subject in 2011, the Departments have consistently interpreted the broad discretion granted to HRSA in section 2713(a)(4) as including the power to reconcile the ACA's preventive-services requirement with sincerely held views of conscience on the sensitive subject of contraceptive coverage—namely, by exempting churches and their integrated auxiliaries from the contraceptive-coverage Mandate. (
The Departments' conclusions are consistent with our interpretation of section 2713 of the PHS Act since 2010, when the ACA was enacted, and since the Departments started to issue interim final regulations implementing that section. The Departments have consistently interpreted section 2713(a)(4) to grant broad discretion to decide the extent to which HRSA will provide for, and support, the coverage of additional women's preventive care and screenings, including the decision to exempt certain entities and plans, and not to provide for or support the application of the Guidelines with respect to those entities or plans. The Departments created an exemption to the contraceptive Mandate when that Mandate was announced in 2011, and then amended and expanded the exemption and added an accommodation process in multiple rulemakings thereafter. The accommodation process requires the provision of coverage or payments for contraceptives to plan participants in an eligible organization's health plan by the organization's insurer or third party administrator. However, the accommodation process itself, in some cases, failed to require contraceptive coverage for many women, because—as the Departments acknowledged at the time—the enforcement mechanism for that process, section 3(16) of ERISA, does not provide a means to impose an obligation to provide contraceptive coverage on the third party administrator of self-insured church plans (see 80 FR 41323). Non-exempt employers participate in many church plans. Therefore, in both the previous exemption, and in the previous accommodation's application to self-insured church plans, the Departments have been choosing not to require contraceptive coverage for certain kinds of employers since the Guidelines were adopted. In doing so, the Departments have been acting contrary to commenters who contended the Departments had no authority to create exemptions under section 2713 of the PHS Act, or its incorporation into ERISA and the Code, and who contended instead that the Departments must enforce Guidelines on the broadest spectrum of group health plans as possible, even including churches (see, for example, 2012 final regulations at 77 FR 8726).
The Departments' interpretation of section 2713(a)(4) is confirmed by the ACA's statutory structure. Congress did not intend to require entirely uniform coverage of preventive services (see for
Some commenters argue that Executive Order 13535's reference to implementing the ACA consistent with certain conscience laws does not justify creating exemptions to contraceptive coverage in the Guidelines, because those laws do not specifically require exemptions in the Guidelines. The Departments, however, believe that they are acting consistent with Executive Order 13535 by creating exemptions using HRSA's authority under section 2713(a)(4), and the Departments' administrative authority over the implementation of section 2713(a) of the PHS Act. Executive Order 13535, issued upon the signing of the ACA, specified that “longstanding Federal laws to protect conscience . . . remain intact,” including laws that protect holders of religious beliefs or moral convictions from certain requirements in health care contexts. Although the text of Executive Order 13535 does not require the expanded exemptions confirmed in these final rules, the expanded exemptions are, as explained below, consistent with longstanding federal laws to protect conscience objections, based on religious beliefs or moral convictions regarding certain health matters, and are consistent with the intent that the ACA be implemented in accordance with the conscience protections set forth in those laws.
Some commenters contended that, even though Executive Order 13535 refers to the Church Amendments, the intention of those statutes is narrow, should not be construed to extend to entities instead of to individuals, and should not be construed to prohibit procedures. But those comments mistake the Departments' position. The Departments are not construing the Church Amendments to require these exemptions, nor do the exemptions prohibit any procedures. Instead, through longstanding federal conscience statutes, Congress has established consistent principles concerning respect for sincerely held moral convictions in sensitive healthcare contexts.
Some commenters stated that the Supreme Court ruled that the exemptions provided for houses of worship and integrated auxiliaries were required by the First Amendment. From this, commenters concluded that the exemptions for houses of worship and integrated auxiliaries are legally authorized, but that exemptions beyond those are not. But the Supreme Court did not rule on the question whether the exemptions provided for houses of worship and integrated auxiliaries were required by the First Amendment, and the Court did not say the Departments must apply the contraceptive Mandate unless RFRA prohibits us from doing so.
The appropriateness of including exemptions to protect moral convictions is informed by Congress's long history of providing exemptions for moral convictions, especially in certain health care contexts.
The Department received numerous comments about its decision in the Moral IFC to exercise its discretion to provide moral exemptions to, and an accommodation under, the contraceptive Mandate. Some commenters agreed with the Departments' decision in the Moral IFC, arguing that it is appropriate to exercise the Departments' discretion to protect moral convictions in light of Congress's history of protecting moral convictions in various contexts, especially concerning health care. Other commenters disagreed, saying that existing conscience statutes protecting moral convictions do not require these exemptions and, therefore, the exemptions should not be offered. Some commenters stated that because Congress has provided conscience protections, but did not specifically provide them in section 2713(a)(4), conscience protections are inappropriate in the implementation of that section. Still other commenters went further, disagreeing with conscience protections regarding contraceptives, abortions, or health care in general.
In deciding the most appropriate way to exercise our discretion in this context, the Departments draw on the most recent statements of Congress, along with nearly 50 years of statutes and Supreme Court precedent discussing the protection of moral convictions in certain circumstances—particularly in the context of health care and health coverage. Most recently, Congress expressed its intent on the matter of Government-mandated contraceptive coverage when it declared, with respect to the possibility that the District of Columbia would require contraceptive coverage, that “it is the intent of Congress that any legislation enacted on such issue should include a `conscience clause' which provides exceptions for religious beliefs and moral convictions.” Consolidated Appropriations Act, 2018, Div. E, section 808, Public Law 115-141, 132 Stat. 348, 603 (Mar. 23, 2018);
The Departments also consider significant the many statutes listed above, in section I—Background footnote 1, that show Congress's consistent protection of moral convictions alongside religious beliefs in the federal regulation of health care. These include laws such as the Church Amendments (dating back to 1973), which we discuss at length below, to the 2018 Consolidated Appropriations Act discussed above. Notably among those laws, and in addition to the Church Amendments, Congress has enacted protections for health plans or health care organizations in Medicaid or Medicare Advantage to object “on moral or religious grounds” to providing coverage of certain counseling or referral services. 42 U.S.C. 1395w-22(j)(3)(B) (protecting against forced counseling or referrals in Medicare + Choice (now Medicare Advantage) managed care plans with respect to objections based on “moral or religious grounds”); 42 U.S.C. 1396u-2(b)(3) (protecting against forced counseling or referrals in Medicaid managed care plans with respect to objections based on “moral or religious grounds”). Congress has also protected individuals who object to prescribing or providing contraceptives contrary to their “religious beliefs or moral convictions.” Consolidated Appropriations Act, 2018, Public Law 115-141, Division E, section 726(c);
The Departments disagree with commenters that suggested we should not consider Congress's history of protecting moral objections in certain health care contexts due to Congress's failure to explicitly include exemptions in section 2713(a)(4) itself. The argument by these commenters proves too much, since Congress also did not specifically require contraceptive coverage in section 2713 of the PHS Act. This argument would also negate not just these expanded exemptions, but the previous exemptions provided for houses of worship and integrated auxiliaries, and the indirect exemption for self-insured church plans that use the accommodation. Where Congress left so many matters concerning section 2713(a)(4) to agency discretion, the Departments consider it appropriate to implement these expanded exemptions in light of Congress's long history of respecting moral convictions in the context of certain federal health care requirements.
One of the most important and well-established federal statutes respecting conscientious objections in specific health care contexts was enacted over the course of several years beginning in 1973, initially as a response to court decisions raising the prospect that entities or individuals might be required to facilitate abortions or sterilizations because they had received federal funds. These sections of the U.S. Code are known as the Church Amendments, named after their primary sponsor, Senator Frank Church (D-Idaho). The Church Amendments specifically provide conscience protections based on sincerely held moral convictions, not just religious beliefs. Among other things, the amendments protect the recipients of certain federal health funds from being required to perform, assist, or make their facilities available for abortions or sterilizations if they object “on the basis of religious beliefs or moral convictions,” and they prohibit recipients of certain federal health funds from discriminating against any personnel “because he refused to perform or assist in the performance of such a procedure or abortion on the grounds that his performance or assistance in the performance of the procedure or abortion would be contrary to his religious beliefs or moral convictions” (42 U.S.C. 300a-7(b), (c)(1)). Later additions to the Church Amendments protect other conscientious objections, including some objections on the basis of moral conviction to “any lawful health service,” or to “any part of a health service program.” (42 U.S.C. 300a-7(c)(2), (d)). In contexts covered by those sections of the Church Amendments, the provision or coverage of certain contraceptives, depending on the circumstances, could constitute “any lawful health service” or a “part of a health service program.” As such, the protections provided by those provisions of the Church Amendments would encompass moral objections to contraceptive services or coverage.
The Church Amendments were enacted in the wake of the Supreme Court's decision in
The Congressional Record contains discussions that occurred when the protection for moral convictions was first proposed in the Church Amendments. When Senator Church introduced the first of those amendments in 1973, he cited not only
Mr. STEVENSON. Mr. President, first of all I commend the Senator from Idaho for bringing this matter to the attention of the Senate. I ask the Senator a question.
One need not be of the Catholic faith or any other religious faith to feel deeply about the worth of human life. The protections afforded by this amendment run only to those whose religious beliefs would be offended by the necessity of performing or
As mortals, we cannot with confidence say, when life begins. But whether it is life, or the potentiality of life, our moral convictions as well as our religious beliefs, warrant protection from this intrusion by the Government. Would, therefore, the Senator include moral convictions?
Would the Senator consider an amendment on page 2, line 18 which would add to religious beliefs, the words “or moral”?
Mr. CHURCH. I would suggest to the Senator that perhaps his objective could be more clearly stated if the words “or moral conviction” were added after “religious belief.” I think that the Supreme Court in considering the protection we give religious beliefs has given comparable treatment to deeply held moral convictions. I would not be averse to amending the language of the amendment in such a manner. It is consistent with the general purpose. I see no reason why a deeply held moral conviction ought not be given the same treatment as a religious belief.
Mr. STEVENSON. The Senator's suggestion is well taken. I thank him.
As the debate proceeded, Senator Church went on to quote
Senator James L. Buckley (C-NY), speaking in support of the amendment, added the following perspective:
Mr. BUCKLEY. Mr. President, I compliment the Senator from Idaho for proposing this most important and timely amendment. It is timely in the first instance because the attempt has already been made to compel the performance of abortion and sterilization operations on the part of those who are fundamentally opposed to such procedures. And it is timely also because the recent Supreme Court decisions will likely unleash a series of court actions across the United States to try to impose the personal preferences of the majority of the Supreme Court on the totality of the Nation.
I believe it is ironic that we should have this debate at all. Who would have predicted a year or two ago that we would have to guard against even the possibility that someone might be free [sic]
I am delighted that the Senator from Idaho has amended his language to include the words “moral conviction,” because, of course, we know that this is not a matter of concern to any one religious body to the exclusion of all others, or even to men who believe in a God to the exclusion of all others. It has been a traditional concept in our society from the earliest times that the right of conscience, like the paramount right to life from which it is derived, is sacred.
In support of the same protections when they were debated in the U.S. House, Representative Margaret Heckler (R-MA)
These first sections of the Church Amendments, codified at 42 U.S.C. 300a-7(b) and (c)(1), passed the House 372-1, and were approved by the Senate 94-0. 119 Congr. Rec. at H4149; 119 Congr. Rec. S10405 (June 5, 1973). The subsequently adopted provisions that comprise the Church Amendments similarly extend protection to those organizations and individuals who object to the provision of certain services on the basis of their moral convictions, as well as those who object to such services on the basis of religious beliefs. And, as noted above, subsequent statutes add protections for moral objections in many other situations. These include, for example:
• Protections for individuals and entities that object to abortion.
• Protections for entities and individuals that object to providing or covering contraceptives.
• Protections for entities and individuals that object to performing, assisting, counseling, or referring as pertains to suicide, assisted suicide, or advance directives.
The Departments believe that the intent behind Congress's protection of moral convictions in certain health care contexts, especially to protect entities and individuals from governmental coercion, supports the Departments' decision in the Moral IFC and these final rules to protect sincerely held moral convictions from governmental compulsion threatened by the contraceptive Mandate.
As reflected in the legislative history of the first Church Amendments, the Supreme Court has long afforded protection to moral convictions alongside religious beliefs. Indeed, Senator Church cited
In the context of this particular Mandate, it is also worth noting that, in
The tradition of protecting moral convictions in certain health contexts is not limited to laws passed by Congress. Multiple federal regulations protect objections based on moral convictions in such contexts.
Forty-five states have health care conscience protections covering objections to abortion; several of these also cover sterilization or contraception.
These various statutes and regulations reflect an important governmental interest in protecting moral convictions in appropriate health contexts. The contraceptive Mandate implicates that governmental interest. Many persons and entities object to the Mandate in part because they consider some forms of FDA-approved contraceptives to be morally equivalent to abortion due to the possibility that such items may prevent the implantation of a human embryo after fertilization.
The Departments also look to guidance from, and draw support for the Moral IFC and these final rules from, the broader history of respect for conscience in the laws and founding principles of the United States. Members of Congress specifically relied on the American tradition of respect for conscience when they decided to protect moral convictions in health care. In supporting the protection of conscience based on non-religious moral convictions, Senator Buckley declared “[i]t has been a traditional concept in our society from the earliest times that the right of conscience, like the paramount right to life from which it is derived, is sacred.” Representative Heckler similarly stated that “the right of moral conscience . . . has always been a part of our national tradition.” This tradition is reflected, for example, in a letter President George Washington wrote saying that “[t]he Citizens of the United States of America have a right to applaud themselves for having given to mankind examples of an enlarged and liberal policy: A policy worthy of imitation. All possess alike liberty of conscience and immunities of
These Founding Era statements of general principle do not specify how they would be applied in a particular health care context, and the Departments do not suggest that the specific protections offered in the Moral IFC and these final rules would be required or necessarily appropriate in any other context that does not raise the specific concerns implicated by this Mandate. These final rules do not address in any way how the Government would balance its interests with respect to other health services not encompassed by the contraceptive Mandate.
Protecting moral convictions, as set forth in these expanded exemptions and accommodation in these final rules, is consistent with recent executive orders. President Trump's Executive Order concerning this Mandate directed the Departments to consider providing protections, not specifically for “religious” beliefs, but for “conscience.” We interpret that term to include both religious beliefs and moral convictions. Moreover, President Trump's first Executive Order, E.O. 13765, declared that “the Secretary of Health and Human Services (Secretary) and the heads of all other executive departments and agencies (agencies) with authorities and responsibilities under the [ACA] shall exercise all authority and discretion available to them to waive, defer, grant exemptions from, or delay the implementation of any provision or requirement of the Act that would impose a fiscal burden on any state or a cost, fee, tax, penalty, or regulatory burden on individuals, families, healthcare providers, health insurers, patients, recipients of healthcare services, purchasers of health insurance, or makers of medical devices, products, or medications.” The exemption and accommodation adopted in these final rules relieves a regulatory burden imposed on entities with moral convictions opposed to providing certain contraceptive coverage and is therefore consistent with both Executive Orders.
The Departments have further taken into consideration the litigation surrounding the Mandate in exercising their discretion to adopt the exemption in these final rules. Among the lawsuits challenging the Mandate, two have been filed based in part on non-religious moral convictions. In one case, the Departments are subject to a permanent injunction requiring us to respect the non-religious moral objections of an employer.
The litigation concerning the Mandate has also underscored how important it is for the Government to tread carefully when engaging in regulation concerning sensitive health care areas. As demonstrated by the litigation, as well as the public comments, various citizens sincerely hold moral convictions, which are not necessarily religious, against providing or participating in coverage of contraceptive items included in the Mandate, and some believe that certain contraceptive items may cause early abortions. Providing conscience protections advances the ACA's goal of expanding health coverage among entities and individuals that might otherwise be reluctant to participate in the market. For example, the Supreme Court in
As noted above, the Department received comments expressing diverse views as to whether exemptions based on moral convictions should exist and, if so, whom they should cover.
Some commenters supported the expanded exemptions and accommodation in the Moral IFC, and the choice of entities and individuals to which they applied. They stated the expanded exemptions and accommodation would be an appropriate exercise of discretion and would be consistent with moral exemptions Congress has provided in many similar contexts. Similarly, commenters stated that the accommodation would be an inadequate means to resolve moral objections and that the expanded exemptions are needed. They contended that the accommodation process was objectionable because it was another method of complying with the Mandate, its self-certification or notice involved triggering the very contraceptive coverage that organizations objected to, and the coverage for contraceptive services “hijacked” or flowed in connection with the objecting organizations' health plans. The commenters contended that the seamlessness cited by the Departments between contraceptive coverage and an accommodated plan gives rise to moral objections that organizations would not have with an expanded exemption. Commenters also stated that, with respect to non-profit organizations that have moral objections and only hire persons who agree with those objections, the Mandate serves no legitimate government interest because the mandated coverage is neither wanted nor used and, therefore, would yield no benefits—it would only suppress the existence of non-profit organizations holding those views.
Several other commenters stated that the exemptions were still too narrow. They asked that the exemptions set forth in these final rules be as broad as the exemptions set forth in the Religious IFC concerning sincerely held religious beliefs. Some of these commenters also asked that HHS withdraw its Mandate of contraceptive coverage from the Guidelines entirely. They contended that fertility and pregnancy are generally healthy conditions, not diseases that are appropriately the target of a preventive health service; that contraceptives can pose medical risks for women; and that studies do not show that contraceptive programs reduce abortion rates or unintended pregnancies. Some commented that many women report that they sought an abortion because their contraception failed. Some other commenters contended that, to the extent the Guidelines require coverage of certain drugs and devices that may prevent implantation of an embryo after fertilization, they require coverage of items that are abortifacient and, therefore, violate federal conscience protections such as the Weldon Amendment, Consolidated Appropriations Act, 2017, Public Law 115-31, Div. H, § 507(d).
Other commenters contended that the exemptions in the Moral IFC were too broad. Some of these commenters expressed concern about the prospect of publicly traded for-profit entities also being afforded a moral exemption. One such commenter commented that allowing publicly traded for-profit entities a moral exemption could cause instability and confusion, as leadership changes at such a corporation may effectively change the corporation's eligibility for a moral exemption. Still others stated that the Departments should not exempt various kinds of entities such as businesses, issuers, or nonprofit entities, arguing that only individuals, not entities, can possess moral convictions. Some commenters were concerned that providing moral exemptions would contribute to population growth and related societal woes. Other commenters contended the exemptions and accommodation should not be expanded, but should remain the same as they were in the July 2015 final regulations (80 FR 41318), which did not encompass moral convictions. Other commenters stated that the Departments should not provide exemptions, but merely an accommodation process, to resolve moral objections to the Mandate.
Some commenters objected to providing any exemption or accommodation for moral objections at all. Some of these commenters contended that even the previous regulations allowing an exemption and accommodation were too broad and that no exemptions to the Mandate should exist, in order that contraceptive coverage would be provided to as many women as possible. Other commenters did not go that far, but rejected the idea of exemptions or an accommodation based on moral convictions, contending that such exemptions or accommodation would contribute to population growth and related social woes. Some of these commenters also contended that the exemption in the Moral IFC would constitute an exemption covering every business and non-profit organization.
After considering these comments, and although the previous Administration declined to afford any exemption based on moral convictions, the Departments have concluded that it is appropriate to provide moral exemptions and access to the accommodation, as set forth in these final rules. Congress did not mandate contraceptive coverage, nor provide any explicit guidance about incorporating conscience exemptions into the Guidelines. But as noted above, it is a long-standing Congressional practice to provide consistent exemptions for both religious beliefs and moral convictions in many federal statutes in the health care context, and specifically concerning issues such as abortion, sterilization, and contraception. It is not clear to the Departments that, if Congress had expressly mandated contraceptive coverage in the ACA, it would have done so without providing for similar exemptions. Therefore, the Departments consider it appropriate, to the extent we impose a contraceptive Mandate by the exercise of agency discretion, that we also include an exemption for the protection of moral convictions in certain cases. The exemptions finalized in these final rules are generally consistent with the scope of exemptions that Congress has established in similar contexts. As noted above, the Departments consider the exemptions in these final rules consistent with the intent of Executive Order 13535. The Departments also wish to avoid the stark disparity that may result from respecting religious objections to providing contraceptive coverage among certain entities and individuals, but not respecting parallel objections for moral convictions possessed by any entities and
In addition, the Departments note that a significant majority of states either impose no contraceptive coverage requirement or offer broader exemptions than the exemption contained in the July 2015 final regulations.
The Departments decline to use these final rules to remove the contraceptive Mandate altogether, such as by declaring that HHS acting through HRSA shall not include contraceptives in the list of women's preventive services in Guidelines issued under section 2713(a)(4). HRSA's Guidelines were not issued, ratified, or updated through the regulations that preceded the Moral IFC and these final rules. Those Guidelines were issued in separate processes in 2011 and 2016, directly by HRSA, after consultation with external organizations that operated under cooperative agreements with HRSA to consider the issue, solicit public comment, and provide recommendations. The regulations preceding these final rules attempted only to restate the statutory language of section 2713 in regulatory form, and delineate what exemptions and accommodations would apply if HRSA listed contraceptives in its Guidelines. We decline to use these final rules to direct the separate process that HRSA uses to determine what specific services are listed in the Guidelines generally. Some commenters stated that if contraceptives are not removed from the Guidelines entirely, entities or individuals with moral objections might not qualify for the exemptions or accommodation. As discussed below, however, the exemptions in these rules include a broad range of entities and individuals of whom we have notice may object based on moral convictions. The Departments are not aware of specific employers or individuals whose moral convictions would still be violated by compliance with the Mandate after the issuance of the Moral IFC and these final rules.
Some commenters stated that HRSA should remove contraceptives from the Guidelines because the Guidelines have not been subject to the notice and comment process under the Administrative Procedure Act. Some commenters also contended that the Guidelines should be amended to omit items that may prevent (or possibly dislodge) the implantation of a human embryo after fertilization, in order to ensure consistency with conscience provisions that prohibit requiring plans to pay for or cover abortions. Whether and to what extent the Guidelines continue to list contraceptives, or items considered to prevent implantation of an embryo, for entities not subject to exemptions and an accommodation, and what process is used to include those items in the Guidelines, is outside the scope of these final rules. These final rules focus on what moral exemptions and accommodation shall apply if Guidelines issued under section 2713(a)(4) include contraceptives or items considered to be abortifacient.
Members of the public that support or oppose the inclusion of some or all contraceptives in the Guidelines, or wish to comment concerning the content and process of developing and updating the Guidelines, are welcome to communicate their views to HRSA, at
The Departments also conclude that it would be inadequate to merely attempt to amend or expand the accommodation process to account for moral objectors, instead of providing the exemptions. In the past, the Departments stated in our regulations and court briefs that the previous accommodation required contraceptive coverage in a way that is “seamless” with the coverage provided by the objecting employer. As a result, in significant respects, the accommodation process did not actually accommodate the objections of many entities, as indicated by many entities with religious objections. The Departments have attempted to identify an accommodation that would eliminate the religious plaintiffs' objections, including seeking public comment through a Request For Information, 81 FR 47741 (July 26, 2016), but stated in January 2017 that we were unable to develop such an approach at that time.
Some commenters expressed concern over the lack of a definition of “moral convictions” in the Moral IFC, arguing that, without a definition, any objection could be encompassed by the exemptions even if it is not based on moral convictions. The Departments did not adopt a regulatory definition of “moral convictions” in the Moral IFC, and have decided not to adopt such a definition in response to public comments at this time. Nevertheless, the Departments look to the description of moral convictions in
While moral convictions are the sort of principles that, in the life of an individual, occupy a place parallel to religion, sincerely held moral convictions can also be adopted by corporate bodies, not merely by individuals. Senators Church and Nelson, while discussing the fact that opposition to abortion or sterilization on the basis of “moral questions” does not include capricious opposition to abortion for no reason at all, were specifically talking about opposition to abortion by corporate entities: A “hospital board, or whatever the ruling agency for the hospital was, a governing agency or otherwise.”
The Departments also received comments on their rebalancing of interests as expressed and referenced in the Moral IFC. Some public commenters agreed with the Departments' conclusion that our interest in ensuring contraceptive coverage does not preclude the Departments from offering exemptions and an accommodation for entities, plans, and individuals with a qualifying objection to contraceptive coverage based on moral convictions. Some public commenters pointed out that protecting moral convictions serves to respect not only the interests of certain persons to access contraceptives, but also the interests of other persons to participate in a health coverage market consistent with their moral convictions. Other commenters disagreed with this rebalancing, and contended that the interest of women in receiving contraceptive coverage without cost-sharing is so great that it overrides private interests to the contrary, such that the government should or must force private entities to provide this coverage to other private citizens.
The Departments agree with the commenters who stated that the governmental interest in requiring contraceptive coverage does not override the interest in protecting moral convictions and does not make these expanded exemptions inappropriate. For additional discussion of the Government's balance of interests as applicable to religious beliefs, see section II.C.2.b. of the companion final rules concerning religious exemptions published by the Departments contemporaneously with these final rules elsewhere in today's
The Departments acknowledge that coverage of contraception is an important and highly controversial issue, implicating many different views, as reflected for example in the public comments received on multiple rulemakings over the course of implementation of section 2713(a)(4), added to the PHS Act in 2010. The Departments' expansion of conscience protections for moral convictions, similar to protections contained in numerous statutes governing health care regulation, is not taken lightly. However, after considering public comments on various sides of the issue, and reconsidering the interests served by the Mandate in this particular context, the objections raised, and the relevant federal law, the Departments have determined that affording the exemptions to protect moral convictions is a more appropriate administrative response than continuing to refuse to extend the exemptions and accommodations to certain entities and individuals for whom the Mandate violates their sincerely held moral convictions. Although the number of organizations and individuals that may seek to invoke these exemptions and accommodation may be small, the Departments believe that it is important to provide such protection, given the long-standing recognition of such protections in law and regulation in the health care and health insurance contexts. The Moral IFC and these final rules leave unchanged HRSA's authority to decide whether to include contraceptives in the women's preventive services Guidelines for entities that are not exempted by law, regulation, or the Guidelines. These rules also do not change the many other mechanisms by which the Government advances contraceptive coverage, particularly for low-income women, including through such programs as Medicaid and Title X. The Departments also note that the exemptions created here, like the exemptions created by the previous Administration, do not burden third parties to a degree that counsels against providing the exemptions, as discussed below.
The Department received a variety of comments about the effect that the exemptions and accommodation based on moral convictions would have on third parties. Some commenters stated that the exemptions and accommodation do not impose an impermissible or unjustified burden on third parties, including on women who might otherwise receive contraceptive coverage with no cost sharing. Other commenters disagreed, asserting that the exemptions unacceptably burden women who might lose contraceptive coverage as a result. They contended the exemptions may remove contraceptive coverage, causing women to have higher contraceptive costs, fewer contraceptive options, less ability to use contraceptives more consistently, more
The Departments note that the exemptions in the Moral IFC and these final rules, like the exemptions created by the previous Administration, do not impermissibly burden third parties. Initially, the Departments observe that these rules do not create a governmental burden; rather, they relieve a governmental burden. The ACA did not impose a contraceptive coverage requirement. Agency discretion was exercised to include contraceptives in the Guidelines issued under section 2713(a)(4). That decision is what created and imposed a governmental burden. These rules simply relieve part of that governmental burden. If some third parties do not receive contraceptive coverage from private parties whom the government chooses not to coerce, that result exists in the absence of governmental action—it is not a result the government has imposed. Calling that result a governmental burden rests on an incorrect presumption: That the government has an obligation to force private parties to benefit those third parties, and that the third parties have a right to those benefits. Congress did not create a right to receive contraceptive coverage from other private citizens through section 2713 of the PHS Act, other portions of the ACA, or any other statutes it has enacted. Although some commenters also contended such a right might exist under treaties the Senate has ratified or the Constitution, the Departments are not aware of any source demonstrating that the Constitution or a treaty ratified by the Senate creates a right to receive contraceptive coverage from other private citizens.
The fact that the government at one time exercised its administrative discretion to require private parties to provide coverage to which they morally object, to benefit other private parties, does not prevent the government from relieving some or all of the burden of that Mandate. Otherwise, any governmental coverage requirement would be a one-way ratchet. In the Moral IFC and these final rules, the government has simply restored a zone of freedom where it once existed. There is no statutory or constitutional obstacle to the government doing so, and the doctrine of third party burdens should not be interpreted to impose such an obstacle. Such an interpretation would be especially problematic given the millions of women, in a variety of contexts, whom the Mandate does not ultimately benefit, notwithstanding any expanded exemptions—including through the grandfathering of plans, the previous religious exemptions, and the failure of the accommodation to require delivery of contraceptive coverage in various self-insured church plan contexts.
In addition, the Government is under no constitutional obligation to fund contraception.
Some commenters objected that the exemptions would violate the Establishment Clause of the First Amendment. The Moral IFC and these final rules create exemptions for moral convictions, not religious beliefs, and they do so for the same neutral purposes for which Congress has created similar exemptions for over four decades. Not only do these final rules not violate the Establishment Clause, but the Departments' decision to provide the exemptions and accommodation for moral convictions, instead of limiting the exemptions to identical objections based on religious beliefs, further demonstrates that neither the purpose nor the effect of these exemptions is to establish religion. The Establishment Clause does not force the Department to impose a contraceptive Mandate in violation of the moral convictions of entities and individuals protected by these rules.
American governmental bodies have, in many instances, refrained from requiring certain private parties to cover contraceptive services for other private parties. From 1789 through 2012 (when HRSA's Guidelines went into effect), there was no federal women's preventive services coverage mandate imposed nationally on health insurance and group health plans. The ACA did not require contraceptives to be included in HRSA's Guidelines, and it did not require any preventive services required under section 2713 of the PHS Act to be covered by grandfathered plans. Many states do not impose contraceptive coverage mandates, or they offer religious, and in some cases moral, exemptions to the requirements of such coverage mandates—exemptions that have not been invalidated by federal or state courts. The Departments, in previous regulations, exempted houses of worship and integrated auxiliaries from the Mandate. The Departments then issued a temporary enforcement safe harbor allowing religious nonprofit groups to not provide contraceptive coverage under the Mandate for almost two additional years. The Departments further expanded the houses of worship and integrated auxiliaries exemption through definitional changes. And the Departments created an accommodation process under which many women in self-insured church plans may not ultimately receive contraceptive coverage. The Departments are not aware of federal courts declaring that the exemptions, safe harbor, or accommodations gave rise to third party burdens that required the government to mandate contraceptive coverage by entities eligible for an exemption or accommodation. In addition, many organizations have not been subject to the Mandate in practice because of injunctions they received through litigation, protecting them from federal imposition of the Mandate, including
Commenters offered various assessments of the impact these rules might have on state or local governments. Some commenters stated that the expanded exemptions will not burden state or local governments, or that such burdens should not prevent the Departments from offering those exemptions. Others commenters stated that if the Departments provide expanded exemptions, states or local jurisdictions may face higher costs in providing birth control to women through government programs. The Departments consider it appropriate to offer expanded exemptions, notwithstanding the objection of some state or local governments. Until 2012, there was no federal mandate of contraceptive coverage across health insurance and health plans nationwide. The ACA did not require a contraceptive Mandate, and its discretionary creation by means of HRSA's Guidelines does not translate to a benefit that the federal government owes to state or local governments. The various situations recited in the previous paragraph, in which the federal government has not imposed contraceptive coverage, have not been deemed to cause a cognizable injury to state or local governments. The Departments find no legal prohibition on finalizing these final rules based on the allegation of an impact on state or local governments, and disagree with the suggestion that once having exercised our discretion to deny exemptions—no matter how recently or incompletely—the Departments cannot change course if some state and local governments believe they are receiving indirect benefits from the previous decision.
In addition, the exemptions at issue here are available only to a tiny fraction of entities to which the Mandate would otherwise apply—those with qualifying moral objections. Public comments did not provide reliable data on how many entities would use these expanded moral exemptions, in which states women in those plans would reside, how many of those women would qualify for or use state and local government subsidies of contraceptives as a result, or in which states such women, if they are low income, would go without contraceptives and potentially experience unintended pregnancies that state Medicaid programs would potentially have to cover. As noted below, at least one study
Some commenters contended that the exemptions would constitute unlawful sex discrimination, such as under section 1557 of the Affordable Care Act, Title VII of the Civil Rights Act of 1964, Title IX of the Education Amendments of 1972, or the Fifth Amendment. Some commenters suggested the expanded exemptions would discriminate on bases such as race, disability, or LGBT status, or that they would disproportionately burden certain persons in such categories.
But these rules do not discriminate or draw any distinctions on the basis of sex, pregnancy, race, disability, socio-economic class, LGBT status, or otherwise, nor do they discriminate on any unlawful grounds. The exemptions in these rules do not authorize entities to comply with the Mandate for one person, but not for another person, based on that person's status as a member of a protected class. Instead, they allow entities that have sincerely held moral objections to providing some or all contraceptives included in the Mandate to not be forced to provide coverage of those items to anyone.
Those commenters' contentions about discrimination are unpersuasive for still additional reasons. First, Title VII is applicable to discrimination committed by employers, and these final rules have been issued in the government's capacity as a regulator of group health plans and group and individual health insurance, not in its capacity as an employer.
It is simply not the case that the government's implementation of section 2713(a)(4) is discriminatory against women because exemptions encompass moral objections. The previous rules, as discussed elsewhere herein, do not require contraceptive coverage in a host of plans, including grandfathered plans, plans of houses of worship and integrated auxiliaries, and—through inability to enforce the accommodation on certain third party administrators—plans of many religious non-profits in self-insured church plans. Below, the Departments estimate that nearly all women of childbearing age in the country will be unaffected by these exemptions. In this context, the Departments do not believe that an adjustment to discretionary Guidelines for women's preventive services concerning contraceptives constitutes unlawful sex discrimination. Otherwise, anytime the government exercises its discretion to provide a benefit that is specific to women (or specific to men), it would constitute sex discrimination for the government to reconsider that benefit. Under that theory,
It is not clear that these expanded exemptions will significantly burden women most at risk of unintended pregnancies. Some commenters stated that contraceptives are often readily accessible at relatively low cost. Other commenters disagreed. Some commenters objected that the Moral IFC's estimate of a $584 yearly cost of contraceptives for women was too low. But some of those same commenters provided similar estimates, citing sources claiming that birth control pills can cost up to $600 per year, and stated that IUDs, which can last 3 to 6 years or more,
The Departments do not believe that such differences make it inappropriate to issue the expanded exemptions set forth in these rules. As explained more fully below, the Departments estimate that nearly all women of childbearing age in the country will be unaffected by these exemptions. Moreover, the Departments note that the HHS Office of Population Affairs, within the Office of the Assistant Secretary for Health, has recently issued a proposed rule to amend the regulations governing its Title X family planning program. The proposed rule would amend the definition of “low income family”—individuals eligible for free or low cost contraceptive services—to include women who are unable to obtain certain family planning services under their employer-sponsored health coverage due to their employers' religious beliefs or moral convictions. (83 FR 25502). If that rule is finalized as proposed, it would further reduce any potential effect of these final rules on women's access to contraceptives.
Some commenters stated that the expanded exemptions would violate section 1554 of the ACA. That section says the Secretary of HHS “shall not promulgate any regulation” that “creates any unreasonable barriers to the ability of individuals to obtain appropriate medical care,” “impedes timely access to health care services,” “interferes with communications regarding a full range of treatment options between the patient and the provider,” “restricts the ability of health care providers to provide full disclosure of all relevant information to patients making health care decisions,” “violates the principles of informed consent and the ethical standards of health care professionals,” or “limits the availability of health care treatment for the full duration of a patient's medical needs.” 42 U.S.C. 18114. Such commenters urged, for example, that the Moral IFC created unreasonable barriers to the ability of individuals to obtain appropriate medical care, particularly in areas they said may have a disproportionately high number of entities likely to take advantage of the exemption.
The Departments disagree with these comments about section 1554 of the ACA. The Departments issued previous exemptions and accommodations that allowed various plans to not provide contraceptive coverage on the basis of religious objections; multiple courts considered those regulations; and while many ruled that entities did not need to provide contraceptive coverage, none ruled that the exemptions or accommodations in the regulations violated section 1554 of the ACA. Moreover, the decision not to impose a governmental mandate is not the creation of a “barrier,” especially when that mandate requires private citizens to provide services to other private citizens. This would turn the assumptions of the United States' system of government on its head.
In short, we do not believe sections 1554 or 1557 of the ACA, other nondiscrimination statutes, or any constitutional doctrines, create an affirmative obligation to create, maintain, or impose a Mandate that forces covered entities to provide coverage of preventive contraceptive services in health plans. The ACA's grant of authority to HRSA to provide for, and support, the Guidelines is not transformed by any of the laws cited by commenters into a requirement that, once those Guidelines exist, they can never be reconsidered, or amended because doing so would only affect women's coverage or would allegedly impact particular populations disparately.
In summary, members of the public have widely divergent views on whether the exemptions in the Moral IFC and these final rules are good public policy. Some commenters stated that the exemptions would burden workers, families, and the economic and social stability of the country, and interfere with the physician-patient relationship. Other commenters disagreed, favoring the public policy behind the exemption, and arguing that the exemption would not interfere with the physician-patient relationship. The Departments have determined that these final rules are an appropriate exercise of public policy discretion. Because of the importance of the moral convictions being accommodated, the limited impact of these final rules, and uncertainty about
The Departments received several comments about the decision to issue the Moral IFC as interim final rules with request for comments, instead of as a notice of proposed rulemaking. Several commenters asserted that the Departments had the authority to issue the Moral IFC in that way, agreeing with the Departments that there was explicit statutory authority to do so, good cause under the APA, or both. Other commenters held the opposite view, contending that there was neither statutory authority to issue the rules on an interim final basis, nor good cause under the APA to make the rules immediately effective.
The Departments continue to believe authority existed to issue the Moral IFC as interim final rules. Section 9833 of the Code, section 734 of ERISA, and section 2792 of the PHS Act authorize the Secretaries of the Treasury, Labor, and HHS (collectively, the Secretaries) to promulgate any interim final rules that they determine are appropriate to carry out the provisions of chapter 100 of the Code, part 7 of subtitle B of title I of ERISA, and part A of title XXVII of the PHS Act, which include sections 2701 through 2728 of that Act, and the incorporation of those sections into section 715 of ERISA and section 9815 of the Code. The Religious and Moral IFCs fall under those statutory authorizations for the use of interim final rulemaking. Prior to the Moral IFC, the Departments issued three interim final regulations implementing this section of the PHS Act because of the needs of covered entities for immediate guidance and the weighty matters implicated by the HRSA Guidelines, including issuance of new or revised exemptions or accommodations. (75 FR 41726; 76 FR 46621; 79 FR 51092). The Departments also had good cause to issue the Moral IFC as interim final rules, for the reasons discussed therein.
In any event, the objections of some commenters to the issuance of the Moral IFC as interim final rules with request for comments does not prevent the issuance of these final rules. These final rules were issued after receiving and thoroughly considering public comments as requested in the Moral IFC. These final rules therefore comply with the APA's notice and comment requirements.
The Departments received numerous comments on the health effects of contraception and pregnancy. As noted above, some commenters supported the expanded exemptions, and others urged that contraceptives be removed from the Guidelines entirely, based on the view that pregnancy and the unborn children resulting from conception are not diseases or unhealthy conditions that are properly the subject of preventive care coverage. Such commenters further contended that hormonal contraceptives may present health risks to women. For example, they contended that studies show certain contraceptives cause, or are associated with, an increased risk of depression,
Other commenters disagreed, citing a variety of studies they contend show health benefits caused by, or associated
Some commenters stated that, in the Moral IFC, the Departments relied on incorrect statements concerning scientific studies. For example, some commenters stated that there is no proven increased risk of breast cancer or other risks among contraceptive users. They criticized the Departments for citing studies, including one previewed in the 2011 IOM Report itself (Agency for Healthcare Research and Quality, Report No. 13-E002-EF (June 2013) (cited above)), discussing an association between contraceptive use and increased risks of breast and cervical cancer, and concluding there are no net cancer-reducing benefits of contraceptive use. As described in the Religious IFC, 82 FR 47804, the 2013 Agency for Healthcare Research and Quality study, and other sources, reach conclusions with which these commenters appear to disagree. The Departments consider it appropriate to consider these studies, as well as the studies cited by commenters who disagree with those conclusions.
Some commenters further criticized the Departments for saying two studies cited by the 2011 IOM Report, which asserted an associative relationship between contraceptive use and decreases in unintended pregnancy, did not on their face establish a causal relationship between a broad coverage mandate and decreases in unintended pregnancy. In this respect, as noted in the Religious IFC,
Commenters disagreed about the effects of some FDA-approved contraceptives on embryos. Some commenters agreed with the quotation, in the Moral IFC, of FDA materials
This objection on this issue appears to be partially one of semantics. People disagree about whether to define “conception” or “pregnancy” to occur at fertilization, when the sperm and ovum unite, or days later at implantation, when that embryo has undergone further cellular development, travelled down the fallopian tube, and implanted in the uterine wall. This question is independent of the question of what mechanisms of action FDA-approved or cleared contraceptives may have. It is also a separate question from whether members of the public assert, or believe, that it is appropriate to consider the items “abortifacient”—that is, a kind of abortion, or a medical product that causes an abortion—because they believe abortion means to cause the demise of a post-fertilization embryo inside the mother's body. Commenters referenced scientific studies and sources on both sides of the issue of whether certain contraceptives prevent implantation. Commenters and litigants have positively stated that some of them view certain contraceptives as abortifacients, for this reason.
The Departments do not take a position on the scientific, religious, or moral debates on this issue by recognizing that some people have sincere moral objections to providing contraception coverage on this basis. The Supreme Court has already recognized that such a view can form the basis of an objection based on sincerely held religious belief under RFRA.
The Departments also received comments about their discussion, located in the Religious IFC but partly relied upon in the Moral IFC, concerning uncertainty about the effects the Mandate's expanded exemptions might have on teen sexual activity. In this respect, the Departments stated, “With respect to teens, the Santelli and Melnikas study cited by IOM 2011
Many commenters opposing the moral exemptions misunderstood the Departments' discussion of this issue. Teens are a significant part, though not the entirety, of women the IOM identified as being most at risk of unintended pregnancy. The Departments do not take a position on the empirical question of whether contraception has caused certain reductions in teen pregnancy. Rather, the Departments note that studies suggesting various causes of teen pregnancy and unintended pregnancy in general make it difficult to establish causation between exemptions to the contraceptive Mandate, and an increase in teen pregnancies in particular, or unintended pregnancies in general. For example, a 2015 study investigating the decline in teen pregnancy since 1991 attributed it to multiple factors (including, but not limited to, reduced sexual activity, falling welfare benefit levels, and expansion of family planning services in Medicaid, with the latter accounting for less than 13 percent of the decline). It concluded that “that none of the relatively easy, policy-based explanations for the recent decline in teen childbearing in the United States hold up very well to careful empirical scrutiny.”
As the Departments stated in the Religious IFC, we do not take a position on the variety of empirical questions discussed above. Likewise, these rules do not address the substantive question of whether HRSA should include contraceptives in the women's preventive services Guidelines issued under section 2713(a)(4). Rather, reexamination of the record and review of public comments has reinforced the Departments' view that the uncertainty surrounding these weighty and important issues makes it appropriate to provide the moral exemptions and accommodation if and for as long as HRSA continues to include contraceptives in the Guidelines. The federal government has a long history, particularly in certain sensitive and multi-faceted health issues, of providing moral exemptions from governmental mandates. These final rules are consistent with that history and with the discretion Congress vested in the Departments to implement the ACA.
The Departments also received comments about the health and equality effects of the Mandate more broadly. Some commenters contended that the contraceptive Mandate promoted the health and equality of women, especially low income women, and promoted female participation and
Other commenters, however, disputed the significance of these state statistics, noting that, of the 29 states with contraceptive coverage mandates, only four states have laws that match the federal requirements in scope. Some also observed that, even in states with state contraceptive coverage mandates, self-insured group health plans might escape those requirements, and some states do not mandate the contraceptives to be covered at no out-of-pocket cost to the beneficiary.
The Departments have considered these experiences as relevant to the effect the exemption in these rules might have on the Mandate more broadly. The state mandates of contraceptive coverage still apply to a very large number of plans and plan participants notwithstanding ERISA preemption, and public commenters did not point to studies showing those state mandates reduced unintended pregnancies. The federal contraceptive Mandate, likewise, applies to a broad, but not entirely comprehensive, number of employers. For example, to the extent that houses of worship and integrated auxiliaries may have self-insured to avoid state health insurance contraceptive coverage mandates or for other reasons, those groups were already exempt from the federal Mandate prior to the 2017 Religious and Moral IFCs. The exemptions as set forth in the Moral IFC and in these final rules leave the contraceptive Mandate in place for nearly all entities and plans to which the Mandate has applied. The Departments are not aware of data showing that these expanded exemptions would negate any reduction in unintended pregnancies that might result from the contraceptive Mandate here.
Some commenters took a view that appears to disagree with the assertion in the 2017 Guttmacher study, that “[t]he role that the contraceptive coverage guarantee played in impacting use of contraception at the national level remains unclear, as there was no significant increase in the use of methods that would have been covered under the ACA.” These commenters instead observed that, under the Mandate, more women have coverage of contraceptives and contraception counseling and that more contraceptives are provided without co-pays than before. Still others argued that the Mandate, or other expansions of contraceptive coverage, have led women to increase their use of contraception in general, or to change from less effective, less expensive contraceptive methods to more effective, more expensive contraceptive methods. Some commenters pointed to studies cited in the 2011 IOM Report recommending contraception be included in the Guidelines and argued that certain women will go without certain health care, or contraception specifically, because of cost. They contended that a smaller percentage of women delay or forego health care overall under the ACA
The Departments have reviewed the comments, including studies submitted by commenters either supporting or opposing these expanded exemptions. Based on that review, it is not clear that merely offering the exemption in these rules will have a significant effect on contraceptive use and health, or workplace equality, for the vast majority of women benefitting from the Mandate. There is conflicting evidence regarding whether the Mandate alone, as distinct from contraceptive access more generally, has caused increased contraceptive use, reduced unintended pregnancies, or eliminated workplace disparities, where all other women's preventive services were covered without cost sharing. Without taking a definitive position on those evidentiary issues, however, the Departments
Moreover, the Departments conclude that the best way to balance the various policy interests at stake in the Moral IFC and these final rules is to provide the exemptions set forth herein, even if certain effects may occur among the populations actually affected by the employment of these exemptions. These rules provide tangible conscience protections for moral convictions, and impose fewer governmental burdens on various entities and individuals, some of whom have contended for several years that denying them an exemption from the contraceptive Mandate imposes a burden on their moral convictions. The Departments view the provision of those protections to preserve conscience in this health care context as an appropriate policy option, notwithstanding the widely divergent effects that public commenters have predicted based on different studies they cited. Providing the protections for moral convictions set forth in the Moral IFC and these final rules is not inconsistent with the ACA, and brings this Mandate into better alignment with various other federal conscience protections in health care, some of which have been in place for decades.
Some commenters expressed the view that the exemptions afforded in the Moral IFC and herein violate the RFRA rights of women who might not receive contraceptive coverage as the result of these final rules, by allowing their employers to impose their moral convictions on them by removing contraceptive coverage through use of the exemption. Still other commenters stated that employer payment of insurance premiums is part of any employee's compensation package, the benefits of which employers should not be able to limit. In the Departments' view, the expanded exemptions in these final rules do not prohibit employers from providing contraceptive coverage. Instead, they lift a government burden that was imposed on some employers to provide contraceptive coverage to their employees in violation of those employers' moral convictions. The Departments do not believe RFRA requires, or has ever required, the federal government to force employers to provide contraceptive coverage. The federal government's decision to exempt some entities from a requirement to provide no-cost-sharing services to private citizens does not constitute a federal government-imposed burden on the latter under RFRA.
Some commenters asked the Departments to discuss the interaction between these rules and state laws that either require contraceptive coverage or provide exemptions from those and other requirements. Some commenters argue that providing the exemptions in these rules would negate state contraceptive requirements or narrower state exemptions. Some commenters asked that the Departments specify that these exemptions do not apply to plans governed by state laws that require contraceptive coverage.
The Departments agree that these rules only concern the applicability of the federal contraceptive Mandate imposed pursuant to section 2713(a)(4). They do not regulate state contraceptive mandates or state exemptions. If a plan is exempt under the Moral IFC and these final rules, that exemption does not necessarily exempt the plan or other insurance issuer from state laws that may apply to it. The previous regulations, which offered exemptions for houses of worship and integrated auxiliaries, did not include regulatory language negating the exemptions in states that require contraceptive coverage, although the Departments discussed the issue to some degree in various preambles of those previous regulations. The Departments do not consider it appropriate or necessary in the regulatory text of the moral exemption rules to declare whether the federal contraceptive Mandate would still apply in states that have a state contraceptive mandate, since these rules do not purport to regulate the applicability of state contraceptive mandates.
Some commenters observed that, through ERISA, some entities may avoid state laws that require contraceptive coverage by self-insuring. This is a result of the application of the preemption and savings clauses contained in ERISA to state insurance regulation.
These final rules cannot change statutory ERISA provisions, and do not change the standards applicable to ERISA preemption. To the extent Congress has decided that ERISA preemption includes preemption of state laws requiring contraceptive coverage, that decision occurred before the ACA and was not negated by the ACA. Congress did not mandate in the ACA that any Guidelines issued under section 2713(a)(4) must include contraceptives, nor that the Guidelines must force entities with moral objections to cover contraceptives.
Finally, some commenters expressed concern that providing moral exemptions to the mandate that private parties provide contraception may lead to exemptions regarding other medications or services, like vaccines. The exemptions provided in these rules, however, do not apply beyond the contraceptive coverage requirement implemented through section 2713(a)(4). Specifically, section 2713(a)(2) of the PHS Act requires coverage of “immunizations,” and these exemptions do not encompass that requirement. The fact that the Departments have exempted houses of worship and integrated auxiliaries from the contraceptive Mandate since 2011 did not lead to those entities receiving exemptions under section 2713(a)(2) concerning vaccines. In addition, hundreds of entities have sued the Departments over the implementation of section 2713(a)(4), leading to two decisions of the U.S. Supreme Court, but no similar wave of lawsuits has challenged section 2713(a)(2). The expanded exemptions in these final rules are consistent with a long history of statutes protecting moral convictions from certain health care mandates concerning issues such as sterilization, abortion and birth control.
In this section, the Departments describe the regulations from the Moral IFC, public comments in response to the specific regulatory text set forth in the IFC, the Departments' response to those comments, and, in consideration of those comments, the regulatory text as finalized in this final rule. We also note the regulatory text as it existed prior to the Religious and Moral IFCs, as appropriate. The Departments consider the exemptions finalized here to be an appropriate and permissible policy
As noted above, various members of the public provided comments that were supportive, or critical, of the regulations overall, or of significant policies pertaining to the regulations. To the extent those comments apply to the following regulatory text, the Departments have responded to them above. This section of the preamble responds to comments that pertain more specifically to particular regulatory text.
The previous regulations restated the statutory requirements of section 2713(a) and (a)(4) of the PHS Act, at 26 CFR 54.9815-2713(a)(1) and (a)(1)(iv), 29 CFR 2590.715-2713(a)(1) and (a)(1)(iv), and 45 CFR 147.130(a)(1) and (a)(1)(iv). The Religious IFC modified those restatements to more closely align them with the text of section 2713(a) and (a)(4) of the PHS Act. Those sections cross-reference the other sections of the Departments' rules that provide exemptions to the contraceptive Mandate. After the Religious IFC changed those sections, the Moral IFC inserted, within those cross-references, references to the new § 147.133, which contains the text of the moral exemptions. The insertions correspond to the cross-references to the religious exemptions added by the Religious IFC. The Departments finalize these parts of the Moral IFC without change.
The previous regulations contained no exemption concerning moral convictions, as distinct from religious beliefs. Instead, at 45 CFR 147.131(a), they offered an exemption for houses of worship and integrated auxiliaries. In the remaining part of § 147.131, the previous regulations described the accommodation process for organizations with religious objections. The Religious IFC moved the religious exemption to a new section 45 CFR 147.132, and expanded its scope. The Moral IFC created a new section 45 CFR 147.133, providing exemptions for moral convictions similar to, but not exactly the same as, the exemptions for religious beliefs set forth in § 147.132.
The prefatory language of § 147.133(a) not only specifies that certain entities are “exempt,” but also explains that the Guidelines shall not support or provide for an imposition of the contraceptive coverage requirement to such exempt entities. This is an acknowledgement that section 2713(a)(4) requires women's preventive services coverage only “as provided for in comprehensive guidelines supported by the Health Resources and Services Administration.” To the extent the HRSA Guidelines do not provide for, or support, the application of such coverage to certain entities or plans, the Affordable Care Act does not require the coverage. Those entities or plans are “exempt” by not being subject to the requirements in the first instance. Therefore, in describing the entities or plans as “exempt,” and in referring to the “exemption” encompassing those entities or plans, the Departments also affirm the non-applicability of the Guidelines to them.
The Departments wish to make clear that the expanded exemption set forth in § 147.133(a) applies to several distinct entities involved in the provision of coverage to an objecting employer's employees. This explanation is consistent with how prior regulations have worked by means of similar language. When § 147.133(a)(1) and (a)(1)(i) specify that “[a] group health plan,” “health insurance coverage provided in connection with a group health plan,” and “health insurance coverage offered or arranged by an objecting organization” are exempt “to the extent” of the objections “as specified in paragraph (a)(2),” that language exempts the group health plans of the sponsors that object, and their health insurance issuers in providing the coverage in those plans (whether or not the issuers have their own objections). Consequently, with respect to Guidelines issued under § 147.130(a)(1)(iv) (and as referenced by the parallel provisions in 26 CFR 54.9815 through 2713(a)(1)(iv) and 29 CFR 2590.715 through 2713(a)(1)(v)), the plan sponsor, issuer, and plan covered in the exemption of that paragraph would face no penalty as a result of omitting contraceptive coverage from the benefits of the plan participants and beneficiaries. However, while a plan sponsor's or arranger's objection removes penalties from that group health plan's issuer, it only does so with respect to that group health plan—it does not affect the issuer's coverage for other group health plans where the plan sponsor has no qualifying objection. More information on the effects of the objection of a health insurance issuer in § 147.133(a)(1)(iii) is included below.
The exemptions in § 147.133(a)(1) apply “to the extent” of the objecting entities' sincerely held moral convictions. Thus, entities that hold a requisite objection to covering some, but not all, contraceptive items would be exempt with respect to the items to which they object, but not with respect to the items to which they do not object. Some commenters stated it was unclear whether the plans of entities or individuals that morally object to some but not all contraceptives would be exempt from being required to cover just the contraceptive methods as to which there is an objection, or whether the objection to some contraceptives leads to an exemption from that plan being required to cover all contraceptives. The Departments intend that a requisite moral objection to some, but not all, contraceptives would lead to an exemption only to the extent of that objection: That is, the exemption would encompass only the items to which the relevant entity or individual objects and would not encompass contraceptive methods to which the objection does not apply. To make this clearer, in these final rules the Departments finalize the prefatory language of § 147.133(a) so that the first sentence of that paragraph states that an exemption shall be included, and the Guidelines must not provide for contraceptive coverage, “to the extent of the objections specified below.” The Departments have made corresponding changes to language throughout the regulatory text, to describe the exemptions as applying “to the extent” of the objection(s).
The exemptions contained in previous regulations, at § 147.131(a), did not require an exempt entity to submit any particular self-certification or notice, either to the government or to the entity's issuer or third party administrator, in order to obtain or qualify for their exemption. Similarly, under the expanded exemptions in § 147.133, the Moral IFC did not require exempt entities to comply with a self-certification process. We finalize that approach without change. Although exempt entities do not need to file notices or certifications of their exemption, and these final rules do not impose any new notice requirements on them, existing ERISA rules governing group health plans require that, with respect to plans subject to ERISA, a plan document must include a comprehensive summary of the benefits covered by the plan and a statement of the conditions for eligibility to receive benefits. Under ERISA, the plan
Some commenters supported this approach, while others did not. Those in favor suggested that self-certification forms for an exemption are not necessary, could add burdens to exempt entities beyond those imposed by the previous exemption, and could give rise to objections to the self-certification process itself. Commenters also stated that requiring an exemption form for exempt entities could cause additional operational burdens for plans that have existing processes in place to handle exemptions. Other commenters favored including a self-certification process for exempt entities. They suggested that entities might abuse the availability of an exemption or use their exempt status insincerely if no self-certification process exists, and that the Mandate might be difficult to enforce without a self-certification process.
After considering the comments, the Departments continue to believe it is appropriate to not require exempt entities to submit a self-certification or notice. The previous exemption did not require a self-certification or notice, and the Departments did not collect a list of all entities that used the exemption, although there may have been thousands of houses of worship and integrated auxiliaries covered by the previous exemption and the Departments think it likely that only a small number of entities will use the moral exemption. Adding a self-certification or notice to the exemption would impose an additional paperwork burden on exempt entities that the previous regulations did not impose, and would also involve additional public costs if those certifications or notices are to be reviewed or kept on file by the government.
The Departments are not aware of instances where the lack of a self-certification under the previous exemption led to abuses or to an inability to engage in enforcement. The Mandate is enforceable through various mechanisms in the PHS Act, the Code, and ERISA. Entities that insincerely or otherwise improperly operate as if they are exempt would do so at the risk of enforcement and accountability under such mechanisms. The Departments are not aware of sufficient reasons to believe those measures and mechanisms would fail to deter entities from improperly operating as if they are exempt. Moreover, as noted above, ERISA and other plan disclosure requirements governing group health plans require provision of a comprehensive summary of the benefits covered by the plan and disclosure of any reductions in covered services or benefits, so beneficiaries will know whether their health plan claims a contraceptive Mandate exemption and will be able to raise appropriate challenges to such claims. As a consequence, the Departments believe it is an appropriate balance of various concerns expressed by commenters for these final rules to continue to not require notices or self-certifications for using the exemption.
Some commenters asked the Departments to add language indicating that an exemption cannot be invoked in the middle of a plan year, nor should it be used to the extent inconsistent with laws that apply to, or state approval of, fully insured plans. None of the previous iterations of the exemption regulations included such provisions, and the Departments do not consider them necessary in these final rules. The exemptions in these final rules only purport to exempt plans and entities from the application of the federal contraceptive coverage requirement of the Guidelines issued under section 2713(a)(4). They do not purport to exempt entities or plans from state laws concerning contraceptive coverage, or laws governing whether an entity can make a change (of whatever kind) during a plan year. Final rules governing the accommodation likewise do not purport to obviate the need to follow otherwise applicable rules about making changes during a plan year. (In the companion rules concerning religious beliefs published elsewhere in today's
Commenters also asked that clauses be added to the regulatory text holding issuers harmless where exemptions are invoked by plan sponsors. As discussed above, the exemption rules already specify that where an exemption applies to a group health plan, it encompasses both the group health plan and health insurance coverage provided in connection with the group health plan, and therefore encompasses any impact on the issuer of the contraceptive coverage requirement with respect to that plan. In addition, as discussed in the companion religious final rule published elsewhere in today's
Commenters disagreed about the likely effects of the moral exemptions on the health coverage market. Some commenters stated that expanding the exemptions to encompass moral convictions would not cause complications in the market, while others said that it could, due to such causes as a lack of uniformity among plans, or permitting multiple risk pools. The Departments note that the extent to which plans cover contraception under the prior regulations is already far from uniform. Congress did not require all entities to comply with section 2713 of the PHS Act (under which the Mandate was promulgated)—most notably by exempting grandfathered plans. Moreover, under the previous regulations, issuers were already able to offer plans that omit contraceptives—or only some contraceptives—to houses of worship and integrated auxiliaries, and some commenters and litigants said that issuers were doing so. These cases
Concerning the prospect raised by some commenters of different risk pools between men and women, section 2713(a) of the PHS Act itself provides for some preventive services coverage that applies to both men and women, and some that would apply only to women. With respect to the latter, it does not specify what, if anything, HRSA's Guidelines for women's preventives services would cover, or if contraceptive coverage will be required. The Moral IFC and these final rules do not require issuers to offer health insurance products that satisfy morally objecting entities, they simply make it legal to do so. The Mandate has been imposed only relatively recently, and the contours of its application to objecting entities has been in continual flux, due to various rulemakings and court orders. Overall, concerns raised by some public commenters have not led the Departments to consider it likely that offering these expanded exemptions will cause any injury to the uniformity or operability of the health coverage market.
The exemption in § 147.133(a)(1)(i) of the Moral IFC covers a group health plan and health insurance coverage for non-governmental plan sponsors that object as specified in paragraph (a)(2), and that are either nonprofit organizations, or are for-profit entities that have no publicly traded ownership interests (defined as any class of common equity securities required to be registered under section 12 of the Securities Exchange Act of 1934). The Departments finalize this paragraph without change, and discuss each part of the paragraph in turn.
Under the plan sponsor exemption in § 147.132(a)(1)(i), the prefatory text in that paragraph specifies that it encompasses group health plans, and health insurance coverage provided in connection with such group health plans, that are sponsored by certain kinds of entities, namely, nonprofit organizations or for-profit entities that have no publicly traded ownership interests.
Such plan sponsors, if they are otherwise nonprofit organizations or for-profit entities that have no publicly traded ownership interests, can include entities that are not employers (for example, a union, or a sponsor of a multiemployer plan), where the plan sponsor objects based on sincerely held moral convictions to coverage of contraceptives or sterilization. Plan sponsors encompassed by the exemption can also include employers, and consistent with the definition of “employer” in 29 CFR 2510.3-5, can include association health plans, where the plan sponsor is a nonprofit organization or a for-profit entity that has no publicly traded ownership interests.
Some commenters objected to extending the exemption to plan sponsors that are not single employers, arguing that they could not have the same kind of moral objection that a single employer might have. Other commenters supported the protection of any plan sponsor with the requisite moral objection. The Departments conclude that it is appropriate, where a plan sponsor of a multiemployer plan or multiple employer plan adopts a moral objection using the same procedures that such a plan sponsor might use to make other decisions, to respect that decision by providing an exemption from the Mandate.
The plans of governmental employers are not covered by the plan sponsor exemption in § 147.133(a)(1)(i), which instead limits the moral exemptions to “non-governmental plan sponsors.” As noted above, the Departments sought public comment on whether to extend the exemptions to non-federal governmental plan sponsors. Some commenters suggested that the moral exemptions should include government entities because other conscience laws can include government entities, such as when they oppose offering abortions. Others disagreed, contending that governmental entities should not or cannot object based on moral convictions, or that it would be unlawful for them to do so.
The Departments are sympathetic to the arguments of commenters that favor including government entities in the exemption for moral convictions. The protections outlined in the first paragraph of the Church Amendments for entities that object based on moral convictions to making their facilities or personnel available to assist in the performance of abortions or sterilizations do not turn on the nature of the entity, whether public, private, nonprofit, for-profit, or governmental. (42 U.S.C. 300a-7(b)). Both the Weldon and Coats-Snowe Amendments also protect state and local government entities from providing, promoting, or paying for abortions in particular ways.
At the same time, the Departments do not at this time have information suggesting that an exemption for governmental entities is needed or desired. The Departments have not been sued by any governmental entities raising objections to the Mandate based on non-religious moral convictions. Although the Departments sought public comment on the issue, the Departments received no public comments identifying governmental entities that need or desire such an exemption. Rather, the Departments are aware of governmental entities that, despite not possessing their own objections to contraceptive coverage, have acted to protect their employees who have conscientious objections to receiving contraceptive coverage in their employer-provided health insurance plans.
Thus, in light of the balance of public comments, the Departments decline to extend the moral convictions exemption to governmental entities. As is the case with the Departments' decision not to extend the moral exemption to publicly traded for-profit entities, this decision does not reflect a disagreement with the various conscience statutes that provide exemptions for moral convictions
As discussed above, some commenters opposed offering exemptions based on moral convictions to any plan sponsors, and/or objected to doing so for nonprofit organizations, on various grounds, including but not limited to arguments that the benefits of contraception access should override moral objections, entities cannot assert moral objections, and moral objections burden third parties. Other commenters supported the exemptions, generally defending the interest of nonprofit organizations not to be forced to violate their moral convictions, supporting the history of government protection of moral convictions in similar contexts, and disputing the claims of opponents of the exemptions.
The Departments are aware, through litigation, of only two non-religious nonprofit organizations with moral objections to the contraceptive Mandate. Many more nonprofit religious organizations have sued suggesting—as discussed below—that the effect of this exemption for non-religious nonprofit objections to the Mandate will be far less significant than commenters who oppose the exemption believe it will. The two non-religious nonprofit organizations that challenged the Mandate in court provide a good illustration of the reasons why the Department has decided to provide this exemption to nonprofit organizations. Both organizations have said in court they oppose certain contraceptives on non-religious moral grounds as being abortifacient and state that they only hire employees who share that view. Public comments and litigation reflect that many nonprofit organizations publicly describe their beliefs and convictions. Government records and many of those groups' websites also often reflect those groups' religious or moral character, as the case may be. If a person who desires contraceptive coverage works at a nonprofit organization, the Departments view it as sufficiently likely that the person would know, or would know to ask, whether the organization offers such coverage. The Departments are not aware of federal laws that would require a nonprofit organization that opposes contraceptive coverage to hire a person who disagrees with the organization's view on contraceptive coverage. Instead, nonprofit organizations generally have access to a First Amendment right of expressive association to choose to hire persons (or, in the case of students, to admit them) based on whether they share, or at least will be respectful of, their beliefs.
The Departments agree with commenters who support offering the exemption to nonprofit organizations and believe that doing so is an appropriate protection and is not likely to have a significant impact on women who want contraceptive coverage.
With respect to for-profit organizations addressed in § 147.133(a)(1)(i)(B), in the Moral IFC, the Departments did not limit the exemption to nonprofit organizations, but also included some for-profit entities. Some commenters supported including for-profit entities in the exemption, saying owners of such entities exercise their moral convictions through their businesses, and that such owners should not be burdened by a federal governmental contraceptive Mandate. Other commenters opposed extending the exemption to closely held for-profit entities, saying the entities cannot exercise moral convictions or should not have their moral opposition to contraceptive coverage protected by the exemption. Some commenters stated that the entities should not be able to impose their beliefs about contraceptive coverage on their employees and that doing so constitutes discrimination.
The Departments agree with commenters who support including some for-profit entities in the exemption. Many of the federal health care conscience statutes cited above offer protections for the moral convictions of entities, without regard to whether they operate as nonprofit organizations or for-profit entities. In addition, nearly half of the states either impose no contraceptive coverage requirement or offer “an almost unlimited” exemption encompassing both “religious and secular organizations.”
Extending the exemption to certain for-profit entities is also consistent with the Supreme Court's ruling in
The Moral IFC only extended the exemption covering for-profit entities to those that are closely held, not to for-profit entities that are publicly traded, but asked for comment on whether publicly traded entities should be included in the moral exemption. In this way the Moral IFC differed from the exemption provided to plan sponsors with objections based on sincerely held religious beliefs set forth in the Religious IFC, at § 147.132(a)(1), finalized in companion rules published elsewhere in today's
Some commenters supported including publicly traded entities in the moral exemption, contending that publicly traded entities have historically taken various positions on important public concerns beyond merely seeking the company's own profits, and that nothing in principle would preclude them from using the same mechanisms of corporate decision-making to establish and exercise moral convictions against contraceptive coverage. They observed that large publicly traded entities are exempt from the contraceptive Mandate by means of the grandfathering provision of the ACA, so
Other commenters opposed including publicly traded companies in these moral exemptions. Some stated that such companies could not exercise moral convictions and opposed the effects on women if they would. They also objected that including such companies, along with closely held businesses, would extend the exemptions to all or virtually all companies. Some commenters stated that many publicly traded companies would use a moral exemption if available to them, because many closely held for-profit businesses expressed religious objections to the Mandate, or availed themselves of the religious accommodation.
As is the case for non-federal governmental employers, the Departments are sympathetic to the arguments of commenters that favor including publicly traded entities in the exemption for moral convictions. In the case of particularly sensitive health care matters, several significant federal health care conscience statutes protect entities' moral objections without regard to their ownership status. For example, the first paragraph of the Church Amendments provides certain protections for entities that object based on moral convictions to making their facilities or personnel available to assist in the performance of abortions or sterilizations; the protections of the Church Amendments do not turn on the nature of the entity, whether public, private, nonprofit, for-profit, or governmental. (42 U.S.C. 300a-7(b)). Thus, under section 300a-7(b), a hospital in a publicly traded health system, or a local governmental hospital, could adopt sincerely held moral convictions by which it objects to providing facilities or personnel for abortions or sterilizations, and if the entity receives relevant funds from HHS specified by section 300a-7(b), the protections of that section would apply. Other federal conscience protections in the health sector apply in the same manner:
• The Coats-Snowe Amendment (42 U.S.C. 238n) provides certain protections for health care entities and postgraduate physician training programs that, among other things, choose not to perform, refer for, or provide training for, abortions.
• The Weldon Amendment
• The ACA provides certain protections for any institutional health care entity, hospital, provider-sponsored organization, health maintenance organization, health insurance plan, or any other kind of health care facility, that does not provide any health care item or service furnished for the purpose of causing or assisting in causing assisted suicide, euthanasia, or mercy killing. (42 U.S.C. 18113).
• Social Security Act sections 1852(j)(3)(B) (Medicare) and 1932(b)(3)(B) (Medicaid), 42 U.S.C. 1395w-22(j)(3)(B) and 1396u-2(b)(3)(B), provide protections so that the statutes cannot be construed to require organizations that offer Medicare Advantage and Medicaid managed care plans in certain contexts to provide, reimburse for, or provide coverage of a counseling or referral service if they object to doing so on moral grounds.
• Congress's most recent statement on contraceptive coverage specified that, if the District of Columbia requires “the provision of contraceptive coverage by health insurance plans,” “it is the intent of Congress that any legislation enacted on such issue should include a `conscience clause' which provides exceptions for religious beliefs and moral convictions.” Consolidated Appropriations Act, 2018, Public Law 115-141, Div. E, Sec. 808.
At the same time, as stated in the Moral IFC, the Departments continue to lack significant information about whether there is a need to extend the expanded exemption to publicly traded entities. The Departments have been sued by nonprofit entities expressing objections to the Mandate based on non-religious moral convictions, as well as by closely held for-profit entities expressing religious objections, but not by any publicly traded entities. In addition, the Departments sought public comments on whether publicly traded entities might benefit from extending the moral exemption to them. No such entities were brought to the attention of the Department through the comment process. The Supreme Court concluded it is improbable that publicly traded companies with numerous “unrelated shareholders—including institutional investors with their own set of stakeholders—would agree to run a corporation under the same religious beliefs.”
In light of the balance of public comments, the Departments decline to extend the moral convictions exemption to publicly traded entities. Because the Departments are aware of so many closely-held for-profit entities with religious objections to contraceptive coverage, and of some nonprofit entities with non-religious moral objections to contraceptive coverage, the Departments believe it is reasonably possible that closely held for-profit entities with non-religious moral objections to contraceptive coverage might exist or come into being. The Departments have also concluded that it is reasonably possible, even if improbable, that publicly traded entities with religious objections to contraceptive coverage might exist or come into being. But the Departments conclude there is not a similar probability that publicly traded for-profit entities with non-religious moral objections to contraceptive
In contrast, the Departments finalize, without change, the Moral IFC's extension of the exemptions in these rules to closely held for-profit entities with moral convictions opposed to offering coverage of some or all contraceptives. The Departments conclude that it is sufficiently likely that closely held for-profit entities exist or may come into being and may maintain moral objections to certain contraceptives, so as to support including them in these expanded exemptions. The Departments seek to remove an obstacle that might prevent individuals with moral objections from forming or maintaining such small or closely held businesses and providing health coverage to their employees in accordance with their moral convictions.
In defining what constitutes a closely held for-profit entity to which these exemptions extend, the Moral IFC used language derived from the July 2015 final regulations. Those regulations, in offering the accommodation (not an exemption) to religious (not moral) closely held for-profit entities, did so by attempting to positively define what constitutes a closely held entity, formulating a multi-factor, and partially open-ended, definition for that purpose. (80 FR 41313). Any such positive definition runs up against the myriad state differences in defining such entities and potentially intrudes into a traditional area of state regulation of business organizations. Instead of attempting to positively define closely held businesses in the Moral IFC, however, the Departments considered it much clearer, effective, and preferable to define the category negatively, by reference to one element of the previous definition: that the entity has no publicly traded ownership interest (that is, any class of common equity securities required to be registered under section 12 of the Securities Exchange Act of 1934).
The previous regulations did not exempt plans arranged by institutions of higher education, although they did include, in the accommodation, plans arranged by institutions of higher education similarly to the way in which the regulations provided the accommodation to plans of nonprofit religious employers. (See 80 FR 41347). The Moral IFC provided an exemption, in § 147.133(a)(1)(ii), encompassing institutions of higher education that arrange student health insurance coverage, and stating the exemption would operate in a manner comparable to the exemption for employers with respect to plans they sponsor. In these final rules, the Departments finalize § 147.133(a)(1)(ii) with one change.
These rules treat the health plans of institutions of higher education that arrange student health insurance coverage similarly to the way in which the rules treat the plans of employers. The rules do so by making such student health plans eligible for the expanded exemptions, and by permitting them the option of electing to utilize the accommodation process. Thus, these rules specify, in § 147.133(a)(1)(ii), that the exemption is extended, in the case of institutions of higher education (as defined in 20 U.S.C. 1002) with objections to the Mandate based on sincerely held moral convictions, to their arrangement of student health insurance coverage, in a manner comparable to the exemption for group health insurance coverage provided in connection with a group health plan established or maintained by a plan sponsor.
Some commenters supported including, in the exemptions, institutions of higher education that provide health coverage for students through student health plans but have moral objections to providing certain contraceptive coverage. They stated that moral exemptions allow freedom for certain institutions of higher education to exist, and this in turn gives students the choice of institutions that hold different views on important issues such as contraceptives and abortifacients. Other commenters opposed including the exemption, asserting that expanding the exemption would negatively impact female students because institutions of higher education might not cover contraceptives in student health plans, women enrolled in those plans would not receive access to birth control, and an increased number of unintended pregnancies would result.
In the Departments' view, the reasons for extending the exemption to institutions of higher education are similar to the reasons, discussed above, for extending the exemption to other nonprofit organizations. The Departments are not aware of any institutions of higher education that arrange student health insurance coverage and object to the Mandate based on non-religious moral convictions. But because the Departments have been sued by several institutions of higher education that arrange student health insurance coverage and object to the Mandate based on religious beliefs and by several nonprofit organizations with moral objections, the Departments believe the existence of institutions of higher education with non-religious moral objections, or the possible formation of such entities in the future, is sufficiently possible to justify including protections for such entities in these final rules.
The Departments conclude that this aspect of the exemption is likely to have a minimal impact on contraceptive coverage for women at institutions of higher education. As noted above, the Departments are not aware of any institutions of higher education that would currently qualify for the objection. In addition, only a minority of students in higher education receive health insurance coverage from plans arranged by their colleges or universities, as opposed to from other sources, and an even smaller number receive such coverage from schools objecting to contraceptive coverage. Exempting institutions of higher education that object to contraceptive coverage based on moral convictions does not affect student health insurance contraceptive coverage at the vast majority of institutions of higher education. The exemption simply makes it legal under federal law for institutions to adhere to moral convictions that oppose contraception, without facing penalties for non-compliance that could threaten their existence. This removes a possible barrier to diversity in the nation's higher education system, because it makes it easier for students to attend institutions of higher education that hold those views, if the institutions exist or come into being and students choose to attend them. Moreover, because institutions of higher education have no legal obligation to sponsor student health insurance coverage, providing this moral exemption removes an obstacle to such institutions sponsoring student health insurance coverage, thus possibly encouraging
As noted above, after seeking public comment on whether the final moral exemptions rules should be extended to include non-federal governmental entities, the Departments have concluded they should only include non-governmental entities. For the same reasons, the Departments are inserting a reference into § 147.133(a)(1)(ii) specifying that it includes an institution of higher education “which is non-governmental.” This language is parallel to the same limiting phrase used in the religious exemptions rule governing institutions of higher education, at § 147.132(a)(1)(ii). Thus, the first sentence of § 147.133(a)(1)(ii) is finalized to read: “An institution of higher education as defined in 20 U.S.C. 1002, which is non-governmental, in its arrangement of student health insurance coverage, to the extent that institution objects as specified in paragraph (a)(2) of this section.” The remaining text of § 147.133(a)(1)(ii) is finalized without change.
The Moral IFC extended the exemption, in § 147.133(a)(1)(iii), to health insurance issuers offering group or individual health insurance coverage that sincerely hold their own moral convictions opposed to providing coverage for contraceptive services. The issuer exemption only applied to the group health plan if the plan itself was also exempt under an exemption for the plan sponsor or individuals. In these final rules, the Departments finalize § 147.133(a)(1)(iii) without change.
As discussed above, where the exemption for plan sponsors or institutions of higher education applies, issuers are exempt under those sections with respect to providing contraceptive coverage in those plans. The issuer exemption in § 147.133(a)(1)(iii) adds to that protection, but the additional protection operates in a different way than the plan sponsor exemption operates. The only plan sponsors—or in the case of individual insurance coverage, individuals—who are eligible to purchase or enroll in health insurance coverage offered by an exempt issuer that does not cover some or all contraceptive services, are plan sponsors or individuals who themselves object and whose plans are otherwise exempt based on that objection. An exempt issuer can then offer an exempt product to an entity or individual that is exempt based on either the moral exemptions for entities and individuals, or the religious exemptions for entities and individuals. Thus, the issuer exemption specifies that, where a health insurance issuer providing group health insurance coverage is exempt under paragraph (a)(1)(iii), the plan remains subject to any requirement to provide coverage for contraceptive services under Guidelines issued under § 147.130(a)(1)(iv), unless the plan is otherwise exempt from that requirement. Accordingly, the only plan sponsors, or in the case of individual insurance coverage, individuals, who are eligible to purchase or enroll in health insurance coverage offered by an exempt issuer under this paragraph (a)(1)(iii) that does not include some or all contraceptive services, are plan sponsors or individuals who themselves object and are exempt.
Under these rules, issuers that hold their own objections based on sincerely held moral convictions could issue policies that omit contraception to plan sponsors or individuals that are otherwise exempt based on their moral convictions, or if they are exempt based on their religious beliefs under the companion final rules published elsewhere in today's
Some commenters supported including this exemption for issuers in these rules, both to protect the moral convictions of issuers, and so that, in the future, issuers would be free to organize that may wish to specifically serve plan sponsors and individuals that object to contraception based on religious or moral reasons. Other commenters objected to including an exemption for issuers. Some commenters stated that issuers cannot exercise moral convictions, while others stated that exempting issuers would threaten contraceptive coverage for women. Some commenters stated that it was arbitrary and capricious for the Departments to provide an exemption for issuers if they do not know that issuers with qualifying moral objections exist.
The Departments consider it appropriate to provide this exemption for issuers. Because the issuer exemption only applies where an independently exempt policyholder (entity or individual) is involved, the issuer exemption will not serve to remove contraceptive coverage obligations from any plan or plan sponsor that is not also exempt, nor will it prevent other issuers from being required to provide contraceptive coverage in individual or group insurance coverage.
The issuer exemption serves several interests, even though the Departments are not currently aware of existing issuers that would use it. As noted by some commenters, allowing issuers to be exempt, at least with respect to plan sponsors, plans, and individuals that independently qualify for an exemption, will remove a possible obstacle to issuers with moral convictions being organized in the future to serve entities and individuals that want plans that respect their religious beliefs or moral convictions. Furthermore, permitting issuers to object to offering contraceptive coverage based on sincerely held moral convictions will allow issuers to continue to offer coverage to plan sponsors and individuals, without subjecting them to liability under section 2713(a)(4), or related provisions, for their failure to provide contraceptive coverage. In this way, the issuer exemption serves to protect objecting issuers both from being required to issue policies that cover contraception in violation of the issuers' sincerely held moral convictions and from being asked or required to issue policies that omit contraceptive coverage to non-exempt entities or individuals, thus subjecting the issuers to potential liability if those plans are not exempt from the Guidelines.
The Departments reject the proposition that issuers cannot exercise moral convictions. Many federal health care conscience laws and regulations protect issuers or plans specifically. For example, as discussed above, 42 U.S.C. 1395w-22(j)(3)(B) and 1396u-2(b)(3) protect plans or managed care organizations in Medicare Advantage or Medicaid. The Weldon Amendment specifically protects, among other entities, HMOs, health insurance plans, and “any other kind of health care facility[ies], organization[s] or plan[s]” as a “health care entity” from being required to provide coverage of, or pay for, abortions. See, for example, Consolidated Appropriations Act, 2018, Public Law 115-141, Div. H, Sec. 507(d).
The issuer exemption does not specifically include third party administrators, for the reasons discussed in the companion Religious IFC and final rules concerning religious beliefs issued contemporaneously with these final rules and published elsewhere in today's
The Moral IFC set forth the scope of the moral objection of objecting entities in § 147.133(a)(2), so that it applies to the extent an entity described in paragraph (a)(1), based on sincerely held moral convictions, objects to “establishing, maintaining, providing, offering, or arranging” either “coverage or payments” for contraceptives, or “for a plan, issuer, or third party administrator that provides or arranges such coverage or payments.” The Departments are finalizing this exemption with structural changes separating the second half of the sentence into separate subparagraphs, so as to more clearly specify, as set forth in the Moral IFC text, that the objection may pertain either to coverage or payments for contraceptives, or to a plan, issuer, or third party administrator that provides or arranges such coverage or payments.
Some commenters observed that, by allowing exempt plan sponsors to object to “some or all” contraceptives, this might yield a cafeteria-style approach where different plan sponsors choose various combinations of contraceptives that they wish to cover. Some commenters further observed that this might create a burden on issuers or third party administrators.
The Departments have concluded, however, that just as the previous exemption rules allowed certain religious plan sponsors to object to some or all contraceptives, it is appropriate to maintain that flexibility for entities covered by the expanded exemption. These rules do not require any issuer or third party administrator to contract with an exempt entity or individual if the issuer or third party administrator does not wish to do so, including because the issuer or third party administrator does not wish to offer an unusual plan variation. These rules simply remove the federal Mandate, in some cases, where it could have led to penalties on an employer, issuer, or third party administrator if they wished to sponsor, provide, or administer a plan that omits contraceptive coverage in the presence of a qualifying moral objection. That approach is consistent with the approach under the previous regulations, which did not require issuers and third party administrators to contract with exempt plans of houses of worship or integrated auxiliaries if they did not wish to do so.
The definition does not specify that the moral convictions that can support an exemption need to be non-religious moral convictions. We find it unnecessary to limit the definition in that way. Even though moral convictions need not be based on religious beliefs, religious beliefs can have a moral component. It is not always clear whether a moral conviction is based on religious tenets. As noted in
The Departments are not aware of any entities that qualify for an exemption under the religious exemptions finalized elsewhere in today's
The previous regulations did not provide an exemption for objecting individuals. The Moral IFC provided such an exemption for objecting individuals (referred to here as the “individual exemption”), using the following language at § 147.133(b): “Objecting individuals”. Guidelines issued under § 147.130(a)(1)(iv) by the Health Resources and Services Administration must not provide for or support the requirement of coverage or payments for contraceptive services with respect to individuals who object as specified in this paragraph (b), and nothing in § 147.130(a)(1)(iv), 26 CFR 54.9815-2713(a)(1)(iv), or 29 CFR 2590.715-2713(a)(1)(iv) may be construed to prevent a willing health insurance issuer offering group or individual health insurance coverage, and as applicable, a willing plan sponsor of a group health plan, from offering a separate policy, certificate or contract of insurance or a separate group health plan or benefit package option, to any individual who objects to coverage or payments for some or all contraceptive services based on sincerely held moral convictions.”
The Departments finalize this language, with changes in response to public comments in some of the text and in a new sentence at the end of the paragraph that clarify how the exemption applies.
Section 147.133(b) sets forth a special rule pertaining to individuals (referred to here as the “individual exemption”). This rule exempts plans of certain individuals with moral objections to contraceptive coverage where the plan sponsor and, as applicable, issuer is willing to provide a plan compliant with the individuals' objections to such plan sponsors or individuals, as applicable.
Some commenters supported this exemption as providing appropriate protections for the moral convictions of individuals who obtain their insurance coverage in such places as the individual market or exchanges, or who obtain coverage from a group health plan sponsor that does not object to coverage of contraceptives but is willing (and, as applicable, the issuer is also willing) to provide coverage consistent with an individual's moral objections. They commented that this exemption
Other commenters disagreed and contended that allowing the individual exemption would cause burden and confusion in the insurance market. Some commenters also suggested that the individual exemption should not allow the offering of a separate group health plan because doing so could cause various administrative burdens.
The Departments agree with the commenters who suggested the individual exemption will not burden the insurance market, and, therefore, conclude that it is appropriate to provide the individual exemption where a plan sponsor and, as applicable, issuer are willing to cooperate in doing so. The Departments note that this individual exemption only operates in the case where the issuer is willing to provide the separate option; in the case of coverage provided by a group health plan sponsor, where the plan sponsor is willing; or in the case where both a plan sponsor and issuer are involved, both are willing. The Departments conclude that it is appropriate to provide the individual exemption so that the Mandate will not serve as an obstacle among these various options. Practical difficulties that may be implicated by one option or another will likely be factored into whether plan sponsors and issuers are willing to offer particular options in individual cases. But the Departments do not wish to pose an obstacle to the offering of such coverage.
The Departments note that their decision is consistent with the decision by Congress to provide protections in certain contexts for individuals who object to prescribing or providing contraceptives contrary to their moral convictions.
The individual exemption extends to the coverage unit in which the plan participant, or subscriber in the individual market, is enrolled (for instance, to family coverage covering the participant and his or her beneficiaries enrolled under the plan), but does not relieve the plan's or issuer's obligation to comply with the Mandate with respect to the group health plan generally, or, as applicable, to any other individual policies the issuer offers. Thus, this individual exemption allows plan sponsors and issuers that do not specifically object to contraceptive coverage to offer morally acceptable coverage to their participants or subscribers who do object, while offering coverage that includes contraception to participants or subscribers who do not object. The July 2013 regulations stated that, because employees of objecting houses of worship and integrated auxiliaries are relatively likely to oppose contraception, exempting those organizations “does not undermine the governmental interests furthered by the contraceptive coverage requirement.” (78 FR 39874). For parallel reasons, as the Departments stated in the Moral IFC (83 FR at 47853 through 47854), this individual exemption does not undermine the governmental interests furthered by the contraceptive coverage requirement, because, when the exemption is applicable, the individual does not want the coverage, and therefore would not use the objectionable items even if they were covered.
This individual exemption can apply with respect to individuals in plans sponsored by private employers or governmental employers. For example, in one case brought against the Departments, the State of Missouri enacted a law under which the state is not permitted to discriminate against insurance issuers that offer group health insurance policies without coverage for contraception based on employees' religious beliefs “or moral convictions,” or against the individual employees who accept such offers.
In the separate companion IFC to the Moral IFC—the Religious IFC—the Departments, at § 147.133(b), provided a similar individual exemption, but we used slightly different operative language. Where the Moral IFC said a willing issuer and plan sponsor may offer “a separate policy, certificate or contract of insurance or a separate group health plan or benefit package option, to any individual who objects” under the individual exemption, the Religious IFC described what may be offered to objecting individuals as “a separate benefit package option, or a separate policy, certificate or contract of insurance.” Some commenters observed this difference and asked whether the language was intended to encompass the same options. The Departments intended these descriptions to include the same scope of options. Some commenters suggested that the individual exemption should not allow the offering of “a separate group health plan,” because doing so could cause various administrative burdens. The Departments disagree, since group health plan sponsors and group and individual health insurance issuers would be free to decline to provide that option, including because of administrative burdens. In addition, the Departments wish to clarify that, where an employee claims the exemption, a willing issuer and a willing employer may, where otherwise permitted, offer the employee participation in a group health insurance policy or benefit option that complies with the employee's objection. Consequently, these rules finalize the individual exemption by making a technical change to the language to adopt the formulation, “a separate policy, certificate or contract of insurance or a separate group health plan or benefit package option, to any group health plan sponsor (with respect to an individual) or individual, as applicable, who objects.”
This individual exemption cannot be used to force a plan (or its sponsor) or an issuer to provide coverage omitting contraception, or, with respect to health insurance coverage, to prevent the application of state law that requires coverage of such contraceptives or
The Departments received numerous comments about the administrative burden from the potential variations in moral convictions held by individuals. Some commenters welcomed the ability of individuals covered by the individual exemption to be able to assert an objection to either some or all contraceptives, while others expressed concern that the variations in the kinds of contraceptive coverage to which individuals object might make it difficult for willing plan sponsors and issuers to provide coverage that complies with the moral convictions of an exempt individual.
If an individual only objects to some contraceptives, and the individual's issuer and, as applicable, plan sponsor are willing to provide the individual a package of benefits omitting such coverage, but for practical reasons can only do so by providing the individual with coverage that omits all—not just some—contraceptives, the Departments believe that it favors individual freedom and market choice, and does not harm others, to allow the issuer and plan sponsor to provide, in that case, a plan omitting all contraceptives if the individual is willing to enroll in that plan. The language of the individual exemption set forth in the Moral IFC implied this conclusion by specifying that the Guidelines requirement of contraceptive coverage did not apply where the individual objected to some or all contraceptives. Notably, that language differed from the language applicable to the exemptions under § 147.133(a), which specifies that those exemptions apply “to the extent” of the moral objections, so that, as discussed above, they include only those contraceptive methods to which the objection applied. In response to comments suggesting the language of the individual exemption was not sufficiently clear on this distinction, however, the Departments in these rules finalize the individual exemption at § 147.133(b), with the following change, by adding the following sentence at the end of the paragraph: “Under this exemption, if an individual objects to some but not all contraceptive services, but the issuer, and as applicable, plan sponsor, are willing to provide the plan sponsor or individual, as applicable, with a separate policy, certificate or contract of insurance or a separate group health plan or benefit package option that omits all contraceptives, and the individual agrees, then the exemption applies as if the individual objects to all contraceptive services.”
Some commenters asked for plain language guidance and examples about how the individual exemption might apply in the context of employer-sponsored insurance. Here is one such example. An employee is enrolled in group health coverage through her employer. The plan is fully insured. If the employee has sincerely held moral convictions objecting to her plan including coverage for contraceptives, she could raise this with her employer. If the employer is willing to offer her a plan that omits contraceptives, the employer could discuss this with the insurance agent or issuer. If the issuer is also willing to offer the employer, with respect to the employee, a group health insurance policy that omits contraceptive coverage, the individual exemption would make it legal for the group health insurance issuer to omit contraceptives for her and her beneficiaries under her policy, for her employer to sponsor that plan for her, and for the issuer to issue such a plan to the employer, to cover that employee. This would not affect other employees' plans—those plans would still be subject to the Mandate and would continue to cover contraceptives. But if either the employer, or the issuer, is not willing (for whatever reason) to offer a plan or a policy for that employee that omits contraceptive coverage, these rules do not require them to do so. The employee would have the choice of staying enrolled in a plan with its coverage of contraceptives, not enrolling in that plan, seeking coverage elsewhere, or seeking employment elsewhere.
For all these reasons, these rules adopt the individual exemption language from the Religious IFC with changes, to read as follows: “(b)
The previous regulations did not offer the accommodation process to entities with moral non-religious objections. The Religious IFC amended the accommodation regulations to offer it to all entities that are exempt on the basis of religious beliefs under § 147.132, as an optional process in which such entities could participate voluntarily. The Moral IFC did not change that accommodation process, but inserted references in it to the new section § 147.133, alongside the references to section § 147.132. These changes made entities eligible for the voluntary accommodation process if they are exempt on the basis of moral convictions. The references were inserted in 45 CFR 147.131, 26 CFR 54.9815-2713A, and 29 CFR 2590.715-2713A.
In these rules, the Departments finalize, without change, the Moral IFC's revisions of 45 CFR 147.131, 26 CFR 54.9815-2713A, and 29 CFR 2590.715-2713A. The operation of the accommodation process, changes made in the Religious IFC, and public comments concerning the accommodation, are more fully described in the Religious IFC, and in the companion final rules concerning the religious exemptions and accommodation, published elsewhere in today's
Many commenters supported extending the accommodation process to entities with objections based on moral convictions. Others objected to doing so, raising arguments parallel to their objections to creating exemptions for group health plan sponsors with moral convictions. For much the same reasons discussed above concerning why the Departments find it appropriate to exempt entities with moral objections to contraceptive coverage, the Departments find it appropriate to extend the optional accommodation process to these entities. The Departments observe that, to the extent such entities wish to use the process, it will not be an obstacle to contraceptive coverage, but will instead help deliver contraceptive coverage to women who receive health coverage from such entities while respecting the moral convictions of the entities. The Departments are not aware of entities with non-religious moral convictions against contraceptive coverage that also consider the accommodation acceptable and would opt into it, but we are aware of a small number of entities with non-religious moral objections to the Mandate. The Departments, therefore, continue to consider it appropriate to extend the optional accommodation to such entities in case any wish to use it. Below, albeit based on very limited data, the Departments estimate that a small number of entities with non-religious moral objections may use the accommodation process.
The previous regulations did not define contraceptive services. The Guidelines issued in 2011 included, under “Contraceptive methods and counseling,” “[a]ll Food and Drug Administration approved contraceptive methods, sterilization procedures, and patient education and counseling for all women with reproductive capacity.” The previous regulations concerning the exemption and the accommodation used the terms “contraceptive services” and “contraceptive coverage” as catch-all terms to encompass all of those Guidelines requirements. The 2016 update to the Guidelines are similarly worded. Under “Contraception,” they include the “full range of contraceptive methods for women currently identified by the U.S. Food and Drug Administration,” “instruction in fertility awareness-based methods,” and “[c]ontraceptive care” to “include contraceptive counseling, initiation of contraceptive use, and follow-up care (
To more explicitly state that the expanded exemptions encompass any of the contraceptive or sterilization services, items, procedures, or related patient education or information that have been required under the Guidelines, the Moral IFC included a definition of contraceptive services, benefits or coverage, at 45 CFR 147.133(c). These rules finalize that definition without change.
The Departments finalize, without change, the severability clause set forth at § 147.133(d).
Some commenters noted that some drugs included in the preventive services contraceptive Mandate can also be useful for treating certain existing health conditions, and that women use them for non-contraceptive purposes. Certain commenters urged the Departments to clarify that the final rules do not permit employers to exclude from coverage medically necessary prescription drugs used for non-preventive services. Some commenters suggested that moral objections to the Mandate should not be permitted in cases where contraceptive methods are used to treat such existing medical conditions and not for preventive purposes, even if those contraceptive methods can also be used for contraceptive purposes.
Section 2713(a)(4) only applies to “preventive” care and screenings. The statute does not allow the Guidelines to mandate coverage of services provided solely for a non-preventive use, such as the treatment of an existing condition. The Guidelines implementing this section of the statute are consistent with that narrow authority. They state repeatedly that they apply to “preventive” services or care.
Some commenters observed that pharmacy claims do not include a medical diagnosis code, so that plans may be unable to discern whether a drug approved by FDA for contraceptive uses is actually applied for a preventive or contraceptive use. Section 2713(a)(4), however, draws a distinction between preventive and other kinds of care and screenings. That subsection does not authorize the Departments to impose a coverage mandate of services that are not at least partly applied for a preventive use, and the Guidelines themselves do not require coverage of care unless it is contraceptive in purpose. These rules do not prohibit issuers from covering drugs and devices that are approved for contraceptive uses even when those drugs and devices are
Some commenters agreed with the Departments' statement in the Moral IFC that the moral exemptions are likely to affect only a very small number of women otherwise receiving coverage under the Mandate. Other commenters disagreed, stating that the exemptions could take contraceptive coverage away from many or most women. Still others opposed establishing the exemptions, but contended that accurately determining the number of women affected by the exemptions is not possible. Public comments included various statements that these exemptions would impact coverage for a large number of women, while others stated they would affect only a very small number. But few, if any, public commenters provided data predicting a precise number of entities that would make use of the exemptions for moral convictions nor a precise number of employees that would potentially be affected.
After reviewing the public comments, the Departments do not find the suggestions of commenters who predicted a very large impact any more reliable than the estimates set forth in the Religious and Moral IFCs. Therefore, the Departments conclude that the estimates of regulatory impact made in the Religious and Moral IFCs are still the best estimates available. The Departments' estimates are discussed in more detail in the following section.
The Departments have examined the impacts of these final rules as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354, section1102(b) of the Social Security Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 1999), the Congressional Review Act (5 U.S.C. 804(2)) and Executive Order 13771 on Reducing Regulation and Controlling Regulatory Costs (January 30, 2017).
Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, and 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.
Section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action that is likely to result in a regulation: (1) Having an annual effect on the economy of $100 million or more in any 1 year, or adversely and materially affecting a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or state, local, or tribal governments or communities (also referred to as “economically significant”); (2) creating a serious inconsistency or otherwise interfering with an action taken or planned by another agency; (3) materially altering the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raising novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order.
A regulatory impact analysis must be prepared for major rules with economically significant effects ($100 million or more in any 1 year), and an “economically significant” regulatory action is subject to review by OMB. As discussed below regarding their anticipated effects, the these final rules are not likely to have economic impacts of $100 million or more in any one year, and therefore do not meet the definition of “economically significant” under Executive Order 12866. However, OMB has determined that the actions are significant within the meaning of section 3(f)(4) of the Executive Order. Therefore, OMB has reviewed these final rules and the Departments have provided the following assessment of their impact.
The Religious IFC amended the Departments' July 2015 final regulations. The Moral IFC amended those regulations further, and added an additional rule at 45 CFR part 147.133. These final rules adopt as final, and further amend, the amendments made by the Moral IFC. The Departments do so in conjunction with the amendments made in the companion final rules concerning religious beliefs published elsewhere in today's
The Departments acknowledge that expanding the exemption to include objections based on moral convictions might result in less insurance coverage of contraception for some women who may want the coverage. Although the Departments do not know the exact scope of that effect attributable to the moral exemption in these final rules, we believe it to be small.
With respect to the exemption for nonprofit organizations with objections based on moral convictions, as noted
The Departments also assume that those nine entities will operate in a fashion similar to the two similar entities of which we are aware, so that their employees will likely share their views against coverage of certain contraceptives. This is consistent with the conclusion in previous regulations that no significant burden or costs would result from exempting houses of worship and integrated auxiliaries. (See 76 FR 46625 and 78 FR 39889). The Departments reached that conclusion without ultimately requiring that houses of worship and integrated auxiliaries only hire persons who agree with their views against contraception and without requiring that such entities actually oppose contraception in order to be exempt (in contrast, the exemption here requires the exempt entity to actually possess sincerely held moral convictions objecting to contraceptive coverage). In concluding that the exemption for houses of worship and integrated auxiliaries would result in no significant burden or costs, the Departments relied on the assumption that the employees of exempt houses of worship and integrated auxiliaries likely share their employers' opposition to contraceptive coverage.
A similar assumption is appropriate with respect to the expanded exemption for nonprofit organizations with objections based on moral convictions. To the knowledge of the Departments, the vast majority of organizations objecting to the Mandate assert objections based on religious beliefs. The only nonprofit organizations of which they are aware that possess non-religious moral convictions against some or all contraceptive methods only hire persons who share their convictions. It is possible that the exemption for nonprofit organizations with moral convictions in these final rules could be used by a nonprofit organization that employs persons who do not share the organization's views on contraception, but it was also possible under the Departments' previous regulations that a house of worship or integrated auxiliary could employ persons who do not share their views on contraception.
These rules extend the exemption to include institutions of higher education that arrange student coverage and have non-religious moral objections to the Mandate, and make exempt entities with moral objections eligible to avail themselves of the accommodation. The Departments are not aware of any institutions of higher education with this kind of non-religious moral convictions. Moreover, the Departments believe the overall number of entities that would object to the Mandate based on non-religious moral convictions is already very small. The only entities of which we are aware that have raised such objections are not institutions of higher education. Public comments did not reveal the existence of any institutions of higher education with such moral convictions. Therefore, for the purposes of estimating the anticipated effect of these final rules on contraceptive coverage of women who wish to receive such coverage, the Departments assume that—at this time—no entities with non-religious moral objections to the Mandate will be institutions of higher education that arrange student coverage, and no other entities with non-religious moral objections will opt into the accommodation. We wish to make the expanded exemption and accommodation available to such entities in case they do exist or might come into existence, based on reasons similar to those given above for why the exemptions and accommodations are extended to other entities.
The Departments believe that the exemption for issuers with objections based on moral convictions will not result in a distinct effect on contraceptive coverage for women who wish to receive it, because that exemption only applies in cases where plan sponsors or individuals are also otherwise exempt, and the effect of those exemptions is discussed elsewhere herein, or in the companion final rules concerning religious beliefs published elsewhere in today's
The moral exemption will also cover for-profit entities that do not have publicly traded ownership interests and that have non-religious moral objections to the Mandate, if such entities exist. Some commenters agreed that the impact of these final rules would be no more than the Departments estimated in the Moral IFC, and some commenters stated the impact would be much smaller. Other commenters disagreed, suggesting that the expanded exemptions risked removing contraceptive coverage from more than 55 million women receiving the benefits of the preventive services Guidelines, or even risked removing contraceptive coverage from over 100 million women. Some commenters cited studies indicating that, nationally, unintended
Some of the comments opposing these exemptions assert that they will lead to a large number of entities dropping contraceptive coverage. The Departments disagree; they are aware of only two entities that hold non-religious moral convictions against contraceptive coverage. Both only hire employees that share their beliefs, and one will not be affected by these final rules because it is protected by an injunction from any regulations implementing the contraceptive Mandate. Commenters cited no other specific entities that might assert these moral convictions, and did not provide better data to estimate how many entities might exist. Likewise, the Departments find it unlikely that any of the vast majority of entities that covered contraceptives before this Mandate was announced in 2011 would terminate such coverage because of these exemptions based on moral convictions. The Departments also find it unlikely that a significant number of for-profit entities, whose plans include a significant number of women, omitted contraceptive coverage before the ACA on the basis of objections grounded in non-religious moral convictions, and would claim an exemption under these final rules. No such entities, or data concerning such entities, were identified by public commenters, nor are the Departments aware of any involved in litigation over the Mandate.
Numerous for-profit entities claiming religious objections have filed suit challenging the Mandate. Among the over 200 entities that brought legal challenges, only two entities (less than 1 percent) raised non-religious moral objections—and both were nonprofit organizations. Among the general public, polls vary about religious beliefs, but one prominent poll shows that 89 percent of Americans say they believe in God.
The moral exemption encompassing certain for-profit entities could result in the removal of contraceptive coverage from women who do not share their employers' views. The Departments used data from the Current Population Survey (CPS) and the Medical Expenditure Panel Survey-Insurance Component (MEPS-IC) to obtain an estimate of the number of policyholders that will be covered by the plans of the nine for-profit entities we assume may make use of these expanded exemptions.
The Departments estimate that these final rules will not result in any additional burden or costs on issuers or third party administrators. As discussed above, we assume that no entities with non-religious moral convictions will avail themselves of the accommodation, although the Departments wish to make it available in case an entity voluntarily opts into it in order to allow contraceptive coverage to be provided to its plan participants and beneficiaries. While these final rules make it legal for issuers to offer insurance coverage that omits contraceptives to/for exempt entities and individuals, these final rules do not require issuers to do so. Finally, because the accommodation process was not previously available to entities that possess non-religious moral objections to the Mandate, the Departments do not anticipate that these final rules will result in any burden from such entities acting to revoke their accommodated status.
The Departments believe the foregoing analysis represents a reasonable estimate of the likely impact under the exemptions finalized in these final rules. The Departments acknowledge uncertainty in the estimate and, therefore, conducted a second analysis using an alternative framework, which is set forth in the companion final rules concerning religious beliefs issued contemporaneously with these final rules and published elsewhere in today's
The Departments reiterate the rareness of instances in which we are aware that employers assert non-religious objections to contraceptive coverage based on sincerely held moral convictions, as discussed above, and also that in the few instances where such an objection has been raised, employees of such employers also opposed contraception.
These regulations are not subject to review under section 6(b) of Executive Order 12866 pursuant to the Memorandum of Agreement (April 11, 2018) between the Department of the Treasury and the Office of Management and Budget regarding review of tax regulations.
The Regulatory Flexibility Act (RFA) (5 U.S.C. 601
The Departments carefully considered the likely impact of the rules on small entities in connection with their assessment under Executive Order 12866. The Departments do not expect that these final rules will have a significant economic effect on a substantial number of small entities, because they will not result in any additional costs to affected entities. Instead, by exempting from the Mandate small businesses and nonprofit organizations with moral objections to some or all contraceptives and/or sterilization—businesses and organizations which would otherwise be faced with the dilemma of complying with the Mandate (and violating their moral convictions), or of following their moral convictions and incurring potentially significant financial penalties for noncompliance—the Departments have reduced regulatory burden on small entities. Pursuant to section 7805(f) of the Code, the notice of proposed rulemaking preceding these regulations was submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on their impact on small business.
Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the
The Departments estimate that these final rules will not result in additional burdens not accounted for as set forth in companion final rules concerning religious beliefs issued contemporaneously with these final rules and published elsewhere in today's
As discussed above, however, the Departments assume that no entities with non-religious moral objections to the Mandate will use the accommodation. The Departments know that no such entities were eligible for it until now, so that no entity possesses an accommodated status that would need to be revoked. Therefore, the Departments believe that the burden for these ICRs is accounted for in the collection approved under OMB Control Numbers 0938-1344, as described in the final rules concerning religious beliefs issued contemporaneously with these final rules.
Under the Paperwork Reduction Act, an agency may not conduct or sponsor, and an individual is not required to respond to, a collection of information unless it displays a valid OMB control number. In accordance with the requirements of the PRA, the ICR for the EBSA Form 700 and alternative notice have previously been approved by OMB under control numbers 1210-0150 and 1210-0152. In an effort to consolidate the number of information collections the Department is combining OMB control numbers 1210-0150 and 1210-0152 under OMB control number 1210-0150 and discontinuing OMB control number 1210-0152.
A copy of the ICR may be obtained by contacting the PRA addressee shown below or at
Consistent with the analysis in the HHS PRA section above, although these final rules make entities with certain moral convictions eligible for the accommodation, the Department assumes (1) that no entities will use the accommodation rather than the exemption, and (2) entities using the moral exemption would not have to revoke an accommodation, because they previously were not eligible for it. Therefore, the Department believes these final rules do not involve additional burden not accounted for under OMB control number 1210-0150, which is published elsewhere in today's issue of the
Executive Order 13765 (January 20, 2017) directs that, “[t]o the maximum extent permitted by law, the Secretary of Health and Human Services (Secretary) and the heads of all other executive departments and agencies (agencies) with authorities and responsibilities under the [Affordable Care] Act shall exercise all authority and discretion available to them to waive, defer, grant exemptions from, or delay the implementation of any provision or requirement of the Act that would impose a fiscal burden on any state or a cost, fee, tax, penalty, or regulatory burden on individuals, families, healthcare providers, health insurers, patients, recipients of healthcare services, purchasers of health insurance, or makers of medical devices, products, or medications.” In addition, agencies are directed to “take all actions consistent with law to minimize the unwarranted economic and regulatory burdens of the [Affordable Care Act], and prepare to afford the States more flexibility and control to create a more free and open healthcare market.” The Moral IFC and these final rules exercise the discretion provided to the Departments under the Affordable Care Act and other laws to grant exemptions and thereby minimize regulatory burdens of the Affordable Care Act on the affected entities and recipients of health care services.
Consistent with Executive Order 13771 (82 FR 9339, February 3, 2017), the Departments have estimated the costs and cost savings attributable to these rules. As discussed in more detail in the preceding analysis, these final rules lessen incremental reporting costs.
The Unfunded Mandates Reform Act of 1995 (section 202(a) (Pub. L. 104-4), requires the Departments to prepare a written statement, which includes an assessment of anticipated costs and benefits, before issuing “any rule that includes any federal mandate that may result in the expenditure by state, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any 1 year.” In 2018, that threshold is approximately $150 million. For purposes of the Unfunded Mandates Reform Act, the Moral IFC and these final rules do not include any federal mandate that may result in expenditures by state, local, or tribal governments, nor do they include any federal mandates that may impose an annual burden of $150 million or more on the private sector.
Executive Order 13132 outlines fundamental principles of federalism, and requires the adherence to specific criteria by federal agencies in the process of their formulation and implementation of policies that have “substantial direct effects” on states, the relationship between the federal government and states, or the distribution of power and responsibilities among the various levels of government. Federal agencies promulgating regulations that have these federalism implications must consult with state and local officials, and describe the extent of their consultation and the nature of the concerns of state and local officials in the preamble to the regulation.
These rules do not have any Federalism implications, since they only provide exemptions from the contraceptive and sterilization coverage requirement in HRSA Guidelines supplied under section 2713 of the PHS Act.
The Department of the Treasury regulations are adopted pursuant to the authority contained in sections 7805 and 9833 of the Code.
The Department of Labor regulations are adopted pursuant to the authority contained in 29 U.S.C. 1002(16), 1027, 1059, 1135, 1161-1168, 1169, 1181-1183, 1181 note, 1185, 1185a, 1185b, 1185d, 1191, 1191a, 1191b, and 1191c; sec. 101(g), Public Law 104-191, 110 Stat. 1936; sec. 401(b), Public Law 105-200, 112 Stat. 645 (42 U.S.C. 651 note); sec. 512(d), Public Law 110-343, 122 Stat. 3881; sec. 1001, 1201, and 1562(e), Public Law 111-148, 124 Stat. 119, as amended by Public Law 111-152, 124 Stat. 1029; Secretary of Labor's Order 1-2011, 77 FR 1088 (Jan. 9, 2012).
The Department of Health and Human Services regulations are adopted pursuant to the authority contained in sections 2701 through 2763, 2791, and 2792 of the PHS Act (42 U.S.C. 300gg through 300gg-63, 300gg-91, and 300gg-92), as amended; and Title I of the Affordable Care Act, sections 1301-1304, 1311-1312, 1321-1322, 1324, 1334, 1342-1343, 1401-1402, and 1412, Public Law 111-148, 124 Stat. 119 (42 U.S.C. 18021-18024, 18031-18032, 18041-18042, 18044, 18054, 18061, 18063, 18071, 18082, 26 U.S.C. 36B, and 31 U.S.C. 9701).
Excise taxes, Health care, Health insurance, Pensions, Reporting and recordkeeping requirements.
Continuation coverage, Disclosure, Employee benefit plans, Group health plans, Health care, Health insurance, Medical child support, Reporting and recordkeeping requirements.
Health care, Health insurance, Reporting and recordkeeping requirements, State regulation of health insurance.
For the reasons set forth in this preamble, 26 CFR part 54 is amended as follows:
26 U.S.C. 7805. * * *
42 U.S.C. 300gg through 300gg-63, 300gg-91, and 300gg-92, as amended.
(a) * * *
(1) Guidelines issued under § 147.130(a)(1)(iv) by the Health Resources and Services Administration must not provide for or support the requirement of coverage or payments for contraceptive services with respect to a group health plan established or maintained by an objecting organization, or health insurance coverage offered or arranged by an objecting organization, to the extent of the objections specified below. Thus the Health Resources and Service Administration will exempt from any guidelines' requirements that relate to the provision of contraceptive services:
(ii) An institution of higher education as defined in 20 U.S.C. 1002, which is non-governmental, in its arrangement of student health insurance coverage, to the extent that institution objects as specified in paragraph (a)(2) of this section. In the case of student health
(2) The exemption of this paragraph (a) will apply to the extent that an entity described in paragraph (a)(1) of this section objects, based on its sincerely held moral convictions, to its establishing, maintaining, providing, offering, or arranging for (as applicable):
(i) Coverage or payments for some or all contraceptive services; or
(ii) A plan, issuer, or third party administrator that provides or arranges such coverage or payments.
(b)
Environmental Protection Agency (EPA).
Proposed rule.
EPA is proposing significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for 66 chemical substances which were the subject of premanufacture notices (PMNs). The chemical substances are subject to Orders issued by EPA pursuant to section 5(e) of TSCA. This action would require persons who intend to manufacture (defined by statute to include import) or process any of these 66 chemical substances for an activity that is proposed as a significant new use to notify EPA at least 90 days before commencing that activity. The required notification initiates EPA's evaluation of the intended use within the applicable review period. Persons may not commence manufacture or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required with that determination.
Comments must be received on or before December 31, 2018.
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2018-0650, 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
You may be potentially affected by this action if you manufacture, process, or use the chemical substances contained in this proposed rule. 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:
• Manufacturers or processors of one or more subject chemical substances (NAICS codes 325 and 324110),
This action may also affect certain entities through pre-existing import certification and export notification rules under TSCA. Chemical importers are subject to the TSCA section 13 (15 U.S.C. 2612) import certification requirements promulgated at 19 CFR 12.118 through 12.127 and 19 CFR 127.28. Chemical importers must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA. Importers of chemicals subject to final SNURs must certify their compliance with the SNUR requirements. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. In addition, any persons who export or intend to export a chemical substance that is the subject of this proposed rule on or after December 17, 2018 are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see § 721.20), and must comply with the export notification requirements in 40 CFR part 707, subpart D.
1.
2.
EPA is proposing these SNURs under TSCA section 5(a)(2) for chemical substances that were the subject of PMNs. These proposed SNURs would require persons to notify EPA at least 90 days before commencing the manufacture or processing of a chemical substance for any activity proposed as a significant new use. Receipt of such notices would allow EPA to assess risks that may be presented by the intended uses and, if appropriate, to regulate the proposed use before it occurs. Additional rationale and background to these proposed rules are more fully set out in the preamble to EPA's first direct final SNUR published in the
Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that a use of a chemical substance is a “significant new use.” EPA must make this determination by rule after considering all relevant factors, including the four bulleted TSCA section 5(a)(2) factors listed in Unit III. Once EPA determines that a use of a chemical substance is a significant new use, TSCA section 5(a)(1)(B) requires persons to submit a significant new use notice (SNUN) to EPA at least 90 days before they manufacture or process the chemical substance for that use (15 U.S.C. 2604(a)(1)(B)(i)). TSCA
General provisions for SNURs appear in 40 CFR part 721, subpart A. These provisions describe persons subject to the rule, recordkeeping requirements, and exemptions to reporting requirements. Provisions relating to user fees appear at 40 CFR part 700. According to § 721.1(c), persons subject to SNURs must comply with the same SNUN requirements and EPA regulatory procedures as submitters of PMNs under TSCA section 5(a)(1)(A). In particular, these requirements include the information submission requirements of TSCA section 5(b) and 5(d)(1), the exemptions authorized by TSCA section 5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once EPA receives a SNUN, EPA must either determine that the significant new use is not likely to present an unreasonable risk of injury or take such regulatory action as is associated with an alternative determination before the manufacture or processing for the significant new use can commence. If EPA determines that the significant new use is not likely to present an unreasonable risk, EPA is required under TSCA section 5(g) to make public, and submit for publication in the
Section 5(a)(2) of TSCA states that EPA's determination that a use of a chemical substance is a significant new use must be made after consideration of all relevant factors, including:
• The projected volume of manufacturing and processing of a chemical substance.
• The extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance.
• The extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance.
• The reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance.
In addition to these factors enumerated in TSCA section 5(a)(2), the statute authorizes EPA to consider any other relevant factors.
To preliminarily determine what would constitute a significant new use for the 66 chemical substances that are the subject of these SNURs, EPA considered relevant information about the toxicity of the chemical substances and potential human exposures and environmental releases that may be associated with the conditions of use of the substances, in the context of the four bulleted TSCA section 5(a)(2) factors listed in this unit.
EPA is proposing significant new use and recordkeeping requirements for 66 chemical substances in 40 CFR part 721, subpart E. In this unit, EPA provides the following information for each chemical substance:
• PMN number.
• Chemical name (generic name, if the specific name is claimed as CBI).
• Chemical Abstracts Service (CAS) Registry number (if assigned for non-confidential chemical identities).
• Basis for the TSCA section 5(e) Order.
• Information identified by EPA that would help characterize the potential health and/or environmental effects of the chemical substance in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by the SNUR. This information may include testing required in a TSCA section 5(e) Order to be conducted by the PMN submitter, as well as testing not required to be conducted but which would also help characterize the potential health and/or environmental effects of the PMN substance. Any recommendation for information identified by EPA was made based on EPA's consideration of available screening-level data, if any, as well as other available information on appropriate testing for the chemical substance. Further, any such testing identified by EPA that includes testing on vertebrates was made after consideration of available toxicity information, computational toxicology and bioinformatics, and high-throughput screening methods and their prediction models. EPA also recognizes that whether testing/further information is needed will depend on the specific exposure and use scenario in the SNUN. EPA encourages all SNUN submitters to contact EPA to discuss any potential future testing. See Unit VII. for more information.
• CFR citation assigned in the regulatory text section of the proposed rule.
The regulatory text section of each proposed rule specifies the activities that would be designated as significant new uses. Certain new uses, including exceedance of production volume limits (
These proposed rules include 66 PMN substances that are subject to Orders issued under TSCA section 5(e)(1)(A) or section 5(f)(3)(A). Each Order is based on one or more of the findings in TSCA section 5(a)(3)(A) or section 5(a)(3)(B): There is insufficient information to permit a reasoned evaluation; in the absence of sufficient information to permit a reasoned evaluation, the activities associated with the PMN substances may present unreasonable risk to health or the environment; the substance is or will be produced in substantial quantities, and enters or may reasonably be anticipated to enter the environment in substantial quantities or there is or may be significant (substantial) human exposure to the substance; presents an unreasonable risk of injury to health or environment. Those Orders require protective measures to limit exposures or otherwise mitigate the potential unreasonable risk. The proposed SNURs would identify as significant new uses any manufacturing, processing, use, distribution in commerce, or disposal that does not conform to the restrictions imposed by the underlying Orders, consistent with TSCA section 5(f)(4).
Where EPA determined that the PMN substance may present an unreasonable risk of injury to human health via inhalation exposure, the underlying TSCA section 5(e) Order usually requires, among other things, that potentially exposed employees wear specified respirators unless actual measurements of the workplace air show that air-borne concentrations of the PMN substance are below a New Chemical Exposure Limit (NCEL) that is established by EPA to provide adequate protection to human health. In addition to the actual NCEL concentration, the comprehensive NCELs provisions in TSCA section 5(e) Orders, which are modeled after Occupational Safety and Health Administration (OSHA) Permissible Exposure Limits (PELs) provisions, include requirements addressing performance criteria for sampling and analytical methods, periodic monitoring, respiratory protection, and recordkeeping.
1. Submit to EPA certain toxicity testing before manufacturing the confidential aggregate production volume specified in the Order;
2. Use of personal protective equipment to prevent dermal exposure where there is a potential for dermal exposure;
3. Use of a National Institute of Occupational Safety and Health (NIOSH) certified respirator with an assigned protection factor (APF) of 10 where there is a potential for inhalation exposure or compliance with a NCEL of 2 mg/m
4. Release of the PMN substance to water without resulting in surface water concentrations that exceed 1 ppb; and
5. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the Safety Data Sheet (SDS).
The proposed SNUR would designate as a “significant new use” the absence of these protective measures.
1. No manufacturing, processing, or use of the PMN substance in any manner that generates a vapor, dust, mist, or aerosol; and
2. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a “significant new use” the absence of these protective measures.
1. Use of personal protective equipment to prevent dermal exposure where there is potential for dermal exposure;
2. Use of a NIOSH-certified respirator with an APF of at least 50 where there is a potential for inhalation exposure;
3. No use of the PMN substance other than as a chemical intermediate;
4. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS; and
5. No release of the PMN substance resulting in surface water concentrations that exceed 1 ppb.
The proposed SNUR would designate as a “significant new use” the absence of these protective measures.
1. Use of a NIOSH-certified respirator with an APF of at least 50 where there is a potential for inhalation exposure or when the PMN substance is in a mixture at a concentration below 1.0 percent by weight, an APF of 10;
2. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS;
3. Not modifying the processes or uses described in the PMN such that occupational exposure is increased;
4. Use of the PMN substance only as a site-limited intermediate;
5. Conducting and reporting to EPA an elemental analysis for the composition of the PMN substance six months after filing the notice of commencement and every six months, at each use site, for three years thereafter; and
6. Conducting and reporting to EPA an elemental analysis each time a change in the manufacturing process could result in the PMN substance possessing a different elemental composition.
The proposed SNUR would designate as a “significant new use” the absence of protective measures 1, 2, 3, 4, and manufacture of the substance with an elemental composition different from that described in the PMN.
1. Use of personal protective equipment to prevent dermal exposure where there is a potential for dermal exposure;
2. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS;
3. Manufacturing, processing, or use of the PMN substance only for the confidential use specified in the Order;
4. No processing or use of the PMN substance in application methods that generate a vapor, mist, or aerosol; and
5. No release of the PMN substance to surface waters.
The proposed SNUR would designate as a “significant new use” the absence of these protective measures.
1. Use of personal protective equipment where there is a potential for dermal exposure;
2. Refrain from manufacturing (including import) the PMN substance for use other than as a chemical intermediate;
3. No manufacturing, processing or use of the substance that would result in inhalation exposures by vapor, dust, mist, or aerosol;
4. No release of the PMN substance resulting in surface water concentrations that exceed 67 ppb; and
5. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a “significant new use” the absence of these protective measures.
1. Use of personal protective equipment to prevent dermal exposure where there is potential for dermal exposure;
2. Use of a NIOSH certified respirator with an APF of at least 10 where there is potential for inhalation exposure;
3. Use of the confidential engineering controls specified in the Order;
4. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS;
5. Refraining from domestic manufacture in the United States (
6. Use of the PMN substance only for the confidential use specified in the Order;
7. No manufacture of the PMN substance beyond an annual production volume specified in the Order;
8. Disposal of the PMN substance only by incineration; and
9. No release of the PMN substance to surface waters.
The proposed SNUR would designate as a “significant new use” the absence of these protective measures.
1. Use of the PMN substances only for the confidential uses specified in the Order;
2. Use of the confidential engineering controls specified in the Order;
3. No manufacturing or use of the PMN substances with methods that generate a dust, spray, mist, or aerosol;
4. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS; and
5. Disposal of the PMN substances only by incineration or with onsite pre-treatment of water releases at an onsite waste water treatment plant with at least 96% efficiency.
The proposed SNUR would designate as a “significant new use” the absence of these protective measures.
1. Refraining from domestic manufacture in the United States (
2. No manufacture of the PMN substance beyond a confidential maximum annual manufacture (which includes import) volume; and
3. Use the PMN substance only for the confidential uses specified in the Order. The proposed SNUR would designate as a “significant new use” the absence of these protective measures.
1. Refrain from manufacturing, processing or using the PMN substance in a manner that generates a vapor, mist, or aerosol, or that results in inhalation exposure;
2. Refraining from domestic manufacture in the United States (
3. No use of the PMN substance other than as a polymer intermediate; and
4. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a “significant new use” the absence of these protective measures.
1. Refraining from domestic manufacture in the United States (
2. Use of personal protective equipment to prevent dermal exposure where there is potential for dermal exposure;
3. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS;
4. Not manufacture (which under TSCA includes importing) the PMN substance to contain no more than 0.1% residual isocyanate by weight; and
5. No use of the PMN substance other than as a chemical intermediate for thermoset plastic material.
The proposed SNUR would designate as a “significant new use” the absence of these protective measures.
1. Submit to EPA certain toxicity testing before exceeding the 24-month and 6-year time limit specified in the Order;
2. Use of personal protective equipment where there is a potential for dermal exposure;
3. Use of a NIOSH certified respirator with an APF of at least 1,000 where there is a potential for inhalation exposure;
4. As an alternative to using respirators maintain workplace airborne concentrations of the PMN substances at or below a specified NCEL of 0.000092 mg/m
5. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS;
6. Manufacture and process the PMN substances only in a facility where all process air streams containing the PMN substances pass through control technology (such as a high-efficiency particulate air (HEPA) filter) with a rated removal efficiency of at least 99.99%.
7. Dispose of the PMN substances and manufacture, processing, and use waste streams containing the PMN substances by landfill or by metal reclamation by a person who agrees to follow the terms of the Order.
The proposed SNUR would designate as a “significant new use” the absence of these protective measures.
1. Provide personal protective equipment to its workers to prevent dermal exposure where there is potential for dermal exposure;
2. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS;
3. Use of the PMN substance only for the confidential use specified in the PMN; and
4. Refrain from manufacturing, processing, or using the PMN substance in a manner that results in inhalation exposure to vapors, dusts, mists or aerosols.
The proposed SNUR would designate as a “significant new use” the absence of these protective measures.
1. Provide personal protective equipment to its workers to prevent dermal exposure where there is potential for dermal exposure;
2. Use of a NIOSH-certified respirator with an APF of at least 50 to prevent inhalation exposure where there is potential for inhalation exposure;
3. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS;
4. Use of the PMN substance only for the confidential use specified in the Order; and
5. Dispose of the PMN substance only by incineration with an efficiency not less than 99.9%.
The proposed SNUR would designate as a “significant new use” the absence of these protective measures.
1. Use of personal protective equipment to prevent dermal exposure where there is a potential for dermal exposure;
2. Use of a NIOSH-certified respirator with an APF of 50 or an APF of 1000 if spray applied where there is a potential for inhalation exposure;
3. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS;
4. Refraining from domestic manufacture in the United States (
5. Not manufacturing (which under TSCA includes import) the PMN substance with more than 0.25% residual isocyanate;
6. Manufacture (which under TSCA includes import) the PMN substance to have a number average molecular weight of greater than or equal to 2,280 Daltons (weight percent); and
7. Use the PMN substance only as a dual-cure adhesion coating or barrier.
The proposed SNUR would designate as a “significant new use” the absence of these protective measures.
1. Use of personal protective equipment to prevent dermal exposure where there is a potential for dermal exposure;
2. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS;
3. Refrain from manufacturing (excluding import) of the PMN substances in the United States;
4. Refrain from manufacturing (including import), processing, or using the PMN substances in a manner that would generate vapors, mists, aerosols or dusts; and
5. Refrain from manufacturing, processing, or using the PMN substances for consumer use or for commercial uses that could introduce the substance into a consumer setting.
The proposed SNUR would designate as a “significant new use” the absence of these protective measures.
The proposed SNUR would designate as a “significant new use” the absence of this protective measure.
1. Refrain from using the PMN substances other than for oil and gas well performance or monitoring well performance;
2. Submit to EPA certain toxicity testing before exceeding the specified confidential production volume limits in the Order;
3. No manufacture of the PMN substances beyond an annual confidential production volume specified in the Order;
4. Use of personal protective equipment to prevent dermal exposure where there is a potential for dermal exposure;
5. Use of engineering controls as specified in the Order;
6. Use of a NIOSH certified respirator with an APF of 50 where there is a potential for inhalation exposure or compliance with a NCEL of 0.0184 mg/m
7. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS;
8. Limit the amount of the PMN substances handled at processing and use sites as specified in the Order;
9. Limit manufacturing and use to liquid formulations for P-17-441 to 442 and P-17- 444 to 449;
10. No release of P-17-405 to 412 and P-17-0423 resulting in surface water concentrations that exceed 8 ppb; and
11. No release of P-17-414 to 418, P-17-420-422, P-17-441 to 442 and P-17-444 to 450 resulting in surface water concentrations that exceed 460 ppb.
The proposed SNUR would designate as a “significant new use” the absence of these protective measures.
1. Refrain from manufacturing (excluding import) the PMN substances in the United States;
2. Refrain from using the PMN substances other than as tracers in aqueous solution, or in a solid blend with polymer, or in a solid proppant bead form to measure flow in deep oil-bearing or gas-bearing strata;
3. Limit the amount of the PMN substances handled at processing and use sites to no more than 50 kg/day/site in aggregate for the solid formulations that generate a dust;
4. Provide personal protective equipment to its workers to mitigate dermal exposure to the PMN substances where there is potential for dermal exposure;
5. Establishment and use of a hazard communication program, including
6. No release of the PMN substances resulting in surface water concentrations that exceed 300 ppb;
The proposed SNUR would designate as a “significant new use” the absence of these protective measures.
1. Submission of certain toxicity testing before exceeding the confidential production volume limit in the Order for P-17-443;
2. Manufacture the PMN substance only as a liquid formulation with the engineering controls specified in the Order for P-17-443;
3. Refrain from using the PMN substance other than as a tracer in aqueous solution, a solid blend with polymer, or a solid proppant bead form to measure flow in deep oil-bearing or gas-bearing strata (non-confidential uses specified in the Order for P-17-434), or for the confidential use specified in the Order for P-17-443. The Order for P-17-434 allows processing and use of solid forms of the PMN substance but no more than 50 kg/site/day for those forms that generate a dust. Other manufacturers and processors would need to submit a SNUN to manufacture or process solid forms of the PMN substance.
4. Use of personal protective equipment to mitigate dermal exposure to the PMN substance where there is potential for dermal exposure; and
5. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a “significant new use” the absence of these protective measures.
1. Provide personal protective equipment to its workers to prevent dermal exposure where there is potential for dermal exposure; and
2. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a “significant new use” the absence of these protective measures.
1. Refraining from domestic manufacture in the United States (
2. Use of the PMN substance only for primer coating for corrosion protection;
3. Import the PMN substance with an average molecular weight greater than 1026 daltons and with low weight fractions no more than 15.3% less than 500 daltons and 25% less than 1000 daltons;
4. Use of personal protective equipment where there is a potential for dermal exposure;
5. Use of a NIOSH-certified respirator with an APF of at least 50 where there is a potential for inhalation exposure; and
6. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS.
The proposed SNUR would designate as a “significant new use” the absence of these protective measures.
During review of the PMNs submitted for the chemical substances that are subject to these proposed SNURs, EPA concluded that for all 66 chemical substances regulation was warranted under TSCA section 5(e), pending the development of information sufficient to make reasoned evaluations of the health or environmental effects of the chemical substances. The basis for such findings is outlined in Unit IV. Based on these findings, TSCA section 5(e) Orders requiring the use of appropriate exposure controls were negotiated with the PMN submitters. The proposed SNURs would identify as significant new uses any manufacturing, processing, use, distribution in commerce, or disposal that does not conform to the restrictions imposed by the underlying Orders, consistent with TSCA section 5(f)(4).
EPA is proposing these SNURs for specific chemical substances which have undergone premanufacture review because the Agency wants to achieve the following objectives with regard to the significant new uses designated in this rule:
• EPA would receive notice of any person's intent to manufacture or process a listed chemical substance for the described significant new use before that activity begins.
• EPA would have an opportunity to review and evaluate data submitted in a SNUN before the notice submitter begins manufacturing or processing a listed chemical substance for the described significant new use.
• EPA would be able to either determine that the prospective manufacture or processing is not likely to present an unreasonable risk, or to take necessary regulatory action associated with any other determination, before the described significant new use of the chemical substance occurs.
• EPA would identify as significant new uses any manufacturing, processing, use, distribution in commerce, or disposal that does not conform to the restrictions imposed by the underlying Orders, consistent with TSCA section 5(f)(4).
Issuance of a SNUR for a chemical substance does not signify that the chemical substance is listed on the TSCA Chemical Substance Inventory (TSCA Inventory). Guidance on how to determine if a chemical substance is on the TSCA Inventory is available on the internet at
To establish a significant new use, EPA must determine that the use is not ongoing. The chemical substances subject to this proposed rule have undergone premanufacture review. In cases where EPA has not received a notice of commencement (NOC) and the chemical substance has not been added to the TSCA Inventory, no person may commence such activities without first submitting a PMN. Therefore, for chemical substances for which an NOC has not been submitted EPA concludes that the designated significant new uses are not ongoing.
When chemical substances identified in this proposed rule are added to the TSCA Inventory, EPA recognizes that, before the rule is effective, other persons might engage in a use that has been identified as a significant new use. However, TSCA section 5(e) Orders have been issued for all of the chemical substances, and the PMN submitters are prohibited by the TSCA section 5(e) Orders from undertaking activities which would be designated as significant new uses. The identities of 42 of the 66 chemical substances subject to this proposed rule have been claimed as confidential and EPA has not received any post-PMN
Therefore, EPA designates November 15, 2018 as the cutoff date for determining whether the new use is ongoing. The objective of EPA's approach is to ensure that a person cannot defeat a SNUR by initiating a significant new use before the effective date of the final rule. In developing this proposed rule, EPA has recognized that, given EPA's general practice of posting proposed rules on its website a week or more in advance of
Persons who begin commercial manufacture or processing of the chemical substances for a significant new use identified as of that date would have to cease any such activity upon the effective date of the final rule. To resume their activities, these persons would have to first comply with all applicable SNUR notification requirements and wait until EPA has conducted a review of the notice, made an appropriate determination on the
EPA recognizes that TSCA section 5 does not require developing any particular new information (
In the absence of a TSCA section 4 test rule covering the chemical substance, persons are required only to submit information in their possession or control and to describe any other information known to or reasonably ascertainable by them (see 40 CFR 720.50). However, upon review of PMNs and SNUNs, the Agency has the authority to require appropriate testing. Unit IV. lists potentially useful information identified by EPA that would help characterize the potential health and/or environmental effects of the PMN/SNUN substance for all of the listed SNURs. EPA recognizes that the 2016 Lautenberg Amendments have led to modifications in our approach to testing requirements, including an increased consideration of alternatives to vertebrate testing. Descriptions of tests/information needs are provided for informational purposes only and EPA strongly encourages persons, before performing any testing, to consult with the Agency pertaining to protocol selection. Pursuant to TSCA section 4(h), which pertains to reduction of testing in vertebrate animals, EPA encourages consultation with the Agency on the use of alternative test methods and strategies (also called New Approach Methodologies, or NAMs), if available, to generate the potentially useful information. EPA encourages dialogue with Agency representatives to help determine how best the submitter can meet both the data needs and the objective of TSCA section 4(h). To access the OCSPP test guidelines referenced in this document electronically, please go to
In certain of the TSCA section 5(e) Orders for the chemical substances that would be regulated under this proposed rule, EPA has established production limits in view of the lack of data on the potential health and environmental risks that may be posed by the significant new uses or increased exposure to the chemical substances. These limits cannot be exceeded unless the PMN submitter first submits the results of specified tests that would permit a reasoned evaluation of the potential risks posed by these chemical substances. Listings of the tests specified in the TSCA section 5(e) Orders are included in Unit IV. The proposed SNURs contain the same production limits as the TSCA section 5(e) Orders. Exceeding these production limits is defined as a significant new use. Persons who intend to exceed the production limit must notify the Agency by submitting a SNUN at least 90 days in advance of commencement of non-exempt commercial manufacture or processing and wait until EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required with that determination.
Any request by EPA for the testing described in the Orders was made based on EPA's consideration of available screening-level data, if any, as well as other available information on appropriate testing for the PMN substances. Further, any such testing/information request on the part of EPA that includes testing on vertebrates was made after consideration of available toxicity information, computational toxicology and bioinformatics, and high-throughput screening methods and their prediction models.
The potentially useful information listed in Unit IV. may not be the only means of addressing the potential risks of the chemical substance. EPA recommends that potential SNUN submitters contact EPA early enough so that they will be able to conduct the appropriate tests.
SNUN submitters should be aware that EPA will be better able to evaluate SNUNs which provide detailed information on the following:
• Human exposure and environmental release that may result from the significant new use of the chemical substances.
• Information on risks posed by the chemical substances compared to risks posed by potential substitutes.
According to § 721.1(c), persons submitting a SNUN must comply with the same notification requirements and EPA regulatory procedures as persons submitting a PMN, including submission of test data on health and environmental effects as described in § 720.50. SNUNs must be submitted on EPA Form No. 7710-25, generated using e-PMN software, and submitted to the Agency in accordance with the procedures set forth in § 720.40 and § 721.25. E-PMN software is available electronically at
EPA has evaluated the potential costs of establishing SNUN requirements for potential manufacturers and processors of the chemical substances subject to this proposed rule. EPA's complete economic analysis is available in the docket under docket ID number EPA-HQ-OPPT-2018-0650.
This proposed rule would establish SNURs for several new chemical substances that were the subject of PMNs and TSCA section 5(e) Orders. 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).
According to PRA (44 U.S.C. 3501
The information collection requirements related to this proposed rule have already been approved by OMB pursuant to PRA under OMB control number 2070-0012 (EPA ICR No. 574). This action does not impose any burden requiring additional OMB approval. If an entity were to submit a SNUN to the Agency, the annual burden is estimated to average between 30 and 170 hours per response. This burden estimate includes the time needed to review instructions, search existing data sources, gather and maintain the data needed, and complete, review, and submit the required SNUN.
Send any comments about the accuracy of the burden estimate, and any suggested methods for minimizing
Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
Based on EPA's experience with proposing and finalizing SNURs, State, local, and Tribal governments have not been impacted by these rulemakings, and EPA does not have any reasons to believe that any State, local, or Tribal government will be impacted by this action. As such, EPA has determined that this proposed rule would not impose any enforceable duty, contain any unfunded mandate, or otherwise have any effect on small governments subject to the requirements of UMRA sections 202, 203, 204, or 205 (2 U.S.C. 1501
This proposed rule would not have a 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, as specified in Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999).
This proposed rule would not have Tribal implications because it is not expected to have substantial direct effects on Indian Tribes. This proposed rule would not significantly nor uniquely affect the communities of Indian Tribal governments, nor would it involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000), do not apply to this action.
This proposed rule is not subject to Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because this is not an economically significant regulatory action as defined by Executive Order 12866, and this action does not address environmental health or safety risks disproportionately affecting children.
This proposed rule is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001), because this proposed rule is not expected to affect energy supply, distribution, or use and because this proposed rule is not a significant regulatory action under Executive Order 12866.
In addition, since this proposed rule would not involve any technical standards, NTTAA section 12(d) (15 U.S.C. 272 note), does not apply to this action.
This proposed rule does not entail special considerations of environmental justice related issues as delineated by Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).
Environmental protection, Chemicals, Hazardous substances, Reporting and recordkeeping requirements.
Therefore, it is proposed that 40 CFR chapter I be amended as follows:
15 U.S.C. 2604, 2607, and 2625(c).
(a)
(2) The significant new uses are:
(i)
(A) As an alternative to the respirator requirements in paragraph (a)(2)(i) of this section, a manufacturer or processor may choose to follow the new chemical exposure limit (NCEL) provision listed in the TSCA section 5(e) Order for this substance. The NCEL is 2 mg/m
(B) [Reserved].
(ii)
(iii)
(iv)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(v)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(A) As an alternative to the respirator requirements in paragraph (a)(2)(i) of this section, a manufacturer or processor may choose to follow the new chemical exposure limit (NCEL) provision listed in the TSCA section 5(e) Order for this substance. The NCEL 0.000092 mg/m
(B) [Reserved].
(ii)
(iii)
(iv)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(A) As an alternative to the respirator requirements in paragraph (a)(2)(i) of this section, a manufacturer or processor may choose to follow the new chemical exposure limit (NCEL) provision listed in the TSCA section 5(e) Order for this substance. The NCEL 0.000092 mg/m
(B) [Reserved].
(ii)
(iii)
(iv)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii) [Reserved]
(b)
(1)
(2)
(a)(1) The chemical substances identified generically in the table of this section are subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i)
(iii)
(iv)
(b)
(1)
(2)
(3)
(a)(1) The chemical substances identified generically in the table of this section are subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i)
(A) As an alternative to the respirator requirements in paragraph (a)(2)(i) of this section, a manufacturer or processor may choose to follow the new chemical exposure limit (NCEL) provision listed in the TSCA section 5(e) Order for the substances. The NCEL is 0.0184 mg/m3 as an 8-hour time weighted average. Persons who wish to pursue NCELs as an alternative to § 721.63 respirator requirements may request to do so under § 721.30. Persons whose § 721.30 requests to use the NCELs approach are approved by EPA will be required to follow NCELs provisions comparable to those contained in the corresponding TSCA section 5(e) Order.
(B) [Reserved].
(ii)
(iii)
(iv)
(b)
(1)
(2)
(3)
(a)(1) The chemical substances listed in the table of this section are subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i)
(ii)
(iii)
(iv)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(3)
(a)
(2) The significant new uses are:
(i)
(ii)
(b)
(1)
(2)
(a)
(2) The significant new uses are:
(i)
(ii)
(iii)
(b)
(1)
(2)
(b) The suspension and limitation on entry pursuant to section 1 of this proclamation shall not apply to any alien who enters the United States at a port of entry and properly presents for inspection, or to any lawful permanent resident of the United States.
(c) Nothing in this proclamation shall limit an alien entering the United States from being considered for withholding of removal under section 241(b)(3) of the INA (8 U.S.C. 1231(b)(3)) or protection pursuant to the regulations promulgated under the authority of the implementing legislation regarding the Convention Against Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment, or limit the statutory processes afforded to unaccompanied alien children upon entering the United States under section 279 of title 6, United States Code, and section 1232 of title 8, United States Code.
(d) No later than 90 days after the date of this proclamation, the Secretary of State, the Attorney General, and the Secretary of Homeland Security shall jointly submit to the President, through the Assistant to the President for National Security Affairs, a recommendation on whether an extension or renewal of the suspension or limitation on entry in section 1 of this proclamation is in the interests of the United States.
(a) if any provision of this proclamation, or the application of any provision to any person or circumstance, is held to be invalid, the remainder of this proclamation and the application of its other provisions to any other persons or circumstances shall not be affected thereby; and
(b) if any provision of this proclamation, or the application of any provision to any person or circumstance, is held to be invalid because of the failure to follow certain procedures, the relevant executive branch officials shall implement those procedural requirements to conform with existing law and with any applicable court orders.
(i) the authority granted by law to an executive department or agency, or the head thereof; or
(ii) the functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals.
(b) This proclamation shall be implemented consistent with applicable law and subject to the availability of appropriations.
(c) This proclamation 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.
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